{"id":123263,"date":"2020-04-16T10:34:30","date_gmt":"2020-04-21T01:10:09","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/123263\/"},"modified":"2020-04-21T09:10:10","modified_gmt":"2020-04-21T01:10:10","slug":"9fea09a742","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/123263\/","title":{"rendered":"CDE\u300a\u5730\u8212\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u6076\u6027\u80bf\u7624\u9002\u5e94\u75c7\uff09\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b"},"content":{"rendered":"
\n

\"CDE\u300a\u5730\u8212\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u6076\u6027\u80bf\u7624\u9002\u5e94\u75c7\uff09\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\"<\/p>\n

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\u8054\u7cfb\u4eba\uff1a\u5f20\u8679\u3001\u8d75\u8096<\/span><\/p>\n

\u8054\u7cfb\u65b9\u5f0f\uff1azhanghong@cde.org.cn\uff0czhaox@cde.org.cn<\/span><\/p>\n

\u611f\u8c22\u60a8\u7684\u53c2\u4e0e\u548c\u5927\u529b\u652f\u6301\u3002<\/span><\/p>\n


<\/section>\n
\u9644\u4ef6<\/span>1<\/span><\/section>\n
 <\/span><\/section>\n
\u5730\u8212\u5355\u6297\u6ce8\u5c04\u6db2\u751f\u7269\u7c7b\u4f3c\u836f\uff08\u6076\u6027\u80bf\u7624\u9002\u5e94\u75c7\uff09\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09<\/span><\/strong><\/span><\/section>\n
 <\/span><\/section>\n
\u4e00\u3001<\/span><\/strong>\u6982\u8ff0<\/span><\/strong><\/span><\/section>\n
\u5730\u8212<\/span>\u5355\u6297\uff08Denosumab\uff09\u662f<\/span>\u5728\u4e2d\u56fd\u4ed3\u9f20\u5375\u5de2\u7ec6\u80de\u4e2d\u8868\u8fbe\u7684\u5168\u4eba<\/span>\u5355\u514b\u9686\u514d\u75ab\u7403\u86cb\u767d<\/span>G2 (IgG2) \u6297\u4f53\uff0c\u4f5c\u7528\u4e8e\u6838\u56e0\u5b50<\/span><\/span>\u03baB\u53d7\u4f53\u6fc0\u6d3b\u56e0\u5b50\uff08<\/span><\/span>RANK\uff09\u914d\u4f53<\/span>\u3002\u8be5<\/span>\u54c1\u79cd\u7531\u7f8e\u56fd\u5b89\u8fdb<\/span>\u516c\u53f8\u7814\u53d1\u4e0a\u5e02<\/span>\uff0c\u6839\u636e<\/span>\u9002\u5e94\u75c7\u4e0d\u540c\uff0c\u6709\u4e24\u4e2a<\/span>\u89c4\u683c\u7684<\/span>\u4ea7\u54c1\uff0c\u5546\u54c1\u540d\u5206\u522b<\/span>\u4e3a\uff1aXGEVA<\/span>\u00ae<\/span><\/sup>\uff08<\/span>70mg\/ml\uff0c<\/span>120mg:1.7ml<\/span>\uff09\u548c<\/span>PROLIA<\/span>\u00ae<\/span><\/sup>\uff08<\/span>60mg\/ml\uff0c<\/span>60<\/span><\/span>mg:1<\/span>ml\uff09<\/span>\u3002\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u5730\u8212\u5355\u6297\u4ee5\u5546\u54c1<\/span>\u540d<\/span>XGEVA\u00d2<\/span><\/sup>\uff08\u4ee5\u53ca\u5728\u65e5\u672c\u4ee5\u5546\u54c1\u540d<\/span>R<\/span>ANMARK\u00d2<\/span><\/sup>\uff09\u83b7\u6279\u7528\u4e8e\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u548c\u5b9e\u4f53\u80bf\u7624\u9aa8\u8f6c\u79fb\u60a3\u8005\u4e2d\u9aa8<\/span>\u76f8\u5173\u4e8b\u4ef6\uff08skeletal<\/span>-related event\uff0cSRE\uff09\u7684\u9884\u9632\uff0c\u4ee5\u53ca\u9aa8\u5de8\u7ec6\u80de\u7624 <\/span>(<\/span><\/span>giant cell tumor of bone\uff0cGCTB) \u6210\u4eba\u548c\u9aa8\u9abc\u6210\u719f\u7684\u9752\u5c11\u5e74\u60a3\u8005\u7684\u6cbb\u7597\u3002\u5728\u4e00\u4e9b\u56fd\u5bb6\uff0c<\/span>XGEVA<\/span><\/span>\u00d2<\/span><\/sup>\u8fd8\u88ab\u6279\u51c6\u7528\u4e8e\u53cc\u81a6\u9178\u76d0\u96be\u6cbb\u7684\u6076\u6027\u80bf\u7624\u9ad8\u9499\u8840\u75c7\u7684\u6cbb\u7597<\/span>[<\/span><\/sup>1<\/span><\/sup>]<\/span><\/sup>\u3002\u5730\u8212\u5355\u6297\u4ee5\u5546\u54c1\u540d\u79f0<\/span>PROLIA<\/span>\u00d2<\/span><\/sup>\u83b7\u6279\u7528\u4e8e\u7edd\u7ecf\u540e\u9aa8\u8d28\u758f\u677e\u75c7\u3002<\/span><\/span><\/section>\n
2019\u5e74<\/span>5<\/span>\u6708\u5730\u8212\u5355\u6297\u5728<\/span>\u4e2d\u56fd\u5927\u9646\u83b7\u6279<\/span>\u4e0a\u5e02<\/span>[<\/span><\/sup>2<\/span><\/sup>]<\/span><\/sup>\uff0c\u5546\u54c1\u540d\u4e3a<\/span>\u5b89\u52a0\u7ef4<\/span>\u00d2<\/span><\/sup>\uff0c\u6279\u51c6\u7684\u9002\u5e94\u75c7\u4e3a\uff1a<\/span>\u7528\u4e8e\u6cbb\u7597\u4e0d\u53ef\u624b\u672f<\/span>\u5207\u9664\u6216\u8005\u624b\u672f\u5207\u9664\u53ef\u80fd\u5bfc\u81f4\u4e25\u91cd\u529f\u80fd\u969c\u788d\u7684\u9aa8\u5de8\u7ec6\u80de\u7624\uff0c\u5305\u62ec<\/span>\u6210\u4eba\u548c\u9aa8\u9abc\u53d1\u80b2\u6210\u719f\uff08\u5b9a\u4e49\u4e3a\u81f3\u5c11<\/span>1\u5904\u6210\u719f\u957f\u9aa8\u4e14\u4f53\u91cd<\/span>\u226545 kg\uff09\u7684<\/span>\u9752\u5c11\u5e74\u60a3\u8005\u3002<\/span><\/span><\/span><\/section>\n
\u5730\u8212<\/span>\u5355\u6297\u5e8f\u5217\u7684\u4e2d<\/span>\u56fd\u4e13\u5229\u5c06<\/span>\u4e8e<\/span>2022\u5e74\u5230\u671f\uff0c\u56fd\u5185\u5236\u836f<\/span>\u4f01\u4e1a\u7eb7\u7eb7\u52a0\u5165\u5176\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7814\u53d1\u3002\u672c\u6587\u5728\u539f<\/span>\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\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><\/sup>3<\/span><\/sup>]<\/span><\/sup>\uff08\u4ee5\u4e0b\u7b80\u79f0<\/span>\u201c\u6307\u5bfc\u539f\u5219\u201d\uff09\u57fa\u7840\u4e0a\uff0c\u7ed3\u5408\u5730\u8212<\/span>\u5355\u6297\u7684\u7279\u70b9\uff0c\u91cd\u70b9<\/span>\u63a2\u8ba8\u5f53\u524d<\/span>\u666e\u904d\u5173\u6ce8\u7684\u4e34\u5e8a\u7814\u7a76\u7b56\u7565\u548c\u4e34\u5e8a<\/span>\u8bd5\u9a8c\u8bbe\u8ba1\u95ee\u9898\uff0c\u4ee5\u671f\u4e3a\u56fd\u5185\u5730\u8212\u5355\u6297<\/span>\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u4e34\u5e8a\u7814\u53d1\u63d0\u4f9b\u53c2\u8003<\/span>\u3002\u672c\u6587<\/span>\u4ec5\u8ba8\u8bba\u5e94\u7528<\/span>\u4e8e\u80bf\u7624\u60a3\u8005\u7684XGEVA<\/span>\u00ae<\/span><\/sup>\u751f\u7269<\/span>\u7c7b\u4f3c\u836f<\/span>\u7684\u7814\u53d1\u8003\u8651<\/span>\u3002<\/span> <\/span><\/section>\n
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\u539f\u5219\u4e0a\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u8bd5\u9a8c\u9700\u8981\u8fdb\u884c<\/span>1\u9879\u5065\u5eb7<\/span>\u53d7\u8bd5\u8005\u5355\u6b21<\/span>\u7ed9\u836f\u836f\u4ee3<\/span>\u52a8\u529b\u5b66\u6bd4\u5bf9<\/span>\u7814\u7a76\uff0c\u9a8c\u8bc1<\/span>\u5019\u9009\u836f\u4e0e\u539f\u7814\u836fPK\u7279\u5f81\u7684\u76f8\u4f3c\u6027\u3002\u4e34\u5e8a<\/span>\u6bd4\u5bf9\u7814\u7a76\u9700<\/span>\u9009\u62e9\u56fd\u5185\u5df2\u7ecf\u83b7<\/span>\u6279\u9002\u5e94\u75c7\u4eba\u7fa4\uff0c\u4e0e\u539f\u7814\u836f\u8fdb\u884c1\u9879<\/span><\/span>\u201c\u5934\u5bf9\u5934<\/span>\u201d<\/span>\u6bd4\u8f83\u7684\u4e34\u5e8a<\/span>\u7b49\u6548\u6027\u7814\u7a76\u4ee5\u652f\u6301\u5176<\/span>\u6ce8\u518c\u4e0a\u5e02<\/span>\u3002\u6309\u6b64\u4e34\u5e8a<\/span>\u7814\u53d1\u601d\u8def\uff0c<\/span>\u5b8c\u6210\u5355\u4e2a\u9002\u5e94\u75c7\u7684\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\uff0c<\/span>\u53ef\u5bfb\u6c42<\/span>\u5916\u63a8\u5176\u5b83\u76f8\u540c<\/span>\u4f5c\u7528\u673a\u5236\u9002\u5e94\u75c7\uff0c<\/span>\u540c\u65f6\u5e94\u8003\u8651\u5176\u4e0e\u539f\u7814\u836f\u7684\u6574\u4f53\u76f8\u4f3c\u6027\u3002<\/span><\/span><\/section>\n
\u4e09\u3001<\/span><\/strong>\u5730\u8212<\/span><\/strong>\u5355\u6297\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u8981\u70b9<\/span><\/strong><\/span><\/section>\n
\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u6bd4\u5bf9\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\u3002<\/span>\u4e34\u5e8a\u7814\u7a76\u4e2d\u5e94\u91c7\u7528\u4e0e\u56fd\u5185<\/span>\u8fdb\u53e3\u76f8\u540c\u6765\u6e90\u7684\u539f\u7814\u836f\u4f5c\u4e3a<\/span>\u5bf9\u7167\u3002\u5982\u679c\u9009\u62e9\u5176\u4ed6\u6765\u6e90\u7684<\/span>\u539f\u7814\u4ea7\u54c1<\/span>\uff0c\u5e94\u63d0\u4f9b\u4e0e\u56fd\u5185\u8fdb\u53e3\u5730\u8212<\/span>\u5355\u6297\u539f<\/span>\u7814\u836f\u7684\u53ef\u6bd4\u6027\u8bc1\u636e\u3002<\/span><\/span><\/section>\n
\uff08\u4e00\uff09<\/span><\/strong>\u836f\u4ee3\u52a8\u529b\u5b66\u6bd4\u5bf9\u7814\u7a76<\/span><\/strong><\/span><\/section>\n
\u8bd5\u9a8c\u8bbe\u8ba1\uff1a<\/span><\/strong>\u5730\u8212\u5355\u6297\u534a\u8870\u671f\u8f83\u957f\uff0c\u5e73\u5747\u6d88\u9664<\/span>\u534a\u8870\u671f\u4e3a28\u5929<\/span>\uff0c\u4e14\u5177\u6709\u6f5c\u5728\u514d\u75ab\u539f\u6027\u7b49\u7279\u5f81<\/span>\uff0c\u5efa\u8bae\u91c7\u7528\u5355\u6b21\u7ed9\u836f\u7684<\/span>\u968f\u673a\u3001\u53cc\u76f2\u3001\u5e73\u884c\u5bf9\u7167\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u8bc4\u4ef7\u5176PK\u7279\u5f81\u7684\u76f8\u4f3c\u6027<\/span>\u3002 <\/span><\/span><\/section>\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<\/span>\u4e4b\u95f4<\/span>PK\u7279\u5f81\u7684\u4e00\u81f4\u6027\uff0c\u4ec5<\/span>\u9009\u62e9\u5065\u5eb7\u6210\u5e74<\/span>\u7537\u6027\u5fd7\u613f\u8005\u662f\u53ef\u884c<\/span>\u7684\u3002\u7531\u4e8e<\/span>\u5730\u8212<\/span>\u5355\u6297\u7684\u6e05\u9664\u7387<\/span>\u548c\u5206\u5e03\u5bb9\u79ef\u53d7<\/span>\u4f53\u91cd\u5f71\u54cd\uff0c\u5efa\u8bae\u5c3d\u91cf<\/span>\u63a7\u5236\u53d7\u8bd5\u8005\u4f53\u91cd\u5728<\/span>\u76f8\u5bf9\u8f83\u7a84\u7684\u8303\u56f4\u5185\u3002<\/span><\/span><\/span><\/section>\n
\u5242\u91cf\u53ca\u7ed9\u836f\u9014\u5f84\uff1a<\/span><\/strong>\u9009\u62e9\u7684\u7ed9\u836f\u5242\u91cf\u5e94\u80fd\u654f\u611f\u5730\u5206\u8fa8\u5019\u9009\u836f\u548c\u539f<\/span>\u7814\u836f<\/span><\/span>PK\u7279\u5f81\u5dee\u5f02\u3002<\/span>\u5730\u8212<\/span>\u5355\u6297\u5242\u91cf\u4f4e\u4e8e<\/span><\/span>60 mg\u65f6<\/span>\u5448\u975e\u7ebf\u6027\u836f\u4ee3\u52a8\u529b\u5b66<\/span>\uff0c\u4f46\u5728\u66f4\u9ad8\u5242\u91cf\u4e0b\u5730\u8212\u5355\u6297\u66b4\u9732\u4e0e<\/span>\u5242\u91cf\u5448\u5927\u81f4\u7684\u6bd4\u4f8b\u6027\u5347\u9ad8\u3002\u56e0\u6b64<\/span>\uff0c\u63a8\u8350\u91c7\u7528\u5b9e\u9645<\/span>\u5e94\u7528\u4e2d\u7684\u7ed9\u836f\u5242\u91cf\uff0c<\/span>\u5373\uff1a<\/span><\/span>120mg\/<\/span>1.7ml\/\u6b21\uff0c\u76ae\u4e0b\u6ce8\u5c04\u3002\u5efa\u8bae<\/span>\u9009\u62e9\u7edf\u4e00\u7684\u6ce8\u5c04\u90e8\u4f4d\u3002<\/span><\/span><\/section>\n
\u7ec8\u70b9\u6307\u6807\u4e0e\u754c\u503c\uff1a<\/span><\/strong>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<\/span>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d1\u5e03<\/span>\u7684\u300a<\/span>\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\u300b<\/span><\/span>[<\/span><\/sup>4<\/span><\/sup>]<\/span><\/sup>\uff0c<\/span>AUC0-\u221e<\/span><\/sub>\u548c<\/span>Cmax<\/span><\/sub>\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>AUC0-t<\/span><\/sub>\u8fd8\u662f<\/span>AUC0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u7ec8\u70b9\u5c1a\u672a\u5f62\u6210\u4e00\u81f4\u610f\u89c1\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>0-\u221e<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9<\/span>[<\/span><\/sup>5<\/span><\/sup>]<\/span><\/sup>\u3002\u76ee\u524d\u7684\u89c2\u70b9\u8ba4\u4e3a<\/span>AUC0-t<\/span><\/sub>\u662f\u901a\u8fc7\u5b9e\u9645\u6d4b\u91cf\u503c\u8ba1\u7b97\u83b7\u5f97\u7684\uff0c\u8003\u8651\u5230\u751f\u7269\u7c7b\u4f3c\u836f\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u7279\u6027\u548c\u5b9e\u9645\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53d6\u8840\u70b9\u8bbe\u7f6e\u7684\u76f8\u5173\u6027\uff0c\u63a8\u8350<\/span>AUC0-t<\/span><\/sub>\u548c<\/span>Cmax<\/span><\/sub>\u4f5c\u4e3a\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u6307\u6807\uff0c<\/span><\/span>AUC0-\u221e<\/span><\/sub>\u3001\u3001<\/span>t<\/span>max<\/span><\/sub>\u3001<\/span>Vd<\/span><\/sub>\u548c<\/span>t1\/2<\/span><\/sub>\u4f5c\u4e3a\u6b21\u8981\u7814\u7a76\u7ec8\u70b9\u91cd\u70b9\u8fdb\u884c\u6bd4\u8f83\u5206\u6790\u3002<\/span>\u7b49\u6548\u6027\u754c\u503c\u5efa\u8bae\u8bbe\u5b9a\u4e3a<\/span>80%-125%\u3002<\/span><\/span><\/section>\n
\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u901a\u5e38<\/span>90<\/span>%\u7f6e\u4fe1\u533a\u95f4\u53ef\u63a5\u53d7\u7684\u7b49\u6548\u6027\u5224\u65ad\u754c\u503c\u4e3a<\/span>80%-125%<\/span>\uff0c\u4f30<\/span>\u7b97\u6837\u672c\u91cf\u65f6<\/span>\u628a\u63e1\u5ea6\u53ef\u4ee5\u53d6<\/span><\/span>80%\u53ca<\/span>\u4ee5\u4e0a\u3002\u8fd8<\/span>\u5e94\u7ed3\u5408\u539f\u7814\u836f\u65e2\u5f80\u4fe1\u606f\u53ca<\/span>\u836f\u4ee3\u53c2\u6570\u53d8\u5f02\u60c5\u51b5\u7efc\u5408\u8003\u8651<\/span>\u3002<\/span><\/span><\/section>\n
\uff08\u4e8c\uff09\u4e34\u5e8a<\/span><\/strong>\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76<\/span><\/strong><\/span><\/section>\n
XGEVA<\/span>\u00d2<\/span><\/sup>\u5728<\/span>\u5168\u7403\u8303\u56f4\u5185\u83b7\u6279<\/span>\u7684\u9002\u5e94\u75c7\u4e3a\uff1a1\u3001\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u548c\u5b9e\u4f53\u80bf\u7624\u9aa8\u8f6c\u79fb\u60a3\u8005\u4e2d\u9aa8<\/span>\u76f8\u5173\u4e8b\u4ef6\u7684\u9884\u9632\uff1b<\/span>2\u3001\u4e0d\u9002\u5408<\/span>\u624b\u672f\u7684\u9aa8\u5de8\u7ec6\u80de\u7624\u6210\u4eba\u548c\u9aa8\u9abc\u6210\u719f\u7684\u9752\u5c11\u5e74\u60a3\u8005\u7684\u6cbb\u7597\uff1b<\/span>3\u3001\u53cc\u81a6\u9178\u76d0\u96be\u6cbb\u7684\u6076\u6027\u80bf\u7624\u9ad8\u9499\u8840\u75c7\u7684\u6cbb\u7597\u3002\u76ee\u524d<\/span>\u5b89\u52a0\u7ef4\u00ae\u5728<\/span>\u4e2d\u56fd\u4ec5\u83b7\u6279<\/span>\u7528\u4e8e\u9aa8\u5de8\u7ec6\u80de\u7624\u9002\u5e94\u75c7\uff0c\u4f46\u8003\u8651<\/span>\u9aa8\u5de8\u7ec6\u80de\u7624\u60a3\u8005<\/span>\u6570\u91cf\u8f83\u5c11\uff0c\u8fdb\u884c\u4e34\u5e8a<\/span>\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u5b9e\u65bd\u56f0\u96be\u8f83\u5927\uff0c\u5efa\u8bae<\/span>\u5728\u5b9e\u4f53\u80bf\u7624\u9aa8\u8f6c\u79fb\u60a3\u8005\u4e2d\u8fdb\u884c<\/span>\u5730\u8212\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u3002<\/span><\/span><\/span><\/section>\n
\u8bd5\u9a8c\u8bbe\u8ba1\uff1a<\/span><\/strong>\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u7684\u4e3b\u8981<\/span>\u76ee\u7684\u662f\u8bc1\u660e\u751f\u7269<\/span>\u7c7b\u4f3c\u836f\u4e0e\u539f\u7814\u836f\u4e34\u5e8a\u7597\u6548\u7684\u76f8\u4f3c\uff0c\u63a8\u8350\u91c7\u7528\u7b49\u6548\u6027\u8bbe\u8ba1\uff0c\u4ee5\u8fdb\u53e3\u539f\u7814\u836f\u4e3a\u5bf9\u7167\uff0c\u8fdb\u884c\u968f\u673a\u3001\u53cc\u76f2\u3001\u5e73\u884c\u5bf9\u7167\u8bd5\u9a8c\u3002<\/span><\/span><\/section>\n
\u7ed9\u836f\u65b9\u6848<\/span>\/\u5242\u91cf\uff1a<\/span><\/strong>\u5efa\u8bae\u6309<\/span>\u539f\u7814\u836f\u5883\u5916<\/span>\u8bf4\u660e\u4e66\u4e2d\u6279\u51c6\u7684\u7ed9\u836f\u65b9\u6848\u548c\u5242\u91cf\u7ed9\u836f\uff0c\u5373\uff1a<\/span><\/span>120mg\/<\/span>1.7ml\/\u6b21\uff0c\u6bcf\u56db\u5468\u4e00\u6b21\uff0c\u76ae\u4e0b\u6ce8\u5c04\u3002<\/span><\/span><\/span><\/section>\n
\u4e3b\u8981<\/span><\/strong>\u7ec8\u70b9<\/span><\/strong>\u6307\u6807<\/span><\/strong>\uff1a<\/span><\/strong>\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\u3002\u591a\u79cd\u9aa8\u4ee3\u8c22\u751f\u5316\u6307\u6807\uff0c<\/span>\u5982I\u578b\u80f6\u539f<\/span>C\u7aef\u80bd\uff08<\/span>CT<\/span>x\uff09<\/span>\u3001I\u578b\u80f6\u539fN\u7aef\u80bd\uff08NT<\/span>x\uff09<\/span>\u3001\u9aa8<\/span>\u7279\u5f02\u6027\u78b1\u6027\u78f7\u9178\u9176\uff08<\/span><\/span>BAP\uff09\u7b49<\/span>\uff0c\u53ef\u7528\u4e8e<\/span>\u8bc4\u4ef7\u9aa8\u4ee3\u8c22\u72b6\u6001\u3002\u5728\u591a\u9879\u6076\u6027<\/span>\u80bf\u7624\u9aa8\u8f6c\u79fb\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u7ecf<\/span>\u5c3f\u808c\u9150\u6821\u6b63\u7684\u5c3f<\/span><\/span>NTx\uff08<\/span>uNTx\/uCr\uff09\u5df2\u88ab<\/span>\u8bc1\u660e\u4e0e\u9aa8<\/span>\u76f8\u5173\u4e8b\u4ef6\u7684\u53d1\u751f\u5177\u6709\u76f8\u5173\u6027<\/span><\/span>[6<\/span><\/sup>–<\/span><\/sup>9]<\/span><\/sup>\u3002<\/span>XGEVA\u00d2<\/span><\/sup>\u7684\u6ce8\u518c\u7814\u7a76\u9009\u53d6\u7684\u4e3b\u8981\u7ec8\u70b9\u4e3a\u81f3\u9996\u6b21SRE\u65f6\u95f4\u3002\u7531\u4e8e\u89c2\u5bdf\u5230\u8be5\u7ec8\u70b9\u5dee\u5f02\u7684\u89c2\u6d4b\u5468\u671f\u957f\uff0c\u6240\u9700\u6837\u672c\u91cf\u8f83\u5927\uff0c\u56e0\u6b64\u5728\u5730\u8212<\/span>\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u53d1\u7684\u7814\u7a76\u4e2d\u53ef\u91c7\u53d6\u7597\u6548<\/span>\u66ff\u4ee3\u7ec8\u70b9\uff0c<\/span>\u5373\u9aa8\u8f6c\u5316\u6307\u6807<\/span>uNTx\/uCr\u8ddd<\/span>\u57fa\u7ebf\u503c\u53d8\u5316\u7684<\/span>\u767e\u5206\u6bd4\u4f5c\u4e3a<\/span>\u4e3b\u8981\u7ec8\u70b9\u3002\u53c2\u8003<\/span>\u539f\u7814\u836f\u4e34\u5e8a\u7814\u7a76\u8d44\u6599<\/span>\uff0c\u5728\u5730\u8212\u5355\u6297\u7ed9\u836f\u540e\uff0c<\/span>uNTX\/<\/span>uCr\u5feb\u901f\u3001<\/span>\u6301\u7eed\u964d\u4f4e\uff0c<\/span>\u5c24\u5176\u5728\u7b2c13\u5468\u5de6\u53f3\u65f6\uff0c<\/span>uNTX\/<\/span><\/span>uCr\u964d\u5e45<\/span>\u6700\u5927\u3002\u7531\u6b64\u63a8\u8350\u9009\u62e9\u7b2c<\/span>13\u5468<\/span><\/span>uNTx\/uCr\u8ddd<\/span>\u57fa\u7ebf\u503c\u53d8\u5316\u7684<\/span>\u767e\u5206\u6bd4\u4f5c\u4e3a<\/span>\u4e3b\u8981\u7ec8\u70b9\u3002<\/span><\/span><\/span><\/section>\n
\u4e0d\u540c\u539f\u53d1<\/span>\u90e8\u4f4d\u7684\u5b9e\u4f53\u7624\u60a3\u8005<\/span>uNTX\/uCr\u57fa\u7ebf<\/span>\u503c\u53ef\u80fd\u5b58\u5728<\/span>\u8f83\u5927\u5dee\u5f02\uff0c\u7531\u6b64\u5bfc\u81f4<\/span>\u4e3b\u8981\u7ec8\u70b9\u6d4b\u91cf<\/span>\u503c\u53d8\u5f02\u5927\u3002\u56e0\u6b64<\/span>\uff0c\u5982<\/span>III\u671f\u7814\u7a76\u5165\u7ec4\u591a\u79cd<\/span>\u7624\u79cd\uff0c\u5e94\u5173\u6ce8\u4e3b\u8981<\/span>\u7ec8\u70b9\u6d4b\u91cf\u503c<\/span>\u7684\u53d8\u5f02<\/span>\u60c5\u51b5\u3002<\/span><\/span><\/section>\n
\u7b49\u6548<\/span><\/strong>\u6027\u754c\u503c<\/span><\/strong>\u548c<\/span><\/strong>\u6837\u672c\u91cf\uff1a<\/span><\/strong>\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u7597\u6548\u6bd4\u8f83\u7814\u7a76\u4e2d\uff0c\u9700\u8981\u5408\u7406\u9009\u62e9\u6bd4\u503c\u6216\u5dee\u503c\u4f5c\u4e3a\u4e3b\u8981\u7ec8\u70b9\u6307\u6807\u7684\u6548\u5e94\u91cf\u3002\u7b49\u6548\u6027\u754c\u503c\u4e00\u822c\u57fa\u4e8e\u539f\u7814\u4ea7\u54c1\u7597\u6548\u7684\u7f6e\u4fe1\u533a\u95f4\u8fdb\u884c\u4f30\u7b97\uff0c\u5e76\u7ed3\u5408\u4e34\u5e8a\u610f\u4e49\u8fdb\u884c\u786e\u5b9a\u3002\u539f\u7814\u4ea7\u54c1\u7684\u7597\u6548\u901a\u5e38\u4f9d\u636e\u4e8e\u539f\u7814\u4ea7\u54c1\u4e0e\u6807\u51c6\u6cbb\u7597\uff08\u6216\u5b89\u6170\u5242\uff09\u968f\u673a\u5bf9\u7167\u4f18\u6548\u6027\u7814\u7a76\u7684<\/span>Meta\u5206\u6790\u7ed3\u679c\u5f97\u51fa\u3002<\/span>\u7eb3\u5165<\/span>Meta\u5206\u6790\u6587\u732e\u7684\u9009\u62e9\u3001\u5206\u6790\u7ed3\u679c\u7684\u5229\u7528\u7b49\u9700\u8981\u7efc\u5408\u8003\u8651\u76ee\u6807\u9002\u5e94\u75c7\u56fd\u5185\u5916\u4e34\u5e8a\u5b9e\u8df5\u3001\u79cd\u65cf\u5dee\u5f02\u3001\u6837\u672c\u91cf\u53ef\u884c\u6027\u7b49\u56e0\u7d20\u3002<\/span> <\/span><\/span><\/section>\n
\u6839\u636e<\/span>XGEVA\u00ae<\/span><\/sup>\u4e34\u5e8a\u7814\u7a76\u6570\u636e\u4e2d<\/span>XGEVA\u00ae<\/span><\/sup>\u4e0e\u5511\u6765\u81a6\u9178\u4e24\u7ec4\u7b2c<\/span>13\u5468<\/span>uNTx\/uCr<\/span>\uff08\u5bf9\u6570\u5316\uff09\u8f83\u57fa\u7ebf\u53d8\u5316\u7684\u7ed3\u679c\uff0c\u7ed3\u5408\u4e34\u5e8a\u610f\u4e49\u4ee5\u53ca\u5b9e\u8df5\u64cd\u4f5c\u7684\u53ef\u884c\u6027\uff0c\u5efa\u8bae\u7b49\u6548\u6027\u754c\u503c\u53d6\u503c\u4e3a<\/span>0.135<\/span>\u3002\u8003\u8651\u5230\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u4e2d\u516c\u5171\u6807\u51c6\u5dee\u76f8\u5bf9<\/span>XGEVA<\/span>\u00ae<\/span><\/sup>\u7814\u7a76\u7684\u516c\u5171\u6807\u51c6\u5dee\u53ef\u80fd\u8f83\u5c0f\uff0c\u56e0\u6b64\u5728\u8ba1\u7b97\u6837\u672c\u91cf\u65f6\u53ef\u4ee5\u5bf9\u6807\u51c6\u5dee\u8fdb\u884c\u9002\u5f53\u7684\u8c03\u6574\uff0c\u628a\u63e1\u5ea6\u4e00\u822c\u8bbe\u7f6e\u5728<\/span>80%\u4ee5\u4e0a\uff0c\u57fa\u4e8e\u4e0a\u8ff0\u53c2\u6570\u5bf9\u6837\u672c\u91cf\u8fdb\u884c\u5408\u7406\u7684\u4f30\u7b97\u3002<\/span><\/span><\/section>\n
\uff08\u4e09\uff09\u5176\u4ed6<\/span><\/strong>\u9700\u8981<\/span><\/strong>\u91cd\u70b9<\/span><\/strong>\u5173\u6ce8\u7684\u95ee\u9898<\/span><\/strong><\/span><\/section>\n
1. <\/span><\/strong>\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u7814\u7a76<\/span><\/strong><\/span><\/section>\n
\u514d\u75ab\u539f\u6027\u7814\u7a76\u5e94\u8d2f\u7a7f\u5728\u751f\u7269\u5927\u5206\u5b50\u836f\u7269\u6574\u4e2a\u7814\u53d1\u8fc7\u7a0b\u4e2d\u3002\u514d\u75ab\u539f\u6027\u4e3b\u8981\u901a\u8fc7\u68c0\u6d4b\u6297\u836f\u6297\u4f53\uff08anti-drugs antibodies, <\/span>ADA\uff09\u548c\u4e2d\u548c\u6297\u4f53\uff08<\/span>Nab<\/span>\uff09\u7684\u53d1\u751f\u7387\u6765\u8bc4\u4ef7\u3002<\/span><\/span><\/section>\n
\u514d\u75ab\u539f\u6027\u8bd5\u9a8c\u7ed3\u679c\u4e0e\u68c0\u6d4b\u65b9\u6cd5\u7684\u654f\u611f\u6027\u3001<\/span>\u7279\u5f02\u6027\u53ca\u836f\u7269\u8010\u53d7\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\u901a\u5e38<\/span>\uff0c\u4e34\u5e8a\u514d\u75ab\u539f\u6027\u8003\u5bdf<\/span>\u7814\u7a76\uff08\u5305\u62ec<\/span>ADA\u548cNa<\/span>b\uff09\u4e0e\u4e34\u5e8a\u6709\u6548\u6027\u6bd4\u5bf9\u7814\u7a76\u5728\u540c\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8fdb\u884c\u3002\u63a8\u8350\u6240\u6709<\/span>\u53d7\u8bd5\u8005\u5747\u5e94\u8fdb\u884c\u514d\u75ab\u539f\u6027<\/span>\u7684\u8003\u5bdf\uff0c\u91c7\u6837\u65f6\u95f4\u70b9\u8bbe\u7f6e<\/span>\u5e94\u81f3\u5c11<\/span>\u5305\u62ec\u9996\u6b21\u7ed9\u836f\u524d\uff0c<\/span>\u7b2c4\u5468<\/span>\u6216\/\u548c\u7b2c<\/span>12<\/span>\u5468\uff0c\u53ca<\/span>\u672b\u6b21\u7ed9\u836f\u540e\u4e00\u4e2a\u6708\uff0c<\/span>\u8fdb\u800c\u8bc1\u5b9e\u5019\u9009\u836f\u5728\u6297\u4f53<\/span>\u9633\u6027\u7387\u3001<\/span>\u6297\u4f53\u6ef4\u5ea6\u3001<\/span>\u6297\u4f53\u51fa\u73b0\u65f6\u95f4\u548c\u4e2d\u548c<\/span>\u6297\u4f53\u53d1\u751f\u7387\u7b49\u65b9\u9762\u4e0d\u9ad8\u4e8e<\/span>\u539f\u7814\u836f\u3002\u540c\u65f6\uff0c\u6240\u6d89\u53ca\u7814\u7a76\u5e94\u8bc1\u660e\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u539f\u7814\u836f\u5728\u514d\u75ab\u539f\u6027\u65b9\u9762\u5e94\u4e0d\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u5dee\u522b\u3002<\/span><\/span><\/span><\/section>\n
\u5730\u8212<\/span>\u5355\u6297\u539f\u7814\u4ea7\u54c1\u7684\u514d\u75ab\u539f\u6027\u8f83\u4f4e\uff0c\u53c2\u8003<\/span>\u539f\u7814\u4ea7\u54c1\u7684\u8bf4\u660e\u4e66\uff1a\u201c\u91c7\u7528\u7535\u5316\u5b66\u53d1\u5149\u6865\u63a5\u514d\u75ab\u5206\u6790\uff0c\u63a5\u53d7\u5242\u91cf\u8303\u56f4\u4e3a<\/span>30-180 mg\u6bcf<\/span>4<\/span>\u5468\u4e00\u6b21\u6216\u6bcf<\/span>12<\/span>\u5468\u4e00\u6b21\u957f\u8fbe<\/span>3<\/span>\u5e74\u7684\u5730\u8212\u5355\u6297\u6cbb\u7597\uff0c<\/span>\u5c11\u4e8e<\/span>1%(7\/2758)\u7684\u60a3\u8005\u7ed3\u5408\u6297\u4f53\u8bd5\u9a8c\u5448\u9633\u6027\u3002\u91c7\u7528\u4e00\u79cd\u4f53\u5916\u57fa\u4e8e\u7ec6\u80de\u7684\u5316\u5b66\u53d1\u5149\u751f\u7269\u5206\u6790\u65b9\u6cd5\u8bc4\u4f30\u65f6\uff0c\u7ed3\u5408\u6297\u4f53\u8bd5\u9a8c\u9633\u6027\u7684\u60a3\u8005\u4e2d\u65e0<\/span>1<\/span>\u4f8b\u4e2d\u548c\u6297\u4f53\u8bd5\u9a8c\u5448\u9633\u6027\u201d\u3002\u5efa\u8bae\u5bf9\u5730\u8212\u5355\u6297\u751f\u7269<\/span>\u7c7b\u4f3c\u836f\u514d\u75ab\u539f\u6027\u7684\u8003\u5bdf\u81f3\u5c11\u6301\u7eed1\u5e74<\/span>\u3002<\/span><\/span><\/section>\n
\u5b89\u5168\u6027\u8003\u5bdf<\/span>\u5728\u836f\u4ee3\u548c\u6709\u6548\u6027\u6bd4\u5bf9\u8bd5\u9a8c\u7814\u7a76\u4e2d\u5747<\/span>\u5e94\u8fdb\u884c\u8003\u5bdf<\/span>\uff0c\u5bf9\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7684\u7c7b\u578b\u3001\u4e25\u91cd\u6027\u548c\u9891\u7387\u7b49\u8fdb\u884c\u6bd4\u8f83\uff0c\u5c24\u5176\u662f\u7279\u5b9a<\/span>\u7684\u91cd\u70b9\u5173\u6ce8\u7684\u4e0d\u826f\u53cd\u5e94\u3002<\/span><\/section>\n
2.<\/span><\/strong> <\/strong>\u60a3\u8005<\/span><\/strong>\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76<\/span><\/strong><\/span><\/section>\n
\u901a\u5e38<\/span>\uff0c\u5728\u8fdb\u884c\u60a3\u8005\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u65f6\u5e94\u540c\u6b65\u5f00\u5c55\u591a\u6b21<\/span>\u7ed9\u836fPK\u7814\u7a76\uff0c\u8fdb\u800c<\/span>\u8bc4\u4f30\u5019\u9009<\/span>\u836f\u4e0e\u539f<\/span>\u7814\u836f\u5728\u60a3\u8005\u4e2d\u7684<\/span>PK\u76f8\u4f3c\u6027\u8d8b\u52bf\u3002<\/span>PK<\/span>\u91c7\u6837\u70b9\u8bbe\u7f6e<\/span>\u4ee5\u80fd\u591f\u8f83\u6e05\u6670\u5730\u53cd\u6620\u4e24\u8005<\/span>\u6574\u4f53<\/span>PK\u7279\u5f81\u4e3a\u539f\u5219\u3002\u8003\u8651<\/span>\u5230\u76ae\u4e0b\u6ce8\u5c04\u7ed9\u836f\u7684<\/span>\u5438\u6536\u8fc7\u7a0b\uff0c\u63a8\u8350\u60a3\u8005<\/span>\u591a\u6b21\u7ed9\u836f\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u5728\u5438\u6536\u5230\u8fbe\u7a33\u6001\u65f6\u8fdb\u884c\u91c7\u6837\uff0c\u6bd4\u8f83\u5019\u9009\u836f\u548c\u539f<\/span>\u7814\u836f\u4e4b\u95f4\u836f\u7269\u66b4\u9732\u91cf\uff08<\/span><\/span>Ctrough,ss<\/span><\/sub>\uff09\u7684\u76f8\u4f3c\u6027\u3002<\/span><\/span><\/span><\/section>\n
\uff08\u56db\uff09\u9002\u5e94\u75c7\u5916\u63a8<\/span><\/strong><\/span><\/section>\n
\u9002\u5e94\u75c7\u5916\u63a8\uff08<\/span>extrapolation\uff09\u662f\u6307\u5728\u751f\u7269\u7c7b\u4f3c\u53d1\u4e2d\u6279\u51c6\u4e00\u4e2a\u6ca1\u6709\u4e0e\u539f\u7814\u836f\u8fdb\u884c\u76f4\u63a5\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u7684\u9002\u5e94\u75c7\u3002\u5982\u679c\u5728\u539f\u7814\u836f\u5df2\u6279\u51c6\u9002\u5e94\u75c7\u67d0\u4e00\u4e2a\u4eba\u7fa4\u4e2d\u5b8c\u6210\u4e86\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u7cfb\u7edf\u6bd4\u5bf9\u7814\u7a76\uff0c\u90a3\u4e48\u5019\u9009\u836f\u5c31\u6709\u53ef\u80fd\u57fa\u4e8e\u5df2\u6709\u7684\u6570\u636e\u548c\u4fe1\u606f\u5bfb\u6c42\u539f\u7814\u836f\u5df2\u6279\u51c6\u5176\u4ed6\u76f8\u540c<\/span>\u4f5c\u7528\u673a\u5236\u9002\u5e94\u75c7\u7684\u83b7\u6279\u3002\u9002\u5e94\u75c7\u5916\u63a8\u7684\u524d\u63d0\u662f\u751f\u7269\u7c7b\u4f3c\u836f\u4e0e\u539f\u7814\u836f\u7684\u751f\u7269\u76f8\u4f3c\u6027\u5df2\u7ecf\u88ab\u8bc1\u5b9e\u3002\u9002\u5e94\u75c7\u5916\u63a8\u4e3b\u8981\u57fa\u4e8e\u751f\u7269\u7c7b\u4f3c\u836f\u6bd4\u5bf9\u7814\u7a76\u6240\u6709\u53ef\u83b7\u5f97\u7684\u6570\u636e\u548c\u4fe1\u606f\u3001\u539f\u7814\u836f\u5176\u4ed6\u6279\u51c6\u9002\u5e94\u75c7\u4e34\u5e8a\u7814\u7a76\u5728\u5b89\u5168\u6027\u548c\u7597\u6548\u65b9\u9762\u7684\u91cd\u8981\u53d1\u73b0\u548c\u5bf9\u539f\u7814\u836f\u6bcf\u4e2a\u9002\u5e94\u75c7\u4f5c\u7528\u673a\u5236\u79d1\u5b66\u8ba4\u77e5\u7684\u7efc\u5408\u8003\u8651\u3002\u7533\u62a5\u5355\u4f4d\u5fc5\u987b\u63d0\u4f9b\u5145\u5206\u7684\u79d1\u5b66\u8bc1\u636e\u4ee5\u652f\u6301\u9002\u5e94\u75c7\u5916\u63a8\u7684\u7533\u8bf7\u3002<\/span><\/span><\/section>\n
\u56db\u3001\u5c0f\u7ed3<\/span><\/strong><\/span><\/section>\n
\u5730\u8212\u5355\u6297\u751f\u7269\u7c7b\u4f3c\u836f\u4e34\u5e8a\u76f8\u4f3c\u6027\u7814\u7a76\u5e94\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\u836f\u76f8\u4f3c\u6027\u4e3a\u76ee\u6807\uff0c\u540c\u65f6\u517c\u987e\u8be5\u54c1\u79cd\u7684\u7279\u6027\uff0c\u8fdb\u884c\u6709\u9488\u5bf9\u6027\u7684\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u8bbe\u8ba1\u3002\u9f13\u52b1\u7814\u53d1\u4f01\u4e1a\u4e0e\u7ba1\u7406\u90e8\u95e8\u8fdb\u884c<\/span>\u6c9f\u901a\uff0c\u63a2\u7d22\u66f4\u52a0<\/span>\u7b80\u4fbf\u9ad8\u6548\u7684\u7814\u7a76\u8bbe\u8ba1\u65b9\u6cd5\u3002<\/span><\/section>\n
\u53c2\u8003<\/span><\/strong>\u6587\u732e\uff1a<\/span><\/strong><\/span><\/section>\n
[1]XGEVA\u00ae<\/span><\/sup>\u7f8e\u56fd\u8bf4\u660e\u4e66\u3002<\/span><\/span><\/section>\n
https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125320s201lbl.pdf<\/span><\/section>\n
[2] \u5b89\u52a0\u7ef4<\/span>\u00d2<\/span><\/sup>\u4e2d\u56fd\u8bf4\u660e\u4e66\u3002<\/span><\/span><\/section>\n
[3]\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u3002\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u3002<\/span><\/span>http:\/\/www.nmpa.gov.cn\/WS04\/CL2138\/300003.html<\/span>.<\/span><\/section>\n
[4] \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u3002\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\u3002<\/span><\/span><\/section>\n
http:\/\/www.cde.org.cn\/zdyz.do?method=largePage&id=227<\/span><\/section>\n
[5] U.S. Food and Drug Administration. Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product [EB\/OL]. (2016-12-29).<\/span><\/section>\n
https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm397017.pdf<\/span><\/section>\n
[6] Coleman R E, Major P, Lipton A, et al. Predictive value of bone resorption and formation markers in cancer patients with bone metastases receiving the bisphosphonate zoledronic acid. [J]. Journal of Clinical Oncology, 2005, 23(22):4925-4935.<\/span><\/section>\n
[7] Saad F, Gleason D M, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma.[J]. J Natl Cancer Inst, 2002, 94(19):1458-1468.<\/span><\/section>\n
[8] Lipton A, Steger G G, Figueroa J, et al. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases.[J]. Journal of Clinical Oncology Official Journal of the American Society of Clinical Oncology, 2007, 25(28):4431.<\/span><\/section>\n
[9] Fizazi K, Lipton A, Mariette X, et al. Randomized Phase II Trial of Denosumab in Patients With Bone Metastases From Prostate Cancer, Breast Cancer, or Other Neoplasms After Intravenous Bisphosphonates [J]. Journal of Clinical Oncology, 2009, 27(10):1564-1571.<\/span><\/section>\n

<\/section>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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