{"id":123020,"date":"2020-04-08T05:52:58","date_gmt":"2020-04-21T01:07:20","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/123020\/"},"modified":"2020-04-21T09:07:21","modified_gmt":"2020-04-21T01:07:21","slug":"b83b3f2bbf","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/123020\/","title":{"rendered":"CDE\u65b0\u589e2\u4e2a\u5355\u6297\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u8d1d\u4f10\u73e0\u5355\u3001\u66f2\u59a5\u73e0\u5355\u6297\uff09"},"content":{"rendered":"
\n

CDE\u8fd1\u671f\u53d1\u5e03\u901a\u77e5\uff0c\u516c\u5f00\u5f81\u6c42\u300a<\/span>\u8d1d\u4f10\u73e0\u5355\u6297<\/span>\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u300a<\/span>\u66f2\u59a5\u73e0\u5355\u6297<\/span>\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\uff0c\u6b64\u524d\u5df2\u7ecf\u516c\u5f00\u5f81\u6c42<\/span>\u963f\u8fbe\u6728\u5355\u6297<\/span>\u4ee5\u53ca<\/span>\u5229\u59a5\u6614\u5355\u6297<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff1a<\/span><\/p>\n

CDE\u53d1\u5e03\u300a\u963f\u8fbe\u6728\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<\/span><\/a>
<\/p>\n

CDE\uff1a\u300a\u5229\u59a5\u6614\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<\/span><\/a>
<\/p>\n

\u836f\u5ba1\u8bba\u575b | \u963f\u8fbe\u6728\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8003\u8651\u8981\u70b9<\/span><\/a>
<\/p>\n

\"CDE\u65b0\u589e2\u4e2a\u5355\u6297\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u8d1d\u4f10\u73e0\u5355\u3001\u66f2\u59a5\u73e0\u5355\u6297\uff09\"<\/p>\n

\u8d1d\u4f10\u73e0\u5355\u6297\u662f\u7531\u4e2d\u56fd\u4ed3\u9f20\u5375\u5de2\u7ec6\u80de\u8868\u8fbe\u7684\u7279\u5f02\u6027\u9776\u5411\u6e38\u79bbVEGF\u7684\u91cd\u7ec4\u4eba\u6e90\u5316IgG1\u5355\u514b\u9686\u6297\u4f53\uff0c\u901a\u8fc7\u963b\u65ad\u6e38\u79bbVEGF\u4e0e\u5176\u53d7\u4f53\uff08Flt-1\u548cKDR\uff09\u7ed3\u5408\uff0c\u6291\u5236\u80bf\u7624\u65b0\u751f\u8840\u7ba1\u751f\u6210\uff0c\u53d1\u6325\u6297\u80bf\u7624\u4f5c\u7528\u3002\u8d1d\u4f10\u73e0\u5355\u6297\u7531\u7f8e\u56fd\u57fa\u56e0\u6cf0\u514b\u516c\u53f8\u7814\u53d1\u4e0a\u5e02\uff0c\u5546\u54c1\u540d\u4e3a\uff1a\u5b89\u7ef4\u6c40<\/span>\u00ae<\/sup>\uff0c\u5728\u6211\u56fd\u5df2\u83b7\u6279\u7528\u4e8e\u665a\u671f\u80ba\u764c\u548c\u7ed3\u76f4\u80a0\u764c\u6cbb\u7597\u591a\u5e74\uff0c\u4e34\u5e8a\u83b7\u76ca\u660e\u786e\uff0c\u662f\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u70ed\u70b9\uff0c\u56fd\u5185\u5916\u5df2\u6709\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u83b7\u6279\u4e0a\u5e02\u3002\u4e3a\u4e86\u66f4\u597d\u5730\u63a8\u52a8\u8be5\u54c1\u79cd\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\uff0c\u6211\u4eec\u5728\u300a\u8d1d\u4f10\u73e0\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8003\u8651\u8981\u70b9\u300b\u57fa\u7840\u4e0a\uff0c\u6309\u76f8\u5173\u8981\u6c42\u8f6c\u5316\u4e3a\u300a\u8d1d\u4f10\u73e0\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002<\/span>
<\/span><\/section>\n
\u6211\u4eec\u8bda\u631a\u5730\u6b22\u8fce\u793e\u4f1a\u5404\u754c\u5bf9\u5f81\u6c42\u610f\u89c1\u7a3f\u63d0\u51fa\u5b9d\u8d35\u610f\u89c1\u548c\u5efa\u8bae\uff0c\u5e76\u53ca\u65f6\u53cd\u9988\u7ed9\u6211\u4eec\uff0c\u4ee5\u4fbf\u540e\u7eed\u5b8c\u5584\u3002\u5f81\u6c42\u610f\u89c1\u65f6\u9650\u4e3a\u81ea\u53d1\u5e03\u4e4b\u65e5\u8d77\u4e00\u4e2a\u6708\u3002<\/span><\/section>\n
\u60a8\u7684\u53cd\u9988\u610f\u89c1\u8bf7\u53d1\u5230\u4ee5\u4e0b\u8054\u7cfb\u4eba\u7684\u90ae\u7bb1\uff1a<\/span><\/section>\n
\u8054\u7cfb\u4eba\uff1a\u5468\u660e\u3001\u9648\u4e1c\u6885<\/span><\/section>\n
\u8054\u7cfb\u65b9\u5f0f\uff1a <\/span>zhoum@cde.org.cn<\/span>\uff0c<\/span>chendm@cde.org.cn<\/span><\/section>\n
\u611f\u8c22\u60a8\u7684\u53c2\u4e0e\u548c\u5927\u529b\u652f\u6301\u3002<\/span><\/section>\n

\"CDE\u65b0\u589e2\u4e2a\u5355\u6297\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u8d1d\u4f10\u73e0\u5355\u3001\u66f2\u59a5\u73e0\u5355\u6297\uff09\"<\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\uff08Trastuzumab\uff09\u662f\u7531\u745e\u58eb\u7f57\u6c0f\u516c\u53f8\u7814\u53d1\u7684\u4e00\u79cd\u91cd\u7ec4DNA\u884d\u751f\u7684\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\uff0c\u80fd\u591f\u7279\u5f02\u6027\u5730\u4f5c\u7528\u4e8e\u4eba\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53-2\uff08HER2\uff09\u7684\u7ec6\u80de\u5916\u90e8\u4f4d\u7b2cIV\u4e9a\u533a\uff0c\u7ade\u4e89\u6027\u963b\u65ad\u4eba\u4f53\u8868\u76ae\u751f\u957f\u56e0\u5b50\u4e0eHER2\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6291\u5236\u80bf\u7624\u7ec6\u80de\u7684\u751f\u957f\u3002\u5546\u54c1\u540d\u4e3a\uff1a\u8d6b\u8d5b\u6c40\uff08Herceptin<\/span>\u00ae<\/sup>\uff09\u3002\u76ee\u524d\uff0c\u56fd\u5185\u5916\u533b\u836f\u4f01\u4e1a\u7eb7\u7eb7\u52a0\u5165\u5230\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u4e2d\u5e76\u5df2\u6709\u4ea7\u54c1\u6309\u751f\u7269\u7c7b\u4f3c\u836f\u83b7\u6279\u4e0a\u5e02\u3002\u4e3a\u4e86\u66f4\u597d\u5730\u63a8\u52a8\u8be5\u54c1\u79cd\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\uff0c\u6211\u4eec\u5728\u300a\u6ce8\u5c04\u7528\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u53ca\u5ba1\u8bc4\u8003\u8651\u8981\u70b9\u300b\u57fa\u7840\u4e0a\uff0c\u73b0\u6309\u76f8\u5173\u8981\u6c42\u8f6c\u5316\u4e3a\u300a\u66f2\u59a5\u73e0\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002<\/span>
<\/span><\/section>\n
\u6211\u4eec\u8bda\u631a\u5730\u6b22\u8fce\u793e\u4f1a\u5404\u754c\u5bf9\u5f81\u6c42\u610f\u89c1\u7a3f\u63d0\u51fa\u5b9d\u8d35\u610f\u89c1\u548c\u5efa\u8bae\uff0c\u5e76\u53ca\u65f6\u53cd\u9988\u7ed9\u6211\u4eec\uff0c\u4ee5\u4fbf\u540e\u7eed\u5b8c\u5584\u3002\u5f81\u6c42\u610f\u89c1\u65f6\u9650\u4e3a\u81ea\u53d1\u5e03\u4e4b\u65e5\u8d77\u4e00\u4e2a\u6708\u3002<\/span><\/section>\n
\u60a8\u7684\u53cd\u9988\u610f\u89c1\u8bf7\u53d1\u5230\u4ee5\u4e0b\u8054\u7cfb\u4eba\u7684\u90ae\u7bb1\uff1a<\/span><\/section>\n
\u8054\u7cfb\u4eba\uff1a\u590f\u7433\uff0c\u5b8b\u5a9b\u5a9b<\/span><\/section>\n
\u8054\u7cfb\u65b9\u5f0f\uff1a xialin@cde.org.cn\uff0csongyy @cde.org.cn<\/span><\/section>\n
\u611f\u8c22\u60a8\u7684\u53c2\u4e0e\u548c\u5927\u529b\u652f\u6301\u3002<\/span><\/section>\n


<\/span><\/p>\n

\u9644\u4ef61<\/span><\/p>\n

\u8d1d\u4f10\u73e0\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219<\/span><\/strong><\/span><\/p>\n

\uff08\u5f81\u6c42<\/span><\/strong>\u610f\u89c1\u7a3f\uff09<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u6982\u8ff0<\/span><\/strong><\/span><\/p>\n

\u8d1d\u4f10\u73e0\u5355\u6297\u662f\u7f8e\u56fd\u57fa\u56e0\u6cf0\u514b\u516c\u53f8\u539f\u7814\u3001\u7531\u4e2d\u56fd\u4ed3\u9f20\u5375\u5de2\u7ec6\u80de\u8868\u8fbe\u7684\u7279\u5f02\u6027\u9776\u5411\u6e38\u79bb\u8840\u7ba1<\/span>\u5185\u76ae\u751f\u957f\u56e0\u5b50\uff08<\/span>vascular endothelial growth factor, VEGF\uff09\u7684\u91cd\u7ec4\u4eba\u6e90\u5316<\/span>IgG1<\/span>\u5355\u514b\u9686\u6297\u4f53\uff0c\u901a\u8fc7\u963b\u65ad\u6e38\u79bb<\/span>VEGF<\/span>\u4e0e\u5176\u53d7\u4f53\uff08<\/span>Flt-1<\/span>\u548c<\/span>KDR<\/span>\uff09\u7ed3\u5408\uff0c\u6291\u5236\u80bf\u7624\u65b0\u751f\u8840\u7ba1\u751f\u6210\uff0c\u53d1\u6325\u6297\u80bf\u7624\u4f5c\u7528\u3002\u8d1d\u4f10\u73e0\u5355\u6297\u6700\u65e9\u4e8e<\/span>2004<\/span>\u5e74<\/span>2<\/span>\u6708\u83b7\u5f97<\/span><\/span>\u7f8e\u56fd<\/span>FDA\u6279\u51c6\uff0c\u8054\u5408<\/span><\/span>\u4ee5\u6c1f\u5c3f\u5627\u5576\u4e3a\u57fa\u7840\u7684\u5316\u7597\u65b9\u6848\u7528\u4e8e\u521d\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u7684<\/span>\u6cbb\u7597\uff0c\u5546\u54c1\u540d\u4e3a<\/span>AVASTIN<\/span>TM<\/span><\/sup>[1]<\/span><\/sup>\u3002\u622a\u81f3\u76ee\u524d\uff0c<\/span>AVASTIN\u5df2\u83b7\u7f8e\u56fd<\/span>FDA<\/span>\u6279\u51c6\u7528\u4e8e<\/span><\/span>\u665a\u671f\u975e\u9cde\u72b6\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08<\/span>non<\/span>-small cell lung cancer, NSCLC<\/span>\uff09\u3001\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u3001\u590d\u53d1\u6027\u80f6\u8d28\u6bcd\u7ec6\u80de\u7624\u3001\u8f6c\u79fb\u6027\u80be\u764c\u3001\u5bab\u9888\u764c\u548c\u5375\u5de2\u764c\u7b49\u80bf\u7624\u9002\u5e94\u75c7<\/span>[2]<\/span><\/sup>\u3002<\/span>AVASTIN\uff08\u4e2d\u56fd\u5546\u54c1\u540d\u4e3a\u5b89\u7ef4\u6c40\uff09\u4e8e<\/span>2010<\/span>\u5e74<\/span>2<\/span>\u6708\u83b7\u4e2d\u56fd<\/span><\/span>\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u6279\u51c6\u8fdb\u53e3\u6ce8\u518c\uff0c\u9002\u5e94\u75c7\u4e3a\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\uff0c\u540e\u589e\u52a0\u975e\u9cde<\/span>NSCLC\u9002\u5e94\u75c7\u3002\u622a\u81f3\u76ee\u524d\uff0c<\/span>AVASTIN<\/span>\u5728\u5168\u7403\u8d85\u8fc7<\/span>100<\/span>\u4e2a\u56fd\u5bb6\u548c\u533a\u57df\u83b7\u6279\u4e86\u4e03\u4e2a\u80bf\u7624\u9002\u5e94\u75c7\uff0c<\/span><\/span>\u662f\u76ee\u524d\u6297\u80bf\u7624\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u70ed\u70b9\u3002<\/span><\/span><\/p>\n

AVASTIN\u80bf\u7624\u9002\u5e94\u75c7\u5e7f\u6cdb\u3001\u4e14\u4e13\u5229\u5df2\u9646\u7eed\u8fc7\u671f\uff08\u6b27\u6d32\u4e13\u5229<\/span>2019<\/span>\u5e74\uff0c\u7f8e\u56fd\u4e13\u5229<\/span>2017<\/span>\u5e74\uff09<\/span><\/span>[3]<\/span><\/sup>\uff0c\u76ee\u524d\u56fd\u5185\u5916\u591a\u4e2a\u533b\u836f\u4f01\u4e1a\u6b63\u5728\u7814\u53d1\u5176\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u5e76\u5df2\u6709\u751f\u7269\u7c7b\u4f3c\u836f\u83b7\u5f97\u6279\u51c6<\/span>[4-5]<\/span><\/sup>\u3002\u4e3a\u66f4\u597d\u63a8\u52a8\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u5f00\u53d1\uff0c\u5728\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08<\/span>National Medical Products Administration, NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u5df2\u53d1\u5e03\u7684\u300a\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b<\/span><\/span>[6]<\/span><\/sup>\u57fa\u7840\u4e0a\uff0c\u7ed3\u5408\u5b89\u7ef4\u6c40\u7279\u70b9\uff0c\u64b0\u5199\u4e86\u672c\u6280\u672f\u6307\u5bfc\u539f\u5219\uff0c\u5c06\u4ee5\u5ba1\u8bc4\u89c6\u89d2\uff0c\u8ba8\u8bba\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u65b9\u6848\u8bbe\u8ba1\u53ca\u5ba1\u8bc4\u8003\u8651\uff0c\u4ee5\u671f\u89c4\u8303\u548c\u4fc3\u8fdb\u6211\u56fd\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u3002<\/span><\/span><\/p>\n

\u4e8c\u3001<\/span><\/strong>\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7814\u7a76\u7b56\u7565<\/span><\/strong><\/span><\/p>\n

\u751f\u7269\u7c7b\u4f3c\u53d1\u603b\u4f53\u601d\u8def\u662f\u4ee5\u6bd4\u5bf9\u8bd5\u9a8c\u4e3a\u57fa\u7840\uff0c\u8bc1\u660e\u5176\u4e0e\u5b89\u7ef4\u6c40\u7684\u76f8\u4f3c\u6027\u3002\u91c7\u7528\u9010\u6b65\u9012\u8fdb\u7684\u7b56\u7565\uff0c\u5206\u9636\u6bb5\u5f00\u5c55\u836f\u5b66\u3001\u836f\u7406\u6bd2\u7406\u548c\u4e34\u5e8a\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u6839\u636e\u524d\u671f\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u7ed3\u679c\u8bbe\u8ba1\u540e\u7eed\u7814\u7a76\u3002<\/span><\/p>\n

\u6839\u636e\u524d\u671f\u836f\u5b66\u548c\u836f\u7406\u6bd2\u7406\u6bd4\u5bf9\u8bd5\u9a8c\u7ed3\u679c\uff0c\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u53d1\uff0c<\/span>\u836f\u5b66\u548c\u836f\u7406\u6bd2\u7406\u8bd5\u9a8c\u8bc1\u660e\u8bd5\u9a8c\u836f\u4e0e\u5b89\u7ef4\u6c40\u76f8\u4f3c\uff0c\u6309\u7167\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u8def\u5f84\u5f00\u5c55\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u8bd5\u9a8c\u548c\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u9274\u4e8e\u5b89\u7ef4\u6c40\u56fd\u5185\u5916\u6279\u51c6\u7684\u9002\u5e94\u75c7\u5b58\u5728\u5dee\u5f02\uff0c\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u53ef\u80fd\u4f1a\u51fa\u73b0\u4ee5\u4e0b\u56db\u79cd\u9009\u62e9\uff1a<\/span>     <\/span>\u2460<\/span>\u9009\u62e9\u56fd\u5185\u6279\u51c6\u9002\u5e94\u75c7\uff0c\u5f00\u5c55\u4e0e\u5b89\u7ef4\u6c40<\/span>\u201c\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\u7684\u7b49\u6548\u6027\u7814\u7a76\uff0c\u5f53\u524d\u5927\u591a\u9009\u62e9\u521d\u6cbb\u7684\u8f6c\u79fb\u6027\u975e\u9cde<\/span>NSCLC<\/span>\uff0c\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u4e3a\u76f8\u5bf9\u654f\u611f\u7684\u6307\u6807\u5ba2\u89c2\u7f13\u89e3\u7387\uff08<\/span><\/span>object<\/span>ive response rate, <\/span>ORR<\/span>\uff09\u3002<\/span>     <\/span>\u2461<\/span>\u9009\u62e9\u56fd\u5185\u6279\u51c6\u9002\u5e94\u75c7\uff0c\u4f46\u4e0d\u4e0e\u5b89\u7ef4\u6c40<\/span>\u201c\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\uff0c\u800c\u4e0e\u5b89\u7ef4\u6c40\u5916\u7684\u5176\u5b83\u53ef\u9009\u6807\u51c6\u6cbb\u6bd4\u8f83\uff0c\u4ee5\u65e0\u8fdb\u5c55\u751f\u5b58\uff08<\/span><\/span>progres<\/span>s<\/span>ion<\/span> free survival, <\/span>PFS<\/span>\uff09\u6216\u603b\u751f\u5b58\u671f\uff08<\/span>overall <\/span>survival, <\/span>OS<\/span>\uff09\u7b49\u5e38\u89c1\u4e34\u5e8a\u7ec8\u70b9\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002<\/span>     <\/span>\u2462<\/span>\u9009\u62e9\u56fd\u5916\u6279\u51c6\u4f46\u56fd\u5185\u5c1a\u672a\u6279\u51c6\u7684\u9002\u5e94\u75c7\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\uff0c\u5982\u80be\u764c\u3001\u5375\u5de2\u764c\u7b49\uff0c\u4e0e\u76ee\u6807\u9002\u5e94\u75c7\u5f53\u524d\u53ef\u9009\u6807\u51c6\u6cbb\u7597\u6bd4\u8f83\uff0c\u4ee5<\/span>PFS\u6216<\/span>OS<\/span>\u7b49\u5e38\u89c1\u4e34\u5e8a\u7ec8\u70b9\u4e3a\u4e3b\u8981\u7ec8\u70b9\u3002<\/span>     <\/span>\u2463<\/span>\u9009\u62e9\u56fd\u5185\u5916\u5747\u672a\u6279\u51c6\u7684\u9002\u5e94\u75c7\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\uff0c\u5982\u89c6\u7f51\u819c\u9ec4\u6591\u53d8\u6027\u3002<\/span>     \u9488\u5bf9\u4e0a\u8ff0\u60c5\u5f62\uff0c<\/span><\/span>\u2460<\/span>\u79cd\u65b9\u5f0f\u662f\u5f53\u524d\u7814\u53d1\u4f01\u4e1a\u6700\u5e38\u9009\u62e9\u7684\u8def\u5f84\uff0c\u662f\u63a8\u8350\u7684\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u53d1\u7b56\u7565\uff0c\u6309\u6b64\u8def\u5f84\u5b8c\u6210\u5355\u4e2a\u9002\u5e94\u75c7\u7684\u7814\u7a76\uff0c\u6280\u672f\u5ba1\u8bc4\u901a\u8fc7\u5373\u53ef\u83b7\u5f97\u56fd\u5185\u5b89\u7ef4\u6c40\u5df2\u83b7\u6279\u7684\u5176\u5b83\u9002\u5e94\u75c7\u5916\u63a8\uff08\u5177\u4f53\u65b9\u6848\u8bbe\u8ba1\u8981\u70b9\u8be6\u89c1\u540e\u8ff0\uff09\u3002\u6309\u7167<\/span>\u2461\u2462\u2463<\/span>\u7684\u8def\u5f84\u7684\u7814\u53d1\u7b56\u7565\uff0c\u7531\u4e8e\u672a\u4e0e\u5b89\u7ef4\u6c40<\/span>\u201c\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\uff0c\u65e0\u6cd5\u8bc1\u660e\u76f8\u4f3c\u6027\uff0c<\/span><\/span>\u2461\u2462\u2463<\/span>\u4e0d\u80fd\u652f\u6301\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u8bc4\u4ef7\u3002<\/span><\/span><\/p>\n

\u4e09\u3001<\/span>\u8d1d\u4f10\u73e0\u5355\u6297\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u8981\u70b9<\/span><\/strong>     \u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u901a\u5e38\u4ece\u836f\u4ee3\u52a8\u529b\u5b66\uff08<\/span>pharmacokinetics, <\/span><\/span>PK<\/span>\uff09\u548c<\/span>\/\u6216\u836f\u6548\u5b66\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u5f00\u59cb\uff0c\u6839\u636e\u5176\u76f8\u4f3c\u6027\u8bc4\u4ef7\u7ed3\u679c\u518d\u8003\u8651\u540e\u7eed\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u5e94\u4ee5\u8bc1\u660e\u8bd5\u9a8c\u836f\u4e0e\u539f\u7814\u836f\u7684\u76f8\u4f3c\u6027\u4e3a\u76ee\u7684\uff0c\u8fdb\u884c\u7814\u7a76\u8bbe\u8ba1\uff0c\u5e76\u5728\u4fdd\u969c\u79d1\u5b66\u53ef\u8bc4\u4f30\u7684\u524d\u63d0\u4e0b\u7b80\u5316\u7814\u7a76\u3002\u56e0\u5b89\u7ef4\u6c40\u7f3a\u4e4f\u5408\u9002\u7684\u836f\u6548\u5b66\u7ec8\u70b9\uff0c\u56e0\u6b64\uff0c\u5f53\u524d\u56fd\u5185\u5916\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u591a\u91c7\u7528\u4e00\u9879\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u7814\u7a76\u548c\u4e00\u9879\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span>1.<\/span><\/strong> PK\u6bd4\u5bf9\u7814\u7a76<\/span><\/span><\/strong>     <\/span>\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong>\uff1a\u53c2\u7167\u4e00\u822c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u8bbe\u8ba1\uff0c\u7ed3\u5408\u5b89\u7ef4\u6c40\u534a\u8870\u671f\u8f83\u957f\uff08<\/span>18-20\u5929\uff09\uff0c\u4e14\u6709\u514d\u75ab\u539f\u6027\u7b49\u7279\u70b9\uff0c\u4e0d\u9002\u7528\u4ea4\u53c9\u8bbe\u8ba1\u8bc4\u4ef7\u5176\u751f\u7269\u7b49\u6548\u6027\uff0c\u5efa\u8bae\u91c7\u7528\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u7ef4\u6c40\u5e73\u884c\u5bf9\u7167\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/span><\/span><\/p>\n

\u5355\u6b21\u7ed9\u836f<\/span>PK\u6bd4\u5bf9\u7814\u7a76\u6613\u4e8e\u6bd4\u8f83\u51fa\u7ec4\u95f4\u5dee\u5f02\uff0c\u63a8\u8350\u8fdb\u884c\u5355\u6b21\u7ed9\u836f\u7684<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u591a\u6b21\u7ed9\u836f<\/span>PK\u6bd4\u5bf9\u7814\u7a76\u4e0d\u5982\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u654f\u611f\uff0c\u4f46\u53ef\u53cd\u6620\u8bd5\u9a8c\u836f\u7269\u5242\u91cf\u548c\u65f6\u95f4\u76f8\u5173\u7684\u514d\u75ab\u539f\u6027\uff0c\u4ee5\u53ca\u9176\u4ecb\u5bfc\u3001\u9776\u4ecb\u5bfc\u3001<\/span>FcRn<\/span>\u4ecb\u5bfc\u7b49\u76f8\u5173\u7684\u836f\u7269\u6e05\u9664\u3002\u5efa\u8bae\u5728\u5b8c\u6210\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u5224\u5b9a\u76f8\u4f3c\u540e\uff0c\u5728\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u671f\u95f4\uff0c\u8003\u5bdf\u591a\u6b21\u7ed9\u836f\u7684<\/span>PK<\/span>\u7279\u5f81\u3002\u514d\u75ab\u539f\u6027\u7684\u8bc4\u4ef7\u5e94\u5f53\u8d2f\u7a7f\u6574\u4e2a\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u7814\u7a76\u4eba\u7fa4<\/span><\/strong>\uff1a\u5065\u5eb7\u5fd7\u613f\u8005\u662f\u8f83\u4e3a\u7406\u60f3\u7684\u5747\u8d28\u4eba\u7fa4\uff0c\u53ef\u66f4\u654f\u611f\u8bc4\u4ef7\u8bd5\u9a8c\u836f\u4e0e\u5b89\u7ef4\u6c40\u4e4b\u95f4\u7684<\/span>PK\u5dee\u5f02\u3002\u7531\u4e8e\u4e3b\u8981\u7814\u7a76\u76ee\u7684\u662f\u8003\u5bdf<\/span>PK<\/span>\u76f8\u4f3c\u6027\uff0c\u56e0\u6b64\u53ef<\/span><\/span>\u53ea<\/span>\u9009\u62e9\u7537\u6027\u5065\u5eb7\u5fd7\u613f\u8005\u3002\u80bf\u7624\u60a3\u8005\u56e0\u4e3a\u81ea\u8eab\u57fa\u7840\u75be\u75c5\u7684\u5f71\u54cd\uff0c\u4e0d\u5229\u4e8e\u5bf9<\/span>PK\u5dee\u5f02\u7684\u6bd4\u5bf9\u8bc4\u4ef7\uff0c\u6545\u4e0d\u63a8\u8350\u9009\u62e9\u80bf\u7624\u60a3\u8005\u8fdb\u884c<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/span><\/p>\n

\u53c2\u7167\u836f\u6765\u6e90\uff1a<\/span><\/strong>\u4e34\u5e8a\u7814\u7a76\u4e2d\u5e94\u5c3d\u53ef\u80fd\u9009\u62e9\u4e2d\u56fd\u5e02\u552e\u4ea7\u54c1\u4f5c\u4e3a\u53c2\u7167\u836f\uff0c\u5982\u679c\u9009\u62e9\u975e\u6211\u56fd\u83b7\u6279\u8fdb\u53e3\u6ce8\u518c\u6765\u6e90\u7684\u53c2\u7167\u836f\uff0c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u59cb\u524d\u5e94\u63d0\u4f9b\u4e0d\u540c\u6765\u6e90\u539f\u7814\u836f\u4e4b\u95f4\u53ef\u6bd4\u7684\u8bc1\u636e\u6216\u5f00\u5c55\u4e0d\u540c\u6765\u6e90\u539f\u7814\u836f\u54c1\u7684\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u5242\u91cf\u53ca\u7ed9\u836f\u9014\u5f84<\/span><\/strong>\uff1a<\/span>PK\u6bd4\u5bf9\u7814\u7a76\u4ee5\u8bc1\u5b9e<\/span>PK<\/span>\u76f8\u4f3c\u6027\u4e3a\u76ee\u7684\uff0c\u4e0d\u8981\u6c42\u5fc5\u987b\u91c7\u7528\u5b89\u7ef4\u6c40\u7684\u4e34\u5e8a\u63a8\u8350\u5242\u91cf\u3002\u5728<\/span>1 mg\u00b7kg<\/span><\/span>-1<\/span><\/sup>~10 mg\u00b7kg<\/span>-1<\/span><\/sup>\u7684\u5242\u91cf\u8303\u56f4\u5185\uff0c\u5b89\u7ef4\u6c40\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u5448\u7ebf\u6027\u7279\u5f81<\/span>[2]<\/span><\/sup>\uff0c\u56e0\u6b64\u53ef\u5728\u6b64\u8303\u56f4\u5185\u9009\u62e9\u7ed9\u836f\u5242\u91cf\u3002\u5982\u9009\u62e9\u5065\u5eb7\u53d7\u8bd5\u8005\uff0c\u4ece\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u89d2\u5ea6\uff0c\u5e94\u5728\u68c0\u6d4b\u65b9\u6cd5\u5141\u8bb8\u7684\u6700\u4f4e\u5b9a\u91cf\u4e0b\u9650\u5185\uff0c\u5c3d\u53ef\u80fd\u9009\u62e9\u8f83\u4f4e\u7684\u7ed9\u836f\u5242\u91cf\u3002\u540c\u65f6\u8f83\u4f4e\u7684\u7ed9\u836f\u5242\u91cf\u53ef\u66f4\u654f\u611f\u6bd4\u5bf9\u51fa\u8bd5\u9a8c\u836f\u4e0e\u5b89\u7ef4\u6c40\u7684\u5dee\u5f02\u3002\u56e0\u6b64\u5355\u6b21\u7ed9\u836f<\/span>PK\u6bd4\u5bf9\u7814\u7a76\u63a8\u8350\u7684\u7ed9\u836f\u5242\u91cf\u4e3a<\/span>1 mg\u00b7kg<\/span><\/span>-1<\/span><\/sup>\u3002\u56e0\u65b9\u6cd5\u5b66\u7684\u56e0\u7d20<\/span>\uff0c<\/span>3 mg\u00b7kg<\/span>-1<\/span><\/sup>\u4e5f\u53ef\u63a5\u53d7\u3002\u7ed9\u836f\u9014\u5f84\u4e3a\u9759\u8109\u7ed9\u836f\uff0c\u4e0e\u5b89\u7ef4\u6c40\u4e00\u81f4\u3002\u7ed9\u836f\u65f6\u5e94\u6ce8\u610f\u63a7\u5236\u8f93\u6ce8\u901f\u5ea6\uff0c\u4fdd\u6301\u4e00\u81f4\u7684\u7ed9\u836f\u65f6\u95f4\uff0c\u4ee5\u5229\u4e8e\u76f8\u4f3c\u6027\u8bc4\u4ef7\u3002<\/span><\/span><\/p>\n

\u7ec8\u70b9\u6307\u6807\u4e0e\u754c\u503c<\/span><\/strong>\uff1a<\/span>PK\u6bd4\u5bf9\u7814\u7a76\u4e3b\u8981\u7ec8\u70b9\u6307\u6807\u7684\u9009\u62e9\u662f\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u5173\u952e\u3002\u6839\u636e\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7684\u76f8\u5173\u6307\u5bfc\u539f\u5219<\/span><\/span>[7]<\/span><\/sup>\uff0c\u66f2\u7ebf\u4e0b\u9762\u79ef\uff08<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\uff09\u548c\u8fbe\u5cf0\u6d53\u5ea6\uff08<\/span>C<\/span>max<\/span><\/sub>\uff09\u662f\u5224\u65ad\u53e3\u670d\u56fa\u4f53\u5236\u5242\u751f\u7269\u7b49\u6548\u6027\u7684\u4e3b\u8981\u53c2\u6570\u3002\u4f46\u5728\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7b49\u6548\u6027\u8bc4\u4ef7\u4e2d\uff0c\u9009\u62e9<\/span>AUC<\/span>0-t<\/span><\/sub>\u8fd8\u662f<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u7ec8\u70b9\uff0c\u5c1a\u5b58\u4e89\u8bae\u3002<\/span>FDA\u5728\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u6307\u5bfc\u539f\u5219\u4e2d\u9759\u8109\u7ed9\u836f\u503e\u5411\u4e8e\u9009\u62e9<\/span>AUC<\/span><\/span>0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u3002\u56e0<\/span>AUC<\/span>0-t<\/span><\/sub>\u662f\u901a\u8fc7\u5b9e\u9645\u6d4b\u91cf\u503c\u8ba1\u7b97\u83b7\u5f97\uff0c\u8003\u8651\u5230\u751f\u7269\u7c7b\u4f3c\u836f<\/span>PK\u7279\u6027\u548c\u5b9e\u9645\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53d6\u8840\u70b9\u8bbe\u8ba1\u7684\u76f8\u5173\u6027\uff0c\u6211\u4eec\u63a8\u8350<\/span>AUC<\/span><\/span>0-t<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u6307\u6807\u3002<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u548c<\/span>C<\/span>max<\/span><\/sub>\u4f5c\u4e3a\u6b21\u8981\u7814\u7a76\u7ec8\u70b9\u8fdb\u884c\u6bd4\u8f83\u5206\u6790\u3002\u7b49\u6548\u6027\u754c\u503c\u5efa\u8bae\u8bbe\u5b9a\u4e3a<\/span>80%-125%\u3002<\/span><\/span><\/span><\/p>\n

\u6837\u672c\u91cf<\/span><\/strong>\uff1a\u6837\u672c\u91cf\u6839\u636e\u8bbe\u5b9a\u7684\u7b49\u6548\u6027\u754c\u503c\uff08<\/span>80%-125%\uff09\u3001\u7f6e\u4fe1\u533a\u95f4\uff08<\/span>90%<\/span>\uff09\u3001\u628a\u63e1\u5ea6\uff08\u901a\u5e38<\/span>80%<\/span>\u4ee5\u4e0a\uff09\u7b49\u53c2\u6570\u8ba1\u7b97\uff0c\u540c\u65f6\u5e94\u8003\u8651\u5b89\u7ef4\u6c40\u7684<\/span>PK<\/span>\u53d8\u5f02\uff0c\u5efa\u8bae\u7814\u53d1\u8005\u6839\u636e\u81ea\u8eab\u4ea7\u54c1\u60c5\u51b5\u548c\u7814\u53d1\u76ee\u6807\u9002\u5f53\u6269\u5927\u6837\u672c\u91cf\u4ee5\u9632\u540e\u7eed\u5206\u6790\u4e0d\u8db3\u3002<\/span> <\/span>2. \u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76<\/span><\/span><\/strong>    <\/span><\/strong>\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong>\uff1a\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u5e94\u9075\u5faa\u4ee5\u5b89\u7ef4\u6c40\u4e3a\u5bf9\u7167\uff0c\u8fdb\u884c\u968f\u673a\u3001\u53cc\u76f2\u3001\u5e73\u884c\u5bf9\u7167\u7684\u7b49\u6548\u6027\u8bbe\u8ba1\u3002<\/span>     <\/span>\u7814\u7a76\u4eba\u7fa4<\/span><\/strong>\uff1a\u5e94\u57fa\u4e8e\u5b89\u7ef4\u6c40\u5df2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u548c\u83b7\u6279\u9002\u5e94\u75c7\u9009\u62e9\u6700\u80fd\u53cd\u6620\u4e34\u5e8a\u7597\u6548\u7684\u4eba\u7fa4\uff0c\u8d1d\u4f10\u73e0\u5355\u6297\u76ee\u524d\u5728\u56fd\u5185\u6279\u51c6\u7684\u9002\u5e94\u75c7\u4e3a<\/span>\u201c\u8054\u5408\u4ee5\u6c1f\u5c3f\u5627\u5576\u4e3a\u57fa\u7840\u7684\u5316\u7597\u7528\u4e8e\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u7684\u6cbb\u7597\uff1b\u8054\u5408\u4ee5\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u7528\u4e8e\u4e0d\u53ef\u5207\u9664\u7684\u665a\u671f\u3001\u8f6c\u79fb\u6027\u6216\u590d\u53d1\u6027\u975e\u9cde\u72b6\u7ec6\u80de<\/span>NSCLC<\/span>\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597<\/span>\u201d<\/span><\/span>[2]<\/span><\/sup>\u3002\u8d1d\u4f10\u73e0\u5355\u6297\u5728<\/span>NSCLC\u5f00\u5c55\u4e86\u591a\u9879\u5927\u578b\u7684\u4e0e\u542b\u94c2\u5316\u7597\u8054\u5408\u7684\u968f\u673a\u5bf9\u7167\u7814\u7a76\uff0c\u53ef\u83b7\u5f97\u53c2\u8003\u7684\u7597\u6548\u6570\u636e\u76f8\u5bf9\u8f83\u591a\uff0c\u5305\u62ec\u56fd\u5185\u5f00\u5c55\u7684\u8054\u5408\u5361\u94c2\u4e0e\u7d2b\u6749\u9187\u7684\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c<\/span>YO25404<\/span><\/span>[8]<\/span><\/sup>\u3002\u56e0\u6b64\uff0c\u63a8\u8350\u9009\u62e9\u8f6c\u79fb\u6027\u6216\u590d\u53d1\u6027\u975e\u9cde\u72b6\u7ec6\u80de<\/span>NSCLC\u60a3\u8005\u4f5c\u4e3a\u7814\u7a76\u4eba\u7fa4\uff0c\u8fd9\u4e5f\u662f\u76ee\u524d\u56fd<\/span><\/span>\u5185<\/span>\u5916\u5728\u7814\u4ea7\u54c1\u5747\u91c7\u7528\u7684\u7814\u7a76\u4eba\u7fa4\u3002\u5728\u6211\u56fd\u521d\u6cbb\u7684\u975e\u9cde<\/span>NSCLC\u4eba\u7fa4\u4e2d<\/span>EGFR<\/span>\u7b49\u9a71\u52a8\u57fa\u56e0\u7a81\u53d8\u9891\u7387\u9ad8\u4e8e\u9ad8\u52a0\u7d22\u4eba<\/span><\/span>[9]<\/span><\/sup>\uff0c\u5177\u6709\u9a71\u52a8\u57fa\u56e0\u7a81\u53d8\u7684\u60a3\u8005\u5e94\u5148\u63a5\u53d7\u76f8\u5e94\u9776\u5411\u836f\u7269\u6cbb\u7597\u6cbb\u7597<\/span>[10]<\/span><\/sup>\uff0c\u4e14<\/span>AVASTIN\u5168\u7403\u7814\u7a76\u4eba\u7fa4\u591a\u4e3a\u975e\u4e9a\u88d4\uff0c\u9a71\u52a8\u57fa\u56e0\u7a81\u53d8\u7387\u4f4e\u3002\u672a\u6765\u5728\u4e2d\u56fd\u5f00\u5c55\u7684\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u987b\u7b26\u5408\u80ba\u764c\u7684\u4e34\u5e8a\u8bca\u7597\u5b9e\u8df5\u6392\u9664\u9a71\u52a8\u57fa\u56e0\u7a81\u53d8\u60a3\u8005\u3002<\/span><\/span><\/span><\/p>\n

\u5c3d\u7ba1\u7ed3\u76f4\u80a0\u764c\u9002\u5e94\u75c7\u4e5f\u5728\u4e2d\u56fd\u83b7\u5f97\u4e86\u6279\u51c6\uff0c\u4f46\u652f\u6301\u5728\u4e2d\u56fd\u6ce8\u518c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u91c7\u7528\u7684\u662f\u8d1d\u4f10\u73e0\u5355\u6297\u8054\u5408\u6539\u826f\u4f0a\u7acb\u66ff\u5eb7\u3001<\/span>5-\u6c1f\u5c3f\u5627\u5576\u548c\u4e9a\u53f6\u9178\u7684\u5316\u7597\u65b9\u6848\uff0c\u800c\u5f53\u524d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u7684\u63a8\u8350\u6cbb\u7597\u65b9\u6848\u5df2\u7ecf\u53d1\u751f\u6539\u53d8\uff0c\u4e3a<\/span>FOLFOX\/ FOLFIRI<\/span>\u8054\u5408\u897f\u59a5\u6614\u5355\u6297\uff08\u63a8\u8350\u7528\u4e8e<\/span>Ras <\/span>\u57fa\u56e0\u91ce\u751f\u578b\u75c5\u4eba\uff09\u6216<\/span>FOLFOX\/FOLFIRI\/CapeOx<\/span>\u8054\u5408\u8d1d\u4f10\u73e0\u5355\u6297\u3002\u4e0d\u540c\u8054\u5408\u65b9\u6848\u4e2d\u8d1d\u4f10\u73e0\u5355\u6297\u7ed9\u836f\u5242\u91cf\u4e5f\u4e0d\u540c\u3002\u56e0\u6b64\uff0c\u5728\u65b0\u65b9\u6848\u4e0b\u53ef\u53c2\u8003\u7684\u4e2d\u56fd\u4eba\u7fa4\u7597\u6548\u6570\u636e\u6709\u9650\u3002\u4e14\u5b89\u7ef4\u6c40\u5728\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u4e2d\u5bf9\u7f13\u89e3\u7387\u7684\u63d0\u9ad8\u76f8\u5bf9\u4e8e\u80ba\u764c\u4f4e\uff0c\u5f00\u5c55\u7b49\u6548\u6027\u7814\u7a76\u96be\u5ea6\u5927\u3002<\/span> <\/span>\u5982\u9009\u62e9\u7ed3\u76f4\u80a0\u4e3a\u76ee\u6807\u7814\u7a76\u4eba\u7fa4\u3002\u5efa\u8bae\u5728\u7814\u7a76\u5f00\u5c55\u524d\uff0c\u4e0e\u7ba1\u7406\u90e8\u95e8\u6c9f\u901a\u4eba\u7fa4\u9009\u62e9\u3001\u8054\u5408\u5316\u7597\u65b9\u6848\u3001\u7814\u7a76\u7ec8\u70b9\u3001\u548c\u7b49\u6548\u754c\u503c\u5173\u952e\u7814\u7a76\u8bbe\u8ba1\u3002<\/span>     <\/span>\u7ed9\u836f\u65b9\u6848<\/span>\/\u5242\u91cf<\/span><\/span><\/strong>\uff1a\u5242\u91cf\u9009\u62e9\u53ef\u5728\u53c2\u7167\u836f\u7ed9\u836f\u5242\u91cf\u8303\u56f4\u5185\u9009\u62e9\u4e00\u4e2a\u5242\u91cf\u8fdb\u884c\u3002\u539f\u7814\u4ea7\u54c1\u5728\u4e0d\u540c\u9002\u5e94\u75c7\u4e0d\u540c\u7684\u8054\u5408\u65b9\u6848\u4e2d\u63a8\u8350\u5242\u91cf\u4e0d\u540c\u3002\u56fd\u5185\u6279\u51c6\u7684\u7ed9\u836f\u5242\u91cf\u5728\u7ed3\u76f4\u80a0\u764c\u9002\u5e94\u75c7\u4e3a<\/span>5<\/span> <\/span>mg\u00b7kg<\/span>-1<\/span><\/sup>\uff0c\u6bcf<\/span>2\u5468\u4e00\u6b21\uff0c\u5728<\/span>NSCLC<\/span>\u9002\u5e94\u75c7\u4e3a<\/span>15<\/span><\/span> <\/span>mg\u00b7kg<\/span>-1<\/span><\/sup>\uff0c\u6bcf<\/span>3\u5468\u4e00\u6b21\u3002\u5982\u9009\u62e9<\/span>NSCLC<\/span>\u4e3a\u7814\u7a76\u4eba\u7fa4\uff0c\u987b\u9009\u62e9<\/span>15<\/span><\/span> <\/span>mg\u00b7kg<\/span>-1<\/span><\/sup>\uff0c\u6bcf<\/span>3\u5468\u4e00\u6b21\uff0c\u4e0e\u5b89\u7ef4\u6c40\u56fd\u5185\u83b7\u6279\u7684\u5242\u91cf\u4e00\u81f4\u3002<\/span><\/span><\/span><\/p>\n

\u7814\u7a76\u7ec8\u70b9<\/span><\/strong>\uff1a\u5f53\u524d\u666e\u904d\u63a5\u53d7\u4ee5<\/span>ORR\u4e3a\u4e3b\u8981\u7ec8\u70b9\uff0c\u56fd\u5185\u5916\u5728\u7814\u7684\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u80ba\u764c<\/span><\/span>\u2162<\/span>\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5747\u91c7\u7528<\/span>ORR\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u3002<\/span><\/span><\/span><\/p>\n

\u7814\u7a76\u6587\u732e\u663e\u793a\uff0c\u5f53\u5355\u72ec\u7ed9\u4e88\u542b\u94c2\u5316\u7597\u65f6\uff0c\u63a5\u53d7<\/span>4\u4e2a\u5468\u671f\u7684\u5316\u7597\u548c\u6301\u7eed\u5316\u7597\u76f4\u81f3\u8fdb\u5c55\u76f8\u6bd4<\/span>ORR<\/span>\u76f8\u4f3c\uff0c\u66f4\u591a\u5468\u671f\u7684\u542b\u94c2\u5316\u7597\u4e0d\u80fd\u63d0\u9ad8<\/span>ORR<\/span><\/span>[11-12]<\/span><\/sup>\u3002\u5728\u4e00\u9879\u65e5\u672c\u5f00\u5c55\u7684\u5316\u7597\u4e0e\u8d1d\u4f10\u73e0\u5355\u6297\u8054\u5408\u7ed9\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u51fa\u73b0\u7f13\u89e3\u7684\u4e2d\u4f4d\u65f6\u95f4\u4e3a<\/span>6\u5468\u3002\u56fd\u5185\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u4e13\u5bb6\u5171\u8bc6\u63d0\u51fa\uff0c\u4e00\u7ebf\u5316\u7597\u5efa\u8bae\u5728<\/span>4<\/span>\u4e2a\u5468\u671f\u540e\u672a\u51fa\u73b0\u7f13\u89e3\u4e14\u4ecd\u5904\u4e8e\u7a33\u5b9a\u7684\u60a3\u8005\u6362\u836f\u6cbb\u7597\u3002\u56e0\u6b64\uff0c\u6709\u7533\u8bf7\u4eba\u63d0\u51fa\u4f7f\u7528\u7b2c<\/span>12<\/span>\u5468<\/span>ORR<\/span>\u4f5c\u4e3a\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u3002<\/span><\/span>\u8003\u8651<\/span>\u7b2c<\/span>12\u5468\u8bc4\u4f30\u80fd\u6536\u96c6\u5230<\/span><\/span>\u7684\u7597\u6548\u6570\u636e\u6210\u719f\u5ea6\u4e0d\u8db3\uff0c<\/span>\u9274\u4e8e\u76ee\u524d\u5b89\u7ef4\u6c40\u4e8e\u5316\u7597\u8054\u5408\u6cbb\u7597\u6700\u654f\u611f\u7684<\/span>ORR\u8bc4\u4f30\u70b9\u7684\u8bc1\u636e\u5c11\uff0c<\/span><\/span>\u5efa\u8bae\u91c7\u7528<\/span>\u7b2c<\/span>18\u5468<\/span>ORR<\/span>\u4f5c\u4e3a<\/span><\/span>\u4e3b\u8981\u7684<\/span>ORR\u5206\u6790<\/span><\/span>\u65f6\u95f4\u70b9\uff0c\u5e76<\/span>\u6536\u96c6\u7b2c<\/span>24\u5468<\/span><\/span>\u6216<\/span>\u66f4\u957f\u7684<\/span>ORR\uff0c\u4ee5\u8fdb\u884c\u66f4\u591a\u6bd4\u5bf9\uff0c\u652f\u6301\u7b49\u6548\u6027\u3002\u540c\u65f6\u6536\u96c6\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08<\/span>duration of response, DOR<\/span>\uff09\u548c<\/span>PFS<\/span>\u7b49\u6b21\u8981\u7ec8\u70b9\u6307\u6807\u4f5c\u4e3a\u652f\u6301\u3002<\/span><\/span><\/span><\/p>\n

\u754c\u503c\u9009\u62e9\u4e0e\u6837\u672c\u91cf\u8ba1\u7b97<\/span><\/strong>\uff1a\u76ee\u524d\u56fd\u9645\u4e0a\u5b66\u672f\u754c\u8ba1\u7b97\u8bbe\u5b9a\u754c\u503c\u65f6\u5bf9\u4f7f\u7528\u5019\u9009\u836f\u7ec4\u4e0e\u53c2\u7167\u836f\u7ec4\u7814\u7a76\u7ec8\u70b9\u7684\u5dee\u503c\u5dee\u503c\uff08<\/span>Risk Difference<\/span>,<\/span> RD\uff09\u6216\u8005\u6bd4\u503c\uff08<\/span>Risk Ratio<\/span><\/span>,<\/span> RR\uff09\u4ecd\u5b58\u5728\u4e89\u8bae\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c<\/span>RR<\/span>\u4e0e<\/span>RD<\/span>\u5728\u5927\u90e8\u5206\u60c5\u51b5\u4e0b\u662f\u76f8\u5f53\u7684\uff0c\u5f53\u524d\u63a8\u8350\u5229\u7528<\/span>RR<\/span>\u8ba1\u7b97\u8bbe\u5b9a\u7b49\u6548\u6027\u754c\u503c\u3002<\/span><\/span>   <\/span>\u76ee\u524d\u53ef\u83b7\u5f97\u7684\u516c\u5f00\u53d1\u8868\u7684\u8d1d\u4f10\u73e0\u5355\u6297\u8054\u5408\u5316\u7597\u4e0e\u5316\u7597\u5355\u7528\u4f5c\u4e3a<\/span>NSCLC\u4e00\u7ebf\u6cbb\u7597\u6bd4\u8f83\u7684<\/span>II\/III<\/span>\u968f\u673a\u5bf9\u7167\u7814\u7a76\u5305\u62ec<\/span>5<\/span>\u9879\u56fd\u5916\u7814\u7a76<\/span><\/span>[13-18]<\/span><\/sup>\u548c\u4e00\u9879\u4e2d\u56fd\u7684\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c<\/span>[9]<\/span><\/sup>\u3002\u754c\u503c\u53ef\u57fa\u4e8e\u7b26\u5408\u7b5b\u9009\u6307\u6807\u7684\u7814\u7a76\u7684\u835f\u8403\u5206\u6790\u5f97\u5230\u7684\u6cbb\u7597\u6548\u5e94\u7f6e\u4fe1\u533a\u95f4\u4e0b\u9650\u4f30\u7b97\u5f97\u5230\u3002<\/span>FDA\u5728<\/span>2016<\/span>\u5e74\u53d1\u8868\u7684\u4e00\u7bc7\u6587\u732e\u63d0\u51fa<\/span><\/span>[12]<\/span><\/sup>\uff0c\u5982\u679c\u57fa\u4e8e<\/span>4\u9879\u8d1d\u4f10\u73e0\u5355\u6297\u56fd\u5916\u7684\u968f\u673a\u5bf9\u7167\u7814\u7a76\u8fdb\u884c\u835f\u8403\u5206\u6790\uff0c\u5f97\u5230\u7b49\u6548\u6027\u754c\u503c\u5728<\/span>[0.7368,1.3572]<\/span>\uff0c\u6309<\/span>80%<\/span>\u7684\u628a\u63e1\u5ea6\uff0c\u4f30\u7b97\u6700\u4f4e\u6837\u672c\u91cf\u4e3a<\/span>608<\/span>\u4f8b\u3002\u5728\u4e2d\u56fd\uff0c\u53ef\u4ee5\u8003\u8651\u7eb3\u5165\u8d1d\u4f10\u73e0\u5355\u6297\u5728\u4e2d\u56fd\u5728\u8f6c\u79fb\u6027\u6216\u590d\u53d1\u6027\u975e\u9cde\u72b6\u7ec6\u80de<\/span>NSCLC<\/span>\u60a3\u8005\u4e2d\u7684\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76<\/span>YO25404<\/span>\u6570\u636e\uff0c\u57fa\u4e8e\u6b64\u8ba1\u7b97\u5f97\u5230\u5408\u7406\u7684\u754c\u503c\uff0c\u8003\u8651<\/span>YO25404<\/span>\u7814\u7a76\u7684\u6837\u672c\u91cf\u5c0f\uff0c\u4e14\u8bbe\u8ba1\u5b9e\u65bd\u65f6\u672a\u6392\u9664<\/span>EGFR<\/span>\u7b49\u9a71\u52a8\u57fa\u56e0\u7a81\u53d8\uff0c\u5c1a\u672a\u77e5\u7a81\u53d8\u578b\u548c\u91ce\u751f\u578b\u60a3\u8005\u63a5\u53d7\u5316\u7597\u7684<\/span>ORR<\/span>\u5dee\u5f02\uff0c\u8bf7\u6743\u8861\u5c06<\/span>YO25404<\/span>\u7814\u7a76\u7eb3\u5165\u835f\u8403\u5206\u6790\u8ba1\u7b97\u7b49\u6548\u6027\u754c\u503c\u7684\u504f\u501a\u3002\u5728\u9488\u5bf9\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u4f1a\u8bae\u8ba8\u8bba\u4e2d\uff0c\u5efa\u8bae\u754c\u503c\u6309<\/span>RR<\/span>\u8bbe\u5b9a\u4e3a\uff08<\/span>0.75<\/span>\uff0c<\/span>1\/0.75<\/span>\uff09\u3002\u5982\u679c\u524d\u671f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u6570\u636e\u8868\u660e\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53c2\u7167\u836f\u5177\u6709\u4e00\u81f4\u6027\uff0c\u90a3\u4e48\u91c7\u7528\u5b9e\u9645<\/span>RR<\/span>\u7684<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u8fdb\u884c\u7b49\u6548\u6027\u5224\u65ad\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff0c<\/span><\/span>\u628a\u63e1\u5ea6\u7531\u7814\u53d1\u8005\u6839\u636e\u4ea7\u54c1\u81ea\u8eab\u98ce\u9669\u8bbe\u5b9a\uff0c\u901a\u5e38\u4e0d\u4f4e\u4e8e<\/span>80%\u3002\u57fa\u4e8e\u4e0a\u8ff0\u53c2<\/span><\/span>\u6570\u5408\u7406\u4f30\u7b97\u6837\u672c\u91cf\u3002\u5982\u6309\u5168\u7403\u5f00\u53d1\u7b56\u7565\uff0c\u987b\u8003\u8651\u6ee1\u8db3\u4e0d\u540c\u76d1\u7ba1\u90e8\u95e8\u7684\u8981\u6c42\u3002<\/span>3.\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u7814\u7a76<\/span><\/span><\/strong>     \u514d\u75ab\u539f\u6027\u7814\u7a76\u662f\u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u8981\u7684\u91cd\u8981\u7814\u7a76\u9879\u76ee\uff0c\u5e94\u8d2f\u7a7f\u5728\u6574\u4e2a\u7814\u53d1\u8fc7\u7a0b\u3002<\/span> <\/span>\u5b89\u7ef4\u6c40\u7684\u514d\u75ab\u539f\u6027\u8f83\u4f4e\uff0c\u76ee\u524d\u53ef\u83b7\u5f97\u7684\u5b89\u7ef4\u6c40\u514d\u75ab\u539f\u6027\u7684\u6570\u636e\u663e\u793a\uff1a\u5728\u7ed3\u80a0\u764c\u8f85\u52a9\u6cbb\u7597\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u91c7\u7528\u5316\u5b66\u53d1\u5149\u68c0\u6d4b\u6cd5\u5728<\/span>2233<\/span>\u4f8b\u53ef\u8bc4\u4ef7\u60a3\u8005\u4e2d\uff0c\u6d4b\u5f97<\/span>14<\/span>\u4f8b\u60a3\u8005\uff08<\/span>0.63%<\/span>\uff09\u6cbb\u7597\u5f15\u8d77\u7684\u6297\u8d1d\u4f10\u73e0\u5355\u6297\u6297\u4f53\u8bd5\u9a8c\u7ed3\u679c\u9633\u6027\u3002\u5728\u8fd9<\/span>14<\/span>\u4f8b\u60a3\u8005\u4e2d\uff0c<\/span>3<\/span>\u4f8b\u60a3\u8005\u91c7\u7528\u9176\u8054\u514d\u75ab\u5438\u9644\u6d4b\u5b9a\u6cd5\u68c0\u6d4b\u5230\u6297\u8d1d\u4f10\u73e0\u5355\u6297\u4e2d\u548c\u6297\u4f53\u9633\u6027<\/span><\/span>[2]<\/span><\/sup>\u3002\u8fd9\u4e9b\u6297\u8d1d\u4f10\u73e0\u5355\u6297\u6297\u4f53\u7684\u4e34\u5e8a\u610f\u4e49\u5c1a\u672a\u53ef\u77e5\u3002\u514d\u75ab\u539f\u6027\u8bd5\u9a8c\u7ed3\u679c\u4e0e\u68c0\u6d4b\u65b9\u6cd5\u7684\u654f\u611f\u6027\u548c\u7279\u5f02\u6027\u9ad8\u5ea6\u76f8\u5173\uff0c\u5e76\u4e14\u53ef\u80fd\u53d7\u4ee5\u4e0b\u51e0\u79cd\u56e0\u7d20\u7684\u5f71\u54cd\uff1a\u8840\u6837\u7684\u5904\u7406\u3001\u53d6\u6837\u7684\u65f6\u95f4\u3001\u5408\u5e76\u7528\u836f\u4ee5\u53ca\u5408\u5e76\u7684\u75be\u75c5\u7b49\u3002\u7531\u4e8e\u4e0a\u8ff0\u539f\u56e0\uff0c\u6bd4\u8f83\u6297\u8d1d\u4f10\u73e0\u5355\u6297\u6297\u4f53\u7684\u53d1\u751f\u7387\u548c\u6297\u5176\u5b83\u836f\u7269\u6297\u4f53\u7684\u53d1\u751f\u7387\u53ef\u80fd\u6709\u8bef\u5bfc\u6027\u3002\u57fa\u4e8e\u4e0a\u8ff0\u6709\u9650\u7684\u5185\u5bb9\u548c\u6587\u732e\u8d44\u6599\uff0c\u7ed3\u5408\u6297\u836f\u6297\u4f53\u8fdf\u53d1\u51fa\u73b0\u7684\u7ecf\u9a8c\uff0c\u5efa\u8bae\u514d\u75ab\u539f\u6027\u7684\u6bd4\u5bf9\u7814\u7a76\u81f3\u5c11\u83b7\u5f97\u81f3<\/span>45\u5468\u4ee5\u4e0a\u3002\u53ef\u5728\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u4e2d\u5f00\u5c55\u514d\u75ab\u539f\u6027\u6bd4\u5bf9\u7814\u7a76\u3002\u5728\u5c1a\u4e0d\u660e\u786e\u8bd5\u9a8c\u836f\u7684\u514d\u75ab\u539f\u6027\uff0c\u5728\u5b8c\u6210\u9884\u8bbe\u7684\u6709\u6548\u6027\u7ec8\u70b9\u89c2\u5bdf\u540e\uff0c\u53ef\u8bbe\u8ba1\u4ea4\u53c9\u7528\u836f\uff0c\u4ee5\u6536\u96c6\u66f4\u5927\u6837\u672c\u4eba\u7fa4\u4f7f\u7528\u5019\u9009\u836f\u7269\u7684\u514d\u75ab\u539f\u6027\u3002<\/span>     \u5b89\u5168\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u540c\u6837\u5728\u836f\u4ee3\u3001\u836f\u6548\u548c<\/span>\/<\/span>\u6216\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u4e2d\u8fdb\u884c\uff0c\u5bf9\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7684\u7c7b\u522b\u3001\u4e25\u91cd\u6027\u548c\u53d1\u751f\u7387\u7b49\u8fdb\u884c\u89c2\u5bdf\u6bd4\u8f83\uff0c\u5c24\u5176\u662f\u5b89\u7ef4\u6c40\u7684\u91cd\u8981\u4e0d\u826f\u53cd\u5e94\u3002\u5efa\u8bae\u63d0\u4f9b\u8db3\u591f\u957f\u89c2\u5bdf\u5468\u671f\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u4ee5\u5145\u5206\u66b4\u9732\u8bd5\u9a8c\u836f\u7684\u6f5c\u5728\u98ce\u9669\u3002\u7ed3\u5408\u514d\u75ab\u539f\u6027\u6bd4\u5bf9\u8003\u8651\uff0c\u5efa\u8bae\u5728\u5b8c\u6210\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u89c2\u5bdf\u540e\u81f3\u5c11\u6536\u96c6\u5355\u836f\u7ef4\u6301\u6cbb\u7597\u4e00\u5e74\u7684\u5b89\u5168\u6027\u6570\u636e\uff0c\u751f\u5b58\u968f\u8bbf<\/span>2<\/span>\u5e74\u6570\u636e\u3002<\/span><\/span>\u56db<\/span><\/strong>\u3001<\/span><\/strong>\u5c0f\u7ed3<\/span><\/strong>     \u8d1d\u4f10\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u76f8\u4f3c\u6027\u7814\u7a76\u9700\u8003\u8651\u5b89\u7ef4\u6c40\u4ea7\u54c1\u7279\u6027\uff0c\u9075\u5faa\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u76f8\u4f3c\u6027\u8bc4\u4ef7\u7684\u4e00\u822c\u89c4\u5f8b\uff0c\u6709\u9488\u5bf9\u6027\u7684\u8fdb\u884c\u8bbe\u8ba1\u548c\u7814\u7a76\u3002\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7814\u7a76\u7684\u8bbe\u8ba1\u4e0e\u8bc4\u4ef7\u539f\u5219\uff0c\u5747\u5e94\u4ee5\u80fd\u8bc1\u5b9e\u5019\u9009\u836f\u7269\u4e0e\u539f\u7814\u4ea7\u54c1\u76f8\u4f3c\u6027\u4e3a\u76ee\u6807\uff0c\u5728\u6709\u5408\u7406\u79d1\u5b66\u4f9d\u636e\u7684\u524d\u63d0\u4e0b\u7b80\u5316\u3002\u9f13\u52b1\u7814\u53d1\u4f01\u4e1a\u4e0e\u7ba1\u7406\u90e8\u95e8\u7684\u6c9f\u901a\uff0c\u5171\u540c\u63a2\u7d22\u66f4\u79d1\u5b66\u9ad8\u6548\u7684\u7814\u7a76\u8bbe\u8ba1\u3002<\/span><\/span><\/span><\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/strong><\/span><\/p>\n

[1] FDA. AVASTIN [EB\/OL]. Washington FDA. <\/span>https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2004\/125085lbl.pdf<\/span>.<\/span><\/p>\n

[2] FDA.AVASTIN[EB\/OL]. Washington FDA. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/125085s323lbl.pdf.<\/span><\/p>\n

[3] MULLARD A. Can next-generation antibodies offset biosimilar competition?[J]. Nat Rev Drug Discov. 2012, 11(6):426-428.<\/span><\/p>\n

[4] FDA. MVASI. Washington FDA. <\/span>https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761028s000lbl.pdf<\/span>.<\/span><\/p>\n

[5] FDA.ZIRABEV. Washington FDA. <\/span>https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761099s000lbl.pdf<\/span>.<\/span><\/section>\n

<\/section>\n
[6] \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09.[EB\/OL]. \u5317\u4eac:\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40. <\/span>http:\/\/www.nmpa.gov.cn\/WS04\/CL2138\/300003.html<\/span>.<\/span><\/section>\n
[7] \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219[EB\/OL]. \u5317\u4eac:\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. http:\/\/www.nmpa.gov.cn\/WS04\/CL2042.<\/span><\/section>\n
[8] ZHOU C, WU YL, CHEN G, et al. BEYOND: a randomized, double-blind,placebo-controlled, multicenter, phase III study of first-line carboplatin\/paclitaxel plus bevacizumab or placebo in chinese patients with advanced or recurrent non squamous non-small-cell lung cancer[J]. J Clin Oncol.2015, 33(19):2197-2204.<\/span><\/section>\n
[9] SHI Y, AU JS, THONGPRASERT S, et al. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER) [J]. J Thorac Oncol. 2014, 9(2):154-162.<\/span><\/section>\n
[10] \u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a.\u539f\u53d1\u6027\u80ba\u764c\u8bca\u7597\u89c4\u8303\uff082018\u5e74\u7248\uff09[EB\/OL]. \u5317\u4eac:\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a. http:\/\/www.nhc.gov.cn\/.      <\/span><\/section>\n
 [11] RECK M, VON PAWEL J, ZATLOUKAL P, et al. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for non-squamous non-small-cell lung cancer: results from a randomized phase III trial(AVAiL) [J]. Ann Oncol.2010, 21, 1804\u20131809.<\/span><\/section>\n
[12] HE K, CHEN H, GWISE T, et al.Statistical Considerations in Evaluating a Biosimilar Product in an OncologyClinical Study [J]. Clin Cancer Res. 2016, 22(21):5167-5170.<\/span><\/section>\n
[13] SOCINSKI MA, SCHELL MJ, PETERMAN A, et al. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB\/IV non-small-cell lung cancer [J]. J Clin Oncol. 2002, 20(5):1335-1343.<\/span><\/section>\n
[14] PARK JO, KIM SW, AHN JS, et al. Phase III trial of two versus four additional cycles in patients who are non-progressive after two cycles of platinum-based chemotherapy in non small-cell lung cancer [J]. J ClinOncol. 2007, 25(33):5233-5239.<\/span><\/section>\n
[15] NIHO S, KUNITOH H, NOKIHARA H, et al. Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer [J]. Lung Cancer. 2012, 76(3):362-367. <\/span><\/section>\n
[16] SANDLER A, GRAY R, PERRY MC, et al. Paclitaxel\u2013carboplatin alone or with bevacizumab for non-small-cell lung cancer [J]. N Engl J Med. 2006, 355:2542\u20132550.<\/span><\/section>\n
[17] NISHIO M, HORAI T, KUNITOH H, et al. Randomized,open-label, multicenter phase II study of bevacizumab in combination with carboplatin and paclitaxel in chemotherapy-naive Japanese patients with advanced or recurrent nonsquamous non-small cell lung cancer (NSCLC): JO19907 [J]. J Clin Oncol. 2009; 27(15s).<\/span><\/section>\n
[18] JOHNSON DH, FEHRENBACHER L, NOVOTNY WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer [J]. J Clin Oncol. 2004, 22:2184\u20132191.<\/span><\/section>\n

<\/section>\n

\u9644\u4ef61<\/span><\/strong><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219<\/span><\/strong><\/p>\n

\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09<\/span><\/strong><\/p>\n

\u4e00\u3001\u6982\u8ff0<\/span><\/strong><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\uff08<\/span>Trastuzumab<\/span>\uff09\u662f\u7531\u745e\u58eb\u7f57\u6c0f\u516c\u53f8\u7814\u53d1\u7684\u4e00\u79cd\u91cd\u7ec4<\/span>DNA<\/span>\u884d\u751f\u7684\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\uff0c\u542b\u4eba<\/span>IgG1<\/span>\u4e9a\u578b\u6846\u67b6\uff0c\u4e92\u8865\u51b3\u5b9a\u533a\u6e90\u81ea\u9f20\u6297<\/span>p185 HER2 <\/span>\u6297\u4f53\uff0c\u80fd\u591f\u7279\u5f02\u6027\u5730\u4f5c\u7528\u4e8e\u4eba\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53<\/span>-2(human epidermal growth factor receptor-2<\/span>\uff0c<\/span>HER-2)<\/span>\u7684\u7ec6\u80de\u5916\u90e8\u4f4d\u7b2c<\/span>IV<\/span>\u4e9a\u533a\uff0c\u7ade\u4e89\u6027\u963b\u65ad\u4eba\u4f53\u8868\u76ae\u751f\u957f\u56e0\u5b50\u4e0e<\/span>HER2<\/span>\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6291\u5236\u80bf\u7624\u7ec6\u80de\u7684\u751f\u957f\u3002<\/span><\/span><\/p>\n

\u7f57\u6c0f\u516c\u53f8\u7684\u6ce8\u5c04\u7528\u66f2\u59a5\u73e0\u5355\u6297\uff08<\/span>Herceptin<\/span>\u00ae<\/span><\/sup>\uff0c\u8d6b\u8d5b\u6c40<\/span>\u00ae<\/span><\/sup>\uff09\u6700\u65e9\u4e8e<\/span>1998<\/span>\u5e74<\/span>9<\/span>\u6708<\/span>25<\/span>\u65e5\u83b7\u5f97\u7f8e\u56fd<\/span>FDA<\/span>\u6279\u51c6\u4e0a\u5e02\uff0c<\/span>2002<\/span>\u5e74\u8fdb\u53e3\u4e2d\u56fd\uff0c\u76ee\u524d\u83b7\u6279\u7684\u9002\u5e94\u75c7\u4e3a\uff1a\u5355\u836f\u7528\u4e8e\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\uff1b\u8054\u5408\u7d2b\u6749\u9187\u6216\u8005\u591a\u897f\u4ed6\u8d5b\u7528\u4e8e<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\uff1b<\/span>HER2<\/span>\u9633\u6027\u7684\u65e9\u671f\u4e73\u817a\u764c\uff1b<\/span>HER2<\/span>\u9633\u6027\u7684\u8f6c\u79fb\u6027\u80c3\u764c<\/span>[1]<\/span><\/sup>\u3002<\/span><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u5728\u6b27\u76df\u548c\u7f8e\u56fd\u7684\u4e13\u5229\u5df2\u5230\u671f\uff0c\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u6210\u4e3a\u70ed\u70b9\uff0c\u76ee\u524d<\/span>FDA<\/span>\u548c\u6b27\u76df\u5df2\u6279\u51c6\u591a\u4e2a\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e0a\u5e02\u3002\u672c\u6307\u5bfc\u539f\u5219\u5728<\/span>NMPA<\/span>\u5df2\u53d1\u5e03\u7684\u300a\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b<\/span>[2]<\/span><\/sup>\u57fa\u7840\u4e0a\uff0c\u7ed3\u5408\u8be5\u54c1\u79cd\u7684\u7279\u70b9\uff0c\u5bf9\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u7b56\u7565\u548c\u65b9\u6848\u8bbe\u8ba1\u8981\u70b9\u8fdb\u884c\u63a2\u8ba8\uff0c\u4ee5\u671f\u4e3a\u7814\u53d1\u76f8\u5173\u4eba\u5458\u63d0\u4f9b\u53c2\u8003\u3002<\/span><\/span><\/p>\n

\u4e8c\u3001\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7814\u7a76\u7b56\u7565<\/span><\/strong><\/span><\/p>\n

\u751f\u7269\u7c7b\u4f3c\u53d1\u603b\u4f53\u601d\u8def\u662f\u4ee5\u6bd4\u5bf9\u8bd5\u9a8c\u8bc1\u660e\u5176\u4e0e\u53c2\u7167\u836f\u7684\u76f8\u4f3c\u6027\u4e3a\u57fa\u7840\uff0c\u652f\u6301\u5176\u5b89\u5168\u3001\u6709\u6548\u548c\u8d28\u91cf\u53ef\u63a7\u3002\u91c7\u7528\u9010\u6b65\u9012\u8fdb\u7684\u987a\u5e8f\uff0c\u5206\u9636\u6bb5\u5f00\u5c55\u836f\u5b66\u3001\u975e\u4e34\u5e8a\u3001\u4e34\u5e8a\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u6839\u636e\u524d\u671f\u6bd4\u5bf9\u8bd5\u9a8c\u7ed3\u679c\u8bbe\u8ba1\u540e\u7eed\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u3002<\/span><\/p>\n

\u6839\u636e\u524d\u671f\u836f\u5b66\u548c\u836f\u7406\u6bd2\u7406\u6bd4\u5bf9\u8bd5\u9a8c\u7ed3\u679c\uff0c\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u53d1\uff0c\u836f\u5b66\u548c\u836f\u7406\u6bd2\u7406\u8bd5\u9a8c\u8bc1\u660e\u5019\u9009\u836f\u4e0e\u8d6b\u8d5b\u6c40\u76f8\u4f3c\uff0c\u7533\u8bf7\u4eba\u7ee7\u7eed\u6309\u7167\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u8def\u5f84\u5f00\u5c55\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u8bd5\u9a8c\u548c\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u9274\u4e8e\u8d6b\u8d5b\u6c40\u5728\u56fd\u5185\u83b7\u6279\u591a\u4e2a\u9002\u5e94\u75c7\uff0c\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u53ef\u80fd\u4f1a\u51fa\u73b0\u4ee5\u4e0b\u51e0\u79cd\u9009\u62e9\uff1a<\/span><\/p>\n

a. <\/span>\u9009\u62e9\u56fd\u5185\u6279\u51c6\u9002\u5e94\u75c7\uff1a<\/span> \u201c<\/span>\u672a\u63a5\u53d7\u8fc7\u5316\u7597\u7684<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\uff08<\/span>metastatic breast cancer<\/span>\uff0c<\/span>MBC<\/span>\uff09<\/span>\u201d<\/span>\u4e3a\u7814\u7a76\u4eba\u7fa4\uff0c\u5f00\u5c55\u4e0e\u8d6b\u8d5b\u6c40<\/span>\u201c<\/span>\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\u7684\u7b49\u6548\u6027\u7814\u7a76\uff0c\u4e3b\u8981\u7ec8\u70b9\u9009\u62e9\u654f\u611f\u7684\u7597\u6548\u6307\u6807\u5ba2\u89c2\u7f13\u89e3\u7387\uff08<\/span>objective response rate<\/span>\uff0c<\/span>ORR<\/span>\uff09\u4f5c\u4e3a\u66ff\u4ee3\u7ec8\u70b9\u3002<\/span><\/span><\/p>\n

b. <\/span>\u9009\u62e9\u56fd\u5185\u6279\u51c6\u9002\u5e94\u75c7\uff1a<\/span>\u201cHER2<\/span>\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\uff08<\/span>early breast cancer<\/span>\uff0c<\/span>EBC<\/span>\uff09\u672f\u524d\u65b0\u8f85\u52a9\u6cbb\u7597<\/span>\u201d<\/span>\uff0c\u5f00\u5c55\u4e0e\u8d6b\u8d5b\u6c40<\/span>\u201c<\/span>\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\u7684\u7b49\u6548\u6027\u7814\u7a76\uff0c\u4e3b\u8981\u7ec8\u70b9\u9009\u62e9\u654f\u611f\u7684\u7597\u6548\u6307\u6807\u75c5\u7406\u5b8c\u5168\u7f13\u89e3\u7387\uff08<\/span>complete remission of pathology<\/span>\uff0c<\/span>pCR<\/span>\uff09\u4f5c\u4e3a\u66ff\u4ee3\u7ec8\u70b9\u3002<\/span><\/span><\/p>\n

c. <\/span>\u9009\u62e9\u56fd\u5185\u6279\u51c6\u9002\u5e94\u75c7\uff1a<\/span>\u201c<\/span>\u672a\u63a5\u53d7\u8fc7\u5316\u7597\u7684<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u80c3\u817a\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u817a\u764c\uff08<\/span>metastatic gastric or gastroesophageal junction adenocarcinoma<\/span>\uff09<\/span>\u201d<\/span>\u4e3a\u7814\u7a76\u4eba\u7fa4\uff0c\u5f00\u5c55\u4e0e\u8d6b\u8d5b\u6c40<\/span>\u201c<\/span>\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\u7684\u7b49\u6548\u6027\u7814\u7a76\uff0c\u4e3b\u8981\u7ec8\u70b9\u9009\u62e9\u654f\u611f\u7684\u7597\u6548\u6307\u6807<\/span>ORR<\/span>\u4f5c\u4e3a\u66ff\u4ee3\u7ec8\u70b9\u3002\u5bf9\u8be5\u7b56\u7565\u7684\u53ef\u884c\u6027\u8ba8\u8bba\u89c1\u540e\u8ff0\u3002<\/span><\/span><\/p>\n

\u6309\u4ee5\u4e0a\u8def\u5f84\u5b8c\u6210\u5355\u4e2a\u9002\u5e94\u75c7\u7684\u7814\u7a76\uff0c\u6280\u672f\u5ba1\u8bc4\u901a\u8fc7\u540e\u53ef\u83b7\u5f97\u5916\u63a8\u5176\u5b83\u9002\u5e94\u75c7\u7684\u6279\u51c6\u3002<\/span><\/p>\n

\u4e09\u3001\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u8981\u70b9<\/span><\/strong><\/span><\/p>\n

\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u901a\u5e38\u4ece\u836f\u4ee3\u52a8\u529b\u5b66\uff08<\/span>pharmacokinetics<\/span>\uff0c<\/span>PK<\/span>\uff09\u548c<\/span>\/<\/span>\u6216\u836f\u6548\u5b66\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u5f00\u59cb\uff0c\u6839\u636e\u5176\u76f8\u4f3c\u6027\u8bc4\u4ef7\u7ed3\u679c\u518d\u8003\u8651\u540e\u7eed\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u3002\u7814\u7a76\u8bbe\u8ba1\u5e94\u5f53\u4ee5\u8bc1\u660e\u5019\u9009\u836f\u4e0e\u539f\u7814\u836f\u7684\u76f8\u4f3c\u6027\u4e3a\u76ee\u7684\uff0c\u8fdb\u884c\u79d1\u5b66\u5408\u7406\u7684\u7814\u7a76\u8bbe\u8ba1\uff0c\u5728\u6709\u5408\u7406\u79d1\u5b66\u4f9d\u636e\u7684\u524d\u63d0\u4e0b\uff0c\u5c3d\u53ef\u80fd\u7684\u7b80\u5316\u7814\u7a76\uff0c\u964d\u4f4e\u6210\u672c\u3002\u5f53\u524d\u56fd\u5185\u5916\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u53d1\u591a\u4e3a\u4e00\u9879\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u7814\u7a76\u548c\u4e00\u9879\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/p>\n

1. PK<\/span><\/strong>\u6bd4\u5bf9\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

\u8bd5\u9a8c\u8bbe\u8ba1\uff1a<\/span><\/strong>\u8d6b\u8d5b\u6c40\u5728\u6bcf\u4e09\u5468\u4e00\u6b21\u7ed9\u836f\u65b9\u6848\u4e0b\uff0c<\/span>MBC<\/span>\u7684\u534a\u8870\u671f\u4e3a<\/span>15.1-23.3<\/span>\u5929\uff0c<\/span> EBC<\/span>\u7684\u534a\u8870\u671f\u4e3a<\/span>17.5-26.6<\/span>\u5929\uff0c<\/span>AGC<\/span>\u7684\u534a\u8870\u671f\u4e3a<\/span>12.6-20.6<\/span>\u5929\uff1b\u5728\u6bcf\u5468\u4e00\u6b21\u7ed9\u836f\u65b9\u6848\u4e0b\uff0c<\/span>MBC<\/span>\u7684\u534a\u8870\u671f\u4e3a<\/span>17.2-20.4<\/span>\u5929\uff0c<\/span>EBC<\/span>\u7684\u534a\u8870\u671f\u4e3a<\/span>19.7-23.2<\/span>\u5929<\/span>[1]<\/span><\/sup>\u3002\u53c2\u7167\u4e00\u822c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u8bbe\u8ba1\uff0c\u7ed3\u5408\u66f2\u59a5\u73e0\u5355\u6297\u534a\u8870\u671f\u8f83\u957f\uff0c\u5177\u6709\u514d\u75ab\u539f\u6027\u7b49\u7279\u70b9\uff0c\u672c\u54c1\u4e0d\u9002\u7528\u4e8e\u4ea4\u53c9\u8bbe\u8ba1\u8bc4\u4ef7\u5176\u751f\u7269\u7b49\u6548\u6027\uff0c\u5efa\u8bae\u91c7\u7528\u968f\u673a\u3001\u53cc\u76f2\u3001\u8d6b\u8d5b\u6c40\u5bf9\u7167\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/span><\/p>\n

\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u6613\u4e8e\u6bd4\u8f83\u51fa\u7ec4\u95f4\u5dee\u5f02\uff0c\u56e0\u800c\u63a8\u8350\u8fdb\u884c\u5355\u6b21\u7ed9\u836f\u7684<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u3002\u591a\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u4e0d\u5982\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u654f\u611f\uff0c\u4f46\u53ef\u4ee5\u95f4\u63a5\u53cd\u6620\u66f2\u59a5\u73e0\u5355\u6297\u836f\u7269\u5242\u91cf\u4f9d\u8d56\u548c\u65f6\u95f4\u4f9d\u8d56\u6027\u76f8\u5173\u7684\u514d\u75ab\u539f\u6027\uff0c\u4ee5\u53ca\u9776\u4ecb\u5bfc\u3001<\/span>FcRn<\/span>\u4ecb\u5bfc\u3001\u9176\u4ecb\u5bfc\u7b49\u76f8\u5173\u7684\u836f\u7269\u6e05\u9664\u3002\u5efa\u8bae\u5728\u5b8c\u6210\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u5224\u5b9a\u76f8\u4f3c\u6027\u540e\uff0c\u5728\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u671f\u95f4\uff0c\u540c\u65f6\u8003\u5bdf\u591a\u6b21\u7ed9\u836f\u7684<\/span>PK<\/span>\u7279\u5f81\u3002\u514d\u75ab\u539f\u6027\u7684\u8bc4\u4ef7\u5e94\u5f53\u8d2f\u7a7f\u5728\u6574\u4e2a\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u4e2d\u3002<\/span><\/span><\/p>\n

\u7814\u7a76\u4eba\u7fa4\uff1a<\/span><\/strong>\u5065\u5eb7\u5fd7\u613f\u8005\u662f\u8f83\u4e3a\u7406\u60f3\u7684\u5747\u8d28\u6027\u53d7\u8bd5\u4eba\u7fa4\uff0c\u80fd\u66f4\u597d\u7684\u53cd\u6620\u51fa\u5019\u9009\u836f\u4e0e\u539f\u7814\u836f\u4e4b\u95f4\u7684<\/span>PK<\/span>\u5dee\u5f02\u3002\u66f2\u59a5\u73e0\u5355\u6297\u4e3a\u975e\u7ec6\u80de\u6bd2\u6027\u836f\u7269\uff0c\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u5165\u9009\u5065\u5eb7\u5fd7\u613f\u8005\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff0c\u4f46\u4ecd\u5fc5\u987b\u5145\u5206\u8003\u8651\u7ed9\u836f\u5242\u91cf\uff0c\u5c3d\u91cf\u4fdd\u62a4\u5065\u5eb7\u53d7\u8bd5\u8005\u3002\u7531\u4e8e\u7814\u7a76\u4e3b\u8981\u76ee\u7684\u662f\u8003\u5bdf<\/span>PK<\/span>\u76f8\u4f3c\u6027\uff0c\u65e0\u9700\u8003\u8651\u6027\u522b\u5dee\u5f02\uff0c\u56e0\u6b64\u53ef\u53ea\u9009\u62e9\u5065\u5eb7\u7537\u6027\u5fd7\u613f\u8005\u3002<\/span><\/span><\/p>\n

\u53c2\u7167\u836f\u6765\u6e90\uff1a<\/span><\/strong>\u4e34\u5e8a\u7814\u7a76\u4e2d\u5e94\u5c3d\u53ef\u80fd\u9009\u62e9\u4e2d\u56fd\u5e02\u552e\u4ea7\u54c1\u4f5c\u4e3a\u53c2\u7167\u836f\uff0c\u5982\u679c\u9009\u62e9\u975e\u6211\u56fd\u83b7\u6279\u8fdb\u53e3\u6ce8\u518c\u6765\u6e90\u7684\u53c2\u7167\u836f\uff0c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u59cb\u524d\u5e94\u63d0\u4f9b\u4e0d\u540c\u6765\u6e90\u539f\u7814\u836f\u4e4b\u95f4\u53ef\u6bd4\u7684\u8bc1\u636e\u6216\u5f00\u5c55\u4e0d\u540c\u6765\u6e90\u539f\u7814\u836f\u54c1\u7684\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/p>\n

\u5242\u91cf\u53ca\u7ed9\u836f\u9014\u5f84\uff1a<\/span><\/strong>\u539f\u5219\u4e0a\uff0c\u4e0d\u8981\u6c42\u5bf9\u6bcf\u79cd\u6cbb\u7597\u5242\u91cf\u5747\u8fdb\u884c<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\uff0c\u5e94\u9009\u62e9\u80fd\u68c0\u6d4b\u51fa\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53c2\u7167\u836f\u7684<\/span>PK<\/span>\u6f5c\u5728\u5dee\u5f02\u7684\u6700\u654f\u611f\u7684\u5242\u91cf\u3002\u5982\u96be\u4ee5\u786e\u5b9a\u6700\u654f\u611f\u7684\u5242\u91cf\uff0c\u5219\u63a8\u8350\u9009\u53d6\u6700\u4f4e\uff08\u9776\u4ecb\u5bfc\u7684\u6e05\u9664\u8fd8\u672a\u9971\u548c\uff09\u548c\u6700\u9ad8\uff08\u975e\u7279\u5f02\u6027\u6e05\u9664\u5360\u4e3b\u5bfc\uff09\u6cbb\u7597\u5242\u91cf\u3002\u5982\u6bd4\u8f83\u9776\u4ecb\u5bfc\u7684\u6e05\u9664\u4e4b\u95f4\u7684\u5dee\u5f02\uff0c\u9009\u62e9\u6700\u4f4e\u6cbb\u7597\u5242\u91cf\u8fdb\u884c\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u662f\u6700\u5408\u7406\u7684\u8bd5\u9a8c\u8bbe\u8ba1<\/span>[3]<\/span><\/sup>\u3002\u5f53\u524d\u5df2\u6279\u51c6\u4e0a\u5e02\u548c\u5728\u7814\u7684\u4ea7\u54c1\u4e2d\uff0c\u5355\u6b21\u7ed9\u836f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u6700\u5e38\u9009\u53d6\u7684\u7ed9\u836f\u5242\u91cf\u4e3a<\/span>6mg\/kg<\/span>\uff0c\u662f\u591a\u4e2a\u9002\u5e94\u75c7\u63a8\u8350\u7684\u66f2\u59a5\u73e0\u5355\u6297<\/span>q3w<\/span>\u7ed9\u836f\u65b9\u6848\u7684\u7ef4\u6301\u5242\u91cf\u3002\u7ed9\u836f\u9014\u5f84\u9009\u62e9\u9759\u8109\u7ed9\u836f\uff0c\u8f93\u6ce8\u65f6\u95f4\u7ef4\u6301\u81f3\u5c11<\/span>90min<\/span>\u3002\u9759\u8109\u7ed9\u836f\u65f6\u5e94\u6ce8\u610f\u63a7\u5236\u8f93\u6ce8\u901f\u5ea6\uff0c\u5c3d\u91cf\u4f7f\u7ed9\u836f\u7ed3\u675f\u7684\u65f6\u95f4\u4e00\u81f4\uff0c\u4ee5\u907f\u514d\u5bf9\u76f8\u4f3c\u6027\u8bc4\u4f30\u9020\u6210\u975e\u9884\u671f\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

\u7ec8\u70b9\u6307\u6807\u4e0e\u754c\u503c\uff1a<\/span><\/strong>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u4e3b\u8981\u7ec8\u70b9\u6307\u6807\u7684\u9009\u62e9\u662f\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u5173\u952e\u3002\u6839\u636e\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7684\u76f8\u5173\u6307\u5bfc\u539f\u5219<\/span>[4]<\/span><\/sup>\uff0c\u66f2\u7ebf\u4e0b\u9762\u79ef\uff08<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\uff09\u548c\u8fbe\u5cf0\u6d53\u5ea6\uff08<\/span>Cmax<\/span>\uff09\u662f\u5224\u65ad\u751f\u7269\u7b49\u6548\u6027\u7684\u4e3b\u8981\u53c2\u6570\u3002\u4f46\u662f\u5728\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u4e2d\uff0c\u9009\u62e9<\/span>AUC<\/span>0-t<\/span><\/sub>\u8fd8\u662f<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u7ec8\u70b9\uff0c\u5c1a\u5b58\u5728\u4e00\u5b9a\u4e89\u8bae\u3002<\/span>FDA<\/span>\u5728\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u6307\u5bfc\u539f\u5219\u4e2d\u9759\u8109\u7ed9\u836f\u503e\u5411\u4e8e\u9009\u62e9<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9<\/span>[5]<\/span><\/sup>\u3002\u76ee\u524d\u8ba4\u4e3a<\/span>AUC0-t<\/span>\u662f\u901a\u8fc7\u5b9e\u9645\u6d4b\u91cf\u503c\u8ba1\u7b97\u83b7\u5f97\u7684\uff0c\u8003\u8651\u5230\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u6027\u548c\u5b9e\u9645\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53d6\u8840\u70b9\u8bbe\u8ba1\u7684\u76f8\u5173\u6027\uff0c\u63a8\u8350<\/span>AUC<\/span>0-t<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u6307\u6807\u3002<\/span>AUC<\/span>0-\u221e<\/span><\/sub>\u548c<\/span>Cmax<\/span>\u4f5c\u4e3a\u6b21\u8981\u7814\u7a76\u7ec8\u70b9\u91cd\u70b9\u8fdb\u884c\u6bd4\u8f83\u5206\u6790\u3002\u7b49\u6548\u6027\u754c\u503c\u6839\u636e\u5e38\u89c4\u5efa\u8bae\u8bbe\u5b9a\u4e3a<\/span>80%-125%<\/span>\u3002<\/span><\/span><\/p>\n

\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u6837\u672c\u91cf\u6839\u636e\u8bbe\u5b9a\u7684\u7b49\u6548\u6027\u754c\u503c\uff08<\/span>80%-125%<\/span>\uff09\u3001\u7f6e\u4fe1\u533a\u95f4\uff08<\/span>90%<\/span>\uff09\u548c\u628a\u63e1\u5ea6\uff08\u901a\u5e38<\/span>80%<\/span>\u4ee5\u4e0a\uff09\u7b49\u53c2\u6570\u8ba1\u7b97\uff0c\u540c\u65f6\u5e94\u7ed3\u5408\u8d6b\u8d5b\u6c40\u65e2\u5f80\u4fe1\u606f\u8003\u8651\u836f\u4ee3\u53c2\u6570\u53d8\u5f02\u60c5\u51b5\u7efc\u5408\u8003\u8651\u3002<\/span><\/span><\/p>\n

2. <\/span><\/strong>\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

\u8bd5\u9a8c\u8bbe\u8ba1\uff1a<\/span><\/strong>\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u76ee\u7684\u662f\u8bc1\u660e\u4e0e\u8d6b\u8d5b\u6c40\u4e34\u5e8a\u7597\u6548\u7684\u76f8\u4f3c\uff0c\u56e0\u6b64\uff0c\u5e94\u9009\u62e9\u6700\u6613\u68c0\u6d4b\u51fa\u836f\u7269\u76f8\u5173\u5dee\u5f02\u7684\u6700\u654f\u611f\u60a3\u8005\u4eba\u7fa4\u548c\u4e34\u5e8a\u7ec8\u70b9\uff0c\u540c\u65f6\u63a7\u5236\u4e0e\u60a3\u8005\u548c\u75be\u75c5\u76f8\u5173\u7684\u56e0\u7d20\u81f3\u6700\u5c0f\u5316\u3002\u7814\u7a76\u5e94\u9075\u5faa\u4ee5\u539f\u7814\u836f\u4e3a\u5bf9\u7167\uff0c\u8fdb\u884c\u968f\u673a\u3001\u53cc\u76f2\u3001\u5e73\u884c\u5bf9\u7167\u7b49\u6548\u6027\u8bbe\u8ba1\u3002<\/span><\/span><\/p>\n

\u7814\u7a76\u4eba\u7fa4\uff1a<\/span><\/strong>\u5e94\u57fa\u4e8e\u8d6b\u8d5b\u6c40\u5df2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u548c\u83b7\u6279\u9002\u5e94\u75c7\u9009\u62e9\u6700\u654f\u611f\u7684\u5747\u8d28\u60a3\u8005\u4eba\u7fa4\uff08\u75be\u75c5\u4e25\u91cd\u7a0b\u5ea6\u548c\u65e2\u5f80\u6cbb\u7597\u7ebf\u6570\u4e0d\u540c\u7684\u60a3\u8005\uff0c\u9884\u671f\u5bf9\u7814\u7a76\u836f\u7269\u4ea7\u751f\u7684\u5e94\u7b54\u4e5f\u4e0d\u540c\uff0c\u589e\u52a0\u7814\u7a76\u7684\u53d8\u5f02\u5ea6\uff09\u3002<\/span><\/span><\/p>\n

\u8d6b\u8d5b\u6c40\u7528\u4e8e<\/span>HER2<\/span>\u9633\u6027<\/span>EBC<\/span>\u65b0\u8f85\u52a9\u6cbb\u7597\u7684\u9002\u5e94\u75c7\u4e8e<\/span>2019<\/span>\u5e74<\/span>1<\/span>\u6708\u83b7\u6279\uff0c\u8be5\u60a3\u8005\u4eba\u7fa4\u75be\u75c5\u80cc\u666f\u8f83\u5355\u7eaf\uff0c\u65e2\u5f80\u672a\u63a5\u53d7\u8fc7\u6cbb\u7597\uff0c\u5747\u8d28\u6027\u66f4\u9ad8\uff0c\u662f\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u654f\u611f\u4eba\u7fa4<\/span>[6]<\/span><\/sup>\uff0c\u76ee\u524d\u83b7\u6279\u4e0a\u5e02\u548c\u5728\u7814\u7684\u751f\u7269\u7c7b\u4f3c\u836f\u6700\u5e38\u9009\u62e9\u8be5\u9002\u5e94\u75c7\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u3002\u53ef\u9009\u62e9\u5e8f\u8d2f\u6216\u8054\u5408\u65b9\u6848\u3002<\/span><\/span><\/p>\n

\u8d6b\u8d5b\u6c40\u5728\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u4e00\u7ebf\u6cbb\u7597\u4e2d\u5f00\u5c55\u4e86\u591a\u9879\u5927\u578b\u7684\u4e0e\u7d2b\u6749\u7c7b\u5316\u7597\u8054\u5408\u7684\u968f\u673a\u5bf9\u7167\u7814\u7a76<\/span>[7-9]<\/span><\/sup>\uff0c\u53ef\u53c2\u8003\u7684\u7597\u6548\u6570\u636e\u76f8\u5bf9\u8f83\u591a\uff0c\u56e0\u6b64\uff0c<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u4e00\u7ebf\u6cbb\u7597\u60a3\u8005\u4e5f\u662f\u5e38\u9009\u62e9\u7684\u7814\u7a76\u4eba\u7fa4\u3002\u5982\u9009\u62e9\u4e0e\u5176\u4ed6\u5316\u7597\u836f\u7269\u8054\u5408\u65b9\u6848\uff0c\u5e94\u63d0\u4f9b\u8db3\u591f\u53ef\u9760\u7684\u968f\u673a\u5bf9\u7167\u7814\u7a76\u7684\u6570\u636e\u652f\u6301\uff0c\u5426\u5219\u4e0d\u5229\u4e8e\u7b49\u6548\u754c\u503c\u7684\u8bbe\u7f6e\u548c\u8bc4\u4ef7\u3002<\/span> <\/span><\/span><\/p>\n

\u4e8c\u7ebf\u53ca\u4e8c\u7ebf\u4ee5\u4e0a\u7684<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u5bf9\u66f2\u59a5\u73e0\u5355\u6297\u8054\u5408\u5316\u7597\u6216\u5355\u836f\u6cbb\u7597\u7684\u5e94\u7b54\u7387\u76f8\u5bf9\u8f83\u4f4e\uff0c\u4e0d\u662f\u8bc4\u4ef7\u4e34\u5e8a\u6709\u6548\u6027\u7684\u654f\u611f\u4eba\u7fa4\uff0c\u4e14\u76f8\u5173\u4e34\u5e8a\u7814\u7a76\u7684\u7597\u6548\u6570\u636e\u5927\u591a\u662f\u9488\u5bf9\u4e8c\u7ebf\u53ca\u4ee5\u4e0a\u7684\u603b\u4f53\u60a3\u8005\u4eba\u7fa4\uff0c\u5e76\u672a\u533a\u5206\u5177\u4f53\u5404\u7ebf\u7684\u6cbb\u7597\u5e94\u7b54\u60c5\u51b5\u3002\u800c\u9274\u4e8e\u4e0d\u540c\u7ebf\u6570\u60a3\u8005\u7684\u6cbb\u7597\u5e94\u7b54\u4e0d\u540c\uff0c\u4e0d\u5efa\u8bae\u91c7\u7528\u8de8\u7ebf\u9009\u62e9\u60a3\u8005\u4eba\u7fa4\u7684\u7814\u7a76\u8bbe\u8ba1\u3002<\/span><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u7528\u4e8e<\/span>HER2<\/span>\u9633\u6027\u4e73\u817a\u764c\u7684\u672f\u540e\u8f85\u52a9\u6cbb\u7597\u7684\u7597\u6548\u8bc4\u4ef7\u7ec8\u70b9\u6307\u6807\u5982\u65e0\u4e8b\u4ef6\u751f\u5b58\u671f\uff08<\/span>event-free survival<\/span>\uff0c<\/span>EFS<\/span>\uff09\u6216\u65e0\u75c5\u751f\u5b58\u671f\uff08<\/span>disease-free survival<\/span>\uff0c<\/span>DFS<\/span>\uff09\u7684\u89c2\u5bdf\u65f6\u95f4\u90fd\u8f83\u957f\uff0c\u4e14\u6ca1\u6709\u5408\u9002\u7684\u66ff\u4ee3\u7ec8\u70b9\u6307\u6807\uff0c\u56e0\u6b64\u4e0d\u63a8\u8350\u9009\u4f5c\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u76ee\u6807\u9002\u5e94\u75c7\u3002<\/span><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u5728\u56fd\u5185\u4e5f\u5df2\u83b7\u6279\u8054\u5408\u5316\u7597\u7528\u4e8e<\/span>HER2<\/span>\u9633\u6027<\/span>AGC<\/span>\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\u3002<\/span>ToGA<\/span>\u7814\u7a76\u7684\u4e2d\u56fd\u4e9a\u7ec4\u5206\u6790\u7ed3\u679c\u663e\u793a\uff0c\u66f2\u59a5\u73e0\u5355\u6297\u8054\u5408\u5316\u7597\uff08\u6c1f\u5c3f\u5627\u5576\u548c\u987a\u94c2\uff09\u4e0e\u5355\u7528\u5316\u7597\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u80c3\u764c\u7684<\/span>ORR<\/span>\u5206\u522b\u4e3a<\/span>36.1%<\/span>\u548c<\/span>33.3%<\/span>\uff0c\u65e0\u8fdb\u5c55\u751f\u5b58\uff08<\/span>progression free survival, PFS\uff09<\/span><\/span>\u5206\u522b\u4e3a<\/span>6.8<\/span>\u548c<\/span>5.5<\/span>\u6708\uff0c\u81f3\u75be\u75c5\u8fdb\u5c55\u65f6\u95f4\uff08<\/span>time to progression<\/span>\uff0c<\/span>TTP<\/span>\uff09\u5206\u522b\u4e3a<\/span>7.2<\/span>\u548c<\/span>5.7<\/span>\u6708<\/span>[1]<\/span><\/sup>\u3002\u4e0e\u4e73\u817a\u764c\u76f8\u6bd4\uff0c<\/span>HER2<\/span>\u9633\u6027\u8f6c\u79fb\u6027\u80c3\u764c\u4ece\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u4e2d\u83b7\u76ca\u7684\u7a0b\u5ea6\u8f83\u5c0f\uff0c\u4e0d\u6613\u89c2\u5bdf\u5230\u5dee\u5f02\uff0c\u5e76\u975e\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u654f\u611f\u4eba\u7fa4\u3002\u6b64\u5916\uff0c\u80c3\u764c\u7684<\/span>HER2<\/span>\u9633\u6027\u7387\u4e5f\u8f83\u4e73\u817a\u764c\u4f4e\uff0c\u56fd\u5185\u4e24\u9879\u5927\u578b\u591a\u4e2d\u5fc3\u7814\u7a76\u6570\u636e\u663e\u793a\uff0c\u4e2d\u56fd\u80c3\u764c\u60a3\u8005\u7684<\/span>HER2<\/span>\u9633\u6027\u7387\u4e3a<\/span>12~13%<\/span>[10,11]<\/span><\/sup>\u3002\u8fd1\u5e74\u6765\uff0c\u5c3d\u7ba1\u66f2\u59a5\u73e0\u8054\u5408\u4e0d\u540c\u5316\u7597\u65b9\u6848\u4e00\u7ebf\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027\u665a\u671f\u80c3\u764c\u7684\u4e34\u5e8a\u7814\u7a76\u5c42\u51fa\u4e0d\u7a77\uff0c\u4e5f\u62a5\u9053\u4e86\u8f83\u9ad8\u7684<\/span>ORR<\/span>\uff0c\u4f46\u8fd9\u4e9b\u7814\u7a76\u5927\u591a\u4e3a\u5355\u81c2\u63a2\u7d22\u6027\u7814\u7a76\uff0c\u5f88\u96be\u4f5c\u4e3a\u7b49\u6548\u754c\u503c\u7684\u53c2\u8003\u3002\u7efc\u5408\u4e0a\u8ff0\u56e0\u7d20\u8003\u8651\uff0c\u9009\u62e9\u80c3\u764c\u4f5c\u4e3a\u7814\u7a76\u4eba\u7fa4\u5b58\u5728\u64cd\u4f5c\u96be\u5ea6\uff0c\u9700\u614e\u91cd\u8003\u8651\u3002<\/span><\/span><\/p>\n

\u7ed9\u836f\u65b9\u6848<\/span><\/strong>\/<\/span><\/strong>\u5242\u91cf\uff1a<\/span><\/strong>\u8d6b\u8d5b\u6c40\u5728\u4e0d\u540c\u9002\u5e94\u75c7\u4e0d\u540c\u7684\u8054\u5408\u65b9\u6848\u4e2d\u53ef\u9009\u62e9<\/span>3<\/span>\u5468\u4e00\u6b21\uff08\u521d\u59cb\u8d1f\u8377\u5242\u91cf\u4e3a<\/span>8mg\/kg<\/span>\uff0c\u968f\u540e<\/span>6mg\/kg<\/span>\u6bcf<\/span>3<\/span>\u5468\u7ed9\u836f\u4e00\u6b21\uff09\u548c\u6bcf\u5468\u4e00\u6b21\uff08\u521d\u59cb\u8d1f\u8377\u5242\u91cf\u4e3a<\/span>4mg\/kg<\/span>\uff0c\u968f\u540e<\/span>2mg\/kg<\/span>\u6bcf\u5468\u7ed9\u836f\u4e00\u6b21\uff09\u7684\u7ed9\u836f\u65b9\u6848\uff0c\u7528\u4e8e\u8f6c\u79fb\u6027\u80c3\u764c\u5219\u4e3a<\/span>3<\/span>\u5468\u4e00\u6b21\u7ed9\u836f\u65b9\u6848\u3002\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u4e2d\u5e94\u9009\u62e9\u4e0e\u539f\u7814\u836f\u56fd\u5185\u83b7\u6279\u7684\u7ed9\u836f\u5242\u91cf\u4e00\u81f4\u3002<\/span><\/span><\/p>\n

\u7814\u7a76\u7ec8\u70b9<\/span><\/strong>\uff1a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u7684\u9009\u62e9\u5e94\u57fa\u4e8e\u80fd\u654f\u611f\u7504\u522b\u51fa\u5019\u9009\u836f\u4e0e\u53c2\u7167\u836f\u7684\u4e34\u5e8a\u7597\u6548\u5dee\u5f02\uff0c\u800c\u80bf\u7624\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u4e2d\u5e38\u7528\u7684\u7597\u6548\u7ec8\u70b9<\/span>PFS<\/span>\u3001\u603b\u751f\u5b58\u671f\uff08<\/span>overall survival, OS\uff09<\/span><\/span>\u5e76\u4e0d\u662f\u6700\u654f\u611f\u7684\u6307\u6807\u3002<\/span>EMA<\/span>\u63a8\u8350\u9009\u62e9\u53ef\u76f4\u63a5\u53cd\u6620\u836f\u7269\u4f5c\u7528\u6d3b\u6027\u7684\u4e34\u5e8a\u7ec8\u70b9\u5982<\/span>ORR<\/span>\u6216<\/span>pCR<\/span>[3]<\/span><\/sup>\u3002\u8d6b\u8d5b\u6c40\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u835f\u8403\u5206\u6790\u4e5f\u63d0\u793a\uff0c<\/span>pCR<\/span>\u548c<\/span>ORR<\/span>\u5206\u522b\u4e3a<\/span>HER2<\/span>\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u65b0\u8f85\u52a9\u6cbb\u7597\u548c\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u4e00\u7ebf\u6cbb\u7597\u7684\u654f\u611f\u7684\u7597\u6548\u7ec8\u70b9\u6307\u6807<\/span>[6]<\/span><\/sup>\uff0c\u53ef\u4f5c\u4e3a\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u4e3b\u8981\u7ec8\u70b9\u3002<\/span><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u8054\u5408\u5316\u7597\u7528\u4e8e<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u4e00\u7ebf\u6cbb\u7597\u65f6\uff0c\u6709\u6548\u5316\u7597\u5e94\u6301\u7eed<\/span>6~8<\/span>\u4e2a\u5468\u671f\uff0c\u5316\u7597\u505c\u6b62\u540e\u66f2\u59a5\u73e0\u5355\u6297\u7ee7\u7eed\u7ef4\u6301\u6cbb\u7597\uff0c\u5982\u9009\u62e9\u66f2\u59a5\u73e0\u5355\u6297\u8054\u5408\u5316\u7597\u7684\u65b9\u6848\uff0c\u5e38\u9009\u62e9<\/span>24<\/span>\u5468<\/span>(8<\/span>\u4e2a\u5468\u671f<\/span>)<\/span>\u7684<\/span>ORR<\/span>\u4f5c\u4e3a\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u3002\u540c\u65f6\u63d0\u4f9b<\/span>PFS<\/span>\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08<\/span>duration of response<\/span>\uff0c<\/span>DoR<\/span>\uff09\u3001<\/span>OS<\/span>\u7b49\u6b21\u8981\u7ec8\u70b9\u6307\u6807\u4f5c\u4e3a\u652f\u6301\u3002<\/span><\/span><\/p>\n

\u754c\u503c\u9009\u62e9\u4e0e\u6837\u672c\u91cf\u8ba1\u7b97\uff1a<\/span><\/strong>\u76ee\u524d\u56fd\u9645\u4e0a\u5b66\u672f\u754c\u8ba1\u7b97\u8bbe\u5b9a\u754c\u503c\u65f6\u5bf9\u4f7f\u7528\u5019\u9009\u836f\u4e0e\u53c2\u7167\u7a76\u7ec8\u70b9\u7684\u5dee\u503c\uff08<\/span>Risk Difference<\/span>\uff0c<\/span>RD<\/span>\uff09\u6216\u8005\u6bd4\u503c\uff08<\/span>Risk Ratio<\/span>\uff0c<\/span>RR<\/span>\uff09\u4ecd\u5b58\u5728\u4e89\u8bae\u3002<\/span>RR<\/span>\u4e0e<\/span>RD<\/span>\u5728\u5927\u90e8\u5206\u60c5\u51b5\u4e0b\u662f\u76f8\u5f53\u7684\uff0c\u4ee5<\/span>RR<\/span>\u8ba1\u7b97\u8bbe\u5b9a\u66f2\u59a5\u73e0\u5355\u6297\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u7684\u7b49\u6548\u754c\u503c\u3002<\/span><\/span><\/p>\n

\u7b49\u6548\u754c\u503c\u53ef\u57fa\u4e8e\u53c2\u7167\u836f\u6cbb\u7597\u6548\u5e94\u7684\u7f6e\u4fe1\u533a\u95f4\u4e0b\u9650\u4f30\u7b97\u5f97\u5230\uff0c\u53c2\u7167\u836f\u6cbb\u7597\u6548\u5e94\u5219\u662f\u53c2\u7167\u836f\u7ec4\u4e0e\u5bf9\u7167\u7ec4\u7684\u7597\u6548\u6bd4\u503c<\/span>\/<\/span>\u5dee\u503c\u3002\u4f8b\u5982\u9009\u62e9\u8054\u5408\u7d2b\u6749\u7c7b\u4e00\u7ebf\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u9002\u5e94\u75c7\u5f00\u5c55\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\uff0c\u53ef\u57fa\u4e8e<\/span>3<\/span>\u9879\u8d6b\u8d5b\u6c40\u8054\u5408\u7d2b\u6749\u7c7b\u5bf9\u6bd4\u5355\u7528\u7d2b\u6749\u7c7b\u5316\u7597\u4e00\u7ebf\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u7684<\/span>II\/III<\/span>\u671f\u968f\u673a\u5bf9\u7167\u7814\u7a76\uff0c\u901a\u8fc7\u835f\u8403\u5206\u6790\u5f97\u5230\u8d6b\u8d5b\u6c40\u8054\u5408\u7d2b\u6749\u7c7b\u4e0e\u5355\u7528\u7d2b\u6749\u7c7b\u4e00\u7ebf\u6cbb\u7597<\/span>HER2<\/span>\u9633\u6027<\/span>MBC<\/span>\u7684<\/span>ORR<\/span>\u7684\u6bd4\u503c\uff08<\/span>RR<\/span>\uff09\u7684\u70b9\u4f30\u8ba1\u503c\u53ca<\/span>95%<\/span>\u53ef\u4fe1\u533a\u95f4\u4e3a<\/span>1.92(1.544, 2.386)<\/span>\uff0c\u5373\u4e3a\u8d6b\u8d5b\u6c40\u5728\u6b64\u9002\u5e94\u75c7\u4e2d\u7684\u6cbb\u7597\u6548\u5e94<\/span>[12]<\/span><\/sup>\u3002\u901a\u5e38\u5c06\u4fdd\u7559\u53c2\u7167\u836f\u6cbb\u7597\u6548\u5e94\u7684<\/span>50%<\/span>\u4f5c\u4e3a\u7b49\u6548\u754c\u503c\u7684\u8bbe\u5b9a\u89c4\u5219\uff0c\u4fdd\u5b88\u7684\u4f30\u8ba1\u8d6b\u8d5b\u6c40\u6cbb\u7597\u6548\u5e94\u4e3a<\/span>1.544<\/span>\uff08\u5373<\/span>95%<\/span>\u53ef\u4fe1\u533a\u95f4\u4e0b\u9650\uff09\uff0c\u90a3\u4e48\u4fdd\u7559\u5176\u6cbb\u7597\u6548\u5e94\u7684<\/span>50%<\/span>\u4e3a<\/span>1.24<\/span>\uff0c\u5373\u7b49\u6548\u8303\u56f4\u7684\u4e0a\u754c\uff0c\u4e0b\u754c\u5219\u4e3a<\/span>0.81 (1\/1.24=0.81)<\/span>\u3002\u5728\u9488\u5bf9\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u4f1a\u8bae\u8ba8\u8bba\u4e2d\uff0c\u5efa\u8bae\u754c\u503c\u6309<\/span>RR<\/span>\u8bbe\u5b9a\u4e3a\uff08<\/span>0.8<\/span>\uff0c<\/span>1.25<\/span>\uff09\u3002\u5982\u679c\u524d\u671f<\/span>PK<\/span>\u6bd4\u5bf9\u7814\u7a76\u6570\u636e\u8868\u660e\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u53c2\u7167\u836f\u5177\u6709\u4e00\u81f4\u6027\uff0c\u90a3\u4e48\u91c7\u7528\u5b9e\u9645<\/span>RR<\/span>\u7684<\/span>90%<\/span>\u4ee5\u4e0a\u7f6e\u4fe1\u533a\u95f4\u8fdb\u884c\u7b49\u6548\u6027\u5224\u65ad\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff0c\u628a\u63e1\u5ea6\u901a\u5e38\u4e0d\u4f4e\u4e8e<\/span>80%<\/span>\uff0c\u57fa\u4e8e\u4e0a\u8ff0\u53c2\u6570\u5408\u7406\u4f30\u7b97\u6837\u672c\u91cf\u3002\u5982\u6309\u5168\u7403\u5f00\u53d1\u7b56\u7565\uff0c\u5219\u9700\u8981\u8003\u8651\u6ee1\u8db3\u4e0d\u540c\u76d1\u7ba1\u90e8\u95e8\u7684\u8981\u6c42\u3002<\/span><\/span><\/p>\n

3. <\/span><\/strong>\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

\u514d\u75ab\u539f\u6027\u7814\u7a76\u662f\u751f\u7269\u5927\u5206\u5b50\u836f\u7269\u7279\u6709\u4e14\u91cd\u8981\u7684\u7814\u7a76\u9879\u76ee\uff0c\u5e94\u8d2f\u7a7f\u5728\u6574\u4e2a\u7814\u53d1\u8fc7\u7a0b\u4e2d\u3002\u5019\u9009\u751f\u7269\u7c7b\u4f3c\u836f\u514d\u75ab\u539f\u6027\u7684\u7814\u7a76\u53ef\u4ee5\u4e0e\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u5728\u540c\u4e00\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e00\u5e76\u8003\u5bdf\uff0c\u514d\u75ab\u539f\u6027\u4e3b\u8981\u901a\u8fc7\u68c0\u6d4b\u6297\u836f\u6297\u4f53\uff08<\/span>anti-drug antibody<\/span>\uff0c<\/span>ADA<\/span>\uff09\u548c\u4e2d\u548c\u6297\u4f53<\/span>(neutralization antibody<\/span>\uff0c<\/span>Nab)<\/span>\u7684\u53d1\u751f\u7387\u6765\u8bc4\u4ef7\u3002<\/span><\/span><\/p>\n

\u76ee\u524d\u53ef\u83b7\u5f97\u7684\u8d6b\u8d5b\u6c40\u514d\u75ab\u539f\u6027\u7684\u4fe1\u606f\u8f83\u6709\u9650\uff1a\u5728\u65e9\u671f\u4e73\u817a\u764c\u65b0\u8f85\u52a9\u6cbb\u7597\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u9759\u8109\u6ce8\u5c04\u7ec4\u6709<\/span>8.1%<\/span>\uff08<\/span>24\/296<\/span>\uff09\u7684\u60a3\u8005\u4ea7\u751f\u4e86\u6297\u66f2\u59a5\u73e0\u5355\u6297\u7684\u6297\u4f53\uff08\u65e0\u8bba\u57fa\u7ebf\u65f6\u662f\u5426\u5b58\u5728\u6297\u4f53\uff09\uff0c\u5176\u4e2d<\/span>2<\/span>\u4f8b\u7684\u57fa\u7ebf\u540e\u6837\u54c1\u4e2d\u68c0\u6d4b\u5230\u6297\u66f2\u59a5\u73e0\u5355\u6297\u7684\u4e2d\u548c\u6297\u4f53\u3002\u8fd9\u4e9b\u6297\u4f53\u7684\u4e34\u5e8a\u76f8\u5173\u6027\u5c1a\u4e0d\u6e05\u695a\uff0c\u4f46\u662f\uff0c\u9759\u8109\u6ce8\u5c04\u66f2\u59a5\u73e0\u5355\u6297\u7ec4\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u7597\u6548\u6216\u7531\u6cbb\u7597\u76f8\u5173\u7684\u4e0d\u826f\u53cd\u5e94\u8bc4\u4f30\u7684\u5b89\u5168\u6027\u6ca1\u6709\u663e\u793a\u53d7\u5230\u8fd9\u4e9b\u6297\u4f53\u7684\u4e0d\u826f\u5f71\u54cd\u3002\u7ed3\u5408<\/span>ADA<\/span>\u8fdf\u53d1\u4ea7\u751f\u7684\u4e00\u822c\u7ecf\u9a8c\u89c4\u5f8b\uff0c\u5efa\u8bae\u66f2\u59a5\u73e0\u5355\u6297\u4e34\u5e8a\u514d\u75ab\u539f\u6027\u6bd4\u5bf9\u7814\u7a76\u5e94\u6709\u8db3\u591f\u957f\u65f6\u95f4\u95f4\u9694\u7684\u6570\u636e\u4ee5\u8bc1\u5b9e\u5019\u9009\u836f\u4e0e\u53c2\u7167\u836f\u5728<\/span>ADA<\/span>\u9633\u6027\u7387\u548c\u6301\u7eed\u65f6\u95f4\u7b49\u65b9\u9762\u5747\u5177\u6709\u76f8\u4f3c\u6027\uff0c\u901a\u5e38\u5e94\u81f3\u5c11\u5305\u62ec\u672b\u6b21\u7ed9\u836f\u540e\u4e00\u4e2a\u6708\u53ca\u7ed3\u675f\u6cbb\u7597\u8bbf\u89c6\u7b49\u91c7\u6837\u65f6\u95f4\u70b9\u3002\u5efa\u8bae\u5bf9\u51fa\u73b0\u5f02\u5e38\u60c5\u51b5\u7684\u75c5\u4f8b\u6839\u636e\u9700\u8981\u9002\u65f6\u589e\u52a0\u68c0\u6d4b\u70b9\uff0c\u5fc5\u8981\u65f6\u5e94\u8003\u5bdf<\/span>ADA<\/span>\u6ef4\u5ea6\u548c\u4e2d\u548c\u6d3b\u6027\u7b49\u3002\u5019\u9009\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u8fc7\u7a0b\u76f8\u5bf9\u7b80\u5316\u3001\u89c2\u5bdf\u65f6\u95f4\u8f83\u77ed\uff0c\u4ea7\u54c1\u7684\u514d\u75ab\u539f\u6027\u5e76\u4e0d\u4e00\u5b9a\u5728\u6709\u9650\u7684\u7814\u7a76\u8fc7\u7a0b\u4e2d\u88ab\u5145\u5206\u68c0\u6d4b\u5230\uff0c\u56e0\u6b64\uff0c\u5efa\u8bae\u7533\u529e\u65b9\u5236\u5b9a\u8be6\u7ec6\u7684\u4e0a\u5e02\u540e\u514d\u75ab\u539f\u6027\u8bc4\u4ef7\u7684\u8ba1\u5212\uff0c\u5305\u62ec\u5efa\u8bae\u7684\u89c2\u5bdf\u65f6\u9650\u3001\u9700\u6536\u96c6\u7684\u68c0\u6d4b\u6307\u6807\u7b49\u3002<\/span><\/span><\/p>\n

\u5b89\u5168\u6027\u6bd4\u5bf9\u7814\u7a76\u540c\u6837\u5728<\/span>PK<\/span>\u548c<\/span>\/<\/span>\u6216\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u4e2d\u8fdb\u884c\uff0c\u5bf9\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7684\u7c7b\u578b\u3001\u4e25\u91cd\u7a0b\u5ea6\u548c\u9891\u7387\u7b49\u8fdb\u884c\u89c2\u5bdf\u6bd4\u8f83\uff0c\u5c24\u5176\u662f\u91cd\u70b9\u5173\u6ce8\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u5982\u5fc3\u810f\u6bd2\u6027\u3002\u5efa\u8bae\u63d0\u4f9b\u8db3\u591f\u957f\u89c2\u5bdf\u5468\u671f\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u4ee5\u5145\u5206\u66b4\u9732\u6f5c\u5728\u7684\u98ce\u9669\u3002<\/span><\/span><\/p>\n

\u56db\u3001\u5c0f\u7ed3<\/span><\/strong><\/span><\/p>\n

\u66f2\u59a5\u73e0\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u9075\u5faa\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u76f8\u4f3c\u6027\u8bc4\u4ef7\u7684\u4e00\u822c\u539f\u5219\uff0c\u5373\u5e94\u5f53\u5728\u6709\u5408\u7406\u79d1\u5b66\u4f9d\u636e\u7684\u524d\u63d0\u4e0b\u5c3d\u53ef\u80fd\u7684\u7b80\u5316\uff0c\u4ee5\u80fd\u8bc1\u5b9e\u5019\u9009\u836f\u4e0e\u539f\u7814\u4ea7\u54c1\u7684\u76f8\u4f3c\u6027\u4e3a\u76ee\u6807\uff0c\u540c\u65f6\u5e94\u517c\u987e\u5176\u4ea7\u54c1\u7279\u5f02\u6027\uff0c\u6709\u9488\u5bf9\u6027\u7684\u8fdb\u884c\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u8bbe\u8ba1\u3002\u9f13\u52b1\u4f01\u4e1a\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5c3d\u65e9\u5c31\u751f\u7269\u7c7b\u4f3c\u836f\u4ea7\u54c1\u7684\u5f00\u53d1\u7b56\u7565\u548c\u7814\u7a76\u8bbe\u8ba1\u4e0e\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5f00\u5c55\u6c9f\u901a\u4ea4\u6d41\uff0c\u4ee5\u5728\u5173\u952e\u6027\u95ee\u9898\u4e0a\u8fbe\u6210\u5171\u8bc6\uff0c\u63d0\u9ad8\u7814\u53d1\u6548\u7387\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u6ce8\u5c04\u7528\u66f2\u59a5\u73e0\u5355\u6297\u8bf4\u660e\u4e66,2019.\u5317\u4eac:\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40.<\/span><\/p>\n

\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09. \u5317\u4eac:\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40.. http:\/\/www.nmpa.gov.cn\/WS04\/CL2138\/300003.html.<\/span><\/p>\n

European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies \u2013 non-clinical and clinical issues.. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf.<\/span><\/p>\n

\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219. \u5317\u4eac:\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. http:\/\/www.nmpa.gov.cn\/WS04\/CL2042.<\/span><\/p>\n

U.S. Food and Drug Administration. Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm397017.pdf<\/span><\/p>\n

JACKISCH C, SCAPPATICCI FA, HEINZMANN D, et al. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation[J]. Future Oncol. 2015, 11:61-71.<\/span><\/p>\n

GASPARINI G, GION M, MARIANI L, et al. Randomized phase trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with HER-2 positive advanced breast cancer[J]. Breast Cancer Res Treat. 2007, 101(3):355-365.<\/span><\/p>\n

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