{"id":31655,"date":"2018-08-08T01:00:00","date_gmt":"2018-08-09T04:17:56","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/%e6%8a%97%e4%bd%93%e8%8d%af%e4%ba%8b-%e7%a5%9e%e8%8d%af%e5%8f%91%e7%a5%9e%e5%8a%9b%ef%bc%8ckeytruda%e7%a9%b6%e7%ab%9f%e7%a5%9e%e5%9c%a8%e5%93%aa%e9%87%8c%ef%bc%9f\/"},"modified":"2018-08-09T12:17:59","modified_gmt":"2018-08-09T04:17:59","slug":"%e6%8a%97%e4%bd%93%e8%8d%af%e4%ba%8b-%e7%a5%9e%e8%8d%af%e5%8f%91%e7%a5%9e%e5%8a%9b%ef%bc%8ckeytruda%e7%a9%b6%e7%ab%9f%e7%a5%9e%e5%9c%a8%e5%93%aa%e9%87%8c%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/31655\/","title":{"rendered":"\u6297\u4f53\u836f\u4e8b |\u201c\u795e\u836f\u201d\u53d1\u795e\u529b\uff0ckeytruda\u7a76\u7adf\u795e\u5728\u54ea\u91cc\uff1f"},"content":{"rendered":"
\n

2018<\/span>\u5e74<\/span>7<\/span>\u6708<\/span>25<\/span>\u65e5\uff0c\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff08<\/span>CFDA<\/span>\uff09\u6b63\u5f0f\u6279\u51c6<\/span>PD-1<\/span><\/strong>\u6291\u5236\u5242\u5e15\u535a\u5229\u73e0\u5355\u6297\u6ce8\u5c04\u6db2<\/span><\/strong>\uff08\u4e2d\u6587\u5546\u54c1\u540d\u53ef\u745e\u8fbe\uff0c\u82f1\u6587\u540d<\/span>Keytruda<\/span>\uff09\u4e0a\u5e02\uff0c\u9488\u5bf9\u7684\u9002\u5e94\u75c7\u4e3a\u524d\u4e00\u79cd\u7597\u6cd5\u6cbb\u7597\u5931\u8d25\u7684\u4e0d\u53ef\u5207\u9664\u6027\u6216\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u3002\u4ece\u7533\u62a5\u4e0a\u5e02\u5230\u83b7\u6279\u4ec5\u7528\u4e86<\/span>5<\/span>\u4e2a\u591a\u6708\uff0c\u8fd9\u6b3e\u98ce\u9761\u6297\u764c\u754c\u7684<\/span>\u201c<\/span>\u795e\u836f<\/span>\u201d<\/span>\u5fc5\u5c06\u5f15\u9886\u4e2d\u56fd\u7684\u80bf\u7624\u6cbb\u7597\u8de8\u5165<\/span>\u201c<\/span>\u514d\u75ab<\/span>K<\/span>\u65f6\u4ee3<\/span>\u201d<\/span>\u3002<\/span><\/span><\/p>\n

Keytruda<\/span>\uff08\u7b80\u79f0<\/span>K<\/span>\u836f\uff09\u662f\u7531\u80bf\u7624\u514d\u75ab\u5de8\u5934\u9ed8\u514b\u516c\u53f8\u7814\u53d1\u751f\u4ea7\u7684\u6297\u80bf\u7624\u836f\u7269\uff0c\u662f<\/span>PD-1<\/span>\u6291\u5236\u5242\u5bb6\u65cf\u7684\u4e00\u4efd\u5b50\u3002\u65e9\u5728\u8fdb\u5165\u4e2d\u56fd\u5e02\u573a\u524d\uff0c<\/span>K<\/span>\u836f\u5c31\u5df2\u5728\u4e0a\u5e02\u4e09\u5e74\u7684\u65f6\u95f4\u91cc\u529f\u6210\u540d\u5c31\uff0c\u5b83\u4e00\u8def\u6295\u5954\u5947\u8ff9\uff0c\u6cbb\u6108\u4e86\u60a3\u665a\u671f\u9ed1\u8272\u7d20\u7624\u7684\u7f8e\u56fd\u524d\u603b\u7edf\u5361\u7279\u3001\u9996\u4e2a\u6210\u529f\u8dfb\u8eab\u80ba\u764c\u4e00\u7ebf\u6cbb\u7597\u7684\u514d\u75ab\u6cbb\u7597\u836f\u7269\u3001\u6210\u529f\u5f81\u670d\u7f8e\u56fd<\/span>FDA<\/span>\u4e00\u6b21\u83b7\u6279<\/span>15<\/span>\u79cd\u80bf\u7624\u9002\u7528\u75c7\u7b49\u7b49\uff0c\u6beb\u4e0d\u5938\u5f20\u5730\u8bf4\uff0c<\/span>K<\/span>\u836f\u662f\u76ee\u524d\u6700\u6210\u529f\u7684\u764c\u75c7\u514d\u75ab\u6cbb\u7597\u836f\u7269\u3002<\/span><\/span><\/p>\n


<\/p>\n

\n
\n
\"\u6297\u4f53\u836f\u4e8b<\/section>\n
\n

K\u836f\u662f\u5982\u4f55\u7206\u53d1\u4e86\u795e\u529b<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u5728\u6211\u4eec\u4eba\u4f53\u81ea\u8eab\u7684\u514d\u75ab\u7cfb\u7edf\u4e2d\uff0c\u6709\u4e00\u4f4d\u6781\u5176\u91cd\u8981\u7684\u514d\u75ab\u536b\u58eb\u53eb\u505a<\/span>T<\/span>\u7ec6\u80de\uff0c\u5f53\u5916\u754c\u7684\u6709\u5bb3\u7269\u8d28\u60f3\u8981\u4fb5\u5165\u4eba\u4f53\u65f6\uff0c<\/span>T<\/span>\u7ec6\u80de\u901a\u5e38\u4f1a\u8bf1\u53d1\u514d\u75ab\u53cd\u5e94\uff0c\u963b\u6321\u6216\u6d88\u706d\u5f02\u7269\u3002<\/span>PD-1<\/span>\u5c31\u50cf\u662f\u8fd9\u4f4d\u536b\u58eb\u7684\u6b7b\u7a74\uff0c\u800c\u80bf\u7624\u7ec6\u80de\u5219\u50cf\u4e2a\u53db\u5f92\uff0c\u7528\u5229\u5668<\/span>PD-L1<\/span>\u72e0\u72e0\u5730\u6233\u8fdb\u4e86\u536b\u58eb\u7684\u6b7b\u7a74\uff0c\u81f4\u4f7f\u536b\u58eb\u65e0\u6cd5\u518d\u7ee7\u7eed\u4fdd\u536b\u6211\u4eec\u7684\u673a\u4f53\u3002\u6b64\u65f6\uff0c<\/span>PD-1<\/span>\u6291\u5236\u5242\uff08<\/span>K<\/span>\u836f\uff09\u5c31\u662f\u536b\u58eb\u7684\u76d4\u7532\uff0c\u6709\u6548\u5730\u963b\u65ad\u4e86\u5229\u5668\u7684\u4f24\u5bb3\uff0c\u4f7f\u5f97\u536b\u58eb\u53ef\u4ee5\u7ee7\u7eed\u4e3a\u4eba\u4f53\u4fdd\u9a7e\u62a4\u822a\u3002<\/span><\/span><\/p>\n

 \"\u6297\u4f53\u836f\u4e8b<\/span><\/p>\n


<\/p>\n


<\/p>\n

\n
\n
\"\u6297\u4f53\u836f\u4e8b<\/section>\n
\n

\u4f55\u65f6\u9700\u8981K\u836f\u7206\u53d1\u795e\u529b<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\u8bf4\u5230<\/span>K<\/span>\u836f\u7684\u4f20\u5947\u6545\u4e8b\u4e4b\u4e00\uff0c\u90a3\u5fc5\u662f\u5728<\/span>2017<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>FDA<\/span>\u505a\u7684\u5212\u65f6\u4ee3\u5ba1\u6279\uff0c\u5728\u533b\u7597\u53f2\u4e0a\u7b2c\u4e00\u6b21\u6ca1\u6709\u6309\u7167\u80bf\u7624\u90e8\u4f4d\u6279\u51c6\u836f\u7269\uff0c\u800c\u662f\u6279\u51c6\u5728\u672b\u7ebf\u4f7f\u7528<\/span>K<\/span>\u836f\uff0c\u5373\u7528\u4e8e<\/span>DNA<\/span>\u9519\u914d\u4fee\u590d\u7f3a\u9677\u81f4\u4f7f\u7684\u6240\u6709\u5b9e\u4f53\u7624\uff0c\u4e5f\u5c31\u662f\u4e0d\u7ba1\u80bf\u7624\u7684\u539f\u53d1\u75c5\u7076\u5728\u54ea\u91cc\uff0c\u53ea\u8981\u5b58\u5728\u9ad8\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\uff08<\/span>MSI-H<\/span>\uff09\u6216\u9519\u914d\u4fee\u590d\u7f3a\u9677\uff08<\/span>dMMR<\/span>\uff09\uff0c\u5c31\u90fd\u53ef\u4ee5\u4f7f\u7528<\/span>K<\/span>\u836f\u6cbb\u7597\u3002<\/span><\/span><\/p>\n

\u53ef\u600e\u6837\u624d\u7b97\u5b58\u5728<\/span>MSI-H<\/span>\u6216<\/span>dMMR<\/span>\uff1f\u90a3\u5c31\u8981\u5148\u4e86\u89e3\u4e00\u4e0b\uff0c\u4ec0\u4e48\u662f<\/span>MSI-H<\/span>\u548c<\/span>dMMR<\/span>\uff1f<\/span>MSI<\/span>\u7684\u68c0\u6d4b\u65b9\u6cd5\u548c\u8bca\u65ad\u6807\u51c6\u53c8\u662f\u4ec0\u4e48\uff1f<\/span><\/span><\/p>\n


<\/p>\n

\n

MSI<\/span><\/strong><\/span>\u5fae\u536b\u661f\uff08<\/span>MS<\/span>\uff09\u662f\u4e00\u79cd\u7531<\/span>1~6<\/span>\u4e2a\u6838\u82f7\u9178\u7ec4\u6210\uff0c\u5177\u6709\u9ad8\u5ea6\u591a\u6001\u6027\u7b80\u5355\u4e32\u8054\u7684<\/span>DNA <\/span>\u5e8f\u5217\uff0c\u5176\u4f5c\u7528\u590d\u6742\u591a\u6837\uff0c\u5728\u67d3\u8272\u4f53\u7ed3\u6784\u7684\u5f62\u6210\u548c\u91cd\u7ec4\u4e2d\u8d77\u91cd\u8981\u4f5c\u7528\uff0c\u53ef\u5f71\u54cd\u57fa\u56e0\u7684\u590d\u5236\u4e0e\u8868\u8fbe\u3002\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\uff08<\/strong><\/span>MSI<\/span><\/strong>\uff09<\/span><\/strong>\u5373\u7531\u4e8e\u590d\u5236\u9519\u8bef\u5bfc\u81f4\u5fae\u536b\u661f\u533a\u57df\u51fa\u73b0\u78b1\u57fa\u5bf9\u7684\u63d2\u5165\u6216\u4e22\u5931\u7684\u73b0\u8c61\u3002<\/span>MSI <\/span>\u6700\u5148\u5728\u7ed3\u76f4\u80a0\u764c\u4e2d\u88ab\u53d1\u73b0\u5e76\u88ab\u8ba4\u4e3a\u662f\u9057\u4f20\u6027\u975e\u606f\u8089\u75c5\u6027\u7ed3\u76f4\u80a0\u764c\uff08<\/span>HNPCC<\/span>\uff09\u7684\u7279\u5f81\uff0c\u6b64\u540e\u53c8\u53d1\u73b0\u4e8e\u591a\u79cd\u6563\u53d1\u6027\u80bf\u7624\u4e2d\uff0c\u5982\u80c3\u764c\u3001\u80ba\u764c\u3001\u5b50\u5bab\u5185\u819c\u764c\u3002<\/span>MSI<\/span>\u53ef\u5206\u4e3a\u9ad8\u4e0d\u7a33\u5b9a\uff08<\/span>MSI-H<\/span>\uff09\u3001\u4f4e\u4e0d\u7a33\u5b9a\uff08<\/span>MSI-L<\/span>\uff09\u548c\u7a33\u5b9a\uff08<\/span>MS-S<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\"\u6297\u4f53\u836f\u4e8b<\/span><\/p>\n


<\/p>\n

\n

MMR<\/span><\/strong><\/span>MSI<\/span>\u7684\u4ea7\u751f\u4e0e<\/span>DNA <\/span>\u9519\u914d\u4fee\u590d<\/span>(MMR)<\/span>\u7cfb\u7edf\u7684\u7f3a\u9677\u6709\u5173\uff0c<\/span>MMR<\/span>\u662f\u4e00\u4e2a\u6d89\u53ca\u591a\u79cd\u86cb\u767d\u8d28\u7684\u9ad8\u5ea6\u4fdd\u5b88\u7684\u7ec6\u80de\u8fc7\u7a0b\uff0c\u5728<\/span>DNA <\/span>\u590d\u5236\u3001\u57fa\u56e0\u91cd\u7ec4\u6216\u7406\u5316\u56e0\u7d20\u635f\u4f24\u7684\u8fc7\u7a0b\u4e2d\u51fa\u73b0\uff0c\u76ee\u524d\u53d1\u73b0<\/span>MMR<\/span>\u76f8\u5173\u86cb\u767d\u81f3\u5c11\u5b58\u5728\u4e03\u79cd\uff0c\u5b83\u4eec\u4e4b\u95f4\u53ef\u7279\u5f02\u6027\u5730\u7ed3\u5408\u5f62\u6210\u529f\u80fd\u6027\u5f02\u4e8c\u805a\u4f53\uff0c\u8bc6\u522b\u5728<\/span>DNA <\/span>\u590d\u5236\u8fc7\u7a0b\u4e2d\u78b1\u57fa\u5bf9\u7684\u9519\u914d\u548c\u5c0f\u6838\u82f7\u9178\uff08<\/span>1~4<\/span>\u4e2a\u78b1\u57fa\u5bf9\uff09\u7684\u63d2\u5165\u6216\u7f3a\u5931\u3002\u6b64\u5916\uff0c<\/span>MMR<\/span>\u57fa\u56e0\u5728\u53cc\u94fe\u65ad\u88c2\u4fee\u590d\u3001\u51cb\u4ea1\u3001\u91cd\u7ec4\u4e2d\u4e5f\u53d1\u6325\u4f5c\u7528\u3002<\/span>MMR<\/span>\u53ef\u5206\u4e3a\u9519\u914d\u4fee\u590d\u7f3a\u9677\uff08<\/span>dMMR<\/span>\uff09\u548c\u6b63\u5e38\uff08<\/span>pMMR<\/span>\uff09\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n

\u76ee\u524d<\/span>MSI<\/span><\/strong>\u7684\u68c0\u6d4b\u65b9\u6cd5<\/span><\/strong><\/span>\u4e3b\u8981\u6709\u4e24\u79cd\uff1a\u4e00\u79cd\u662f\u91c7\u7528<\/span>PCR<\/span>\u6cd5\u5bf9\u5fae\u536b\u661f\u7247\u6bb5\u6269\u589e\u68c0\u6d4b\u5176\u957f\u5ea6\u53d8\u5316\uff0c\u53e6\u4e00\u79cd\u662f\u91c7\u7528\u514d\u75ab\u7ec4\u5316\u6cd5\u68c0\u6d4b\u76f8\u5e94<\/span>MMR<\/span>\u86cb\u767d\uff0c\u5176\u6709\u5f88\u9ad8\u7684\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027\u3002<\/span><\/span><\/p>\n

PCR<\/span><\/strong>\u6cd5<\/span><\/strong><\/span>\uff1a\u8bb8\u591a\u7814\u7a76\u5f97\u51fa\u7684\u7ed3\u8bba\u56e0\u6240\u9009\u7684<\/span>MS<\/span>\u4f4d\u70b9\u7684\u6570\u91cf\u548c\u7c7b\u578b\u4e0d\u540c\u800c\u6709\u5dee\u5f02\uff0c\u4e00\u822c\u53c2\u7167<\/span>NCI <\/span>\u63d0\u51fa\u7684\u9488\u5bf9<\/span>HNPCC<\/span>\u7684<\/span>MSI<\/span>\u8bca\u65ad\u6807\u51c6\uff0c\u91c7\u7528<\/span>BAT-25<\/span>\u3001<\/span>BAT-26<\/span>\u3001<\/span>D2S123<\/span>\u3001<\/span>D5S346<\/span>\u3001<\/span>D17S250<\/span>\u8fd9<\/span>5<\/span>\u4e2a<\/span>MS<\/span>\u4f4d\u70b9\u3002<\/span><\/span><\/p>\n

1. <\/span>\u9ad8\u5ea6\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\uff08<\/span>MSI-H<\/span>\uff09\u4e3a\u51fa\u73b0\u4e24\u4e2a\u6216\u66f4\u591a\u9633\u6027\u4f4d\u70b9\uff08<\/span>\u226530 %<\/span>\uff09\uff1b<\/span><\/span><\/p>\n

2. <\/span>\u4f4e\u9891\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\uff08<\/span>MSI-L<\/span>\uff09\u4e3a\u4e00\u4e2a\u9633\u6027\u4f4d\u70b9\uff08<\/span><30%<\/span>\uff09\uff1b<\/span><\/span><\/p>\n

3. <\/span>\u65e0\u9633\u6027\u4f4d\u70b9\u4e3a\u5fae\u536b\u661f\u7a33\u5b9a\uff08<\/span>MSS<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u514d\u75ab\u7ec4\u5316\u6cd5<\/span><\/strong><\/span>\uff1a\u514d\u75ab\u7ec4\u5316\u4e3b\u8981\u68c0\u6d4b\u764c\u7ec4\u7ec7\u4e2d<\/span>MLH1<\/span>\uff0c<\/span>PMS2<\/span>\uff0c<\/span>MSH2 <\/span>\u53ca<\/span> MSH6 <\/span>\u8fd9<\/span> 4 <\/span>\u79cd\u86cb\u767d\u7684\u8868\u8fbe\uff1a<\/span><\/span><\/p>\n

1. <\/span>\u82e5\u7ed3\u679c\u663e\u793a\u4efb\u4e00\u86cb\u767d\u5b8c\u5168\u7f3a\u5931\uff0c\u5219\u5224\u8bfb\u4e3a<\/span>dMMR<\/span>\uff0c\u8fdb\u800c\u5f97\u51fa<\/span>MSI-H<\/span>\u3002<\/span><\/span><\/p>\n

2. <\/span>\u82e5\u663e\u793a\u65e0\u86cb\u767d\u7f3a\u5931\uff0c\u5219\u5224\u65ad\u4e3a<\/span>pMMR<\/span>\u3002<\/span><\/span><\/p>\n

\u6700\u8fd1<\/span>Ronald J Hause<\/span>\u7b49\u4eba\u5229\u7528\u57fa\u56e0\u7ec4\u5168\u5916\u663e\u5b50\u6d4b\u5e8f\u6280\u672f\uff0c\u5206\u6790\u4e86<\/span>18<\/span>\u4e2d\u764c\u75c7<\/span>5930<\/span>\u4e2a\u57fa\u56e0\u7ec4\uff0c\u53d1\u73b0\u5176\u4e2d<\/span>14<\/span>\u79cd\u764c\u75c7\u60a3\u8005\u764c\u7ec6\u80de\u4e2d\u53d1\u751f<\/span>MSI<\/span>\uff0c\u5176\u4e2d\u5b50\u5bab\u5185\u819c\u764c<\/span>MSI<\/span>\u9891\u7387\u6700\u9ad8\u4e3a<\/span>30%<\/span>\uff0c\u80c3\u764c\u4e0e\u7ed3\u80a0\u764c\u4e3a<\/span>19%<\/span>\u3002\u7814\u7a76\u53d1\u73b0<\/span>10<\/span>\u4e2a\u6700\u6613\u53d1\u751f<\/span>MSI<\/span>\u7684\u4f4d\u70b9\u666e\u904d\u5b58\u5728\u4e8e\u5404\u79cd\u764c\u7ec6\u80de\u4e2d\uff0c\u56e0\u6b64<\/span>MSI<\/span>\u68c0\u6d4b\u53ef\u7528\u4e8e\u5404\u7c7b\u764c\u75c7\u60a3\u8005\u4e2d\uff0c\u4f7f\u5176\u83b7\u5f97\u66f4\u597d\u7684\u6cbb\u7597\u3002<\/span><\/span><\/p>\n

\"\u6297\u4f53\u836f\u4e8b<\/span><\/p>\n

              <\/span>14<\/span>\u79cd\u5e38\u89c1\u764c\u7ec6\u80de\u5185\u53d1\u751f<\/span>MSI-H<\/span>\u7684\u9891\u7387<\/span><\/p>\n

\n
\n
\"\u6297\u4f53\u836f\u4e8b<\/section>\n<\/section>\n<\/section>\n

\u6839\u636e\u6743\u5a01<\/span><\/strong>NCCN<\/span><\/strong>\u6307\u5357\u5bf9<\/span><\/strong>MSI<\/span><\/strong>\u68c0\u6d4b\u65f6\u673a\u63a8\u8350<\/span><\/strong>\uff1a<\/span><\/span><\/p>\n

1. <\/span>\u5bf9\u4e8e\u6240\u6709\u5c0f\u4e8e<\/span>70<\/span>\u5c81\u7684\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u548c\u5927\u4e8e<\/span>70<\/span>\u5c81\u4f46\u7b26\u5408<\/span>Bethesda Guidelines<\/span>\u7684\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u53ef\u63a5\u53d7\u6797\u5947\u7efc\u5408\u5f81\u7b5b\u67e5\uff08<\/span>IHC for MMR OR PCR for MSI<\/span>\uff09\uff1b<\/span><\/span><\/p>\n

2. <\/span>\u514d\u75ab\u7ec4\u5316\u53d1\u73b0<\/span>MLH1<\/span>\u8868\u8fbe\u7f3a\u5931\u4f46<\/span>BRAF V600E<\/span>\u5b58\u5728\uff0c\u53ef\u6392\u9664\u6797\u5947\u7efc\u5408\u5f81\uff1b<\/span><\/span><\/p>\n

3. <\/span>\u6240\u6709<\/span>II<\/span>\u671f\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u5e94\u8be5\u8fdb\u884c<\/span>MMR<\/span>\u6216\u8005<\/span>MSI<\/span>\u68c0\u6d4b\uff1b<\/span><\/span><\/p>\n

4. <\/span>\u6240\u6709\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u90fd\u5e94\u8be5\u8fdb\u884c<\/span>MMR<\/span>\u6216\u8005<\/span>MSI<\/span>\u68c0\u6d4b\u3002<\/span> <\/span><\/span><\/p>\n


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\"\u6297\u4f53\u836f\u4e8b<\/section>\n
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\u795e\u529b\u7206\u53d1\u540e\u7684\u6218\u7ee9<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

K<\/span>\u836f\u4f5c\u4e3a\u80bf\u7624\u514d\u75ab\u6cbb\u7597\u7684\u625b\u628a\u5b50\uff0c\u81ea\u4e0a\u5e02\u540e\u6240\u63d0\u4ea4\u7684\u6210\u7ee9\u5355\u53ef\u8c13\u662f\u60ca\u559c\u4ea4\u96c6\u3002\u636e<\/span>FDA<\/span><\/strong>\u7684\u5b98\u65b9\u6570\u636e<\/span><\/strong>\uff0c<\/span>149<\/span>\u4f8b\u7b26\u5408\u6761\u4ef6\u7684\u5b9e\u4f53\u7624\u60a3\u8005\u63a5\u53d7\u4e86\u6cbb\u7597\uff0c\u4ed6\u4eec\u90fd\u5e26\u6709\u9ad8\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\u6216\u9519\u914d\u4fee\u590d\u7f3a\u9677\u3002\u7ed3\u679c\u663e\u793a\uff0c\u60a3\u8005\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\u8fbe\u5230\u4e86<\/span>39.6%<\/span>\uff0c\u5176\u4e2d\u90e8\u5206\u7f13\u89e3\u8005\u6709<\/span>48<\/span>\u4eba\uff0c\u5b8c\u5168\u7f13\u89e3\u8005\u6709<\/span>11<\/span>\u4eba\u3002\u5728\u51fa\u73b0\u7f13\u89e3\u7684\u60a3\u8005\u4e2d\uff0c\u7f13\u89e3\u65f6\u957f\u8d85\u8fc7\u534a\u5e74\u6bd4\u4f8b\u8d85\u8fc7\u4e86<\/span>78%<\/span>\u3002<\/span><\/span><\/p>\n

\u6b63\u56e0<\/span>K<\/span>\u836f\u7206\u53d1\u7684\u795e\u529b\u8ba9\u4e16\u4eba\u89c1\u5230\u4e86\u5b83\u771f\u6b63\u7684\u5b9e\u529b\uff0c\u4e0e<\/span>2016<\/span>\u5e74\u540c\u671f\u6570\u636e\u76f8\u6bd4\uff0c<\/span>Keytruda<\/span>\u7684\u9500\u552e\u989d\u4ee5<\/span>173.3%<\/span>\u7684\u589e\u901f\u7b11\u50b2\u7fa4\u96c4\u3002\u800c\u5728<\/span>2018Q2<\/span>\u5b63\u5ea6\uff0c<\/span>K<\/span>\u836f\u66f4\u662f\u51ed\u501f\u5728\u80ba\u764c\u5e02\u573a\u7684\u7a33\u5065\u4f18\u52bf\uff0c\u9500\u552e\u989d\u8fbe<\/span>16.67<\/span>\u4ebf\u7f8e\u91d1\uff0c\u4ee5<\/span>0.4<\/span>\u4ebf\u7f8e\u91d1\u7684\u5fae\u5f31\u4f18\u52bf\u9669\u80dc<\/span>Opdivo<\/span>\u3002<\/span><\/span><\/p>\n

\"\u6297\u4f53\u836f\u4e8b<\/span><\/p>\n

2017<\/span>\u5e74\u524d\u4e09\u5b63\u5ea6\u7545\u9500\u6297\u764c\u836f<\/span>Top10<\/span><\/p>\n

\u56e0\u6b64\uff0c\u529f\u6210\u540d\u5c31\u7684<\/span>K<\/span>\u836f\u8fdb\u5165\u4e2d\u56fd\u5e02\u573a\u540e\u53c8\u4f1a\u518d\u6b21\u53d6\u5f97\u600e\u6837\u50b2\u4eba\u7684\u6210\u7ee9\uff0c\u6211\u4eec\u90fd\u62ed\u76ee\u4ee5\u5f85\u3002<\/span><\/span><\/p>\n


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\"\u6297\u4f53\u836f\u4e8b<\/section>\n
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K\u836f\u5f15\u53d1\u7684\u601d\u8003<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u4ece<\/span>2003<\/span>\u5e74\uff0c<\/span>K<\/span>\u836f\u9879\u76ee\u7684\u8bde\u751f\uff0c\u5230\u5982\u4eca\u7684\u4e00\u4e3e\u6210\u540d\uff0c<\/span>K<\/span>\u836f\u7684\u6210\u529f\u4e4b\u8def\u5e76\u4e0d\u662f\u4e00\u5e06\u98ce\u987a\u7684\u3002\u6700\u521d\uff0c\u9ed8\u514b\u516c\u53f8\u7684\u7814\u53d1\u5176\u5b9e\u843d\u540e\u4e8e<\/span>BMS<\/span>\u516c\u53f8\u597d\u51e0\u5e74\uff0c\u5bf9\u4e8e\u9ed8\u514b\u516c\u53f8\u6765\u8bf4\uff0c\u8981\u60f3\u6253\u8d62\u8fd9\u573a\u786c\u4ed7\uff0c\u9700\u8981\u76f8\u5bf9\u66f4\u52a0\u96c6\u4e2d\u7684\u6295\u5165\u3002\u9ed8\u514b\u7814\u53d1\u603b\u76d1<\/span>Roger Perlmutter<\/span>\u8ba4\u4e3a<\/span>Keytruda<\/span>\u7edd\u5bf9\u662f\u4e00\u6b3e\u503c\u5f97\u6574\u4e2a\u9ed8\u514b\u516c\u53f8\u5168\u8eab\u5fc3\u6295\u5165\u7814\u53d1\u7684\u836f\u7269\u3002\u4e8b\u5b9e\u8bc1\u660e\u4e86\uff0c<\/span>Keytruda<\/span>\u7684\u9886\u5bfc\u56e2\u961f\u662f\u975e\u5e38\u6b63\u786e\u7684\uff0c\u5728\u6709\u80fd\u529b\u7684\u7814\u7a76\u8005\u63a8\u8fdb\u7814\u7a76\u7684\u8fc7\u7a0b\u4e2d\uff0c\u8fd8\u6709\u8fdc\u89c1\u548c\u9b44\u529b\u7684\u516c\u53f8\u7ba1\u7406\u5c42\u4eba\u58eb<\/strong><\/span>\u4e3a\u5176\u4fdd\u9a7e\u62a4\u822a\uff0c\u624d\u6709\u4e86<\/span>K<\/span>\u836f\u73b0\u5728\u7684\u4f20\u5947\u3002<\/span><\/span><\/p>\n

\u5176\u5b9e\uff0c\u9664\u4e86\u9ed8\u6c99\u4e1c\u8fd9\u6837\u7684\u8001\u724c\u80bf\u7624\u514d\u75ab\u5de8\u5934\uff0c\u8fd1\u51e0\u5e74\uff0c\u5bcc\u6709\u521b\u65b0\u6027\u3001\u5b9e\u529b\u96c4\u539a\u3001\u4e3b\u653b\u80bf\u7624\u514d\u75ab\u7684\u521b\u65b0\u836f\u516c\u53f8\u4e0d\u5728\u5c11\u6570\uff0c\u6bd4\u5982\u57fa\u77f3\u836f\u4e1a\u3001\u79d1\u671b\u751f\u7269\u3001\u9e3f\u8fd0\u534e\u5b81<\/strong><\/span>\u7b49\u7b49\uff0c\u800c\u8fd9\u4e9b\u516c\u53f8\u867d\u7136\u6210\u7acb\u65f6\u95f4\u4e0d\u957f\uff0c\u4f46\u4e5f\u53d6\u5f97\u4e86\u4e0d\u9519\u7684\u6210\u7ee9\u3002\u5c31\u62ff\u57fa\u77f3\u836f\u4e1a\u6765\u8bf4\uff0c\u4eca\u5e74<\/span>5<\/span>\u6708\u4efd\u5b8c\u6210<\/span>2.6<\/span>\u4ebf\u7f8e\u5143\u5927\u89c4\u6a21<\/span>B<\/span>\u8f6e\u878d\u8d44\uff0c\u518d\u5230<\/span>6<\/span>\u6708\u4efd\u77ed\u77ed<\/span>20<\/span>\u5929\u5185\u8fbe\u6210\u4e24\u9879\u521b\u65b0\u836f\u8de8\u5883\u5546\u4e1a\u5408\u4f5c\u3002\u800c\u57fa\u77f3\u836f\u4e1a\u4f01\u4e1a\u53d1\u5c55\u90e8\u5168\u7403\u4e3b\u7ba1\u3001\u9ad8\u7ea7\u526f\u603b\u88c1\u8881\u658c\u535a\u58eb<\/strong><\/span>\u5728\u52a0\u5165\u57fa\u77f3\u836f\u4e1a\u524d\u5c42\u62c5\u4efb\u9ed8\u6c99\u4e1c\u764c\u75c7\u7c7b\u836f\u7269\u5546\u52a1\u62d3\u5c55\u5168\u7403\u4e3b\u7ba1\u548c\u6267\u884c\u603b\u76d1\uff0c\u6210\u529f\u5b8c\u6210\u4e86\u8d85\u8fc7<\/span>30<\/span>\u9879\u9879\u76ee\u5e76\u8d2d\u3001\u8f6c\u8ba9\u53ca<\/span>Keytruda<\/span>\u5408\u4f5c\u534f\u8bae\u3002\u79d1\u5b66\u4e8b\u52a1\u9ad8\u7ea7\u526f\u603b\u88c1<\/span>JON WANG<\/span>\uff08\u738b\u8f9b\u4e2d\u535a\u58eb\uff09<\/span><\/strong>\u52a0\u5165\u57fa\u77f3\u836f\u4e1a\u524d\uff0c\u66fe\u4efb\u6ce2\u58eb\u987f\u9ed8\u514b\u7814\u7a76\u5b9e\u9a8c\u5ba4<\/span>(Merck Research Laboratories)<\/span>\u7684\u514d\u75ab\u80bf\u7624\u5b66\u7814\u7a76\u4e3b\u4efb\u603b\u76d1\uff0c\u671f\u95f4\u4e3a\u4e86\u66f4\u597d\u5730\u7406\u89e3<\/span>Keytruda<\/span>\u8010\u836f\u673a\u5236\u4ee5\u514b\u670d\u76ee\u524d\u5728\u764c\u75c7\u6cbb\u7597\u4e2d\u7684\u514d\u75ab\u7597\u6cd5\u7684\u5404\u79cd\u969c\u788d\uff0c\u9886\u5bfc\u548c\u4e3b\u6301\u591a\u4e2a\u7814\u7a76\u9879\u76ee\uff0c\u8fd8\u79ef\u6781\u53c2\u52a0\u8bc4\u4f30\u5408\u4f5c\u673a\u4f1a\u4ee5\u4e30\u5bcc\u9ed8\u514b\u7684\u4ea7\u54c1\u7ebf\u53ca\u6269\u5927<\/span>Keytruda<\/span>\u7684\u5e02\u573a\u8303\u56f4\u3002<\/span><\/span><\/p>\n

\u65e0\u8bba\u662f\u8001\u724c\u516c\u53f8\u9ed8\u514b\u8fd8\u662f\u65b0\u5174\u516c\u53f8\u57fa\u77f3\u836f\u4e1a\u3001\u79d1\u671b\u751f\u7269\u3001\u9e3f\u8fd0\u534e\u5b81<\/strong>\u7b49\u7b49\uff0c\u4f18\u79c0\u7684\u56e2\u961f\u914d\u7f6e\u4e0d\u5f97\u4e0d\u8bf4\u662f\u53ca\u5176\u91cd\u8981\u7684\uff0c\u6df1\u8c0b\u8fdc\u8651\u7684\u5c06\u9886\u624d\u80fd\u9886\u5bfc\u597d\u58eb\u5175\u6253\u597d\u80dc\u4ed7\uff0c\u8fd9\u662f\u6bcb\u5eb8\u7f6e\u7591\u7684\u3002\u56e0\u6b64\uff0c\u5728\u5411\u4e0a\u53d1\u5c55\u7684\u8fdb\u7a0b\u4e2d\uff0c\u7814\u53d1\u5c42\u548c\u9886\u5bfc\u5c42\u90fd\u9700\u8981\u4e0d\u65ad\u6c72\u53d6\u77e5\u8bc6\uff0c\u81f3\u5c11\u4fdd\u8bc1\u4e0d\u4f1a<\/span>\u201c<\/span>\u4e66\u5230\u7528\u65f6\u65b9\u6068\u5c11<\/span>\u201d<\/span>\u3002\u4e3a\u6b64\uff0c\u8d1d\u58f3\u793e\u7279\u522b\u8bbe\u8ba1\u4e86<\/span>TP<\/span>\u6297\u4f53\u836f\u7814\u53d1\u8bfe\uff0c\u662f\u8d1d\u58f3\u793e\u8054\u5408\u836f\u5496\u835f\u3001<\/span>ACROBiosystems<\/span>\u3001\u6cf0\u683c\u533b\u836f\u4ee5\u53ca<\/span>CABS (<\/span>\u4e2d\u7f8e\u751f\u7269\u533b\u836f\u534f\u4f1a<\/span>) <\/span>\u3001<\/span>SAPA-GP (<\/span>\u5927\u8d39\u57ce\u7f8e\u4e2d\u533b\u836f\u534f\u4f1a<\/span>)<\/span>\u3001<\/span>CABA(<\/span>\u7f8e\u4e2d\u751f\u7269\u533b\u836f\u534f\u4f1a<\/span>)<\/span>\u7b49\u673a\u6784\uff0c\u8054\u5408\u6253\u9020\u7684\u56fd\u5185\u4e13\u4e1a\u7684\u6297\u4f53\u836f\u7814\u53d1\u8bfe\u7a0b\u3002\u901a\u8fc7\u5c0f\u73ed\u5316\u57f9\u8bad\u548c\u4e0e\u4e00\u7ebf\u79d1\u5b66\u5bb6\u96f6\u8ddd\u79bb\u4e92\u52a8\uff0c\u591a\u7ef4\u5ea6\u770b\u6297\u4f53\u836f\u53d1\u5c55\u5386\u7a0b\u3001\u7814\u53d1\u73b0\u72b6\u548c\u8d8b\u52bf\uff1b\u901a\u8fc7\u5bf9\u5404\u7c7b\u75be\u75c5\u6297\u4f53\u836f\u7269\u7814\u53d1\u6848\u4f8b\u89e3\u8bfb\uff0c\u4eb2\u5386\u6297\u4f53\u836f\u7684\u7acb\u9879\u7684\u5168\u8fc7\u7a0b\uff0c\u542f\u53d1\u7814\u53d1\u601d\u8def\u3002\u52a0\u5165\u6211\u4eec\uff0c\u6216\u8bb8\u53ef\u4ee5\u78b0\u649e\u51fa\u4e0b\u4e00\u4efd\u795e\u529b\uff01<\/span><\/span><\/p>\n

\uff08\u5434\u4f1f\u534e \u7f16\uff09<\/span><\/p>\n


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


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\u4f1a\u8bae\u63a8\u8350<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

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\u4e0a\u6d77\u7ad9|\u836f\u54c1\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\u7814\u7a76\u53ca\u5de5\u827a\u53d8\u66f4\u9a8c\u8bc1\u5b9e\u65bd<\/strong><\/a><\/p>\n

\u57f9\u8bad\u901a\u77e5|2018 CFDA\u300a\u836f\u54c1\u6570\u636e\u7ba1\u7406\u89c4\u8303\u300b\u89e3\u8bfb\u4e0e\u6848\u4f8b\u89e3\u6790<\/strong><\/a><\/p>\n

\u6210\u90fd\u7ad9|\u57fa\u4e8e\u98ce\u9669\u548c\u8bbe\u8ba1\u7684\u836f\u54c1\u65e0\u83cc\u4fdd\u8bc1\u63aa\u65bd\uff08\u7b2c\u4e00\u671f\uff09<\/strong><\/a><\/p>\n

\u6297\u4f53\u836f\u7814\u53d1\u73b0\u72b6\u53ca\u7acb\u9879\u89e3\u6790\uff08\u7b2c\u4e00\u671f\uff09<\/a><\/span><\/strong><\/p>\n

\u5fae\u6d41\u63a7\u6280\u672f\u524d\u6cbf\u7814\u8ba8\u4f1a<\/a><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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