{"id":98658,"date":"2019-04-09T00:00:50","date_gmt":"2019-05-17T08:16:05","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98658\/"},"modified":"2019-05-17T16:16:09","modified_gmt":"2019-05-17T08:16:09","slug":"c9d5c5184a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98658\/","title":{"rendered":"\u6851\u56fd\u536b || 2018 \u5e74\u56fd\u5bb6\u91cd\u5927\u65b0\u836f\u521b\u5236\u4e13\u9879\u8fdb\u5c55\u53ca\u5341\u4e09\u4e94\u5c55\u671b"},"content":{"rendered":"
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\u6851\u56fd\u536b || <\/strong><\/span>2018 \u5e74\u56fd\u5bb6\u91cd\u5927\u65b0\u836f\u521b\u5236\u4e13\u9879\u8fdb\u5c55\u53ca\u5341\u4e09\u4e94\u5c55\u671b<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e2d\u56fd\u751f\u7269\u5de5\u7a0b\u6742\u5fd7 China Biotechnology\uff0c2019\uff0c39( 2) : 3-12<\/p>\n

\u672c\u6587\u6839\u636e\u6851\u56fd\u536b\u9662\u58eb<\/span>\u5728\u7b2c\u5341\u4e00\u5c4a\u4e2d\u56fd\u751f\u7269\u4ea7\u4e1a\u5927\u4f1a\u4e0a\u7684\u6f14\u8bb2\u7a3f\u6574\u7406<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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2006 \u5e74\uff0c\u56fd\u52a1\u9662\u516c\u5e03\u4e86\u300a\u56fd\u5bb6\u4e2d\u957f\u671f\u79d1\u5b66\u548c\u6280\u672f\u53d1\u5c55\u89c4\u5212\u7eb2\u8981( 2006-2020 \u5e74) \u300b\uff0c\u5bf9\u672a\u676515 \u5e74\u6211\u56fd\u79d1\u5b66\u6280\u672f\u53d1\u5c55\u4f5c\u51fa\u4e86\u603b\u4f53\u90e8\u7f72\uff0c\u5e76\u5217\u51fa\u4e8616 \u4e2a\u56fd\u5bb6\u79d1\u6280\u91cd\u5927\u4e13\u9879( \u4ee5\u4e0b\u7b80\u79f0\u201c\u91cd\u5927\u4e13\u9879\u201d) \u3002\u201c\u91cd\u5927\u4e13\u9879\u201d\u662f\u4e3a\u4e86\u5b9e\u73b0\u56fd\u5bb6\u76ee<\/span>\u6807\uff0c\u901a\u8fc7\u6838\u5fc3\u6280\u672f\u7a81\u7834\u548c\u8d44\u6e90\u96c6\u6210\uff0c\u5728\u4e00\u5b9a\u65f6\u9650\u5185\u5b8c\u6210\u7684\u91cd\u5927\u6218\u7565\u4ea7\u54c1\u3001\u5173\u952e\u5171\u6027\u6280\u672f\u548c\u91cd\u5927\u5de5\u7a0b\uff0c\u662f\u6211\u56fd\u79d1\u6280\u53d1<\/span>\u5c55\u7684\u91cd\u4e2d\u4e4b\u91cd\u3002<\/span><\/p>\n

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 ( 2) \u5b8c\u5584\u56fd\u5bb6\u836f\u7269\u521b\u65b0\u4f53\u7cfb\uff0c\u63d0\u5347\u81ea\u4e3b\u521b\u65b0\u548c\u4ea7\u4e1a\u5316\u80fd\u529b\uff0c\u6784\u7b51\u56fd\u5bb6\u836f\u7269\u521b\u65b0\u6280\u672f\u4f53<\/span>\u7cfb;<\/span><\/p>\n

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2<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\u4e30\u7855\u6210\u679c<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u201c\u4e13\u9879\u201d\u7279\u522b\u9488\u5bf910 \u7c7b\u91cd\u5927\u75be\u75c5\u81ea\u4e3b\u521b\u65b0\u54c1\u79cd\u548c\u4e3b\u8981\u4eff\u5236\u836f\u54c1\u7684\u6218\u7565\u5e03\u5c40\uff0c\u5e76\u53d6\u5f97\u4e86\u4e00\u7cfb\u5217\u77a9\u76ee\u6210\u679c\u3002<\/p>\n

\u81ea\u201c\u4e13\u9879\u201d\u5b9e\u65bd\u4ee5\u6765\uff0c\u5df2\u7ecf\u670995 \u4e2a\u54c1\u79cd\u83b7\u5f97\u65b0\u836f\u8bc1\u4e66\uff0c35 \u4e2a\u2160\u7c7b\u65b0\u836f\u83b7\u6279\uff0c\u90e8\u5206\u5df2\u4ea7\u751f\u91cd\u5927\u7ecf\u6d4e\u6548\u76ca\u548c\u793e\u4f1a\u6548\u76ca\uff0c\u5982\u57c3\u514b\u66ff\u5c3c\u3001\u5eb7\u67cf\u897f\u666e\u3001\u963f\u5e15\u66ff\u5c3c\u3001\u5b89\u7f57\u66ff\u5c3c\u3001\u827e\u53ef\u5b81\u548c\u4e50\u590d\u80fd\u7b49\u3002<\/p>\n

\u540c\u65f6\uff0c\u6709200 \u4f59\u9879\u5927\u54c1\u79cd\u836f\u7269\u6280\u672f\u6539\u9020\u5df2\u5b8c\u6210\uff0c\u6d89\u53ca\u56fd\u5bb6\u57fa\u672c\u836f\u726980 \u4f59\u79cd\uff0c\u5982\u6297\u80bf\u7624\u836f\u591a\u897f\u4ed6\u8d5b\u3001\u6297\u4e59\u809d\u836f\u7269\u6069\u66ff\u5361\u97e6\u7b49\u3002\u201c\u4e13\u9879\u201d\u7814\u53d1\u7684\u8bb8\u591a\u836f\u7269\uff0c\u586b\u8865\u4e86\u76f8\u5173\u75be\u75c5\u7684\u7528\u836f\u7a7a\u767d\uff0c\u4e3a\u89e3\u51b3\u767e\u59d3\u91cd\u5927\u75be\u75c5\u7528\u836f\u9700\u6c42\uff0c\u7f13\u89e3\u767e\u59d3\u201c\u770b\u75c5\u96be\u201d\u95ee\u9898\u63d0\u4f9b\u4e86\u6709\u529b\u652f\u6491\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.1 \u91cd\u5927\u521b\u65b0\u836f\u7269\u6210\u679c<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.1.1 \u57c3\u514b\u66ff\u5c3c<\/strong><\/p>\n

Icotinib \u662f\u7531\u676d\u5dde\u8d1d\u8fbe\u836f\u4e1a\u516c\u53f8\u5f00\u53d1\uff0c\u5546\u54c1\u540d: \u51ef\u7f8e\u7eb3Canmana\uff0c2011 \u5e74\u83b7CFDA \u6279\u51c6\u4e0a\u5e02\uff0c\u662f\u6211\u56fd\u7b2c\u4e00\u4e2a\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u5c0f\u5206\u5b50\u9776\u5411\u6297\u764c\u836f\uff0c\u9776\u70b9\u662fEGF\uff32 \u57fa\u56e0\uff0c\u5373\u4e3a\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\u5bb6\u65cf\u4e2d\u7684\u4e00\u5458\u3002<\/p>\n

\u8be5\u836f\u7269\u7684\u8bde\u751f\u7ed3\u675f\u4e86\u6211\u56fd\u5c0f\u5206\u5b50\u9776\u5411\u6297\u764c\u836f\u4f9d\u8d56\u8fdb\u53e3\u7684\u5386\u53f2\u3002\u4e0e\u8fdb\u53e3\u975e\u5c0f\u7ec6\u80de\u80ba\u764c( NSCLC) \u7684\u6cbb\u7597\u836f\u7269\u7279\u7f57\u51ef( \u5373\u5384\u6d1b\u66ff\u5c3c\uff0cErlotinib\uff0c\u745e\u58eb\u7f57\u6c0f\u516c\u53f8\u5f00\u53d1) \u548c\u6613\u745e\u6c99( \u5373\u5409\u975e\u66ff\u5c3c\uff0cGifitinib\uff0c\u82f1\u56fd\u963f\u65af\u5229\u5eb7\u516c\u53f8\u5f00\u53d1) \u76f8\u6bd4\uff0c\u540c\u5c5e\u4e00\u4ee3NSCLC \u9776\u5411\u836f\u7269\uff0c\u4f46\u662f\u57c3\u514b\u66ff\u5c3c\u7684\u6bcf\u5929\u6cbb\u7597\u8d39\u7528\u964d\u4f4e30%\uff0c\u800c\u4e14\u4e2d\u56fd\u5e02\u573a\u5360\u6709\u989d\u5df2\u8fbe38\uff0e 79%\uff0c\u9886\u5148\u4e8e\u5176\u4ed6\u4e24\u6b3e\u8fdb\u53e3\u836f\u7269\u3002<\/p>\n

2016 \u5e74\u548c2017 \u5e74\u7684\u9500\u552e\u989d\u5747\u7a81\u783410 \u4ebf\u5143\u3002\u8be5\u836f\u83b72015 \u5e74\u56fd\u5bb6\u79d1\u6280\u8fdb\u6b65\u4e00\u7b49\u5956\uff0c\u5e76\u7eb3\u51652017 \u7248\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\u3002<\/p>\n

2.1.2 \u5eb7\u67cf\u897f\u666e( \u82f1\u6587\u540d: Conbercept) <\/strong><\/p>\n

\u662f\u65b0\u4e00\u4ee3\u6297VEGF( \u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50) \u7684\u878d\u5408\u86cb\u767d\uff0c\u4e13\u5229\u6301\u6709\u4eba\u4e3a\u6210\u90fd\u5eb7\u5f18\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8( Chengdu Kanghong Biotechnologies Co\uff0e Ltd) \uff0c\u662f\u6211\u56fd\u9996\u4e2a\u81ea\u4e3b\u7814\u53d1\u7684\u65b0\u836f\uff0c\u4e5f\u662f\u4e2d\u56fd\u9996\u4e2a\u83b7\u5f97\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u56fd\u9645\u901a\u7528\u540d\u7684\u62e5\u6709\u5168\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u751f\u7269I \u7c7b\u65b0\u836f\u3002<\/p>\n

\u8be5\u836f\u5e94\u7528\u4e8e\u6cbb\u7597\u65b0\u751f\u8840\u7ba1\u6027( \u6e7f\u6027) \u5e74\u9f84\u76f8\u5173\u6027\u9ec4\u6591\u53d8\u6027( nAMD) \u548c\u7ee7\u53d1\u4e8e\u75c5\u7406\u6027\u8fd1\u89c6\u7684\u8109\u7edc\u819c\u65b0\u751f\u8840\u7ba1( pmCNV) \u5f15\u8d77\u7684\u89c6\u529b\u635f\u4f24\u7684\u91cd\u7ec4\u878d\u5408\u86cb\u767d\u521b\u65b0\u836f\u7269\uff0c2015 \u5e74\u83b7\u5f97\u201c\u4e2d\u56fd\u533b\u836f\u521b\u65b0\u6700\u5177\u5f71\u54cd\u529b\u54c1\u724c\u2014\u2014\u2014\u4e2d\u56fd\u533b\u836f\u6700\u5177\u4e34\u5e8a\u4ef7\u503c\u521b\u65b0\u836f\u5956\u201d; 2016 \u5e74\u83b7\u7f8e\u56fdFDA \u51c6\u8bb8\u8df3\u8fc7\u2160 \u3001\u2161 \u671f\u4e34\u5e8a\uff0c\u76f4\u63a5\u5728\u7f8e\u56fd\u5f00\u5c55\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c; \u6838\u5fc3\u4e13\u52292017 \u5e74\u83b7\u5f97\u4e2d\u56fd\u4e13\u5229\u91d1\u5956\u3002<\/p>\n

\u201c\u4e13\u9879\u201d\u5bf9\u8be5\u54c1\u79cd\u8fdb\u884c\u8fde\u7eed\u8d44\u52a9\uff0c\u5e76\u534f\u8c03CFDA \u5f00\u5c55\u8be5\u54c1\u79cd\u4f18\u5148\/\u7279\u6b8a\u5ba1\u8bc4\uff0c\u4e8e2013 \u5e7412 \u6708\uff0c\u83b7\u5f97\u7528\u4e8e\u6cbb\u7597nAMD \u7684\u65b0\u836f\u8bc1\u4e66\u548c\u836f\u54c1\u6ce8\u518c\u6279\u4ef6; 2017 \u5e745 \u6708\uff0c\u83b7\u5f97\u7528\u4e8e\u6cbb\u7597pmCNV \u7684\u836f\u54c1\u6ce8\u518c\u6279\u4ef6\u3002<\/p>\n

\u5eb7\u67cf\u897f\u666e\u4e0a\u5e02\u540e\uff0c\u51ed\u501f\u826f\u597d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4e0a\u5e02\u4e0d\u5230\u4e09\u5e74\uff0c\u5e02\u573a\u4efd\u989d\u8d85\u8fc7\u56fd\u5916\u540c\u7c7b\u4ea7\u54c1\u96f7\u73e0\u5355\u6297\uff0c\u8feb\u4f7f\u540e\u8005\u5728\u8ddd\u4e13\u5229\u671f\u8fd8\u67094 \u5e74\u7684\u60c5\u51b5\u4e0b\u4e3b\u52a8\u964d\u4ef726%\uff0c\u6253\u7834\u4e86\u56fd\u5916\u4e13\u5229\u836f\u7269\u5728\u4e13\u5229\u671f\u5185\u4e0d\u964d\u4ef7\u7684\u4f20\u7edf\u30022017 \u5e74\uff0c\u8be5\u4ea7\u54c1\u88ab\u7eb3\u5165\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\u3002<\/p>\n

2.1.3 \u897f\u8fbe\u672c\u80fa<\/strong><\/p>\n

\u7531\u6df1\u5733\u5fae\u82af\u751f\u7269\u6280\u672f\u6709\u9650\u516c\u53f8\u5f00\u53d1\u30022014 \u5e74\u83b7CFDA \u6279\u51c6\u4e0a\u5e02\u7684first-in-class \u65b0\u836f\uff0c\u5168\u7403\u9996\u4e2a\u83b7\u6279\u7684\u53e3\u670d\u6cbb\u7597\u5916\u5468T \u7ec6\u80de\u6dcb\u5df4\u7624\u836f\u7269\uff0c\u5168\u7403\u9996\u4e2a\u4e9a\u578b\u9009\u62e9\u6027\u7ec4\u86cb\u767d\u53bb\u4e59\u9170\u5316\u9176( HDAC) \u6291\u5236\u5242\u3002<\/p>\n

\u4e0e\u56fd\u9645\u5df2\u4e0a\u5e02\u7684\u975e\u9009\u62e9\u6027H DAC \u6291\u5236\u5242( \u5982: Vorinostat\uff0c\uff32omidepsin\uff0cBelinostat) \u76f8\u6bd4\uff0c\u897f\u8fbe\u672c\u80fa\u5177\u6709\u66f4\u597d\u7684\u7597\u6548\u2014\u5b89\u5168\u6027\u7efc\u5408\u6307\u6807\uff0c\u751f\u5b58\u671f\u660e\u663e\u5ef6\u957f\uff0c\u4e14\u60a3\u8005\u6708\u5747\u6cbb\u7597\u8d39\u4ec52 \u4e07\u5143\u5de6\u53f3\uff0c\u662f\u56fd\u5916\u5df2\u4e0a\u5e02\u540c\u7c7b\u836f\u7269\u7684\u5341\u5206\u4e4b\u4e00\u30022017 \u5e74\u9500\u552e\u989d9445.1 \u4e07\u5143\u3002\u5b9e\u4f53\u7624\u9002\u5e94\u75c7( \u8054\u5408\u6cbb\u7597) \u5f00\u53d1\uff0c\u9884\u8ba12018 \u5e745 \u6708\u5b8c\u6210\u65b0\u9002\u5e94\u75c7\u7533\u62a5\u3002\u540c\u65f6\u5b9e\u73b0\u4e86\u6e90\u4e8e\u4e2d\u56fd\u53d1\u73b0\u3001\u5168\u7403\u540c\u6b65\u5f00\u53d1\u7684\u6218\u7565\u76ee\u6807\u30022017 \u5e747 \u6708\u8fdb\u5165\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\uff0c\u83b7\u5f972013 \u5e74\u56fd\u5bb6\u79d1\u6280\u8fdb\u6b65\u4e00\u7b49\u5956\u3002<\/p>\n

2.1.4 \u963f\u5e15\u66ff\u5c3c<\/strong><\/p>\n

\u7531\u6c5f\u82cf\u6052\u745e\u533b\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5f00\u53d1\u30022014 \u5e7412 \u6708\u83b7CFDA \u6279\u51c6\u4e0a\u5e02\uff0c\u5168\u7403\u7b2c\u4e00\u4e2a\u5728\u665a\u671f\u80c3\u764c\u88ab\u8bc1\u5b9e\u5b89\u5168\u6709\u6548\u7684\u5c0f\u5206\u5b50\u6297\u8840\u7ba1\u751f\u6210\u9776\u5411\u836f\u7269\uff0c\u76ee\u524d\u665a\u671f\u80c3\u764c\u9776\u5411\u836f\u7269\u4e2d\u552f\u4e00\u7684\u53e3\u670d\u5236\u5242\uff0c\u53ef\u663e\u8457\u5ef6\u957f\u665a\u671f\u80c3\u764c\u60a3\u8005\u7684\u751f\u5b58\u65f6\u95f4\uff0c\u5168\u74032014 \u5e74\u6279\u51c6first-in-class \u65b0\u836f\u4e4b\u4e00\u3002<\/p>\n

\u56fd\u5916\u8fdb\u53e3\u4ea7\u54c1\u4ee5\u8212\u5c3c\u66ff\u5c3c\u4e3a\u4f8b\uff0c\u6bcf\u6708\u7684\u836f\u54c1\u8d39\u4e3a5 \u4e07\u5143\u5de6\u53f3\uff0c\u963f\u5e15\u66ff\u5c3c\u7684\u4ef7\u683c\u4ec5\u4e3a\u56fd\u5916\u540c\u7c7b\u836f\u72691 \/5\uff0c\u51cf\u4f4e\u4e86\u60a3\u8005\u7684\u533b\u7597\u8d39\u30022017 \u5e74\u9500\u552e\u989d14.8 \u4ebf\u5143\u30022017 \u5e747 \u6708\u8fdb\u5165\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\u3002<\/p>\n

2.1.5 EV71 \u624b\u8db3\u53e3\u75c5\u75ab\u82d7<\/strong><\/p>\n

\u56fd\u9645\u9996\u521b\u3001\u5b8c\u5168\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u624b\u8db3\u53e3\u75c5\u75ab\u82d7\uff0c\u4e5f\u662f\u4e16\u754c\u4e0a\u9996\u4e2a\u9488\u5bf9\u513f\u7ae5\u624b\u8db3\u53e3\u75c5\u7684\u75ab\u82d7\u3002<\/p>\n

\u5728\u201c\u4e13\u9879\u201d\u7684\u91cd\u70b9\u652f\u6301\u4e0b\uff0c\u5317\u4eac\u79d1\u5174\u751f\u7269\u5236\u54c1\u7b49\u4e09\u5bb6\u4f01\u4e1a\u8054\u5408\u653b\u5173\u5b8c\u6210\u4e86\u80a0\u9053\u75c5\u6bd271 \u578b\u706d\u6d3b\u75ab\u82d7( Vero\u7ec6\u80de\u3001\u4eba\u4e8c\u500d\u4f53\u7ec6\u80de) I \u671f\u3001II \u671f\u3001III \u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u5206\u522b\u5411CFDA \u9012\u4ea4\u4e86\u65b0\u836f\u8bc1\u4e66\u7533\u8bf7\u3002\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u533b\u5b66\u751f\u7269\u5b66\u7814\u7a76\u6240\u548c\u79d1\u5174\u751f\u7269\u5206\u522b\u4e8e2015 \u5e7412 \u6708\u83b7\u5f97\u80a0\u9053\u75c5\u6bd271 \u578b\u706d\u6d3b\u75ab\u82d7\u751f\u4ea7\u6ce8\u518c\u6279\u51c6\u3002<\/p>\n

2.1.6 \u57c3\u535a\u62c9\u75ab\u82d7<\/strong><\/p>\n

\u7531\u519b\u4e8b\u533b\u5b66\u79d1\u5b66\u9662\u548c\u5eb7\u5e0c\u8bfa\u751f\u7269\u6709\u9650\u516c\u53f8\u8054\u5408\u5f00\u53d1\u3002\u662f\u6211\u56fd\u72ec\u7acb\u7814\u53d1\u3001\u5177\u6709\u5b8c\u5168\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u54c1\u79cd\uff0c\u4e3a\u5168\u7403\u9996\u4e2a2014 \u57fa\u56e0\u578b\u57c3\u535a\u62c9\u75ab\u82d7\uff0c\u51bb\u5e72\u7c89\u9488\u5242\u578b\u8f83\u5176\u4ed6\u56fd\u5bb6\u7814\u53d1\u7684\u6c34\u9488\u75ab\u82d7\u66f4\u6613\u4e8e\u50a8\u5907\u8fd0\u8f93\u548c\u4e34\u5e8a\u5e94\u7528\uff0c\u9002\u4e8e\u51b7\u94fe\u6761\u4ef6\u96be\u4ee5\u4fdd\u8bc1\u7684\u897f\u975e\u5730\u533a\u4f7f\u7528\u3002<\/p>\n

\u201c\u4e13\u9879\u201d\u652f\u6301\u5b8c\u6210\u4e86\u91cd\u7ec4\u57c3\u535a\u62c9\u75c5\u6bd2\u75c5\u75ab\u82d7\u7814\u5236\u53ca\u4e2d\u56fd\u4eba\u7fa4\u548c\u5728\u534e\u975e\u6d32\u4eba\u7fa4\u7684I \u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7814\u7a76\u56e2\u961f\u8054\u5408\u52a0\u62ff\u5927\u56fd\u5bb6\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u5f00\u5c55P4 \u5b9e\u9a8c\u5ba4\u8fdb\u884c\u52a8\u7269\u4f53\u5185\u75ab\u82d7\u529f\u6548\u8bd5\u9a8c\uff0c\u53d6\u5f97\u663e\u8457\u7ed3\u679c\u30022017 \u5e7410 \u6708CFDA \u6279\u51c6\u4e86\u201c\u91cd\u7ec4\u57c3\u535a\u62c9\u75c5\u6bd2\u75c5\u75ab\u82d7( \u817a\u75c5\u6bd2\u8f7d\u4f53) \u201d\u7684\u65b0\u836f\u6ce8\u518c\u7533\u8bf7\u3002<\/p>\n

2. 1.7 \u8d1d\u90a3\u9c81\u80bd\u6ce8\u5c04\u6db2<\/strong><\/p>\n

\u8d1d\u90a3\u9c81\u80bd\u662f\u7531\u4e0a\u6d77\u4ec1\u4f1a\u751f\u7269\u5236\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8\u81ea\u4e3b\u7814\u53d1\u7684\u5168\u7403\u9996\u4e2a\u91cd\u7ec4\u4eba\u80f0\u9ad8\u8840\u7cd6\u7d20\u7c7b\u591a\u80bd-1( GLP-1) \u56fd\u5bb6I \u7c7b\u65b0\u836f\uff0c\u6c28\u57fa\u9178\u5e8f\u5217\u4e0e\u4eba\u6e90GLP-1 \u5b8c\u5168\u4e00\u81f4\uff0c\u4e3b\u8981\u7528\u4e8e\u6cbb\u75972 \u578b\u7cd6\u5c3f\u75c5\uff0c\u80fd\u591f\u8f83\u597d\u5730\u5b9e\u73b0\u80f0\u5c9b\u7d20\u548c\u80f0\u9ad8\u8840\u7cd6\u7d20\u53cc\u6fc0\u7d20\u8c03\u8282\u4f5c\u7528\u3002<\/p>\n

\u201c\u4e13\u9879\u201d\u5728\u201c\u5341\u4e00\u4e94\u201d\u671f\u95f4\u5bf9\u8d1d\u90a3\u9c81\u80bd\u7684\u4e34\u5e8a\u7814\u7a76\u8fdb\u884c\u4e86\u91cd\u70b9\u652f\u6301\uff0c\u8bfe\u9898\u5b9e\u65bd\u671f\u95f4\u65b0\u836f\u4e13\u9879\u63d0\u8bf7\u56fd\u5bb6\u98df\u836f\u76d1\u7ba1\u7406\u603b\u5c40\u5c06\u8be5\u54c1\u79cd\u7eb3\u5165\u65b0\u836f\u5ba1\u8bc4\u5feb\u901f\u901a\u9053\u3002\u5728\u65b0\u836f\u4e13\u9879\u7684\u652f\u6301\u4e0b\uff0c\u987a\u5229\u5b8c\u6210\u4e86\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c2016 \u5e7412 \u6708\u83b7\u6279\u4e0a\u5e02\u3002<\/p>\n

2.1.8 \u82f9\u679c\u9178\u5948\u8bfa\u6c99\u661f<\/strong><\/p>\n

\u7531\u6d59\u6c5f\u533b\u836f\u516c\u53f8\u5f00\u53d1\u7684\u6297\u83cc\u7d20\u7c7b\u836f\u7269\u30022016 \u5e745 \u6708\u83b7CFDA \u6279\u51c6\u4e0a\u5e02\uff0c\u6211\u56fd\u9996\u4e2a\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u7684\u521b\u65b0\u836f\uff0c\u9488\u5bf9\u6027\u6781\u5e7f\uff0c\u6297\u9769\u5170\u9634\u6027\u3001\u9633\u6027\uff0c\u53ca\u975e\u5178\u578b\u75c5\u539f\u83cc\uff0c\u5e76\u9488\u5bf9\u9ad8\u5ea6\u8010\u836f\u6027\u201c\u8d85\u7ea7\u7ec6\u83cc\u201d\u8010\u7532\u6c27\u897f\u6797\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc( M\uff32SA) \uff0c\u53e3\u670d\u53ca\u6ce8\u5c04\u5242\u578b\u517c\u5907\uff0c\u5c5e\u81ea\u6211\u7814\u53d1\u76841\uff0e 1 \u7c7b\u5316\u5b66\u836f\u7269\uff0c\u5168\u7403\u9996\u4e2a\u65e0\u6c1f\u55b9\u8bfa\u916e\u7c7b\u6297\u83cc\u836f\uff0c\u53ef\u4f5c\u4e3a\u793e\u533a\u83b7\u5f97\u6027\u80ba\u708e\u2160\u7c7b\u7528\u836f\u3002<\/p>\n

\u73b0\u5168\u7403\u5df2\u6388\u674332 \u4e2a\u56fd\u5bb6\uff0c\u5c06\u9646\u7eed\u4e0a\u5e02\u3002IMS \u9884\u6d4b\uff0c\u6b27\u7f8e\u5730\u533a\u5e74\u9500\u552e\u89c4\u6a21\u53ef\u8fbe12 \u4ebf\u7f8e\u5143\u5de6\u53f3\u3002<\/p>\n

2. 1. 9 \u76d0\u9178\u5b89\u59a5\u6c99\u661f<\/strong><\/p>\n

\u7531\u4e2d\u79d1\u9662\u4e0a\u6d77\u836f\u7269\u7814\u7a76\u6240\u4e0e\u5b89\u5fbd\u73af\u7403\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u8054\u5408\u5f00\u53d1\u30022009 \u5e744 \u6708\u83b7CFDA\u6279\u51c6\u4e0a\u5e02\uff0c\u6211\u56fd\u7b2c\u4e00\u4e2a\u5177\u6709\u5b8c\u5168\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u6c1f\u55b9\u8bfa\u916e\u7c7b\u836f\u7269\uff0c\u514b\u670d\u6297\u83cc\u6d3b\u6027\u4e0d\u5f3a\u3001\u4ee3\u8c22\u6027\u8d28\u6b20\u4f73\u548c\u526f\u4f5c\u7528\u8f83\u5927\u7b49\u7f3a\u9677\uff0c\u66f4\u5b89\u5168\u3001\u66f4\u9ad8\u6548\u3002\u83b72017 \u5e74\u56fd\u5bb6\u6280\u672f\u53d1\u660e\u5956\u4e8c\u7b49\u5956\u3002<\/p>\n

\u81f32016 \u5e74\u5e95\uff0c\u76d0\u9178\u5b89\u59a5\u6c99\u661f\u7247\u5df2\u5728\u5317\u4eac\u3001\u91cd\u5e86\u7b4922\u4e2a\u7701\u5e02\u81ea\u6cbb\u533a\u7684150 \u591a\u5bb6\u533b\u9662\u548c\u533b\u7597\u673a\u6784\u4f7f\u7528\uff0c\u8fdb\u516510 \u4f59\u4e2a\u5730\u65b9\u7701\u5e02\u533b\u4fdd\u76ee\u5f55\uff0c\u9500\u552e\u989d\u7ea62.35 \u4ebf\u5143\uff0c\u4f7f100 \u4f59\u4e07\u4eba\u6b21\u60a3\u8005\u53d7\u76ca\u3002<\/p>\n

2.1.10 \u5b89\u7f57\u66ff\u5c3c<\/strong><\/p>\n

\u7531\u6b63\u5927\u5929\u6674\u516c\u53f8\u5f00\u53d1\u7684\u6297\u80bf\u7624\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u5546\u54c1\u540d: \u798f\u53ef\u7ef4\u3002\u9002\u5e94\u75c7: \u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u8f6f\u7ec4\u7ec7\u8089\u7624\u548c\u7532\u72b6\u817a\u764c\u3002\u591a\u9776\u70b9: VEGF\uff32\uff0cPDGF\uff32\uff0cFGF\uff32\uff0cc-Kit \u7b49\u6fc0\u9176\u3002\u8be5\u836f\u7269\u7684\u6700\u5927\u7279\u70b9\u662f\u5b83\u7684\u53cc\u91cd\u4f5c\u7528\uff0c\u5373: \u4e09\u6761\u901a\u8def\u963b\u65ad\u80bf\u7624\u8840\u7ba1\u65b0\u751f\uff0c\u6291\u5236\u80bf\u7624\u751f\u957f\uff0c\u56e0\u6b64\u80fd\u663e\u8457\u5ef6\u957f\u65e0\u8fdb\u5c55\u751f\u5b58\u671fPFS \u548c\u603b\u751f\u5b58\u671fOS\u3002<\/p>\n

\u8be5\u836f\u662f\u76ee\u524d\u552f\u4e00\u4e00\u4e2a\u5355\u836f\u6709\u6548\u7684\u6297\u8840\u7ba1\u751f\u6210\u7684\u9776\u5411\u836f\u7269\uff0c\u4e5f\u662f\u7b2c\u4e00\u4e2aNSCLC \u4e09\u7ebf\u6cbb\u7597\u6807\u51c6\u7528\u836f\u3002\u73b0\u6709\u7684\u4e09\u7ebf\u6cbb\u7597\u624b\u6bb5\u7f3a\u4e4f\uff0c\u65e0\u7edf\u4e00\u6807\u51c6\uff0c\u56e0\u6b64\uff0c\u8be5\u836f\u83b7\u5f97\u300aCSCO \u539f\u53d1\u6027\u80ba\u764c\u8bca\u7597\u6307\u5357\u300b\u7684\u63a8\u8350\u30022017 \u5e743 \u6708\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u83b7CFDA \u53d7\u7406\uff0c\u5e76\u4e8e2018 \u5e745 \u67088 \u65e5\u7ecfCFDA \u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n

2. 1. 11 \u4e50\u590d\u80fd<\/strong><\/p>\n

\u7531\u6770\u534e\u751f\u7269\u6280\u672f\u516c\u53f8\u5386\u7ecf18 \u5e74\u3001\u6295\u5165\u5de8\u8d44( 4 \u4ebf\u7f8e\u5143) \u5f00\u53d1\u6210\u529f\u7684\u3001\u5168\u7403\u9996\u521b\u751f\u7269\u65b0\u836f\u91cd\u7ec4\u7ec6\u80de\u56e0\u5b50\u57fa\u56e0\u884d\u751f\u86cb\u767d\u6ce8\u5c04\u6db2\u3002\u8be5\u836f\u53ef\u6cbb\u7597\u4e59\u809d\u75c5\u6bd2e \u6297\u539f( HBeAg) \u9633\u6027\u7684\u6162\u6027\u4e59\u578b\u809d\u708e\u3002<\/p>\n

\u5728\u201c\u4e50\u590d\u80fd\u201d\u4e4b\u524d\uff0c\u4e16\u754c\u4e0a\u6240\u6709\u6cbb\u7597\u4e59\u809d\u836f\u7269\u57fa\u672c\u4e0a\u5747\u5c5e\u4e8e\u53e3\u670d\u6838\u82f7\u7c7b\u6297\u75c5\u6bd2\u836f\u7269\u6216\u666e\u901a\u548c\u957f\u6548\u5e72\u6270\u7d20\u7c7b\u836f\u7269\uff0c\u8fd9\u4e24\u7c7b\u836f\u7269\u6cbb\u75971 \u5e74\u5de6\u53f3\uff0c\u53ea\u80fd\u5728\u7ea630%\u75c5\u4eba\u4e2d\u8fbe\u5230\u6291\u5236\u75c5\u6bd2\u5728\u809d\u7ec6\u80de\u5185\u590d\u5236\u7684\u7597\u6548\u5373e \u6297\u539f\u8840\u6e05\u8f6c\u9634\u6027\uff0c\u800c\u201c\u4e50\u590d\u80fd\u201d\u6cbb\u75973 \u4e2a\u6708\u5c31\u8fbe\u5230\u7ea630%\u7684\u7597\u6548\u8fd9\u4e2a\u5929\u82b1\u677f\uff0c\u6cbb\u75976 \u4e2a\u6708\u8fbe\u523040%\u7597\u6548\uff0c\u6cbb\u75979 \u4e2a\u6708\u8fbe\u5230\u7ea650% \u7597\u6548\uff0c\u201c\u4e50\u590d\u80fd\u201d\u6cbb\u7597\u6162\u6027\u4e59\u809d\u7684\u4e34\u5e8a\u6570\u636e\u663e\u793a\u4e86\u8fdc\u4f18\u4e8e\u73b0\u6709\u4e59\u809d\u6cbb\u7597\u836f\u7269\u7684\u6548\u679c\u3002\u56e0\u6b64\uff0c\u8be5\u836f\u7597\u6548\u7a81\u51fa\u4e14\u7a33\u5b9a\uff0c\u6709\u540e\u7eed\u6548\u679c\u3002\u5176\u4e0d\u826f\u53cd\u5e94\u4e0e\u9633\u6027\u5bf9\u7167<\/p>\n

\u7269\u5e72\u6270\u7d20\u03b12b \u76f8\u4f3c\u3002\u8be5\u836f\u4e8e2018 \u5e745 \u6708\u7ecf\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n

2.1.12 \u827e\u535a\u536b\u6cf0( Albuvirtide) <\/strong><\/p>\n

\u7531\u91cd\u5e86\u524d\u6cbf\u751f\u7269\u6280\u672f\u516c\u53f8\u5f00\u53d1\uff0c\u5c5e\u4e8e\u9488\u5bf9gp41 \u7684\u878d\u5408\u6291\u5236\u5242\uff0c\u4f5c\u7528\u4f4d\u70b9\u662f\u75c5\u6bd2<\/p>\n

\u5916\u819c\u7684\u8de8\u819c\u7cd6\u86cb\u767dgp41\uff0c\u901a\u8fc7\u6291\u5236\u75c5\u6bd2\u5305\u819c\u4e0e\u4eba\u4f53\u7ec6\u80de\u819c\u7684\u878d\u5408\uff0c\u4ece\u800c\u963b\u65adHIV \u7684\u590d\u5236\uff0c\u6545\u800c\u662f\u4e00\u79cd\u878d\u5408\u6291\u5236\u5242\u3002<\/p>\n

\u8fd9\u662f\u5168\u7403\u7b2c\u4e00\u4e2a\u6297\u827e\u6ecb\u75c5\u957f\u6548\u878d\u5408\u6291\u5236\u5242\u30022018 \u5e745 \u670823 \u65e5\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u6b64\u836f\u4e0a\u5e02\u3002\u8be5\u836f\u7684\u7279\u70b9\u662f: ( 1) \u5168\u65b0\u7684\u5206\u5b50\u4f5c\u7528\u673a\u5236: \u5bf9\u8010\u836fHIV \u75c5\u6bd2\u6709\u6548\uff0c\u836f\u7269\u5b89\u5168\u6027\u9886\u5148\u4e8e\u76ee\u524d\u5927\u591a\u6570\u827e\u6ecb\u75c5\u836f\u7269; ( 2) \u957f\u6548: \u6bcf\u5468\u7ed9\u836f\u4e00\u6b21\uff0c\u6bd4\u53e3\u670d\u836f\u66f4\u7075\u6d3b\u7684\u7ed9\u836f\u65f6\u95f4; ( 3) \u53ef\u63d0\u9ad8\u60a3\u8005\u7528\u836f\u4f9d\u4ece\u6027\uff0c\u6539\u5584\u751f\u6d3b\u54c1\u8d28; ( 4) \u53ef\u4e0e\u6d1b\u5339\u90a3\u97e6\u3001\u5229\u6258\u90a3\u97e6\u4e24\u836f\u8054\u5408\u7684\u7b80\u5316\u6cbb\u7597\u7ec4\u5408\u3002<\/p>\n

2.1.13 \u6208\u8bfa\u536b( \u8fbe\u8bfa\u745e\u97e6Danoprevir\uff0cASC08) <\/strong><\/p>\n

2018 \u5e746 \u670811 \u65e5\uff0c\u6d59\u6c5f\u6b4c\u793c\u516c\u53f8\u5f00\u53d1\u7684\u9996\u4e2a\u6297\u4e19\u809d\u75c5\u6bd2HCV \u7684I \u7c7b\u521b\u65b0\u836f\u6208\u8bfa\u536b\ue5f8 ( \u8fbe\u8bfa\u745e\u97e6Danoprevir\uff0cASC08) \u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u4e0a\u5e02\u3002\u6208\u8bfa\u536b\ue5f8 \u662f\u9996\u4e2a\u7531\u4e2d\u56fd\u672c\u571f\u4f01\u4e1a\u5f00\u53d1\u7684\u76f4\u63a5\u6297\u75c5\u6bd2\u836f\u7269( Direct Acting Anti-viral agent\uff0cDAA) \u3002<\/p>\n

\u5b83\u662f\u4e00\u79cd\u65b0\u4e00\u4ee3\u4e19\u809d\u75c5\u6bd2NS3 \/4A \u86cb\u767d\u9176\u6291\u5236\u5242\u3002\u5728\u56fd\u5bb6\u836f\u76d1\u5c40\u548c\u91cd\u5927\u4e13\u9879\u7684\u652f\u6301\u4e0b\uff0c\u6208\u8bfa\u536b\u4ece\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u5927\u6279\u4ef6\u5230\u65b0\u836f\u4e0a\u5e02\uff0c\u4ec5\u7528\u65f633 \u4e2a\u6708\u3002\u76f8\u6bd4\u73b0\u6709\u4f20\u7edf\u7597\u6cd5( \u5e72\u6270\u7d2048 \/72 \u5468\uff0c\u6cbb\u6108\u7387\u4ec5\u4e3a60%) \uff0c\u6b4c\u793c\u65b9\u6848\u5927\u5e45\u5ea6\u63d0\u9ad8\u4e19\u809d\u6cbb\u6108\u7387\u523097%\uff0c\u7597\u7a0b\u7f29\u77ed\u81f312 \u5468\u3002<\/p>\n

\u8be5\u836f\u7684\u7597\u6548\u751a\u81f3\u8d85\u8d8a\u7f8e\u56fd\u5409\u5229\u5fb7( Gilead) \u516c\u53f8\u7684\u957f\u6548\u5e72\u6270\u7d20\u7684\u8054\u5408\u7597\u6cd5\u3002<\/p>\n

2. 1.14 \u7231\u4f18\u7279( \u544b\u55b9\u66ff\u5c3c\u80f6\u56ca) <\/strong><\/p>\n

2018 \u5e749 \u6708\uff0c\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u6cbb\u7597\u836f\u7269\u544b\u55b9\u66ff\u5c3c\u80f6\u56ca( \u7231\u4f18\u7279) \u83b7\u56fd\u5bb6\u836f\u54c1\u76d1<\/p>\n

\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n

\u544b\u55b9\u66ff\u5c3c\u80f6\u56ca\u4e3a\u5883\u5185\u5916\u5747\u672a\u4e0a\u5e02\u7684\u521b\u65b0\u836f\uff0c\u901a\u8fc7\u6211\u56fd\u7684\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\u83b7\u51c6\u4e0a\u5e02\u3002<\/p>\n

\u544b\u55b9\u66ff\u5c3c\u80f6\u56ca\u662f\u6cbb\u7597\u665a\u671f\u7ed3\u76f4\u80a0\u764c\u7684\u6297\u764c\u65b0\u836f\uff0c\u5b83\u8bde\u751f\u4e8e\u4e0a\u6d77\u5f20\u6c5f\u5b9e\u9a8c\u5ba4\uff0c\u5b8c\u5168\u7531\u56fd\u5185\u672c\u571f\u7814\u53d1\uff0c\u5386\u65f612 \u5e74\uff0c\u6295\u8d44\u8d85\u8fc715\u4ebf\u5143\u3002<\/p>\n

\u544b\u55b9\u66ff\u5c3c\u662f\u4e00\u4e2a\u55b9\u5511\u5549\u7c7b\u5c0f\u5206\u5b50\u8840\u7ba1\u751f\u6210\u6291\u5236\u5242\uff0c\u4e3b\u8981\u4f5c\u7528\u9776\u70b9\u662fVEGFR\u6fc0\u9176\u5bb6\u65cf( VEGF\uff321\u30012 \u548c3) \uff0c\u901a\u8fc7\u6291\u5236\u8840\u7ba1\u5185\u76ae\u7ec6\u80de\u8868\u9762\u7684VEGF\uff32 \u78f7\u9178\u5316\u53ca\u4e0b\u6e38\u4fe1\u53f7\u8f6c\u5bfc\uff0c\u6291\u5236\u8840\u7ba1\u5185\u76ae\u7ec6\u80de\u7684\u589e\u6b96\u3001\u8fc1\u79fb\u548c\u7ba1\u8154\u5f62\u6210\uff0c\u4ece\u800c\u6291\u5236\u80bf\u7624\u65b0\u751f\u8840\u7ba1\u7684\u5f62\u6210\uff0c\u6700\u7ec8\u53d1\u6325\u80bf\u7624\u751f\u957f\u6291\u5236\u6548\u5e94\u3002\u544b\u55b9\u66ff\u5c3c\u80f6\u56ca\u4e3a\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u63d0\u4f9b\u4e86\u65b0\u7684\u6cbb\u7597\u9014\u5f84\uff0c\u53ef\u4ee5\u663e\u8457\u5ef6\u957f\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e24\u6b21\u5316\u7597\u65b9\u6848\u4f46\u4ecd\u53d1\u751f\u75be\u75c5\u8fdb\u5c55\u7684\u665a\u671f\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u7684\u751f\u5b58\u671f\u3002<\/p>\n

2.1.15 \u5176\u4ed6\u521b\u65b0\u836f\u7269<\/strong><\/p>\n

( 1) Sabin \u682a\u810a\u9ad3\u7070\u8d28\u708e\u706d\u6d3b\u75ab\u82d7: \u9884\u9632\u810a\u9ad3\u7070\u8d28\u708e; ( 2) \u827e\u745e\u6614\u5e03: \u9aa8\u5173\u8282\u708e; ( 3) \u827e\u62c9\u83ab\u5fb7: \u7c7b\u98ce\u6e7f\u6027\u5173\u8282\u708e; ( 4) \u5de6\u5965\u785d\u5511: \u538c\u6c27\u83cc\u611f\u67d3; ( 5) \u963f\u5229\u6c99\u5766\u916f: \u6297\u9ad8\u8840\u538b\u3002\u7efc\u4e0a\u6240\u8ff0\uff0c35 \u4e2a\u2160\u7c7b\u65b0\u836f\u5982\u88681 \u6240\u793a\u3002<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.2 \u201c\u91cd\u5927\u65b0\u836f\u521b\u5236\u201d\u5728\u201c\u5341\u4e09\u4e94\u201d\u671f\u95f4\u7684\u5c55\u671b\uff0c\u5373\u9884\u671f\u521b\u65b0\u836f\u7269\u6210\u679c<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u5728\u5df2\u7ecf\u53d6\u5f9735 \u4e2a\u521b\u65b0\u836f\u7269\u7684\u57fa\u7840\u4e0a\uff0c\u8fd8\u5c06\u6709\u4e00\u6279\u521b\u65b0\u836f\u7269\u9884\u8ba1\u5728\u8fd1\u671f\u83b7\u6279\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2\uff0e2\uff0e1 \u5316\u5b66\u836f\u7269( \u88682)<\/span><\/strong>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u88682 \u9884\u8ba1\u8fd1\u671f\u83b7\u6279\u7684\u5316\u5b66\u836f\u7269<\/strong><\/span>
<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n


<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2. 2. 2 \u751f\u7269\u836f<\/strong><\/p>\n

\u65e0\u8bba\u662f\u56fd\u5185\u8fd8\u662f\u56fd\u5916\uff0c\u751f\u7269\u5927\u5206\u5b50\u836f\u7269\u662f\u8fd1\u5e74\u6765\u662f\u5189\u5189\u800c\u8d77\u7684\u65b0\u661f\uff0c\u5e76\u5c06\u5728\u672a\u6765\u51e0\u5e74\u5185\u8fbe\u5230\u5168\u740350%\u4ee5\u4e0a\u7684\u836f\u7269\u9500\u552e\u91cf\u3002<\/p>\n

( 1) \u6cbb\u7597\u80bf\u7624\u7684\u91cd\u7ec4\u86cb\u767d\u836f\u7269\uff0c\u5982: \u514d\u75ab\u68c0\u67e5\u70b9( checkpoint) \u5355\u6297\u3002\u4eba\u6e90\u5316PD-1\uff0cCTLA-4 \u6297\u4f53\u5c31\u662f\u8fd9\u79cd\u836f\u7269\u7684\u5178\u578b\u3002\u5728\u7f8e\u56fd\uff0cFDA \u6279\u51c6\u4e0a\u5e02\u7684Keytruda( Pembrolizumab) ( Merck \u5f00\u53d1\u3001\u751f\u4ea7) \u548cOpdivo( Nivolumab) ( BMS \u5f00\u53d1\u3001\u751f\u4ea7) \u90fd\u5c5e\u4e8e\u8fd9\u2160\u7c7b\u836f\u7269\u3002\u4e34\u5e8a\u6548\u679c\uff0c\u76f8\u5f53\u6210\u529f\u3002Keytruda \u5df2\u4e0e2018 \u5e746 \u670826 \u65e5\u7ecfCFDA \u6279\u51c6\u5728\u4e2d\u56fd\u4e5f\u5df2\u4e0a\u5e02\u3002<\/p>\n

\u6297PD-1 \u5355\u6297\u7684\u4f5c\u7528\u673a\u5236( \u7a0b\u5e8f\u6027\u6b7b\u4ea1\u53d7\u4f53-1 \u6291\u5236\u5242) \u5982\u56fe2 \u6240\u793a\uff0c\u591a\u80bd\u6297\u539f\u7ecf\u8fc7T \u7ec6\u80de\u53d7\u4f53( TC\uff32) \u7531\u7ec4\u7ec7\u76f8\u5bb9\u6027\u590d\u5408\u7269( MHC) \u7531\u6297\u539f\u5448\u9012\u7ec6\u80de( APC) \u548c\u80bf\u7624\u7ec6\u80de\u5448\u9012\u7ed9T \u7ec6\u80de\u3002<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n

\u5728T \u7ec6\u80de\u6d3b\u5316\u540e\uff0c\u7a0b\u5e8f\u6027\u7ec6\u80de\u6b7b\u4ea1\u86cb\u767d1( PD-1) \u53d7\u4f53\u5728T \u7ec6\u80de\u8868\u9762\u4e0a\u8868\u8fbe\uff0c\u901a\u8fc7\u548c\u5b83\u4eec\u76842 \u914d\u4f53PD-L1 \u548cPD-L2 \u7ed3\u5408\u6765\u6291\u5236\u514d\u75ab\u5e94\u7b54\u3002<\/p>\n

PD-1 \u7684\u5355\u514b\u9686\u6297\u4f53\u963b\u65ad\u5176\u548cPD-L1 \u7684\u7ed3\u5408\uff0c\u91ca\u653e\u4e86T \u7ec6\u80de\u6740\u4f24\u529b\uff0c\u589e\u5f3a\u80bf\u7624\u514d\u75ab\u529b\u3002\u53e6\u5916\uff0cPD-1 \u548cPD-L1\u53ef\u4ee5\u8bf1\u5bfc\u5176\u4ed6\u514d\u75ab\u7ec6\u80de\uff0c\u4f8bT-\u8c03\u8282( Treg) \u6216\u80a5\u5927\u7ec6\u80de\u3002\u6700\u65b0\u7684\u62a5\u9053\u8fd8\u8ba4\u4e3a\u8fd9\u7c7bPD-L1 \u6297\u4f53\u8fd8\u53ef\u4ee5\u8bf1\u5bfcNK \u7ec6\u80de\u63d0\u9ad8\u5176\u5bf9\u764c\u7ec6\u80de\u7684\u6740\u4f24\u529b\u3002<\/p>\n

\u76ee\u524d\u201c\u4e13\u9879\u201d\u7d2f\u8ba1\u5df2\u652f\u6301\u8bfe\u989818 \u9879( \u5305\u542b\u5b50\u8bfe\u9898) \uff0c\u5176\u4e2d\u4fe1\u8fbe\u751f\u7269\u3001\u541b\u5b9e\u751f\u7269\u3001\u6052\u745e\u5236\u836f\u3001\u767e\u6d4e\u795e\u5dde\u7b49\u5355\u4f4d\u8fdb\u5c55\u8f83\u5feb\uff0c\u591a\u9879\u4ea7\u54c1\u8fdb\u5165\u4e34\u5e8a\u7814\u7a76\u9636\u6bb5\u3002<\/p>\n

( 2) CA\uff32-T \u7ec6\u80de\u6cbb\u7597\u6280\u672f\u3002\u5d4c\u5408\u6297\u539f\u53d7\u4f53( CA\uff32) T \u7ec6\u80de\u662f\u4e00\u79cd\u5229\u7528\u60a3\u8005\u81ea\u8eab\u514d\u75ab\u7cfb\u7edf\u6d88\u706d\u764c\u7ec6\u80de\u7684\u521b\u65b0\u6280\u672f\u3002<\/p>\n

2017 \u5e748 \u670830 \u65e5\u7f8e\u56fdFDA \u6279\u51c6\u9996\u4e2a\u57fa\u56e0\u4ea7\u54c1Kymriah( \u8bfa\u534e) \u4e0a\u5e02\u2460\u3002\u63a5\u7740\uff0cFDA \u53c8\u4e8e2017 \u5e7410 \u670819 \u65e5\u6279\u51c6Kite Pharma \u7684CA\uff32-T \u7597\u6cd5Yescarta( axicabtagene cilolercel) \u4e0a\u5e02\uff0c\u6cbb\u7597\u7279\u5b9a\u7c7b\u578b\u7684\u5927B \u7ec6\u80de\u6dcb\u5df4\u7624\u6210\u4eba\u60a3\u8005\u3002\u8fd9\u4e9b\u60a3\u8005\u66fe\u63a5\u53d7\u81f3\u5c11\u4e24\u6b21\u5176\u5b83\u6cbb\u7597\uff0c\u4f46\u672a\u51fa\u73b0\u7f13\u89e3\uff0c\u6216\u662f\u75be\u75c5\u590d\u53d1\u3002\u5728\u4e00\u9879\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u8d85\u8fc7100 \u540d\u60a3\u8005\u63a5\u53d7\u4e86Yescarta \u6cbb\u7597\uff0c\u5b8c\u5168\u7f13\u89e3\u7387( CS) \u8fbe51%\u3002<\/p>\n

\u57fa\u56e0\u7597\u6cd5\u4ece\u5145\u6ee1\u6f5c\u529b\u7684\u6982\u5ff5\u5230\u53ef\u5b9e\u9645\u64cd\u4f5c\u7684\u6cbb\u7597\u65b9\u6848\uff0c\u5e76\u6cbb\u6108\u4e86\u96be\u6cbb\u800c\u81f4\u547d\u7684\u764c\u75c7\uff0c\u5145\u5206\u663e\u793a\u4e86\u5b83\u7684\u5de8\u5927\u529f\u6548\uff0c\u6fc0\u8d77\u4e86\u6211\u56fd\u79d1\u7814\u4eba\u5458\u7684\u6781\u5927\u70ed\u60c5\u548c\u5174\u8da3\u3002<\/p>\n

\u201c\u4e13\u9879\u201d\u9ad8\u5ea6\u5173\u6ce8CA\uff32-T \u6cbb\u7597\u7684\u7814\u7a76\u8fdb\u5c55\u548c\u8d8b\u52bf\uff0c\u5728\u201c\u5341\u4e09\u4e94\u201d\u89c4\u5212\u4e2d\u4e13\u95e8\u90e8\u7f72\u7528\u4e8e\u80bf\u7624\u6cbb\u7597\u7684CA\uff32-T \u6cbb\u7597\u54c1\u79cd\u7814\u53d1\u4efb\u52a1\uff0c\u4ee5\u63d0\u5347\u6211\u56fd\u6297\u764c\u836f\u7269\u7814\u53d1\u7efc\u5408\u6c34\u5e73\uff0c\u4fdd\u969c\u764c\u75c7\u60a3\u8005\u7528\u836f\u9700\u6c42\u3002\u76ee\u524d\u5b89\u6392\u6d89\u53caCA\uff32-T \u7814\u7a76\u4efb\u52a12 \u9879\uff0c\u4e2d\u592e\u8d22\u653f\u6295\u51651 140 \u4e07\u5143\u3002<\/p>\n

\u5357\u4eac\u4f20\u5947\u751f\u7269\u5728CA\uff32-T \u6cbb\u7597\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u7814\u7a76\u65b9\u9762\u72ec\u6811\u4e00\u5e1c\u53d6\u5f97\u7a81\u7834\u6027\u8fdb\u5c55\uff0c2017 \u5e7412 \u6708\u7eb3\u5165\u4f18\u5148\u5ba1\u6279\u3002\u8fd9\u662f\u4e00\u6b3e\u9776\u5411B \u7ec6\u80de\u6210\u719f\u6297\u539f( BCMA) \u7684\u5d4c\u5408\u6297\u539f\u53d7\u4f53T \u7ec6\u80de\u514d\u75ab\u7597\u6cd5( CA\uff32-T) \u3002B \u7ec6\u80de\u6210\u719f\u6297\u539f( BCMA)\u662f\u4e00\u79cd\u5728\u9aa8\u9ad3\u7624\u7ec6\u80de\u4e0a\u9ad8\u5ea6\u8868\u8fbe\u7684\u86cb\u767d\u8d28\u3002CA\uff32-T \u7597\u6cd5\u901a\u8fc7CA\uff32-T \u6280\u672f\u9776\u5411\u5b9a\u4f4dB \u7ec6\u80de\u6210\u719f\u6297\u539f\uff0c\u5176\u53ef\u80fd\u5177\u6709\u91cd\u65b0\u5b9a\u4e49\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6cbb\u7597\u89c4\u8303\u7684\u6f5c\u529b\uff0c\u5e76\u53ef\u80fd\u5411\u5b9e\u73b0\u60a3\u8005\u6cbb\u6108\u8fc8\u8fdb\u4e00\u6b65\u3002<\/p>\n

2. 2.3 \u5176\u4ed6\u521b\u65b0\u836f\u7269\u548c\u521b\u65b0\u6280\u672f<\/strong><\/p>\n

\u514d\u75ab\u6cbb\u7597\u3001\u57fa\u56e0\u6cbb\u7597\u3001\u57fa\u56e0\u7f16\u8f91\u3001\u5c0f\u6838\u9178\u5e72\u6270\u7b49\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb\uff0c\u4e5f\u7eb7\u7eb7\u5904\u5728\u90e8\u7f72\u3001\u6210\u578b\u3001\u6210\u957f\u7684\u8fc7\u7a0b\u4e2d\uff0c\u9884\u671f\u5728\u201c\u5341\u4e09\u4e94\u201d\u7ed3\u675f\u65f6\u8fd8\u5c06\u51fa\u53f0\u4e00\u6279\u521b\u65b0\u836f\u7269\u6210\u679c\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

2.3 \u4e34\u5e8a\u8bd5\u9a8c\u7684\u65b0\u8981\u6c42\u548c\u65b0\u6c34\u5e73<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u7531\u4e0a\u53ef\u89c1\uff0c\u521b\u65b0\u836f\u7269\u3001\u521b\u65b0\u6280\u672f\u54c1\u79cd\u7e41\u591a\uff0c\u4f5c\u7528\u673a\u5236\u5404\u5f02\uff0c\u56e0\u6b64\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ba1\u7406\u6761\u4f8b\u548c\u6cd5\u89c4\u4e5f\u5fc5\u987b\u4e0e\u65e5\u4ff1\u8fdb\u3002<\/p>\n

2.3.1 \u65b0\u8981\u6c42<\/strong><\/p>\n

( 1) \u4e3a\u4e86\u6709\u673a\u8854\u63a5\u201c\u5341\u4e8c\u4e94\u201d\u3001\u201c\u5341\u4e09\u4e94\u201d\u91cd\u70b9\u652f\u6301\u7684\u521b\u65b0\u836f\u7269\uff0c\u521b\u65b0\u54c1\u79cd\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u5fc5\u987b\u5efa\u7acb\u76f8\u5e94\u7684\u521b\u65b0\u5e73\u53f0\u548c\u521b\u65b0\u65b9\u6848; ( 2) \u4e3a\u4e86\u9002\u5e94\u201c\u9776\u5411\u201d\u836f\u7269\u548c\u4e2a\u6027\u5316\u6cbb\u7597\uff0c\u5fc5\u987b\u5728\u9776\u6807\u786e\u8ba4\u3001\u60a3\u8005\u9074\u9009\u3001\u4f34\u968f\u8bca\u65ad\u3001\u77e5\u60c5\u540c\u610f\u3001\u6570\u7406\u7edf\u8ba1\u3001\u9075\u5faa\u6cd5\u5f8b\u6cd5\u89c4\u7b49\u8bf8\u65b9\u9762\u6709\u4e00\u6574\u5957\u521b\u65b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848; ( 3) \u5e73\u53f0\u6574\u4f53\u7814\u7a76\u6c34\u5e73\u8fbe\u5230\u56fd\u9645\u89c4\u8303\u8981\u6c42;( 4) \u6240\u83b7\u6570\u636e\u53ca\u6570\u636e\u7ba1\u7406\u5b9e\u73b0\u4e0e\u53d1\u8fbe\u56fd\u5bb6( FDA\uff0cEMA\uff0cPMDA \u7b49) \u53cc\u8fb9\u6216\u591a\u8fb9\u4e92\u8ba4\u3002<\/p>\n

2. 3. 2 \u4e34\u5e8a\u8bd5\u9a8c\u5728\u65b0\u836f\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u4ef7\u503c<\/strong><\/p>\n

\u4e34\u5e8a\u8bd5\u9a8c\u5728\u65b0\u836f\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u4ef7\u503c\u5982\u56fe3 \u6240\u793a\u3002<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n

2.3.3 \u4e34\u5e8a\u8bd5\u9a8c\u65b0\u7684\u5386\u53f2\u6761\u4ef6: <\/strong><\/p>\n

\u56fd\u9645\u5316\u5e26\u6765\u5de8\u5927\u673a\u90472017 \u5e746 \u670819 \u65e5\uff0c\u4e2d\u56fdCFDA \u6b63\u5f0f\u52a0\u5165ICH \u7ec4\u7ec7( The<\/p>\n

International Council for Harmonisation of Technical \uff32equirements for Pharmaceuticals for Human Use) \u3002<\/p>\n

ICH \u662f\u4e00\u4e2a\u975e\u5e38\u7279\u522b\u7684\u56fd\u9645\u7ec4\u7ec7\uff0c\u5b83\u8bd5\u56fe\u628a\u836f\u653f\u4e8b\u52a1\u7684\u6743\u5a01\u673a\u6784\u4e0e\u5236\u836f\u4f01\u4e1a\u805a\u5728\u4e00\u8d77\u5546\u8ba8\u6709\u5173\u836f\u7269\u6ce8\u518c\u7684\u65b9\u65b9\u9762\u9762\u7684\u79d1\u5b66\u548c\u6280\u672f\u95ee\u9898\uff0c\u5e76\u5f97\u51fa\u53cc\u65b9\u4e00\u81f4\u63a5\u53d7\u7684\u836f\u7269\u6ce8\u518c\u7684\u6cd5\u5f8b\u6cd5\u89c4\u3002\u56e0\u6b64\uff0c\u901a\u8fc7ICH \u7684\u534f\u8c03\u3001\u6c9f\u901a\u3001\u8865\u5145\u3001\u6539\u8fdb\uff0c\u9010\u6b65\u5b9e\u73b0\u5168\u7403\u4e00\u81f4\u7684\u836f\u7269\u6ce8\u518c\u89c4\u8303\u548c\u6807\u51c6\u3002<\/p>\n

\u81f3\u4eca\uff0c ICH \u5df2\u5bf9\u5168\u7403\u53d1\u51fa\u4e86\u6570\u4ee5\u767e\u8ba1\u7684\u201c\u6307\u5357\u201d\u6587\u4ef6\u5373\u4e34\u5e8a\u8bd5\u9a8c\u548c\u836f\u54c1( \u5305\u62ec\u5668\u68b0) \u6ce8\u518c\u7684\u884c\u4e1a\u884c\u89c4\u3002\u7b80\u5355\u5730\u6982\u62ec\u8d77\u6765\u4e3aQ( quality\uff0c\u8d28\u91cf) \u3001S( safety\uff0c\u5b89\u5168\u6027) \u3001E( efficacy\uff0c\u6709\u6548\u6027) \u3001M( multidisciplinary\uff0c\u591a\u5b66\u79d1\u4ea4\u53c9) \u56db\u4e2a\u8bcd\uff0c\u6bcf\u4e2a\u5b57\u6bcd\u4e0b\u9762\u90fd\u6709\u51e0\u5341\u4e2a\u6307\u5357\u6587\u4ef6\u6765\u52a0\u4ee5\u5177\u4f53\u5c55\u5f00\uff0c\u8fd9\u4e9b\u6307\u5357\u90fd\u662f\u8be5\u7ec4\u7ec7\u6210\u5458\u957f\u671f\u5de5\u4f5c\u7ecf\u9a8c\u7684\u7ed3\u6676\uff0c\u56e0\u6b64\u6db5\u76d6\u4e86\u79d1\u5b66\u548c\u5b9e\u8df5\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u3002<\/p>\n

\u53ef\u4ee5\u8bf4\uff0c\u4e2d\u56fdCFDA \u52a0\u5165ICH \u6807\u5fd7\u7740\u7ed9\u4e2d\u56fd\u7684\u533b\u836f\u5de5\u4e1a\u5e26\u6765\u65b0\u7684\u673a\u9047\u548c\u65b0\u7684\u6311\u6218\u3002\u5177\u4f53\u6765\u8bf4: ( 1) \u4e34\u5e8a\u8bd5\u9a8c\u7684\u76f8\u5173\u65b9\u5171\u540c\u5408\u4f5c\u53ca\u56fd\u9645\u5408\u4f5c; ( 2) \u5efa\u7acb\u4e25\u683c\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb; ( 3) \u5efa\u7acb\u5177\u6709\u56fd\u9645\u6c34\u51c6\u7684\u4e34\u5e8a\u7814\u7a76\u961f\u4f0d; ( 4) \u5efa\u7acb\u4e0e\u56fd\u9645\u63a5\u8f68\u7684\u6cd5\u89c4\u6807\u51c6\uff0c\u540c\u6b65\u5b8c\u5584\u6cd5\u5f8b\u4f53\u7cfb; ( 5) \u5efa\u7acb\u79d1\u5b66\u9ad8\u6548\u7684\u76d1\u7ba1\u673a\u5236; ( 6) \u670d\u52a1\u884c\u4e1a\u7684\u89c4\u8303\u4e0e\u521b\u65b0\uff0c\u5373\u89c4\u8303C\uff32O \u884c\u4e1a\uff0c\u53d1\u5c55\u9002\u7528\u6211\u56fd\u56fd\u60c5\u7684SMO( Site Management Organization) \u6a21\u5f0f\u3002<\/p>\n

2.3.4 GCP \u5e73\u53f0\u7684\u4e13\u4e1a\u6280\u672f\u5efa\u8bbe<\/strong><\/p>\n

( 1) \u5efa\u7acb\u4e0e\u56fd\u9645ICH \u63a5\u8f68\u7684GCP( Good Clinical Practice) \u4e34\u5e8a\u8bc4\u4ef7\u6807\u51c6; ( 2) \u5f3a\u8c03\u9488\u5bf9\u5316\u5b66\u836f\u3001\u751f\u7269\u836f\u548c\u514d\u75ab\u836f\u7269\u7684\u4e0d\u540c\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6cd5\u548c\u8bc4\u4ef7\u4f53\u7cfb; ( 3) \u5168\u9762\u63a8\u52a8\u5927\u6570\u636e\u6280\u672f\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u9010\u6b65\u5efa\u7acb\u7b26\u5408CDISC( \u4e34\u5e8a\u6570\u636e\u4ea4\u6362\u6807\u51c6) \u3001MedD\uff32A( ICH \u56fd\u9645\u533b\u5b66\u7528\u8bed\u8bcd\u5178) \u3001WHO Drug\u3001HL7 ( \u533b\u7597\u4fe1\u606f\u4ea4\u6362\u6807\u51c6) \u548cB\uff32IDG( Biomedical\uff32esearch Integrated Domain Group) \u7684\u6570\u636e\u6807\u51c6; ( 4) \u5efa\u7acb\u9762\u5411\u75be\u75c5\u7684\u4e34\u5e8a\u7814\u7a76\u6570\u636e\u5e93( \u5982\u4f55\u5171\u4eab\u5c1a\u9700\u7814\u7a76) ; ( 5) \u5f3a\u5316GCP \u673a\u6784\u5728\u533b\u9662\u7684\u5b9a\u4f4d\uff0c\u5b8c\u5584GCP \u673a\u6784\u8fd0\u884c\u7684\u652f\u6491\u673a\u5236\uff0c\u4fdd\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b9e\u65bd\u3001\u57f9\u8bad\u4e0e\u7ba1\u7406\u3002<\/p>\n

2.3. 5 \u7cbe\u51c6\u533b\u5b66\u65f6\u4ee3\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d8\u9769<\/strong><\/p>\n

\u7cbe\u51c6\u533b\u5b66\u662f\u5e94\u7528\u73b0\u4ee3\u5206\u5b50\u751f\u7269\u5b66\u3001\u5206\u5b50\u75c5\u7406\u5b66\u3001\u5206\u5b50\u9057\u4f20\u5b66\u3001\u5206\u5b50\u5f71\u50cf\u6280\u672f\u3001\u751f\u7269\u4fe1\u606f\u6280\u672f\u4ee5\u53ca\u76ee\u524d\u70ed\u95e8\u7684\u5927\u6570\u636e\u6280\u672f\u3001\u667a\u80fd\u5316\u6280\u672f\u7b49\uff0c\u7ed3\u5408\u60a3\u8005\u751f\u6d3b\u73af\u5883\u548c\u4e34\u5e8a\u6570\u636e\uff0c\u5b9e\u73b0\u7cbe\u51c6\u7684\u75be\u75c5\u5206\u7c7b\u548c\u8bca\u65ad\uff0c\u5236\u5b9a\u5177\u6709\u4e2a\u6027\u5316\u7684\u75be\u75c5\u9884\u9632\u548c\u8bca\u7597\u65b9\u6848\u7684\u533b\u5b66\u5206\u652f\uff0c\u5305\u62ec\u5bf9\u98ce\u9669\u7684\u7cbe\u786e\u9884\u6d4b\u3001\u75be\u75c5\u7cbe\u786e\u8bca\u65ad\u3001\u75be\u75c5\u7cbe\u786e\u5206\u7c7b\u3001\u836f\u7269\u7cbe\u786e\u5e94\u7528\u3001\u7597\u6548\u7cbe\u786e\u8bc4\u4f30\u3001\u7597\u540e\u7cbe\u786e\u9884\u6d4b\u7b49\u3002\u8fc7\u53bb\u7684\u836f\u7269\u7814\u7a76\u901a\u8fc7\u5bf9\u53d1\u660e\u7684\u65b0\u836f\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7b5b\u9009\u51fa\u83b7\u76ca\u4eba\u7fa4\uff0c\u800c\u73b0\u5728\u662f\u901a\u8fc7\u60a3\u8005\u7684\u751f\u7269\u5b66\u3001\u57fa\u56e0\u7ec4\u5b66\u3001\u86cb\u767d\u7ec4\u5b66\u7684\u5dee\u5f02\u6765\u9009\u62e9\u76f8\u5e94\u7684\u9776\u5411\u836f\u7269\u8fdb\u884c\u8bd5\u9a8c\u5165\u7ec4\u3002<\/p>\n

\u8fd9\u4e24\u8005\u201c\u98a0\u5012\u201d\u662f\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u9886\u57df\u7684\u91cd\u8981\u53d8\u9769\uff0c\u8fc7\u53bb\u5f3a\u8c03\u5173\u6ce8\u836f\u7269\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u7597\u6548\u53ca\u4e0d\u826f\u53cd\u5e94\uff0c\u800c\u73b0\u5728\u7684\u4e34\u5e8a\u7814\u7a76\u66f4\u52a0\u5173\u6ce8\u9884\u6d4b\u751f\u5b58\u3001\u5404\u4e2a\u7814\u7a76\u7ec8\u70b9\u4ee5\u53ca\u5404\u79cd\u5206\u5b50\u6807\u8bb0\u7269( Biomarkers) \uff0c\u8fd9\u4e24\u4e2a\u6539\u53d8\u53ef\u671b\u4f7f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6210\u529f\u7387\u5927\u5927<\/p>\n

\u63d0\u9ad8\u3002<\/p>\n

( 1) \u7bee\u5f0f\u7814\u7a76( Basket trial) \u3002<\/strong><\/p>\n

\u67d0\u79cd\u9776\u70b9\u660e\u786e\u7684\u836f\u7269\u5c31\u662f\u4e00\u4e2a\u7bee\u5b50\uff0c\u5c06\u5e26\u6709\u76f8\u540c\u9776\u57fa\u56e0\u7684\u4e0d\u540c\u764c\u75c7\u653e\u8fdb\u4e00\u4e2a\u7bee\u5b50\u91cc\u8fdb\u884c\u7814\u7a76\u5c31\u662f\u7bee\u5f0f\u7814\u7a76\u3002\u7bee\u5f0f\u7814\u7a76\u7684\u672c\u8d28\u5c31\u662f\u4e00\u79cd\u836f\u7269\u5e94\u5bf9\u4e0d\u540c\u7684\u80bf\u7624\uff0c\u4f7f\u5e26\u6709\u76f8\u540c\u9776\u70b9\u7684\u4e0d\u540c\u7624\u79cd\u60a3\u8005\u80fd\u7528\u540c\u4e00\u79cd\u9776\u5411\u836f\u7269\u6cbb\u7597\uff0c\u5b9e\u73b0\u80bf\u7624\u5f02\u75c5\u540c\u6cbb\uff0c\u4f8b\u5982: \u4e0d\u540c\u80bf\u7624\u79cd\u7c7b\u5374\u5177\u6709\u76f8\u540c\u7684\u751f\u7269\u5b66\u7279\u5f81\u3002( \u56fe4)<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n

( 2) \u4f1e\u5f0f\u7814\u7a76( Umbrella trial) \u3002<\/strong><\/p>\n

\u628a\u5177\u6709\u4e0d\u540c\u9a71\u52a8\u57fa\u56e0\u7684\u80ba\u764c\uff0c\u5982K\uff32AS\u3001EGF\uff32\u3001ALK \u62e2\u805a\u5728\u540c\u4e00\u628a\u96e8\u4f1e\u4e4b\u4e0b\uff0c\u5c06\u4e0d\u540c\u7684\u9776\u70b9\u68c0\u6d4b\u5728\u540c\u4e00\u65f6\u95f4\u91cc\u5b8c\u6210\uff0c\u7136\u540e\u6839\u636e\u4e0d\u540c\u7684\u9776\u57fa\u56e0\u5206\u914d\u7ed9\u4e88\u4e0d\u540c\u7684\u7cbe\u786e\u9776\u5411\u836f\u7269\u3002\u4f1e\u5f0f\u8bd5\u9a8c\u7684\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u5c06\u975e\u5e38\u5c11\u89c1\u7684\u7a81\u53d8\u4e8b\u4ef6\u96c6\u4e2d\u8d77\u6765\uff0c\u53d8\u5c11\u89c1\u4e8b\u4ef6\u4e3a\u201c\u5e38\u89c1\u201d\u4e8b\u4ef6\uff0c\u8fd9\u65e0\u8bba\u5bf9\u52a0\u901f\u5c11\u89c1\u75be\u75c5\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8fd8\u662f\u5bf9\u4e8e\u67d0<\/p>\n

\u4e00\u4e2a\u4f53\u60a3\u8005\u83b7\u5f97\u7cbe\u786e\u6cbb\u7597\u7684\u673a\u4f1a\uff0c\u90fd\u5177\u6709\u7279\u522b\u7684\u610f\u4e49\uff0c\u4f8b\u5982: \u540c\u5c5e\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u4e00\u7c7b\u7684\u60a3\u8005\uff0c\u4f46\u5177\u6709\u4e0d\u540c\u7684\u751f\u7269\u5b66\u7279\u5f81\uff0c\u56e0\u6b64\uff0c\u8981\u6839\u636e\u836f\u7269\u7684\u5df2\u77e5\u7ed3\u6784\u3001\u9776\u70b9\u3001\u836f\u7406\u3001\u6bd2\u7406\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u5404\u79cd\u6570\u636e\u6765\u8bbe\u8ba1\u56e0\u5730\u5236\u5b9c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\uff0c\u4ee5<\/p>\n

\u8fbe\u5230\u9884\u671f\u7684\u7ed3\u679c\u3002( \u56fe5)<\/p>\n

\"\u6851\u56fd\u536b<\/p>\n

2.3.7 \u4e34\u573a\u8bd5\u9a8c\u5c1a\u5b58\u5728\u7684\u95ee\u9898<\/strong><\/p>\n

\u4e0a\u9762\u5df2\u9610\u660e\u4e34\u5e8a\u8bd5\u9a8c\u5728\u6574\u4e2a\u65b0\u836f\u521b\u5236\u8fc7\u7a0b\u4e2d\u7684\u4ef7\u503c\u548c\u5730\u4f4d\uff0c\u53c8\u4ecb\u7ecd\u4e86ICH \u7684\u539f<\/p>\n

\u5219\u548c\u6807\u51c6\uff0c\u6211\u56fd\u76ee\u524d\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8fd8\u5b58\u5728\u7740\u4e00\u4e9b\u4e0d\u8db3\uff0c\u6709\u5f85\u4e8e\u8fdb\u4e00\u6b65\u5b66\u4e60\u548c\u63d0\u9ad8: ( 1) \u8bd5\u9a8c\u65b9\u6848\u6709\u8fdd\u80cc\u6ce8\u518c\u8981\u6c42\u7684\u95ee\u9898; ( 2) \u4e34\u5e8a\u8bd5\u9a8c\u8fc7\u7a0b\u8bb0\u5f55\u53ca\u4e34\u5e8a\u68c0\u67e5\u3001\u5316\u9a8c\u7b49\u6570\u636e\u6eaf\u6e90\u95ee\u9898; ( 3) \u8bd5\u9a8c\u7528\u836f\u54c1\u7ba1\u7406\u8fc7\u7a0b\u4e0e\u8bb0\u5f55\u7684\u95ee\u9898; ( 4) \u5b89\u5168\u6027\u8bb0\u5f55\u3001\u62a5\u544a\u65b9\u9762\u7684\u95ee\u9898; ( 5) \u751f\u7269\u6837\u672c\u7684\u53d6\u6837\u3001\u4fdd\u5b58\u3001\u4f7f\u7528\u3001\u8fd0\u8f93\u3001\u68c0\u6d4b\u8fc7\u7a0b\u548c\u8bb0\u5f55\u7684\u95ee\u9898; ( 6) \u5206\u6790\u6d4b\u8bd5\u56fe\u8c31\u7684\u6eaf\u6e90\u95ee\u9898; ( 7) \u4f26\u7406\u59d4\u5458\u4f1a\u7684\u5ba1\u6838\u548c\u76d1\u7763\u7684\u95ee\u9898\u3002<\/p>\n

\u4ea7\u751f\u4e0a\u8ff0\u95ee\u9898\u7684\u4e3b\u8981\u8d23\u4efb\u4e3b\u4f53\u65e0\u975e\u662f\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7533\u529e\u65b9\u4ee5\u53caC\uff32O \u6216SMO\u3002\u8fd9\u4e9b\u95ee\u9898\u76f4\u63a5\u5f71\u54cd\u4e86\u6211\u56fd\u65b0\u836f\u521b\u5236\u7684\u8d28\u91cf\u548c\u6570\u91cf\uff0c\u4e9f\u5f85\u89e3\u51b3\u3002\u4e3b\u8981\u8981\u6df1\u5165\u5b66\u4e60\u3001\u7406\u89e3\u3001\u843d\u5b9eICH \u5404\u9879\u6587\u4ef6\u7684\u5185\u5bb9\u548c\u7cbe\u795e\uff0c\u7ed3\u5408\u6211\u56fd\u56fd\u60c5\uff0c\u5efa\u7acb\u6211\u56fd\u884c\u4e4b\u6709\u6548\u53c8\u4e0e\u56fd\u9645\u63a5\u8f68\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

3<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u603b\u7ed3\u548c\u5c55\u671b<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u7efc\u4e0a\u6240\u8ff0\uff0c\u6211\u56fd\u7684\u201c\u91cd\u5927\u65b0\u836f\u521b\u5236\u201d\u4e13\u9879\u53d6\u5f97\u4e86\u559c\u4eba\u7684\u7d2f\u7d2f\u7855\u679c\uff0c\u4ea7\u751f\u4e86\u5de8\u5927\u7684\u793e\u4f1a\u7ecf\u6d4e\u6548\u76ca\u3002\u5728\u83b7\u5f97\u521b\u65b0\u836f\u7269\u7684\u540c\u65f6\uff0c\u201c\u4e13\u9879\u201d\u7684\u76ee\u6807\u6b63\u5728\u5168\u9762\u5b9e\u65bd\uff0c\u5e76\u8d8b\u4e8e\u5b8c\u6210\u3002<\/p>\n

( 1) \u5efa\u7acb\u4e86\u56fd\u5bb6\u836f\u7269\u521b\u65b0\u6280\u672f\u4f53\u7cfb\uff0c\u5305\u62ec: a\uff0e \u6297\u4f53\u7b49\u751f\u7269\u5927\u5206\u5b50\u836f\u7269\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb; b\uff0e \u514d\u75ab\u6cbb\u7597\u3001\u57fa\u56e0\u6cbb\u7597\u548c\u6838\u9178\u836f\u7269\u7b49\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb; c\uff0e \u5929\u7136\u4ea7\u7269\u6765\u6e90\u521b\u65b0\u836f\u7269\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb; d\uff0e \u4e2d\u8349\u836f\u65b0\u54c1\u79cd\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb; e\uff0e \u5e94\u6025\u533b\u5b66\u836f\u7269\u7814\u53d1\u5173\u952e\u521b\u65b0\u6280\u672f\u4f53\u7cfb\u3002<\/p>\n

( 2) \u6b63\u5f0f\u52a0\u5165ICH \u7ec4\u7ec7\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u548c\u836f\u7269\u5ba1\u6838\u6ce8\u518c\u6d41\u7a0b\u8d8b\u4e8e\u6210\u719f\uff0cGCP \u5e73\u53f0\u7684\u6280\u672f\u548c\u670d\u52a1\u8fbe\u5230\u56fd\u9645\u6c34\u5e73\u3002<\/p>\n

( 3) \u5b8c\u5584\u548c\u63d0\u9ad8\u4e86\u91cd\u8981\u8d44\u6e90\u6027\u5e73\u53f0\u670d\u52a1\u80fd\u529b\u76f8\u5173\u7684\u5173\u952e\u6280\u672f\u4f53\u7cfb\u3002<\/p>\n

( 4) \u57f9\u517b\u548c\u9020\u5c31\u4e86\u4e00\u6279\u65b0\u836f\u521b\u5236\u4ece\u7814\u53d1\u5230\u751f\u4ea7\uff0c\u4ece\u6ce8\u518c\u5230\u6d41\u901a\u7684\u4e13\u4e1a\u4eba\u624d\u3002<\/p>\n

\u201c\u4e13\u9879\u201d\u7684\u4ea7\u751f\u3001\u5236\u8ba2\u3001\u6267\u884c\u7684\u8fc7\u7a0b\u7ed9\u4e86\u6211\u4eec\u591a\u91cd\u542f\u53d1\u3002\u9996\u5148\uff0c\u65b0\u836f\u521b\u5236\u4e0d\u662f\u4e00\u573a\u96c6\u4e2d\u529b\u91cf\u7684\u6b7c\u706d\u6218\uff0c\u800c\u662f\u4e00\u573a\u8017\u65f6\u8017\u8d22\u7684\u6301\u4e45\u6218\u3002\u4e0a\u9762\u6240\u5217\u7684\u6bcf\u4e00\u4e2a\u836f\u7269\u7684\u6210\u529f\u90fd\u9700\u8981\u5341\u5e74\u5de6\u53f3( \u751a\u81f3\u66f4\u957f) \uff0c\u800c\u4e14\u9700\u8981\u5927\u91cf\u8d44\u91d1\u7684\u6295\u5165\u4ee5\u575a\u6301\u5230\u6700\u540e\u7684\u80dc\u5229\uff0c\u53ef\u4ee5\u8bf4\u8fd9\u662f\u4e00\u4e2a\u9ad8\u98ce\u9669\u7684\u9879\u76ee\u3002<\/p>\n

\u56e0\u6b64\uff0c\u8981\u6c42\u6211\u4eec\u5728\u8bbe\u8ba1\u3001\u90e8\u7f72\u9879\u76ee\u65f6\u5fc5\u987b\u575a\u6301\u79d1\u5b66\u9886\u5148\uff0c\u6df1\u5165\u7814\u7a76\uff0c\u8c28\u614e\u52a1\u5b9e\u5730\u5236\u5b9a\u9879\u76ee\u8ba1\u5212\uff0c\u5e76\u4e14\u5efa\u7acb\u79d1\u5b66\u6709\u6548\u7684\u8bc4\u4f30\u673a\u5236\u6765\u8bc4\u5ba1\u9879\u76ee\u3001\u8bc4\u5ba1\u56e2\u961f\u3001\u8bc4\u5ba1\u8fdb\u7a0b\u3001\u8bc4\u5ba1\u6210\u679c\uff0c\u8fd9\u6837\u624d\u80fd\u907f\u514d\u98ce\u9669\uff0c\u5ba2\u89c2\u516c\u6b63\uff0c\u53ca\u65f6\u5730\u8c03\u6574\u9879\u76ee\u8ba1\u5212\u3002\u5176\u6b21\uff0c\u65b0\u836f\u521b\u5236\u662f\u4e00\u4e2a\u591a\u5b66\u79d1\u4ea4\u9519\u3001\u591a\u5143\u5316\u5408\u4f5c\u7684\u9879\u76ee\u3002<\/p>\n

\u4ece\u65b0\u836f\u53d1\u73b0\u3001\u57fa\u7840\u7814\u7a76\u3001\u4e34\u5e8a\u7814\u7a76\u3001\u4ea7\u4e1a\u5316\u5f00\u53d1\uff0c\u5230\u653f\u5e9c\u76d1\u7ba1\u3001\u60a3\u8005\u53cd\u9988\u3001\u6279\u91cf\u751f\u4ea7\u3001\u5e02\u573a\u6d41\u901a\uff0c\u7b49\u7b49\u3002\u4e0d\u4ec5\u8fc7\u7a0b\u957f\u800c\u590d\u6742\uff0c\u800c\u4e14\u5fc5\u987b\u6709\u65b9\u65b9\u9762\u9762\u7684\u9f0e\u529b\u5408\u4f5c\uff0c\u624d\u80fd\u4fdd\u8bc1\u9879\u76ee\u987a\u5229\u63a8\u8fdb\u3002\u8fd9\u91cc\u7684\u5173\u952e\u662f\u4eba\u624d\uff0c\u8fd9\u4e9b\u4eba\u624d\u8981\u6709\u6574\u5408\u79d1\u7814\u3001\u4f01\u4e1a\u3001\u4e34\u5e8a\u3001\u653f\u5e9c\u3001\u60a3\u8005\u7b49\u4e94\u65b9\u9762\u7684\u8d44\u6e90\u7684\u80fd\u529b\uff0c\u5728\u9879\u76ee\u6267\u884c\u548c\u63a8\u8fdb\u7684\u6f2b\u957f\u8fc7\u7a0b\u4e2d\uff0c\u59cb\u7ec8\u80fd\u56e2\u7ed3\u3001\u7ec4\u7ec7\u548c\u9886\u5bfc\u597d\u5404\u65b9\u9762\u7684\u8d44\u6e90\u4e0e\u529b\u91cf\uff0c\u5411\u4e0b\u4e00\u4e2a\u76ee\u6807\u8fc8\u8fdb\uff0c\u76f4\u81f3\u6700\u540e\u7684\u6210\u529f\u3002\u6700\u540e\uff0c\u8981\u770b\u5230\u4e0e\u4e16\u754c\u53d1\u8fbe\u56fd\u5bb6\u76f8\u6bd4\u7684\u5dee\u8ddd\uff0c\u8981\u771f\u6b63\u6210\u4e3a\u4e00\u4e2a\u521b\u65b0\u578b\u7684\u533b\u836f\u5f3a\u56fd\uff0c\u6211\u4eec\u8fd8\u8981\u5728\u601d\u7ef4\u601d\u8def\uff0c\u65b9\u6cd5\u624b\u6bb5\uff0c\u57fa\u7840\u8bbe\u65bd\uff0c\u7ba1\u7406\u673a\u5236\uff0c\u76d1\u7ba1\u6cd5\u89c4\u7b49\u8bf8\u65b9\u9762\u72e0\u4e0b\u529f\u592b\uff0c\u8981\u6709\u4e00\u4e2a\u7531\u70b9\u5230\u9762\u7684\u7a81\u7834\u3002<\/p>\n

\u5f53\u524d\uff0c\u201c\u5341\u4e09\u4e94\u201d\u8ba1\u5212\u4e34\u8fd1\u7ec8\u70b9\uff0c\u201c\u91cd\u5927\u65b0\u836f\u521b\u5236\u201d\u4e13\u9879\u4e5f\u5904\u5728\u201c\u4e34\u95e8\u4e00\u811a\u201d\u7684\u5173\u952e\u65f6\u671f\u3002<\/p>\n

\u9762\u54112020\uff0c\u5c06\u805a\u7126\u91cd\u70b9\uff0c\u52a0\u5f3a\u652f\u6301\u539f\u59cb\u521b\u65b0\uff0c\u771f\u6b63\u5b9e\u73b0\u201c\u533b\u836f\u5927\u56fd\u201d\u5411\u201c\u533b\u836f\u5f3a\u56fd\u201d\u7684\u8f6c\u53d8\uff0c\u7740\u91cd\u6293\u597d\u4ee5\u4e0b\u51e0\u65b9\u9762\u7684\u5de5\u4f5c:<\/p>\n

( 1) \u805a\u7126\u65b9\u5411\u3001\u7a81\u51fa\u91cd\u70b9\uff0c\u5927\u529b\u5f00\u5c55\u76ee\u6807\u5bfc\u5411\u7684\u539f\u521b\u6027\u836f\u7269\u7814\u7a76;<\/p>\n

( 2) \u5bf9\u73b0\u6709\u91cd\u5927\u54c1\u79cd\u8fdb\u884c\u5bc6\u5207\u8ddf\u8e2a\uff0c\u4ece\u65b0\u9776\u6807\u53d1\u73b0\u3001\u5316\u5408\u7269\u7b5b\u9009\u3001\u6210\u836f\u6027\u7814\u7a76\u3001\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5230\u836f\u7269\u4ea7\u4e1a\u5316\u5f00\u5c55\u5168\u8fc7\u7a0b\u6307\u5bfc\u7ba1\u7406;<\/p>\n

( 3) \u52a0\u5f3a\u653f\u5e9c\u76d1\u7ba1\u90e8\u95e8\u7684\u804c\u80fd\u548c\u670d\u52a1\uff0c\u79d1\u5b66\u5f15\u9886\u3001\u6df1\u5165\u6539\u9769\u3001\u575a\u6301\u5f00\u653e\u3001\u7ed3\u5408\u56fd\u60c5\uff0c\u4e3a\u539f\u59cb\u65b0\u836f\u7684\u521b\u5236\u4fdd\u9a7e\u62a4\u822a;<\/p>\n

( 4) \u5efa\u7acb\u4e0e\u56fd\u5bb6\u81ea\u7136\u79d1\u5b66\u57fa\u91d1\u652f\u6301\u836f\u7269\u7814\u53d1\u9879\u76ee\u7684\u534f\u540c\u548c\u6210\u679c\u8f6c\u5316\u8854\u63a5\u673a\u5236\uff0c\u5e76\u6df1\u5165\u5f00\u5c55\u4e13\u9879\u201c\u5341\u4e09\u4e94\u201d\u4ee5\u540e\u7684\u6218\u7565\u7814\u7a76\uff0c\u91cd\u70b9\u63d0\u51fa\u5bf9\u57fa\u4e8e\u65b0\u5316\u5408\u7269\u3001\u65b0\u9776\u70b9\u3001\u65b0\u673a\u5236\u7b49\u5177\u6709\u539f\u59cb\u521b\u65b0\u6027\u91cd\u5927\u54c1\u79cd\u7684\u652f\u6301\u673a\u5236\u4e0e\u65b9\u6848\uff0c\u7ed3\u5408\u65b0\u7684\u5206\u5b50\u751f\u7269\u5b66\u6280\u672f\u3001\u6d4b\u5e8f\u6280\u672f\u3001\u533b\u5b66\u5f71\u50cf\u6280\u672f\u3001\u4eba\u5de5\u667a\u80fd\u6280\u672f\u3001\u5927\u6570\u636e\u6280\u672f\u7b49\uff0c\u505a\u597d\u4ee5\u521b\u65b0\u836f\u7269\u4e3a\u4e2d\u5fc3\u7684\u751f\u7269\u533b\u836f\u9886\u57df\u521b\u65b0\u53ca\u6838\u5fc3\u6280\u672f\u653b\u5173\u7684\u6218\u7565\u90e8\u7f72\u548c\u53d1\u5c55\u89c4\u5212\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\u6851\u56fd\u536b || 2018 \u5e74\u56fd\u5bb6\u91cd\u5927\u65b0\u836f\u521b\u5236\u4e13\u9879\u8fdb\u5c55\u53ca\u5341\u4e09\u4e94\u5c55\u671b \u6765\u6e90 \u4e2d\u56fd\u751f\u7269\u5de5\u7a0b\u6742\u5fd7 China […]<\/p>\n","protected":false},"author":1,"featured_media":98659,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98658"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=98658"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98658\/revisions"}],"predecessor-version":[{"id":98674,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98658\/revisions\/98674"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98659"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}