{"id":62754,"date":"2018-11-08T01:00:00","date_gmt":"2018-12-07T03:20:50","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/e4dcbe1236\/"},"modified":"2018-12-07T11:20:51","modified_gmt":"2018-12-07T03:20:51","slug":"e4dcbe1236","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/62754\/","title":{"rendered":"\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section  label=\"Powered by 135editor.com\" style=\"font-size:16px;font-family:\u5fae\u8f6f\u96c5\u9ed1;\">\n<section  label=\"Powered by 135editor.com\">\n<section style=\"line-height: 1.8;letter-spacing: 0.5px;box-sizing: border-box;\">\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<p style=\"text-align: center;\"><img class=\"\"       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border-box;\">\u5e94\u7528\u672c\u6307\u5bfc\u539f\u5219\u65f6\uff0c\u8bf7\u540c\u65f6\u53c2\u8003\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Clinical Practice\uff0cGCP\uff09\u3001\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use\uff0cICH\uff09\u548c\u5176\u4ed6\u56fd\u5185\u5916\u5df2\u53d1\u5e03\u7684\u76f8\u5173\u6280\u672f\u6307\u5bfc\u539f\u5219\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: 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border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(62, 62, 62);border-top: 2px solid rgb(62, 62, 62);height: 16px;width: 16px;border-right-color: rgb(62, 62, 62);border-bottom-color: rgb(62, 62, 62);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(51, 66, 159);padding-right: 6px;padding-left: 6px;font-size: 17px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e09\u3001\u786e\u8bc1\u6027\u8bd5\u9a8c\u8bbe\u8ba1\u8003\u8651\u8981\u70b9<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e00\uff09\u7814\u7a76\u76ee\u7684<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u53cc\u76f8\u969c\u788d\uff08Bipolar 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style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: 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style=\"white-space: normal;box-sizing: border-box;\">\u7efc\u4e0a\uff0c\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7814\u7a76\u76ee\u7684\u53ef\u4ee5\u5212\u5206\u4e3a\u4ee5\u4e0b\u56db\u79cd\u60c5\u51b5\uff1a<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u7b2c\u4e00\u79cd\uff0c\u8bc1\u660e\u5355\u836f\uff08\u8bd5\u9a8c\u836f\uff09\u5bf9\u53cc\u76f8\u969c\u788d\u53cc\u76f8\u53d1\u4f5c\uff08\u8e81\u72c2\u53d1\u4f5c\u548c\u6291\u90c1\u53d1\u4f5c\uff09\u5747\u5177\u6709\u6cbb\u7597\u4f5c\u7528\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: 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normal;box-sizing: border-box;\">\u836f\u7269\u5bf9\u8f7b\u8e81\u72c2\u7684\u6cbb\u7597\u4f5c\u7528\u53ef\u901a\u8fc7\u5bf9\u8e81\u72c2\u7684\u6cbb\u7597\u4f5c\u7528\u5916\u63a8\u83b7\u5f97\u3002\u5bf9\u8f7b\u8e81\u72c2\u7684\u6cbb\u7597\u4f5c\u7528\u4e0d\u4f5c\u4e3a\u72ec\u7acb\u7814\u7a76\u76ee\u7684\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e8c\uff09\u53d7\u8bd5\u8005<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5efa\u8bae\u91c7\u7528\u56fd\u9645\u75be\u75c5\u5206\u7c7b\uff08International Classification of Diseases\uff0cICD\uff09\u6216\u7cbe\u795e\u75be\u75c5\u7684\u8bca\u65ad\u548c\u7edf\u8ba1\u624b\u518c\uff08The Diagnostic and Statistical Manual of Mental Disorders\uff0cDSM\uff09\u8bca\u65ad\u7cfb\u7edf\u8fdb\u884c\u53d7\u8bd5\u4eba\u7fa4\u7684\u7b5b\u9009\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5efa\u8bae\u91c7\u7528\u57fa\u4e8eICD\u548cDSM\u7cfb\u7edf\u5f00\u53d1\u7684\u3001\u5df2\u88ab\u5e7f\u6cdb\u9a8c\u8bc1\u7684\u8bca\u65ad\u6027\u91cf\u8868\u4f5c\u4e3a\u8bca\u65ad\u6807\u51c6\u5316\u5de5\u5177\uff0c\u5982\u300aDSM\u7cbe\u795e\u75be\u75c5\u7528\u4e34\u5e8a\u5b9a\u5f0f\u68c0\u67e5\u300b\uff08Structured Clinical Interview for DSM Disorders\uff0cSCID\uff09\u6216\u300a\u7b80\u660e\u56fd\u9645\u795e\u7ecf\u7cbe\u795e\u8bbf\u8c08\u300b\uff08Mini-international Neuropsychiatric Interview\uff0cM.I.N.I.\uff09\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: 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border-box;\">\u57fa\u4e8e\u91cf\u8868\u8bc4\u5206\u7684\u4e25\u91cd\u7a0b\u5ea6\u7b5b\u9009\u4e0e\u7814\u7a76\u76ee\u7684\u76f8\u5173\u3002\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u5bf9\u53cc\u76f8\u969c\u788d\u6291\u90c1\u53d1\u4f5c\u7684\u6cbb\u7597\u4f5c\u7528\uff0c\u901a\u5e38\u5efa\u8bae\u6c49\u5bc6\u5c14\u987f\u6291\u90c1\u91cf\u8868-17\u9879\uff08Hamilton Rating Scale for Depression\uff0cHAMD-17\uff09\u8bc4\u5206\u226518\u5206\uff0c\u6216\u8499\u54e5\u9a6c\u5229-\u827e\u65af\u4f2f\u683c\u6291\u90c1\u91cf\u8868\uff08Montgomery\u2013\u00c5sberg Depression Rating Scale\uff0cMADRS\uff09\u8bc4\u5206\u226522\u5206\u3002\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u5bf9\u53cc\u76f8\u969c\u788d\u8e81\u72c2\u53d1\u4f5c\u7684\u6cbb\u7597\u4f5c\u7528\uff0c\u901a\u5e38\u5efa\u8baeYoung\u8e81\u72c2\u91cf\u8868\uff08Young Mania Rating Scale\uff09\u8bc4\u5206\u226520\u5206\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5982\u679c\u9009\u62e9\u5176\u4ed6\u8bca\u65ad\u7cfb\u7edf\u3001\u8bca\u65ad\u6807\u51c6\u5316\u5de5\u5177\u3001\u57fa\u4e8e\u91cf\u8868\u8bc4\u5206\u7684\u4e25\u91cd\u7a0b\u5ea6\u7b5b\u9009\u6807\u51c6\u7b49\uff0c\u5e94\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u9610\u8ff0\u4f9d\u636e\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e09\uff09\u8bd5\u9a8c\u7c7b\u578b<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u5305\u62ec\u8bc1\u660e\u836f\u7269\u80fd\u591f\u7f13\u89e3\u53d1\u4f5c\u76f8\u6025\u6027\u671f\u75c7\u72b6\u548c\u836f\u7269\u80fd\u591f\u9884\u9632\u53cc\u76f8\u969c\u788d\u53cd\u590d\u53d1\u4f5c\u4e24\u4e2a\u90e8\u5206\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">1.\u77ed\u7a0b\u8bd5\u9a8c<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u77ed\u7a0b\u8bd5\u9a8c\u7684\u4e3b\u8981\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u7f13\u89e3\u53d1\u4f5c\u76f8\u6025\u6027\u671f\u75c7\u72b6\u7684\u4f5c\u7528\u3002\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u9488\u5bf9\u8e81\u72c2\u53d1\u4f5c\uff0c\u89c2\u5bdf\u671f\uff08\u53cc\u76f2\u6cbb\u7597\u671f\uff09\u901a\u5e38\u4e0d\u5c11\u4e8e4\u5468\uff1b\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u9488\u5bf9\u6291\u90c1\u53d1\u4f5c\uff0c\u89c2\u5bdf\u671f\uff08\u53cc\u76f2\u6cbb\u7597\u671f\uff09\u901a\u5e38\u4e0d\u5c11\u4e8e6\u5468\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">2.\u957f\u7a0b\u8bd5\u9a8c<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: 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border-box;\">\u5efa\u8bae\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u5408\u5e76\u7528\u836f\u8fdb\u884c\u660e\u786e\u4e25\u683c\u7684\u89c4\u5b9a\u3002\u5bf9\u4e8e\u5141\u8bb8\u4f7f\u7528\u7684\u5408\u5e76\u7528\u836f\uff0c\u65e0\u8bba\u662f\u8bd5\u9a8c\u524d\u5373\u53ef\u670d\u7528\u8fd8\u662f\u8bd5\u9a8c\u4e2d\u5141\u8bb8\u670d\u7528\u7684\uff0c\u5747\u5e94\u660e\u786e\u5176\u4f7f\u7528\u6761\u4ef6\uff0c\u5217\u51fa\u53ef\u63a5\u53d7\u7684\u5242\u91cf\u8303\u56f4\u53ca\u4f7f\u7528\u671f\u9650\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5fc3\u7406\u54a8\u8be2\u3001\u652f\u6301\u6027\u5fc3\u7406\u6cbb\u7597\u548c\u5eb7\u590d\u6cbb\u7597\u7b49\u662f\u7cbe\u795e\u79d1\u4e34\u5e8a\u6cbb\u7597\u4e2d\u5e38\u89c1\u7684\u8f85\u52a9\u6cbb\u7597\u65b9\u5f0f\u3002\u6539\u826f\u7535\u62bd\u6410\u6cbb\u7597\uff08Modified Electronconvulsive Therapy\uff0cMECT\uff09\u7b49\u7269\u7406\u6cbb\u7597\uff0c\u4ee5\u53ca\u5149\u7167\u6cbb\u7597\u3001\u97f3\u4e50\u7597\u6cd5\u3001\u8fd0\u52a8\u7597\u6cd5\u3001\u9488\u7078\u7b49\u5176\u4ed6\u6cbb\u7597\u65b9\u6cd5\u4e5f\u5df2\u5728\u4e34\u5e8a\u4e0a\u5e7f\u6cdb\u4f7f\u7528\u6216\u5f00\u59cb\u4f7f\u7528\uff08\u6709\u4e9b\u6cbb\u7597\u5c1a\u672a\u83b7\u6279\u9002\u5e94\u75c7\uff09\u3002\u8fd9\u4e9b\u65b9\u5f0f\u672c\u8eab\u53ef\u80fd\u5bf9\u7f13\u89e3\u75c7\u72b6\u6709\u6240\u52a9\u76ca\uff0c\u4e5f\u53ef\u80fd\u4f1a\u589e\u52a0\u5b89\u6170\u5242\u6548\u5e94\uff0c\u4ece\u800c\u5f71\u54cd\u5bf9\u8bd5\u9a8c\u836f\u7269\u5b89\u5168\u6709\u6548\u6027\u7684\u5ba2\u89c2\u8bc4\u4ef7\uff0c\u7279\u522b\u662f\u5f53\u8fd9\u4e9b\u65b9\u5f0f\u7684\u8fd0\u7528\u5728\u5404\u4e2a\u7814\u7a76\u4e2d\u5fc3\u95f4\u4e0d\u7edf\u4e00\u65f6\u3002\u5efa\u8bae\u6839\u636e\u836f\u7269\u7279\u5f81\u53ca\u6cbb\u7597\u5b9a\u4f4d\uff0c\u9884\u5148\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u660e\u786e\u89c4\u5b9a\u662f\u5426\u5141\u8bb8\u4f7f\u7528\u8f85\u52a9\u6cbb\u7597\u65b9\u5f0f\uff0c\u5e76\u5bf9\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u53d1\u751f\u7684\u6240\u6709\u8f85\u52a9\u6cbb\u7597\u65b9\u5f0f\u8fdb\u884c\u8be6\u7ec6\u8bb0\u5f55\uff0c\u5728\u8bd5\u9a8c\u7ed3\u679c\u5206\u6790\u65f6\uff0c\u8ba8\u8bba\u5176\u5bf9\u836f\u7269\u5b89\u5168\u6709\u6548\u6027\u8bc4\u4ef7\u7684\u5f71\u54cd\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e03\uff09\u6570\u636e\u7ba1\u7406\u548c\u7edf\u8ba1\u5206\u6790<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\u4e2d\u5e94\u6e05\u6670\u63cf\u8ff0\u4e3b\u8981\u6307\u6807\u548c\u6b21\u8981\u6307\u6807\u7684\u5b9a\u4e49\uff0c\u5305\u62ec\u5177\u4f53\u89c2\u5bdf\u548c\u6d4b\u91cf\u7684\u65b9\u6cd5\u3001\u89c2\u5bdf\u65f6\u70b9\u3001\u6307\u6807\u5c5e\u6027\u3002\u5982\u679c\u4e3b\u8981\u6307\u6807\u9700\u8981\u901a\u8fc7\u8ba1\u7b97\u5f97\u5230\uff0c\u5219\u9700\u7ed9\u51fa\u76f8\u5e94\u7684\u8ba1\u7b97\u516c\u5f0f\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5206\u6790\u6570\u636e\u96c6\u4e00\u822c\u5305\u62ec\u610f\u5411\u6cbb\u7597\u5206\u6790\uff08Intention to Treat Analysis\uff0cITT\uff09\/\u5168\u5206\u6790\u96c6\uff08Full Analysis Set\uff0cFAS\uff09\u3001\u7b26\u5408\u65b9\u6848\u96c6\uff08Per Protocol Set\uff0cPPS\uff09\u3001\u5b89\u5168\u6027\u6570\u636e\u96c6\uff08Safety Set\uff0cSS\uff09\u3002\u901a\u5e38\uff0c\u5efa\u8bae\u540c\u65f6\u91c7\u7528FAS\u548cPPS\u8fdb\u884c\u4e3b\u8981\u7597\u6548\u6307\u6807\u7684\u7edf\u8ba1\u5206\u6790\uff0c\u4e14\u8981\u6c42\u5bf9\u4e8c\u8005\u7684\u7ed3\u8bba\u8fdb\u884c\u6bd4\u8f83\u5206\u6790\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5b89\u5168\u6027\u5206\u6790\u7684\u8d44\u6599\u4e3b\u8981\u6765\u6e90\u4e8e\u53d7\u8bd5\u8005\u7684\u4e3b\u8bc9\u3001\u75c7\u72b6\u3001\u4f53\u5f81\u4ee5\u53ca\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u7ed3\u679c\u7b49\u3002\u5efa\u8bae\u5bf9\u4e0d\u826f\u4e8b\u4ef6\u91c7\u7528\u7edf\u4e00\u7684\u7f16\u7801\u8bcd\u5178\u8fdb\u884c\u7f16\u7801\uff0c\u6bd4\u5982\u836f\u4e8b\u7ba1\u7406\u7684\u6807\u51c6\u533b\u5b66\u672f\u8bed\u96c6\uff08Medical Dictionary for Regulatory Activities\uff0cMedDRA\uff09\u3002\u5bf9\u4e0d\u826f\u4e8b\u4ef6\u7684\u5206\u6790\uff0c\u5e94\u6309\u4e8b\u4ef6\u53d1\u751f\u7684\u9891\u6570\u3001\u9891\u6b21\u548c\u53d1\u751f\u7387\u63cf\u8ff0\uff0c\u8fdb\u884c\u7ec4\u95f4\u53d1\u751f\u7387\u7684\u6bd4\u8f83\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u671f\u4e2d\u5206\u6790\u7684\u65f6\u70b9\u3001\u5177\u4f53\u5b9e\u65bd\u65b9\u5f0f\u548c\u6240\u91c7\u7528\u7684\u03b1\u6d88\u8017\u51fd\u6570\u7b49\u5e94\u5f53\u4e8b\u5148\u5236\u8ba2\u8ba1\u5212\u5e76\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u9610\u660e\u3002\u5bf9\u4e8e\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u539f\u5219\u4e0a\u4e0d\u5f97\u8fdb\u884c\u8ba1\u5212\u5916\u671f\u4e2d\u5206\u6790\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(62, 62, 62);border-top: 2px solid rgb(62, 62, 62);height: 16px;width: 16px;border-right-color: rgb(62, 62, 62);border-bottom-color: rgb(62, 62, 62);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(51, 66, 159);padding-right: 6px;padding-left: 6px;font-size: 17px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u56db\u3001\u7279\u6b8a\u8003\u8651<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e00\uff09\u7279\u6b8a\u4eba\u7fa4\u8bd5\u9a8c<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">1.\u9ad8\u9f84\/\u8001\u5e74\u4eba\u7fa4<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">50\u5c81\u540e\u9996\u53d1\u7684\u53cc\u76f8\u969c\u788d\u3001\u53cc\u76f8\u969c\u788d\u60a3\u8005\u8fdb\u5165\u8001\u9f84\u3001\u7ee7\u53d1\u4e8e\u8eaf\u4f53\u75be\u75c5\u6216\u7269\u8d28\u4f9d\u8d56\u7b49\u7684\u8001\u5e74\u671f\u53cc\u76f8\u969c\u788d\u5728\u4e34\u5e8a\u4e2d\u5e76\u4e0d\u5c11\u89c1\u3002\u5efa\u8bae\u6839\u636e\u4e34\u5e8a\u9700\u6c42\u548c\u836f\u7269\u7279\u70b9\u7b49\uff0c\u8003\u8651\u5728\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7eb3\u5165\u90e8\u5206\u9ad8\u9f84\/\u8001\u5e74\u4eba\u7fa4\u6216\u8005\u5355\u72ec\u5f00\u5c55\u9ad8\u9f84\/\u8001\u5e74\u4eba\u7fa4\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5fc5\u8981\u6027\u548c\u53ef\u80fd\u6027\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u9ad8\u9f84\/\u8001\u5e74\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u548c\/\u6216\u836f\u6548\u5b66\u7279\u6027\u6709\u53ef\u80fd\u4e0e\u5e74\u8f7b\u6210\u4eba\u60a3\u8005\u5b58\u5728\u5dee\u5f02\u3002\u9ad8\u9f84\/\u8001\u5e74\u60a3\u8005\u7684\u7ed9\u836f\u5242\u91cf\uff0c\u9700\u6709\u53ef\u9760\u7684\u7814\u7a76\u6570\u636e\u4e88\u4ee5\u652f\u6301\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">2.\u513f\u79d1\u4eba\u7fa4<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u53cc\u76f8\u969c\u788d\u4e3b\u8981\u53d1\u75c5\u4e8e\u6210\u4eba\u65e9\u671f\u3002\u5728\u513f\u7ae5\u4e2d\uff0c\u7279\u522b\u662f\u4f4e\u9f84\u513f\u7ae5\u4e2d\u60a3\u75c5\u7387\u4f4e\uff0c\u75c7\u72b6\u4e0d\u5178\u578b\uff0c\u786e\u8bca\u96be\u5ea6\u5927\u3002\u56e0\u6b64\uff0c\u4e0d\u5efa\u8bae\u5728\uff1c6\u5c81\u7684\u513f\u79d1\u4eba\u7fa4\u4e2d\u5f00\u5c55\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5e94\u9996\u5148\u5728\u6210\u4eba\u4e2d\u5f00\u5c55\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8bc1\u660e\u836f\u7269\u6cbb\u7597\u6210\u4eba\u53cc\u76f8\u969c\u788d\u5b89\u5168\u6709\u6548\uff0c\u4e4b\u540e\uff0c\u53ef\u4ee5\u8003\u8651\u6269\u5c55\u9002\u5e94\u75c7\u8303\u56f4\u81f3\u513f\u79d1\u4eba\u7fa4\uff0c\u5177\u4f53\u65b9\u6cd5\u53c2\u8003\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002\u4e0d\u5efa\u8bae\u5728\u7f3a\u4e4f\u6210\u4eba\u5b89\u5168\u6709\u6548\u6027\u6570\u636e\u65f6\uff0c\u76f4\u63a5\u5728\u513f\u79d1\u4eba\u7fa4\u4e2d\u5f00\u5c55\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7531\u4e8e\u7b5b\u9009\u6807\u51c6\u3001\u8bc4\u4ef7\u6807\u51c6\u53ca\u5b89\u5168\u6027\u76d1\u6d4b\u7b49\u65b9\u9762\u96be\u4ee5\u8fbe\u5230\u5145\u5206\u4e00\u81f4\uff0c\u4e0d\u5efa\u8bae\u5728\u6210\u4eba\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u540c\u65f6\u7eb3\u5165\u513f\u79d1\u4eba\u7fa4\u60a3\u8005\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5728\u513f\u79d1\u4eba\u7fa4\u4e2d\u5f00\u5c55\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65f6\uff0c\u5e94\u9996\u5148\u8bc4\u4f30\u513f\u79d1\u4eba\u7fa4\u7684\u4e34\u5e8a\u8868\u73b0\u4e0e\u6210\u4eba\u7684\u76f8\u4f3c\u6027\uff0c\u8003\u8651\u513f\u79d1\u4eba\u7fa4\u4e2d\u5b58\u5728\u7684\u4e00\u4e9b\u4e0e\u5e74\u9f84\u76f8\u5173\u7684\u75c7\u72b6\u7279\u70b9\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u513f\u79d1\u4eba\u7fa4\u7684\u81ea\u6740\u98ce\u9669\u662f\u5df2\u77e5\u7684\u7cbe\u795e\u79d1\u836f\u7269\u5b89\u5168\u6027\u98ce\u9669\u4e4b\u4e00\uff0c\u5728\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5e94\u91cd\u89c6\u5bf9\u53d7\u8bd5\u8005\u81ea\u6740\u98ce\u9669\u7684\u76d1\u6d4b\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u513f\u79d1\u4eba\u7fa4\u7684\u8868\u8fbe\u80fd\u529b\u548c\u5bf9\u75c5\u75c7\u7684\u7406\u89e3\u7a0b\u5ea6\u4e0d\u5982\u6210\u4eba\uff0c\u5728\u8fdb\u884c\u4fe1\u606f\u6536\u96c6\u548c\u62a5\u544a\u7684\u65f6\u5019\uff0c\u5e94\u91c7\u7528\u9002\u5b9c\u7684\u4ea4\u6d41\u624b\u6bb5\u548c\u8bc4\u4f30\u5de5\u5177\uff0c\u5982\u4e13\u4e3a\u513f\u79d1\u4eba\u7fa4\u5f00\u53d1\u7684\u8bc4\u4f30\u91cf\u8868\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e8c\uff09\u589e\u6548\u6cbb\u7597\u8bd5\u9a8c<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u589e\u6548\u6cbb\u7597\uff08Augmentation Treatment\uff09\u662f\u6307\u4f7f\u7528\u4e00\u79cd\u836f\u7269\u589e\u5f3a\u53e6\u4e00\u79cd\u836f\u7269\u7684\u7597\u6548\uff0c\u4ec5\u5728\u4f7f\u7528\u57fa\u7840\u6cbb\u7597\u836f\u7269\u540e\u75c7\u72b6\u7f13\u89e3\u4e0d\u5145\u5206\u65f6\u91c7\u7528\u3002\u901a\u5e38\uff0c\u589e\u6548\u836f\u7269\u5355\u72ec\u7528\u4e8e\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u65f6\u4e0d\u4ea7\u751f\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u75c7\u72b6\u6539\u5584\u6216\u65e0\u6cd5\u6ee1\u8db3\u6cbb\u7597\u8981\u6c42\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5728\u589e\u6548\u6cbb\u7597\u8bd5\u9a8c\u4e2d\uff0c\u5e94\u7eb3\u5165\u5bf9\u57fa\u7840\u6cbb\u7597\u836f\u7269\u90e8\u5206\u6709\u6548\u7684\u60a3\u8005\uff0c\u800c\u4e0d\u5e94\u7eb3\u5165\u5b8c\u5168\u65e0\u6548\u7684\u60a3\u8005\u3002\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u9700\u5bf9\u201c\u90e8\u5206\u6709\u6548\u201d\u7684\u5224\u5b9a\u6807\u51c6\u8fdb\u884c\u660e\u786e\u89c4\u5b9a\uff0c\u5e76\u63d0\u4f9b\u4f9d\u636e\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u901a\u5e38\uff0c\u5728\u5e73\u884c\u5bf9\u7167\u7684\u589e\u6548\u6cbb\u7597\u8bd5\u9a8c\u4e2d\uff0c\u53d7\u8bd5\u8005\u5728\u63a5\u53d7\u5f00\u653e\u7684\u57fa\u7840\u6cbb\u7597\u836f\u7269\u7684\u540c\u65f6\uff0c\u968f\u673a\u63a5\u53d7\u8bd5\u9a8c\u836f\uff08\u589e\u6548\u6cbb\u7597\u836f\u7269\uff09\u6216\u5b89\u6170\u5242\u6cbb\u7597\u3002\u5728\u8bc1\u660e\u9884\u9632\u590d\u53d1\u7597\u6548\u7684\u968f\u673a\u64a4\u836f\u8bd5\u9a8c\u4e2d\uff0c\u53d7\u8bd5\u8005\u5728\u63a5\u53d7\u5f00\u653e\u7684\u57fa\u7840\u6cbb\u7597\u836f\u7269\u8054\u5408\u589e\u6548\u6cbb\u7597\u836f\u7269\u6cbb\u7597\u8fbe\u5230\u7597\u6548\u7a33\u5b9a\u540e\uff0c\u968f\u673a\u63a5\u53d7\u57fa\u7840\u6cbb\u7597\u836f\u7269\u6216\u7ee7\u7eed\u4fdd\u6301\u7a33\u5b9a\u65f6\u7684\u8054\u5408\u6cbb\u7597\u65b9\u6848\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u4e09\uff09\u6570\u636e\u548c\u5b89\u5168\u76d1\u5bdf<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u76d1\u5bdf\u59d4\u5458\u4f1a\uff08Data Monitoring Committee\uff0cDMC\uff09\u4e5f\u79f0\u4e3a\u6570\u636e\u548c\u5b89\u5168\u76d1\u5bdf\u59d4\u5458\u4f1a\uff08DSMB\uff1bDSMC\uff09\uff0c\u7531\u4e00\u7ec4\u5177\u5907\u76f8\u5173\u4e13\u4e1a\u77e5\u8bc6\u548c\u7ecf\u9a8c\u7684\u4e0e\u8bd5\u9a8c\u65e0\u4efb\u4f55\u5229\u76ca\u5173\u7cfb\u7684\u4e13\u4e1a\u4eba\u5458\u7ec4\u6210\uff0c\u5b9a\u671f\u5bf9\u8bd5\u9a8c\u6570\u636e\u8fdb\u884c\u5206\u6790\u8bc4\u4ef7\u3002\u5176\u804c\u8d23\u662f\uff1a\u786e\u4fdd\u53d7\u8bd5\u8005\u5b89\u5168\u548c\u5229\u76ca\uff1b\u786e\u4fdd\u8bd5\u9a8c\u6570\u636e\u7684\u5b8c\u6574\u6027\u548c\u53ef\u4fe1\u6027\uff1b\u53ca\u65f6\u3001\u51c6\u786e\u5730\u5c06\u8bd5\u9a8c\u7ed3\u679c\u53cd\u9988\u5230\u7533\u529e\u65b9\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u7cbe\u795e\u75be\u75c5\u60a3\u8005\u5f80\u5f80\u5c5e\u4e8e\u5f31\u52bf\u7fa4\u4f53\uff0c\u4e3a\u4e86\u4fdd\u8bc1\u53d7\u8bd5\u8005\u7684\u6743\u76ca\uff0c\u540c\u65f6\uff0c\u4e3a\u4e86\u786e\u4fdd\u8bd5\u9a8c\u6570\u636e\u7684\u5b8c\u6574\u6027\u548c\u53ef\u4fe1\u6027\uff0c\u5efa\u8bae\u5728\u521b\u65b0\u7684\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5efa\u7acbDMC\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\uff08\u56db\uff09\u5ba2\u89c2\u68c0\u6d4b\u6307\u6807\u7684\u5e94\u7528<\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u9274\u4e8e\u53cc\u76f8\u969c\u788d\u75c5\u751f\u7406\u7279\u5f81\u7684\u590d\u6742\u6027\uff0c\u8fc4\u4eca\u4e3a\u6b62\uff0c\u8fd8\u6ca1\u6709\u7528\u4e8e\u53cc\u76f8\u969c\u788d\u7b5b\u67e5\u6216\u75c7\u72b6\u8bc4\u4f30\u7684\u5ba2\u89c2\u68c0\u6d4b\u6307\u6807\u88ab\u5e7f\u6cdb\u8ba4\u53ef\u6216\u88ab\u63a8\u8350\u4f7f\u7528\u5728\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u3002\u4f46\u662f\uff0c\u76f8\u5173\u7814\u7a76\u4e0e\u63a2\u7d22\u5df2\u5728\u9010\u6b65\u5f00\u5c55\uff0c\u6bd4\u5982\u836f\u7269\u57fa\u56e0\u7ec4\u5b66\u3001\u751f\u7269\u6807\u5fd7\u7269\u3001\u795e\u7ecf\u5f71\u50cf\u5b66\u3001\u5fae\u751f\u7269\u5b66\u3001\u795e\u7ecf\u514d\u75ab\u7b49\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u968f\u7740\u77e5\u8bc6\u4e0e\u6280\u672f\u7684\u8fdb\u6b65\uff0c\u5728\u6709\u5408\u7406\u4f9d\u636e\u7684\u524d\u63d0\u4e0b\uff0c\u53ef\u4ee5\u8003\u8651\u5728\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u7814\u53d1\u4e2d\u7eb3\u5165\u751f\u7269\u6807\u8bb0\u7269\u7b49\u5ba2\u89c2\u76d1\u6d4b\u6307\u6807\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(62, 62, 62);border-top: 2px solid rgb(62, 62, 62);height: 16px;width: 16px;border-right-color: rgb(62, 62, 62);border-bottom-color: rgb(62, 62, 62);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(51, 66, 159);padding-right: 6px;padding-left: 6px;font-size: 17px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><strong style=\"box-sizing: border-box;\">\u4e94\u3001\u53c2\u8003\u6587\u732e<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: justify;box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">1.\u6c88\u6e14\u90a8.\u7cbe\u795e\u75c5\u5b66\uff08\u7b2c5\u7248\uff09<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">2.\u4e2d\u56fd\u53cc\u76f8\u969c\u788d\u9632\u6cbb\u6307\u5357\uff082015\u5e74\u7248\uff09<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">3.\u53cc\u76f8\u969c\u788d\u6291\u90c1\u53d1\u4f5c\u836f\u7269\u6cbb\u7597\u4e13\u5bb6\u5efa\u8bae.2013\u5e747\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">4. CDE.\u6cbb\u7597\u53cc\u76f8\u969c\u788d\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u8003\u8651\u8981\u70b9.2013\u5e742\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">5.CDE.\u6cbb\u7597\u53cc\u76f8\u969c\u788d\u7684\u836f\u7269\u4e34\u5e8a\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u8bc4\u4ef7\u8981\u70b9.2013\u5e742\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">6.CDE.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u822c\u8003\u8651.2017\u5e741\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">7.CDE.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219.2016\u5e746\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">8.CDE.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u4e0e\u7edf\u8ba1\u5206\u6790\u7684\u8ba1\u5212\u548c\u62a5\u544a\u6307\u5bfc\u539f\u5219.2016\u5e747\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">9.CFDA.\u513f\u79d1\u4eba\u7fa4\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219.2016\u5e743\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">10.CFDA.\u6210\u4eba\u7528\u836f\u6570\u636e\u5916\u63a8\u81f3\u513f\u79d1\u4eba\u7fa4\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219.2017\u5e745\u6708<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">11.\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09\u7cfb\u5217\u6307\u5bfc\u539f\u5219<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">12.EMA.Guideline on Clinical Investigation of Medicinal Products for the Treatment and Prevention of Bipolar Disorder. October 2001<\/span><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><span style=\"font-size: 14px;\">13.FDA.Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors. March 2006.<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"width: 100%;text-align: right;margin-top: -4px;box-sizing: border-box;\">\n<section style=\"width: 50px;height: 4px;margin-left: auto;background-color: rgb(51, 66, 159);box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section  class=\"_135editor\" style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<p><br  \/><\/p>\n<p style=\"text-align: right;\"><strong><span style=\"font-size: 14px;color: #a5a5a5;\">\u6765\u6e90\/\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7f51\u7ad9<\/span><\/strong><br  \/><\/p>\n<\/section>\n<section class=\"_135editor\" style=\"box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;box-sizing: border-box;\"><img class=\"\"     style=\"vertical-align: middle;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/9-1544152851.jpeg\" alt=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\" title=\"\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\"  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<p style=\"text-align: center;\">\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u5173\u4e8e\u53d1\u5e03\u53cc\u76f8\u969c\u788d\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u7684\u901a\u544a &nbsp; &nbsp; \uff082018\u5e74\u7b2c115\u53f7\uff09 \u4e3a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":62755,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/62754"}],"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=62754"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/62754\/revisions"}],"predecessor-version":[{"id":62759,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/62754\/revisions\/62759"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/62755"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=62754"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=62754"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=62754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}