{"id":81894,"date":"2019-04-10T00:00:50","date_gmt":"2019-04-11T06:54:34","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81894\/"},"modified":"2019-04-11T14:54:35","modified_gmt":"2019-04-11T06:54:35","slug":"1a2eb4efc0","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81894\/","title":{"rendered":"\u82e6\u82e6\u5bfb\u89c5\u7684EGFR20\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\u7684NSCLC\u4e34\u5e8a\u6765\u4e86"},"content":{"rendered":"
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 \u767b\u8bb0\u53f7\uff1a<\/td>\nCTR20190582<\/td>\n<\/tr>\n
 \u9002\u5e94\u75c7\uff1a<\/td>\n\u643a\u5e26EGFR 20\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/td>\n<\/tr>\n
 \u8bd5\u9a8c\u901a\u4fd7\u9898\u76ee\uff1a<\/td>\nTAK-788\u6cbb\u7597EGFR 20\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u7684\u7814\u7a76<\/td>\n<\/tr>\n
 \u8bd5\u9a8c\u4e13\u4e1a\u9898\u76ee\uff1a<\/td>\n\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u53e3\u670dEGFR\/HER2\u6291\u5236\u5242TAK-788\uff08AP32788\uff09\u7684\u5b89\u5168\u6027\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u6297\u80bf\u7624\u6d3b\u6027\u7684I\/II\u671f\u7814\u7a76<\/td>\n<\/tr>\n
 \u8bd5\u9a8c\u65b9\u6848\u7f16\u53f7\uff1a<\/td>\nAP32788-15-101\uff1b\u7b2c5.0\u7248<\/td>\n<\/tr>\n
\u7c7b\u578b\uff1a<\/td>\n\u4e8c\u671f\u5355\u81c2\uff0c\u56fd\u9645\u591a\u4e2d\u5fc3<\/td>\n<\/tr>\n
 \u836f\u7269\u540d\u79f0\uff1a<\/td>\nTAK-788\u80f6\u56ca<\/td>\n<\/tr>\n
 \u6765\u6e90\uff1a<\/td>\nNMPA;\u836f\u878d\u5708\u6570\u636e\uff0cPharnex Datamonitor<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


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1.\u836f\u7269\u7533\u529e\u4f01\u4e1a\uff1a\u65e5\u672c\u6b66\u7530\u836f\u54c1\uff08\u4e2d\u56fd\uff09\u6709\u9650\u516c\u53f8\/Takeda Pharmaceutical \/Millennium Pharmaceuticals, Inc.<\/p>\n


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2.\u4e3b\u8981\u76ee\u7684\uff1a\u5728\u60a3\u6709\u643a\u5e26EGFR\u6846\u518520\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC\u5e76\u4e14\u81f3\u5c11\u63a5\u53d7\u8fc7\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC 1\u7ebf\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c\u6839\u636eIRC\u8bc4\u4f30\uff0c\u901a\u8fc7\u786e\u8ba4ORR\u786e\u5b9aTAK-788\u7684\u7597\u6548\u3002<\/p>\n


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3.\u4e2d\u56fd\u62db\u52df18\u4eba\u3002<\/p>\n


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4.\u4e3b\u8981PI\u4e0a\u6d77\u5e02\u80ba\u79d1\u533b\u9662\u5468\u5f69\u5b58\u6559\u6388\u3002\u90ae\u7bb1\uff1acaicunzhou@aliyun.com\u3002\u5730\u5740\uff1a\u4e0a\u6d77\u5e02\u6768\u6d66\u533a\u653f\u6c11\u8def507\u53f7\u3002<\/p>\n


<\/p>\n

\"\u82e6\u82e6\u5bfb\u89c5\u7684EGFR20\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\u7684NSCLC\u4e34\u5e8a\u6765\u4e86\"<\/p>\n


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5.\u5165\u9009\u6807\u51c6<\/p>\n


<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
1<\/td>\n\u7ecf\u7ec4\u7ec7\u5b66\u6216\u7ec6\u80de\u5b66\u8bc1\u5b9e\u4e3a\u5c40\u90e8\u665a\u671f\uff08\u5e76\u4e14\u4e0d\u662f\u9488\u5bf9\u6027\u6cbb\u7597\u7684\u5019\u9009\u4eba\uff09\u6216\u8f6c\u79fb\u6027\u75be\u75c5\uff08IIIB\u6216IV\u671f\uff09\u7684NSCLC\u3002<\/td>\n<\/tr>\n
2<\/td>\n\u5fc5\u987b\u6709\u8db3\u591f\u7684\u80bf\u7624\u7ec4\u7ec7\u8fdb\u884c\u5206\u6790\uff08\u5177\u4f53\u8981\u6c42\u89c1\u300a\u5b9e\u9a8c\u5ba4\u624b\u518c\u300b\uff09\uff0c\u9996\u9009\u5728\u6700\u8fd1\u4e00\u6b21\u65e2\u5f80\u6cbb\u7597\u671f\u95f4\u8fdb\u5c55\u540e\u83b7\u5f97\u7684\u80bf\u7624\u7ec4\u7ec7\u3002<\/td>\n<\/tr>\n
3<\/td>\n\u5fc5\u987b\u6709\u6839\u636eRECIST v1.1\u786e\u5b9a\u7684\u53ef\u6d4b\u91cf\u7684\u75be\u75c5\u3002<\/td>\n<\/tr>\n
4<\/td>\n\u5e74\u9f84\u226518\u5c81\u7684\u7537\u6027\u6216\u5973\u6027\u60a3\u8005\u3002\u5bf9\u4e8e\u65e5\u672c\u60a3\u8005\uff0c\u5e74\u9f84\u5e94\u226520\u5c81\u3002<\/td>\n<\/tr>\n
5<\/td>\n\u7f8e\u56fd\u4e1c\u90e8\u80bf\u7624\u534f\u4f5c\u7ec4\uff08ECOG\uff09\u4f53\u80fd\u72b6\u6001\u8bc4\u5206\u4e3a0\u81f31\u5206\u3002<\/td>\n<\/tr>\n
6<\/td>\n\u9884\u671f\u6700\u77ed\u5bff\u547d\u22653\u4e2a\u6708<\/td>\n<\/tr>\n
7<\/td>\n\u80be\u529f\u80fd\u548c\u809d\u529f\u80fd\u826f\u597d\uff0c\u5b9a\u4e49\u6807\u51c6\u5982\u4e0b\uff1aa. \u8840\u6e05\u603b\u80c6\u7ea2\u7d20\u22641.5\u00d7\u6b63\u5e38\u503c\u4e0a\u9650\uff08ULN\uff09\uff08\u5bf9\u4e8eGilbert\u7efc\u5408\u5f81\u60a3\u8005\u6216\u8005\u5982\u679c\u809d\u529f\u80fd\u5f02\u5e38\u662f\u57fa\u7840\u6076\u6027\u80bf\u7624\u6240\u81f4\uff0c\u5219\u53ef\u63a5\u53d7\u22643.0\u00d7ULN\uff09\uff1bb. \u4e19\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\uff08ALT\uff09\u548c\u5929\u51ac\u6c28\u9178\u6c28\u57fa\u8f6c\u79fb\u9176\uff08AST\uff09\u22642.5\u00d7ULN\uff08\u5982\u679c\u809d\u529f\u80fd\u5f02\u5e38\u7531\u57fa\u7840\u6076\u6027\u80bf\u7624\u6240\u81f4\uff0c\u5219\u53ef\u63a5\u53d7\u22645\u00d7ULN\uff09\uff1bc. \u808c\u9150\u6e05\u9664\u7387\u4f30\u8ba1\u503c\u226530 mL\/min\uff08\u4f7f\u7528Cockcroft-Gault\u516c\u5f0f\u8fdb\u884c\u8ba1\u7b97\uff09\uff1bd. \u8840\u6e05\u767d\u86cb\u767d\u22652 g\/dL\uff1be. \u8840\u6e05\u8102\u80aa\u9176\uff0f\u6dc0\u7c89\u9176\u22641.5\u00d7ULN\u3002<\/td>\n<\/tr>\n
8<\/td>\n\u9aa8\u9ad3\u529f\u80fd\u826f\u597d\uff0c\u5b9a\u4e49\u6807\u51c6\u5982\u4e0b\uff1aa. \u4e2d\u6027\u7c92\u7ec6\u80de\u7edd\u5bf9\u8ba1\u6570\uff08ANC\uff09\u22651.5 \u00d7 109\/L\uff1bb. \u8840\u5c0f\u677f\u8ba1\u6570\u226575\u00d7109\/L\uff1bc. \u8840\u7ea2\u86cb\u767d\u22659.0 g\/dL\u3002<\/td>\n<\/tr>\n
9<\/td>\n\u7b5b\u9009\u65f6\u5fc3\u7535\u56fe\uff08ECG\uff09\u7684QT\u95f4\u671f\u6b63\u5e38\uff0c\u5b9a\u4e49\u4e3aQTcF\u2264450 ms\uff08\u7537\u6027\uff09\u6216\u2264470 ms\uff08\u5973\u6027\uff09\u3002<\/td>\n<\/tr>\n
10<\/td>\n\u5728TAK-788\u9996\u6b21\u7ed9\u836f\u65f6\uff0c\u65e2\u5f80\u6cbb\u7597\u5bfc\u81f4\u7684\u6240\u6709\u6bd2\u6027\u5747\u5df2\u6d88\u9000\u81f3\u22641\u7ea7[\u6839\u636e\u7f8e\u56fd\u56fd\u5bb6\u764c\u75c7\u7814\u7a76\u6240\u4e0d\u826f\u4e8b\u4ef6\u901a\u7528\u672f\u8bed\u6807\u51c6\uff08NCI CTCAE v5.0[18]\uff09\uff0c\u6216\u5df2\u6d88\u9000\u81f3\u57fa\u7ebf\u6c34\u5e73\u3002\u6ce8\uff1a\u5982\u679c\u8ba4\u4e3a\u4e0d\u53ef\u9006\uff0c\u5141\u8bb8\u5b58\u5728\u4e0e\u6cbb\u7597\u76f8\u5173\u7684\uff1e1\u7ea7\u8131\u53d1\u6216\u4e0e\u6cbb\u7597\u76f8\u5173\u76842\u7ea7\u5468\u56f4\u795e\u7ecf\u75c5\u53d8\u3002<\/td>\n<\/tr>\n
11<\/td>\n\u5973\u6027\u60a3\u8005\uff1a\u5728\u7b5b\u9009\u8bbf\u89c6\u524d\u7edd\u7ecf\u81f3\u5c111\u5e74\uff0c\u6216\u624b\u672f\u7edd\u80b2\uff0c\u6216\u5982\u679c\u5176\u5177\u6709\u751f\u80b2\u80fd\u529b\uff0c\u5fc5\u987b\u540c\u610f\u81ea\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\u81f3\u7814\u7a76\u836f\u7269\u672b\u6b21\u7ed9\u836f\u540e30\u5929\u5185\u540c\u65f6\u4f7f\u75281\u79cd\u9ad8\u6548\u7684\u975e\u6fc0\u7d20\u907f\u5b55\u65b9\u6cd5\u548c\u53e6\u59161\u79cd\u6709\u6548\u7684\uff08\u5c4f\u969c\uff09\u907f\u5b55\u65b9\u6cd5\uff0c\u6216\u540c\u610f\u5b9e\u65bd\u771f\u6b63\u7684\u7981\u6b32\uff0c\u8be5\u65b9\u6cd5\u5e94\u4e0e\u53d7\u8bd5\u8005\u9996\u9009\u53ca\u4e00\u822c\u751f\u6d3b\u65b9\u5f0f\u4e00\u81f4\u3002\uff08\u5468\u671f\u6027\u7981\u6b32[\u4f8b\u5982\uff0c\u5973\u6027\u4f34\u4fa3\u6708\u7ecf\u5468\u671f\u8868\u8bb0\u8f7d\u6cd5\u3001\u5b89\u5168\u671f\u907f\u5b55\u6cd5\u3001\u75c7\u72b6\u4f53\u6e29\u6cd5\u907f\u5b55\u3001\u6216\u6392\u5375\u540e\u65b9\u6cd5]\u3001\u4f53\u5916\u5c04\u7cbe\u3001\u4ec5\u4f7f\u7528\u6740\u7cbe\u5242\u4ee5\u53ca\u54fa\u4e73\u671f\u95ed\u7ecf\u907f\u5b55\u6cd5\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5973\u6027\u548c\u7537\u6027\u907f\u5b55\u5957\u4e0d\u53ef\u4e00\u8d77\u4f7f\u7528\u3002\uff09\u3002\u7537\u6027\u60a3\u8005\uff0c\u5373\u4f7f\u5df2\u63a5\u53d7\u8fc7\u624b\u672f\u7edd\u80b2\uff08\u5373\uff0c\u8f93\u7cbe\u7ba1\u5207\u9664\u672f\u540e\u72b6\u6001\uff09\uff1a\u540c\u610f\u5728\u6574\u4e2a\u7814\u7a76\u671f\u95f4\u81f3\u7814\u7a76\u836f\u7269\u672b\u6b21\u7ed9\u836f\u540e30\u5929\u5185\u4f7f\u7528\u6709\u6548\u7684\u5c4f\u969c\u907f\u5b55\u6cd5\uff0c\u6216\u540c\u610f\u5b9e\u65bd\u771f\u6b63\u7684\u7981\u6b32\uff0c\u8be5\u65b9\u6cd5\u5e94\u4e0e\u53d7\u8bd5\u8005\u9996\u9009\u53ca\u4e00\u822c\u751f\u6d3b\u65b9\u5f0f\u4e00\u81f4\u3002\uff08\u5468\u671f\u6027\u7981\u6b32[\u4f8b\u5982\uff0c\u5973\u6027\u4f34\u4fa3\u6708\u7ecf\u5468\u671f\u8868\u8bb0\u8f7d\u6cd5\u3001\u5b89\u5168\u671f\u907f\u5b55\u6cd5\u3001\u75c7\u72b6\u4f53\u6e29\u6cd5\u907f\u5b55\u3001\u6216\u6392\u5375\u540e\u65b9\u6cd5]\u3001\u4f53\u5916\u5c04\u7cbe\u3001\u4ec5\u4f7f\u7528\u6740\u7cbe\u5242\u4ee5\u53ca\u54fa\u4e73\u671f\u95ed\u7ecf\u907f\u5b55\u6cd5\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\u907f\u5b55\u65b9\u6cd5\u3002\u5973\u6027\u548c\u7537\u6027\u907f\u5b55\u5957\u4e0d\u53ef\u4e00\u8d77\u4f7f\u7528\u3002\uff09<\/td>\n<\/tr>\n
12<\/td>\n\u5df2\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\u5e76\u6ce8\u660e\u65e5\u671f\uff0c\u8868\u660e\u53d7\u8bd5\u8005\u5df2\u77e5\u6653\u7814\u7a76\u7684\u6240\u6709\u76f8\u5173\u65b9\u9762\u3002<\/td>\n<\/tr>\n
13<\/td>\n\u613f\u610f\u548c\u80fd\u591f\u9075\u5b88\u9884\u5b9a\u7684\u8bbf\u89c6\u548c\u7814\u7a76\u7a0b\u5e8f\u3002<\/td>\n<\/tr>\n
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