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<\/span><\/strong>\u53d1\u5e03\u65e5\u671f\uff1a20180628<\/span><\/p>\n


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\u56e0\u6b64\uff0c\u6297\u7cbe\u795e\u75c5\u836f\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u8bc1\u660e\u836f\u7269\u5728\u8bca\u7597\u6307\u5357\u63a8\u8350\u7684\u201c\u5168\u75c5\u7a0b\u6cbb\u7597\u201d\u4e2d\u80fd\u591f\u5b9e\u73b0\u5bf9\u75c7\u72b6\u7684\u826f\u597d\u63a7\u5236\uff0c\u5e76\u5177\u6709\u53ef\u63a5\u53d7\u7684\u5b89\u5168\u6027\u3002\u8bd5\u9a8c\u5e94\u5305\u62ec\u8bc1\u660e\u836f\u7269\u80fd\u591f\u7f13\u89e3\u75c7\u72b6\u548c\u836f\u7269\u80fd\u591f\u7ef4\u6301\u7597\u6548\u4e24\u4e2a\u90e8\u5206\uff0c\u540c\u65f6\uff0c\u76f8\u5e94\u63d0\u4f9b\u77ed\u671f\u5b89\u5168\u6027\u548c\u76f8\u5bf9\u957f\u671f\u7684\u5b89\u5168\u6027\u8bc1\u636e\u3002\u539f\u5219\u4e0a\uff0c\u5728\u786e\u8bc1\u836f\u7269\u80fd\u591f\u7f13\u89e3\u75c7\u72b6\u4e14\u77ed\u671f\u5b89\u5168\u6027\u826f\u597d\u7684\u57fa\u7840\u4e0a\uff0c\u8fd8\u5e94\u8fdb\u4e00\u6b65\u5f00\u5c55\u8bc1\u660e\u836f\u7269\u7ef4\u6301\u7597\u6548\u548c\u76f8\u5bf9\u957f\u671f\u5b89\u5168\u6027\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

\uff08\u4e8c\uff09\u53d7\u8bd5\u8005<\/h2>\n

\u6839\u636e\u7814\u7a76\u76ee\u7684\u9009\u62e9\u53d7\u8bd5\u8005\u3002\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u5bf9\u7cbe\u795e\u5206\u88c2\u75c7\u6574\u4f53\u75c7\u72b6\u7684\u6cbb\u7597\u4f5c\u7528\u3002\u901a\u5e38\uff0c\u5efa\u8bae\u9009\u62e9\u521d\u6b21\u53d1\u4f5c\u6216\u591a\u6b21\u53d1\u4f5c\u3001\u5904\u4e8e\u6025\u6027\u53d1\u4f5c\u671f\u4e14\u76ee\u524d\u672a\u63a5\u53d7\u6297\u7cbe\u795e\u75c5\u836f\u6cbb\u7597\u7684\u60a3\u8005\u3002\u5982\u679c\u5fc5\u987b\u4f7f\u7528\u6b63\u5728\u63a5\u53d7\u6297\u7cbe\u795e\u75c5\u836f\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u5e94\u8bbe\u8ba1\u8db3\u591f\u65f6\u95f4\u7684\u5bfc\u5165\u671f\u5bf9\u65e2\u5f80\u836f\u7269\u8fdb\u884c\u6e05\u6d17\u3002<\/p>\n

\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u5bf9\u7cbe\u795e\u5206\u88c2\u75c7\u67d0\u4e00\u79cd\u6216\u51e0\u79cd\u75c7\u72b6\u7fa4\u7684\u6cbb\u7597\u4f5c\u7528\u3002\u5e94\u8bbe\u8ba1\u5408\u7406\u7684\u5165\u6392\u6807\u51c6\uff0c\u7b5b\u9009\u7b26\u5408\u7814\u7a76\u76ee\u7684\u7684\u53d7\u8bd5\u8005\u3002\u5165\u6392\u6807\u51c6\u7684\u8003\u8651\u56e0\u7d20\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u75c5\u53f2\u6761\u4ef6\u3001\u75c5\u7a0b\u6761\u4ef6\u3001\u75c7\u72b6\u4e25\u91cd\u7a0b\u5ea6\u91cf\u8868\u8bc4\u5206\u6761\u4ef6\u3002\u5982\u679c\u91c7\u7528\u52a0\u8f7d\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u8fd8\u5e94\u8003\u8651\u57fa\u7840\u6cbb\u7597\u836f\u7269\u6761\u4ef6\u3002<\/p>\n

\u5efa\u8bae\u91c7\u7528\u56fd\u9645\u75be\u75c5\u5206\u7c7b\uff08internationalClassification of diseases,ICD\uff09\u6216\u7cbe\u795e\u75be\u75c5\u7684\u8bca\u65ad\u548c\u7edf\u8ba1\u624b\u518c\uff08The Diagnostic and Statistical Manual of Mental Disorders, DSM\uff09\u8bca\u65ad\u7cfb\u7edf\u8fdb\u884c\u53d7\u8bd5\u4eba\u7fa4\u7684\u7b5b\u9009\u3002<\/p>\n

\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 clinicalinterview 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

\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\u7cbe\u795e\u5206\u88c2\u75c7\u6574\u4f53\u75c7\u72b6\u7684\u6cbb\u7597\u4f5c\u7528\uff0c\u901a\u5e38\uff0c\u5efa\u8bae\u9633\u6027\u4e0e\u9634\u6027\u75c7\u72b6\u91cf\u8868\uff08The positive and negative syndromescale\uff0cPANSS\uff09\u603b\u5206\u226570\u5206\uff1b\u4e34\u5e8a\u603b\u4f53\u5370\u8c61\u91cf\u8868-\u75be\u75c5\u4e25\u91cd\u7a0b\u5ea6\uff08Clinical Global ImpressionsScale-Severity\uff0cCGI-S\uff09\u8bc4\u5206\u22654\u5206\u3002\u91cf\u8868\u5355\u9879\u5206\u7684\u8981\u6c42\u53ef\u6839\u636e\u7814\u7a76\u76ee\u7684\uff0c\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u4e88\u4ee5\u660e\u786e\u89c4\u5b9a\u3002<\/p>\n

\u5982\u679c\u7814\u7a76\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u5bf9\u7cbe\u795e\u5206\u88c2\u75c7\u67d0\u4e00\u79cd\u6216\u51e0\u79cd\u75c7\u72b6\u7fa4\u7684\u6cbb\u7597\u4f5c\u7528\uff0c\u5e94\u6839\u636e\u4e0e\u7814\u7a76\u76ee\u7684\u7684\u76f8\u5173\u6027\u786e\u5b9a\u91cf\u8868\u4e2d\u75c7\u72b6\u7fa4\u8bc4\u5206\u6807\u51c6\u3002\u901a\u5e38\uff0c\u5efa\u8baePANSS\u91cf\u8868\u4e2d\u4e0e\u7814\u7a76\u76ee\u7684\u76f8\u5173\u6216\u76f8\u5173\u6027\u5f3a\u7684\u5173\u952e\u6761\u76ee\u7684\u5355\u9879\u8bc4\u5206\u22654\u5206\uff0c\u5fc5\u8981\u65f6\uff0c\u4e0e\u7814\u7a76\u76ee\u7684\u4e0d\u76f8\u5173\u6216\u76f8\u5173\u6027\u5f31\u7684\u5173\u952e\u6761\u76ee\u7684\u5355\u9879\u8bc4\u5206\u22643\u5206\u3002<\/p>\n

\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

\uff08\u4e09\uff09\u8bd5\u9a8c\u7c7b\u578b<\/h2>\n

\u6297\u7cbe\u795e\u75c5\u836f\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u5305\u62ec\u8bc1\u660e\u836f\u7269\u80fd\u591f\u7f13\u89e3\u75c7\u72b6\u548c\u836f\u7269\u80fd\u591f\u7ef4\u6301\u7597\u6548\u4e24\u4e2a\u90e8\u5206\u3002<\/p>\n

1.\u77ed\u7a0b\u8bd5\u9a8c<\/p>\n

\u77ed\u7a0b\u8bd5\u9a8c\u7684\u4e3b\u8981\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u7f13\u89e3\u75c7\u72b6\u7684\u4f5c\u7528\u3002\u89c2\u5bdf\u671f\uff08\u53cc\u76f2\u6cbb\u7597\u671f\uff09\u901a\u5e38\u9700\u8981\u81f3\u5c116\u5468\u3002<\/p>\n

2.\u957f\u7a0b\u8bd5\u9a8c<\/p>\n

\u957f\u7a0b\u8bd5\u9a8c\u7684\u4e3b\u8981\u76ee\u7684\u662f\u8bc1\u660e\u836f\u7269\u7ef4\u6301\u7597\u6548\u7684\u4f5c\u7528\u3002\u901a\u5e38\uff0c\u957f\u7a0b\u8bd5\u9a8c\u6709\u4ee5\u4e0b\u4e24\u79cd\u8bbe\u8ba1\u65b9\u6cd5\uff1a<\/p>\n

\u5e73\u884c\u5bf9\u7167\u8bd5\u9a8c\uff1a\u53ef\u4ee5\u662f\u77ed\u7a0b\u8bd5\u9a8c\u7684\u5ef6\u7eed\u3002\u89c2\u5bdf\u671f\u901a\u5e38\u4e0d\u5c11\u4e8e6\u4e2a\u6708\u3002<\/p>\n

\u968f\u673a\u64a4\u836f\u8bd5\u9a8c\uff1a\u968f\u673a\u64a4\u836f\u8bd5\u9a8c\u5206\u4e3a\u4e24\u4e2a\u9636\u6bb5\u3002<\/p>\n

\u7b2c\u4e00\u9636\u6bb5\uff1a\u6240\u6709\u53d7\u8bd5\u8005\u5747\u670d\u7528\u8bd5\u9a8c\u836f\u7269\uff0c\u91c7\u7528\u5f00\u653e\u3001\u975e\u5bf9\u7167\u8bbe\u8ba1\uff0c\u5efa\u8bae\u6301\u7eed\u6cbb\u759712\u5468\uff08\u5305\u62ec\u6ef4\u5b9a\u5bfc\u5165\u671f\u548c\u81f3\u5c116\u81f38\u5468\u7684\u5242\u91cf\u7a33\u5b9a\u671f\uff09\u3002<\/p>\n

\u7b2c\u4e8c\u9636\u6bb5\uff1a\u7b26\u5408\u8981\u6c42\u7684\u53d7\u8bd5\u8005\u8fdb\u5165\u53cc\u76f2\u671f\uff0c\u968f\u673a\u5206\u5165\u8bd5\u9a8c\u836f\u7ec4\u6216\u5b89\u6170\u5242\u7ec4\uff0c\u89c2\u5bdf\u4e24\u7ec4\u7684\u590d\u53d1\u60c5\u51b5\u3002\u53d7\u8bd5\u8005\u6301\u7eed\u63a5\u53d7\u6cbb\u7597\u76f4\u81f3\u8fbe\u5230\u9884\u5148\u89c4\u5b9a\u7684\u590d\u53d1\u6807\u51c6\u6216\u7814\u7a76\u7ed3\u675f\u6807\u51c6\uff0c\u5982\u5728\u89c2\u5bdf\u5230\u591a\u5c11\u8d77\u590d\u53d1\u4e8b\u4ef6\u4e4b\u540e\u7ed3\u675f\u8bd5\u9a8c\u6216\u671f\u4e2d\u5206\u6790\u7ed3\u679c\u9633\u6027\uff08\u8bd5\u9a8c\u836f\u7ec4\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\uff09\u7684\u60c5\u51b5\u4e0b\u7ed3\u675f\u8bd5\u9a8c\u3002<\/p>\n

\u4ece\u7a33\u5b9a\u671f\u8fdb\u5165\u53cc\u76f2\u671f\u65f6\uff0c\u53d7\u8bd5\u8005\u987b\u7b26\u5408\u4ee5\u4e0b\u6807\u51c6\uff1a\u7a33\u5b9a\u671f\u5185\u5242\u91cf\u65e0\u53d8\u5316\uff1b\u6ca1\u6709\u590d\u53d1\u4e8b\u4ef6\uff1bPANSS\u603b\u5206<70\uff08\u6839\u636e\u7814\u7a76\u76ee\u7684\u5141\u8bb8\u76f8\u5e94\u8c03\u6574\uff09\uff1b\u548c\/\u6216PANSS\u91cf\u8868\u4e2d\u4e0e\u7814\u7a76\u76ee\u7684\u76f8\u5173\u6216\u76f8\u5173\u6027\u5f3a\u7684\u75c7\u72b6\u7fa4\u7684\u5355\u9879\u8bc4\u5206\u22643\u5206\uff08\u6839\u636e\u7814\u7a76\u76ee\u7684\u5141\u8bb8\u76f8\u5e94\u8c03\u6574\uff09\u3002<\/p>\n

\u672c\u6307\u5bfc\u539f\u5219\u4e2d\u5efa\u8bae\u7684\u89c2\u5bdf\u671f\u5e76\u975e\u5f3a\u5236\u89c4\u5b9a\u7684\u622a\u6b62\u65f6\u95f4\u70b9\uff0c\u5efa\u8bae\u6839\u636e\u836f\u7269\u7279\u5f81\u548c\u7814\u7a76\u76ee\u7684\uff0c\u786e\u5b9a\u5408\u7406\u7684\u89c2\u5bdf\u671f\uff0c\u5e76\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u9610\u8ff0\u4f9d\u636e\u3002<\/p>\n

\uff08\u56db\uff09\u8bc4\u4f30\u6307\u6807<\/h2>\n

\u76ee\u524d\uff0c\u65e0\u8bba\u662f\u5728\u4e34\u5e8a\u8bca\u7597\u4e2d\u8fd8\u662f\u5728\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5bf9\u7cbe\u795e\u5206\u88c2\u75c7\u4e25\u91cd\u7a0b\u5ea6\u53ca\u6297\u7cbe\u795e\u75c5\u836f\u7597\u6548\u7684\u8bc4\u4f30\u5c1a\u7f3a\u4e4f\u53ef\u9760\u7684\u5ba2\u89c2\u6307\u6807\u3002\u4f7f\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5177\u6709\u826f\u597d\u4fe1\u6548\u5ea6\u7684\u91cf\u8868\u662f\u76ee\u524d\u901a\u884c\u7684\u8bc4\u4f30\u65b9\u6cd5\u3002<\/p>\n

PANSS\u53ef\u4ee5\u533a\u522b\u7cbe\u795e\u5206\u88c2\u75c7\u7684\u5404\u4e2a\u75c7\u72b6\u7fa4\uff0c\u4e0d\u4ec5\u80fd\u591f\u8bc4\u4f30\u7cbe\u795e\u5206\u88c2\u75c7\u6574\u4f53\u75c7\u72b6\u53ca\u5176\u4e25\u91cd\u7a0b\u5ea6\u7684\u6539\u5584\uff0c\u4e5f\u53ef\u4ee5\u8bc4\u4f30\u5404\u4e2a\u75c7\u72b6\u7fa4\u53ca\u5176\u4e25\u91cd\u7a0b\u5ea6\u7684\u6539\u5584\uff0c\u5177\u6709\u75c7\u72b6\u4e25\u91cd\u7a0b\u5ea6\u7684\u8be6\u7ec6\u64cd\u4f5c\u6807\u51c6\uff0c\u5177\u6709\u826f\u597d\u7684\u4fe1\u6548\u5ea6\uff0c\u662f\u6297\u7cbe\u795e\u75c5\u836f\u7814\u53d1\u4e2d\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u91cf\u8868\u3002\u76ee\u524d\uff0c\u5efa\u8bae\u5728\u6297\u7cbe\u795e\u75c5\u836f\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u91c7\u7528PANSS\u4f5c\u4e3a\u7597\u6548\u6307\u6807\u8bc4\u4f30\u5de5\u5177\uff0c\u5305\u62ec\u4e3b\u8981\u7597\u6548\u6307\u6807\uff0c\u4ee5\u53ca\u4ee5\u75c7\u72b6\u7fa4\u4e3a\u5bf9\u8c61\u7684\u6b21\u8981\u7597\u6548\u6307\u6807\u3002<\/p>\n

\u6b21\u8981\u7597\u6548\u6307\u6807\u7684\u8bc4\u4f30\u5de5\u5177\uff0c\u5305\u62ec\u4e34\u5e8a\u603b\u4f53\u5370\u8c61\u91cf\u8868\u3001\u8ba4\u77e5\u529f\u80fd\u8bc4\u4ef7\u91cf\u8868\u3001\u6027\u529f\u80fd\u8bc4\u4ef7\u91cf\u8868\u3001\u751f\u6d3b\u8d28\u91cf\u8bc4\u4ef7\u91cf\u8868\u3001\u793e\u4f1a\u7ecf\u6d4e\u5b66\u8bc4\u4ef7\u91cf\u8868\u7b49\u3002\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\uff0c\u5e94\u9610\u8ff0\u6240\u9009\u62e9\u7684\u91cf\u8868\u7684\u5408\u7406\u6027\u4f9d\u636e\u3002<\/p>\n

\u901a\u5e38\uff0c\u5efa\u8bae\u4ee5\u8bd5\u9a8c\u89c2\u5bdf\u7ec8\u70b9\u76f8\u5bf9\u4e8e\u57fa\u7ebf\u7684\u4e3b\u8981\u7597\u6548\u6307\u6807\uff08\u91cf\u8868\u8bc4\u5206\uff09\u7684\u53d8\u5316\u503c\u4f5c\u4e3a\u6700\u4e3b\u8981\u7684\u7edf\u8ba1\u5b66\u5206\u6790\u5bf9\u8c61\uff0c\u5176\u7edf\u8ba1\u5b66\u5206\u6790\u7ed3\u679c\u4f5c\u4e3a\u8bc4\u4ef7\u836f\u7269\u7597\u6548\u7684\u6700\u4e3b\u8981\u7684\u4f9d\u636e\u3002\u5728\u4ee5\u836f\u7269\u7684\u7ef4\u6301\u7597\u6548\u4e3a\u7814\u7a76\u76ee\u7684\u7684\u957f\u7a0b\u8bd5\u9a8c\u4e2d\uff0c\u6839\u636e\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u53ef\u4ee5\u91c7\u7528\u77ed\u7a0b\u8bd5\u9a8c\u4e3b\u8981\u7597\u6548\u6307\u6807\u7684\u5ef6\u7eed\u89c2\u5bdf\u6216\u8005\u91c7\u7528\u590d\u53d1\u76f8\u5173\u6307\u6807\u4f5c\u4e3a\u4e3b\u8981\u7597\u6548\u6307\u6807\u3002<\/p>\n

\u6709\u6548\u7387\u3001\u7f13\u89e3\u7387\u548c\u590d\u53d1\uff08\u590d\u71c3\uff09\u7387\u4f5c\u4e3a\u4eba\u7fa4\u83b7\u76ca\u7684\u6307\u6807\uff0c\u5728\u836f\u54c1\u4e0a\u5e02\u540e\u7684\u4e34\u5e8a\u8bca\u7597\u5b9e\u8df5\u4e2d\u5177\u6709\u91cd\u8981\u7684\u6307\u5bfc\u4e0e\u53c2\u7167\u610f\u4e49\u3002\u56e0\u6b64\uff0c\u57fa\u4e8e\u4e3b\u8981\u7597\u6548\u6307\u6807\uff08\u91cf\u8868\u8bc4\u5206\uff09\u8ba1\u7b97\u6240\u5f97\u7684\u6709\u6548\u7387\u3001\u7f13\u89e3\u7387\u548c\u590d\u53d1\uff08\u590d\u71c3\uff09\u7387\u901a\u5e38\u4f5c\u4e3a\u5173\u952e\u6b21\u8981\u7597\u6548\u6307\u6807\uff0c\u662f\u8bc4\u4ef7\u836f\u7269\u7597\u6548\u7684\u652f\u6301\u6027\u4f9d\u636e\u3002<\/p>\n

\u6709\u6548\uff08Response\uff09\uff1a\u6709\u6548\u6307\u6cbb\u7597\u540e\u75c7\u72b6\u51cf\u8f7b\uff0c\u4ee3\u8868\u51fa\u73b0\u4e86\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u7597\u6548\u3002\u901a\u5e38\uff0c\u4ee5\u4e3b\u8981\u7597\u6548\u6307\u6807\uff08\u91cf\u8868\u8bc4\u5206\uff09\u53d8\u5316\u7387\u226550%\u6765\u5b9a\u4e49\u3002<\/p>\n

\u7f13\u89e3\uff08Remission\uff09\uff1a\u90e8\u5206\u7f13\u89e3\u662f\u6307\u5148\u524d\u53d1\u4f5c\u540e\u6709\u6240\u6539\u5584\u800c\u73b0\u5728\u90e8\u5206\u7b26\u5408\u8bca\u65ad\u6807\u51c6\u3002\u5b8c\u5168\u7f13\u89e3\u662f\u6307\u5148\u524d\u53d1\u4f5c\u540e\u6ca1\u6709\u4e0e\u969c\u788d\u76f8\u5173\u7684\u7279\u5b9a\u75c7\u72b6\u5b58\u5728\u3002\u7f13\u89e3\u81f3\u5c11\u5305\u62ec\u4e24\u4e2a\u7ef4\u5ea6\uff1a\u75c7\u72b6\u7ef4\u5ea6\u548c\u65f6\u95f4\u7ef4\u5ea6\uff0c\u5373\u75c7\u72b6\u6539\u5584\u6216\u6d88\u5931\uff0c\u5e76\u4e14\uff0c\u80fd\u591f\u7ef4\u6301\u4e00\u6bb5\u65f6\u95f4\uff08\u901a\u5e38\u4e3a6\u4e2a\u6708\uff09\u3002<\/p>\n

\u590d\u53d1\uff08Relapse\uff09\uff1a\u590d\u53d1\u662f\u6307\u5728\u7ecf\u8fc7\u4e00\u6bb5\u6ca1\u6709\u6216\u51e0\u4e4e\u6ca1\u6709\u75c7\u72b6\u7684\u65f6\u95f4\u540e\uff0c\u4e3b\u8981\u7cbe\u795e\u75c5\u6027\u75c7\u72b6\u7684\u91cd\u65b0\u51fa\u73b0\u3002\u5728\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u590d\u53d1\u80fd\u591f\u8f83\u5168\u9762\u548c\u786e\u5207\u7684\u53cd\u6620\u75be\u75c5\u4e0e\u836f\u7269\u6cbb\u7597\u6548\u679c\u4e4b\u95f4\u7684\u5173\u7cfb\u3002\u590d\u71c3\u662f\u6307\u672c\u6b21\u53d1\u4f5c\u65f6\u7684\u75c7\u72b6\u5728\u505c\u6b62\u836f\u7269\u6cbb\u7597\u540e\u5373\u523b\u6216\u51e0\u4e4e\u5373\u523b\u518d\u6b21\u51fa\u73b0\u6216\u52a0\u91cd\uff0c\u901a\u5e38\u7528\u4e8e\u63cf\u8ff0\u7528\u836f\u65f6\u95f4\u8fc7\u77ed\uff08\u76f8\u5bf9\u4e0d\u5f53\u7684\u6cbb\u7597\u884c\u4e3a\uff09\u4ee5\u81f3\u4e8e\u75c7\u72b6\u672a\u8fbe\u5230\u826f\u597d\u63a7\u5236\u7684\u60c5\u51b5\u3002\u65e0\u8bba\u662f\u590d\u53d1\u8fd8\u662f\u590d\u71c3\u90fd\u662f\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u6307\u6807\uff0c\u53ef\u4ee5\u6839\u636e\u836f\u7269\u7279\u70b9\u548c\u7814\u7a76\u76ee\u7684\u8fdb\u884c\u9009\u62e9\uff0c\u9700\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u9610\u8ff0\u5408\u7406\u4f9d\u636e\u5e76\u7ed9\u51fa\u660e\u786e\u7684\u91cf\u5316\u6807\u51c6\u3002<\/p>\n

\u590d\u53d1\u65f6\u95f4\uff1a\u590d\u53d1\u65f6\u95f4\u6307\u81ea\u75c7\u72b6\u7f13\u89e3\u540e\u8bb0\u5f55\u5230\u9996\u4e2a\u590d\u53d1\u4e8b\u4ef6\u4e4b\u95f4\u7684\u65f6\u95f4\u3002\u5728\u968f\u673a\u64a4\u836f\u8bd5\u9a8c\u4e2d\uff0c\u6307\u81ea\u968f\u673a\u5206\u7ec4\u81f3\u53cc\u76f2\u671f\u6cbb\u7597\u4e2d\u8bb0\u5f55\u5230\u9996\u4e2a\u590d\u53d1\u4e8b\u4ef6\u4e4b\u95f4\u7684\u65f6\u95f4\u3002\u8bd5\u9a8c\u65b9\u6848\u4e2d\u5e94\u5bf9\u590d\u53d1\u4e8b\u4ef6\u53ca\u590d\u53d1\u7ed9\u51fa\u660e\u786e\u7684\u53ef\u64cd\u4f5c\u6027\u7684\u91cf\u5316\u6807\u51c6\uff0c\u5982\uff1a\u590d\u53d1\u662f\u6307\u51fa\u73b0\u4ee5\u4e0b\u4efb\u4e00\u60c5\u51b5\uff1a\u4f4f\u9662\u6cbb\u7597\uff08\u590d\u53d1\u524d\u672a\u4f4f\u9662, \u7531\u4e8e\u7cbe\u795e\u5206\u88c2\u75c7\u75c7\u72b6\u6076\u5316\u800c\u4f4f\u9662\uff09\uff1b\u589e\u52a0\u95e8\u8bca\u5c31\u8bca\u9891\u7387\u6216\u9700\u8981\u7d27\u6025\u5e72\u9884\uff1b\u9700\u8981\u6539\u53d8\u6cbb\u7597\u65b9\u6848\uff1b\u51fa\u73b0\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u5f02\u5e38\u884c\u4e3a\uff0c\u5982\u4f24\u4eba\u3001\u81ea\u6740\u6216\u81ea\u4f24\u7b49\uff1bPANSS\u603b\u5206\u53ca\u5355\u9879\u5206\u7684\u53d8\u5316\uff08\u5e94\u7ed9\u51fa\u91cf\u5316\u6807\u51c6\uff09\u3002<\/p>\n

\u76ee\u524d\u6ca1\u6709\u7edf\u4e00\u7684\u5bf9\u4e8e\u7cbe\u795e\u5206\u88c2\u75c7\u6709\u6548\uff08\u7387\uff09\u3001\u7f13\u89e3\uff08\u7387\uff09\u3001\u590d\u53d1\uff08\u7387\uff09\u3001\u590d\u71c3\uff08\u7387\uff09\u3001\u590d\u53d1\u65f6\u95f4\u7b49\u6307\u6807\u7684\u91cf\u5316\u6807\u51c6\u3002\u5efa\u8bae\u8fdb\u884c\u5145\u5206\u8c03\u7814\u548c\u6587\u732e\u6c47\u603b\uff0c\u7ed3\u5408\u4e34\u5e8a\u7ecf\u9a8c\u4e0e\u4e13\u5bb6\u5171\u8bc6\uff0c\u786e\u5b9a\u660e\u786e\u7684\u53ef\u64cd\u4f5c\u6027\u7684\u91cf\u5316\u6807\u51c6\uff0c\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8fdb\u884c\u9610\u8ff0\uff0c\u5e76\u63d0\u4f9b\u4f9d\u636e\u3002<\/p>\n

\u6297\u7cbe\u795e\u75c5\u836f\u5e38\u89c1\u7684\u5b89\u5168\u6027\u98ce\u9669\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a\u9525\u4f53\u5916\u7cfb\u53cd\u5e94\u3001\u5fc3\u8840\u7ba1\u5b89\u5168\u6027\u98ce\u9669\u3001\u81ea\u6740\u98ce\u9669\u3001\u4f53\u91cd\u4e0e\u4ee3\u8c22\u5f02\u5e38\u3001\u6027\u529f\u80fd\u969c\u788d\u3001\u6076\u6027\u7efc\u5408\u5f81\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u75c7\u72b6\u3001\u8840\u6db2\u5b66\u5f02\u5e38\u7b49\u3002\u5728\u6297\u7cbe\u795e\u75c5\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5efa\u8bae\u5bf9\u5df2\u77e5\u5b89\u5168\u6027\u98ce\u9669\u8fdb\u884c\u76d1\u6d4b\uff0c\u540c\u65f6\uff0c\u6839\u636e\u836f\u7269\u836f\u7406\u5b66\u673a\u5236\u53ca\u53d7\u8bd5\u8005\u7279\u5f81\uff0c\u5bf9\u6f5c\u5728\u7684\u5176\u4ed6\u5b89\u5168\u6027\u98ce\u9669\u8fdb\u884c\u76d1\u6d4b\u3002<\/p>\n

\uff08\u4e94\uff09\u5bf9\u7167\u836f<\/h2>\n

\u5efa\u8bae\u6839\u636e\u7814\u7a76\u76ee\u7684\u3001\u8bd5\u9a8c\u8bbe\u8ba1\u7c7b\u522b\u3001\u8bc4\u4f30\u6307\u6807\u7b49\u5408\u7406\u9009\u62e9\u5bf9\u7167\u836f\u3002\u5982\u679c\u91c7\u7528\u4f18\u6548\u8bbe\u8ba1\uff0c\u5bf9\u7167\u836f\u53ef\u4ee5\u662f\u9633\u6027\u836f\u6216\u5b89\u6170\u5242\u3002\u5982\u679c\u91c7\u7528\u975e\u52a3\u6548\u8bbe\u8ba1\uff0c\u5bf9\u7167\u836f\u5e94\u5305\u62ec\u9633\u6027\u836f\u548c\u5b89\u6170\u5242\uff0c\u5373\u4e09\u81c2\u8bd5\u9a8c\u3002\u5728\u4e09\u81c2\u8bd5\u9a8c\u4e2d\uff0c\u5b89\u6170\u5242\u53ef\u4ee5\u4f5c\u4e3a\u5185\u90e8\u8d28\u91cf\u63a7\u5236\u7684\u6807\u51c6\uff0c\u4fdd\u8bc1\u7814\u7a76\u7ed3\u679c\u7684\u53ef\u9760\u6027\u3002<\/p>\n

\u901a\u5e38\uff0c\u9633\u6027\u5bf9\u7167\u836f\u5efa\u8bae\u9009\u62e9\u836f\u7406\u5b66\u673a\u5236\u76f8\u4f3c\u7684\u836f\u7269\u3002\u5168\u65b0\u9776\u70b9\/\u673a\u5236\u836f\u7269\u7684\u8bd5\u9a8c\uff0c\u53ef\u4ee5\u9009\u62e9\u56fd\u5185\u5df2\u4e0a\u5e02\u7684\u3001\u4e34\u5e8a\u5e94\u7528\u5e7f\u6cdb\u7684\u3001\u6709\u5faa\u8bc1\u8bc1\u636e\u7684\u5b89\u5168\u6709\u6548\u6cbb\u7597\u836f\u7269\u4f5c\u4e3a\u9633\u6027\u5bf9\u7167\u836f\u3002\u5982\u6709\u539f\u7814\u836f\u54c1\uff0c\u5efa\u8bae\u4f5c\u4e3a\u9996\u9009\u3002<\/p>\n

\u5efa\u8bae\u5728\u4e25\u5bc6\u7ba1\u7406\u4e0e\u76d1\u6d4b\u7684\u7cbe\u795e\u79d1\u75c5\u623f\u5185\u5f00\u5c55\u5b89\u6170\u5242\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u4e25\u683c\u6267\u884c\u8bd5\u9a8c\u65b9\u6848\u89c4\u5b9a\u7684\u9000\u51fa\u4e0e\u7ec8\u6b62\u7a0b\u5e8f\uff0c\u6700\u5927\u7a0b\u5ea6\u5730\u964d\u4f4e\u53d7\u8bd5\u8005\u98ce\u9669\u3002<\/p>\n

\uff08\u516d\uff09\u5408\u5e76\u6cbb\u7597<\/h2>\n

\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

\u5fc3\u7406\u54a8\u8be2\u3001\u5eb7\u590d\u6cbb\u7597\u3001\u7269\u7406\u6cbb\u7597\u7b49\u662f\u7cbe\u795e\u79d1\u4e34\u5e8a\u4e2d\u5e38\u89c1\u7684\u8f85\u52a9\u6cbb\u7597\u65b9\u5f0f\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

\uff08\u4e03\uff09\u6570\u636e\u7ba1\u7406\u548c\u7edf\u8ba1\u5206\u6790<\/h2>\n

\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

\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5206\u6790\u6570\u636e\u96c6\u4e00\u822c\u5305\u62ec\u610f\u5411\u6cbb\u7597\u5206\u6790\uff08Intention toTreat Analysis\uff0cITT\uff09\/\u5168\u5206\u6790\u96c6\uff08Full Analysis Set\uff0cFAS\uff09\u3001\u7b26\u5408\u65b9\u6848\u96c6\uff08Per ProtocolSet\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

\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\uff08MedicalDictionary 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

\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

\u56db\u3001\u7279\u6b8a\u8003\u8651<\/p>\n

\uff08\u4e00\uff09\u7279\u6b8a\u4eba\u7fa4\u8bd5\u9a8c<\/h2>\n

1. \u8001\u5e74\u4eba\u7fa4<\/p>\n

\u8001\u5e74\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u548c\/\u6216\u836f\u6548\u5b66\u7279\u6027\u6709\u53ef\u80fd\u4e0e\u6210\u4eba\u60a3\u8005\u5b58\u5728\u5dee\u5f02\u3002\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

\u5efa\u8bae\u6839\u636e\u836f\u7269\u7279\u70b9\u3001\u6cbb\u7597\u5b9a\u4f4d\u548c\u4eba\u7fa4\u7279\u5f81\u7b49\uff0c\u8003\u8651\u5728\u6297\u7cbe\u795e\u75c5\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7eb3\u5165\u90e8\u5206\u8001\u5e74\u60a3\u8005\u6216\u8005\u5355\u72ec\u5f00\u5c55\u8001\u5e74\u60a3\u8005\uff08\u4e16\u754c\u536b\u751f\u7ec4\u7ec7WHO\u5b9a\u4e49\u4e3a\u226565\u5c81\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53ef\u80fd\u6027\u3002<\/p>\n

2. \u513f\u79d1\u4eba\u7fa4<\/p>\n

\u7cbe\u795e\u5206\u88c2\u75c7\u8d77\u75c5\u4e8e\u9752\u58ee\u5e74\u3002\u5728\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\u226412\u5c81\u7684\u7cbe\u795e\u5206\u88c2\u75c7\u60a3\u8005\u4e2d\u5f00\u5c55\u6297\u7cbe\u795e\u75c5\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

\u5e94\u9996\u5148\u5728\u6210\u4eba\u4e2d\u5f00\u5c55\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8bc1\u660e\u6297\u7cbe\u795e\u75c5\u836f\u6cbb\u7597\u6210\u4eba\u7cbe\u795e\u5206\u88c2\u75c7\u5b89\u5168\u6709\u6548\uff0c\u4e4b\u540e\uff0c\u53ef\u4ee5\u8003\u8651\u6269\u5c55\u6297\u7cbe\u795e\u75c5\u836f\u7684\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\u6297\u7cbe\u795e\u75c5\u836f\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

\u5728\u513f\u79d1\u4eba\u7fa4\u4e2d\u5f00\u5c55\u6297\u7cbe\u795e\u75c5\u836f\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

\u513f\u79d1\u4eba\u7fa4\u7684\u81ea\u6740\u98ce\u9669\u662f\u5df2\u77e5\u7684\u6297\u7cbe\u795e\u75c5\u836f\u5b89\u5168\u6027\u98ce\u9669\u4e4b\u4e00\uff0c\u5728\u6297\u7cbe\u795e\u75c5\u836f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5e94\u91cd\u89c6\u5bf9\u513f\u79d1\u4eba\u7fa4\u81ea\u6740\u98ce\u9669\u7684\u76d1\u6d4b\u3002<\/p>\n

\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\u65f6\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

\uff08\u4e8c\uff09\u6570\u636e\u548c\u5b89\u5168\u76d1\u5bdf<\/h2>\n

\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)\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

\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\u6297\u7cbe\u795e\u75c5\u836f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5efa\u7acbDMC\u3002<\/p>\n

\uff08\u4e09\uff09\u5ba2\u89c2\u68c0\u6d4b\u6307\u6807\u7684\u5e94\u7528<\/h2>\n

\u9274\u4e8e\u7cbe\u795e\u5206\u88c2\u75c7\u75c5\u751f\u7406\u7279\u5f81\u7684\u590d\u6742\u6027\uff0c\u8fc4\u4eca\u4e3a\u6b62\uff0c\u8fd8\u6ca1\u6709\u7528\u4e8e\u7cbe\u795e\u5206\u88c2\u75c7\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

\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\u6297\u7cbe\u795e\u75c5\u836f\u4e34\u5e8a\u7814\u53d1\u4e2d\u7eb3\u5165\u751f\u7269\u6807\u8bb0\u7269\u7b49\u5ba2\u89c2\u76d1\u6d4b\u6307\u6807\u3002<\/p>\n

\u4e94\u3001\u53c2\u8003\u6587\u732e<\/h1>\n

1.\u6c88\u6e14\u90a8.\u7cbe\u795e\u75c5\u5b66\uff08\u7b2c5\u7248\uff09<\/span><\/p>\n

2.\u4e2d\u56fd\u7cbe\u795e\u5206\u88c2\u75c7\u9632\u6cbb\u6307\u5357\uff082015\u5e74\u7248\uff09<\/span><\/p>\n

3.CFDA.\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u822c\u8003\u8651.2011\u5e747\u6708<\/span><\/p>\n

4.CFDA.\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u836f\u7269\u4e34\u5e8a\u8bc4\u4ef7\u7684\u8003\u8651\u8981\u70b9.2011\u5e746\u6708<\/span><\/p>\n

5.CDE.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u822c\u8003\u8651.2017\u5e741\u6708<\/span><\/p>\n

6.CFDA.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219.2016\u5e746\u6708<\/span><\/p>\n

7.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

8.CFDA.\u513f\u79d1\u4eba\u7fa4\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219.2016\u5e743\u6708<\/span><\/p>\n

9.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

10.\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09\u7cfb\u5217\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

11.EMA.Guideline onclinical investigation of medicinal products in the treatment ofschizophrenia.October 2012.<\/span><\/p>\n

12.FDA.Establishment and Operation of Clinical Trial DataMonitoring Committees for Clinical Trial Sponsors.March 2006.<\/span><\/p>\n


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\u4e00\u7ad9\u5f0f\u7efc\u5408\u670d\u52a1<\/span>CRO<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5e7f\u5dde <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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