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survival\uff0cOS\uff09\u7b49\u3002<\/p>\n\n\n\n<p>\u4ed6\u6307\u51fa\uff0c\u836f\u7269\u76d1\u7ba1\u673a\u6784\u4f1a\u6839\u636e\u6574\u4f53\u7814\u7a76\u8bc1\u636e\u51b3\u5b9a\u662f\u5426\u6279\u51c6\u836f\u7269\u4e0a\u5e02\u3002\u90e8\u5206\u9488\u5bf9\u4e25\u91cd\u75be\u75c5\u3001\u4e14\u6709\u672a\u88ab\u6ee1\u8db3\u533b\u7597\u9700\u8981\u7684\u836f\u7269\uff0c\u53ef\u900f\u8fc7\u300c\u52a0\u901f\u6279\u51c6\u300d\u7b49\u7279\u5b9a\u9014\u5f84\uff0c\u4ee5\u8f83\u65e9\u671f\u7684\u6570\u636e\u63d0\u65e9\u83b7\u6279\uff0c\u4f46\u5176\u540e\u4ecd\u987b\u4ee5\u786e\u8ba4\u6027\u7814\u7a76\u8bc1\u5b9e\u4e34\u5e8a\u6548\u76ca\u3002<\/p>\n\n\n\n<p>\u6797\u533b\u751f\u53c8\u5f3a\u8c03\uff0c\u77e5\u60c5\u540c\u610f\uff08informed consent\uff09\u662f\u4fdd\u969c\u60a3\u8005\u6743\u76ca\u7684\u6838\u5fc3\u3002\u7814\u7a76\u56e2\u961f\u987b\u5411\u60a3\u8005\u4ea4\u4ee3\u7814\u7a76\u76ee\u7684\u3001\u53ef\u80fd\u6548\u76ca\u3001\u5df2\u77e5\u98ce\u9669\u3001\u5176\u4ed6\u6cbb\u7597\u9009\u62e9\uff0c\u4ee5\u53ca\u68c0\u67e5\u3001\u590d\u8bca\u548c\u8d39\u7528\u5b89\u6392\uff0c\u8ba9\u60a3\u8005\u5728\u5145\u5206\u7406\u89e3\u540e\u81ea\u613f\u51b3\u5b9a\u662f\u5426\u53c2\u52a0\u3002\u60a3\u8005\u53ef\u4ee5\u62d2\u7edd\u53c2\u52a0\uff0c\u4ea6\u53ef\u5728\u53c2\u52a0\u540e\u968f\u65f6\u9000\u51fa\uff0c\u800c\u4e0d\u4f1a\u56e0\u6b64\u53d7\u5230\u60e9\u7f5a\uff0c\u6216\u5931\u53bb\u539f\u672c\u6709\u6743\u83b7\u5f97\u7684\u533b\u7597\u7167\u987e\u3002<\/p>\n\n\n\n<p>\u5bf9\u4e8e\u6cbb\u7597\u9009\u62e9\u6709\u9650\u7684\u60a3\u8005\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u80fd\u63d0\u4f9b\u63a5\u89e6\u65b0\u7597\u6cd5\u7684\u673a\u4f1a\uff0c\u7814\u7a76\u671f\u95f4\u4ea6\u4f1a\u6309\u65b9\u6848\u5b9a\u671f\u8bc4\u4ef7\u75c5\u60c5\u53ca\u76d1\u5bdf\u4e0d\u826f\u4e8b\u4ef6\uff08adverse 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of care\uff09\u3002<\/p>\n\n\n\n<p>\u81f3\u4e8e\u5b89\u6170\u5242\uff08placebo\uff09\uff0c\u662f\u5916\u89c2\u4e0e\u7814\u7a76\u836f\u7269\u76f8\u4f3c\u3001\u4f46\u4e0d\u542b\u6d3b\u6027\u6210\u5206\u7684\u5236\u5242\u3002\u6797\u533b\u751f\u6307\u51fa\uff0c\u90e8\u5206\u8bd5\u9a8c\u4f1a\u6bd4\u8f83\u300c\u6807\u51c6\u6cbb\u7597\u52a0\u65b0\u836f\u300d\u4e0e\u300c\u6807\u51c6\u6cbb\u7597\u52a0\u5b89\u6170\u5242\u300d\uff0c\u4e24\u7ec4\u60a3\u8005\u540c\u6837\u63a5\u53d7\u6807\u51c6\u6cbb\u7597\uff0c\u7814\u7a76\u5219\u8bc4\u4ef7\u52a0\u5165\u65b0\u836f\u80fd\u5426\u5e26\u6765\u989d\u5916\u6548\u76ca\uff1b\u90e8\u5206\u7814\u7a76\u66f4\u91c7\u7528\u300c\u53cc\u76f2\u300d\u8bbe\u8ba1\uff0c\u5373\u60a3\u8005\u53ca\u533b\u751f\u5728\u7814\u7a76\u671f\u95f4\u5747\u4e0d\u77e5\u9053\u5206\u7ec4\uff0c\u4ee5\u51cf\u5c11\u4e3b\u89c2\u5224\u65ad\u5bf9\u7ed3\u679c\u7684\u5f71\u54cd\u3002<\/p>\n\n\n\n<p>\u6797\u533b\u751f\u5f3a\u8c03\uff0c\u5f53\u5df2\u6709\u9002\u5408\u60a3\u8005\u7684\u6709\u6548\u6807\u51c6\u6cbb\u7597\u65f6\uff0c\u4e00\u822c\u4e0d\u5e94\u5355\u7528\u5b89\u6170\u5242\u53d6\u4ee3\u3002\u53ea\u6709\u5728\u6807\u51c6\u5904\u7406\u672c\u6765\u5c31\u662f\u89c2\u5bdf\uff0c\u6216\u6ca1\u6709\u5408\u9002\u6709\u6548\u6cbb\u7597\u7b49\u7279\u5b9a\u60c5\u51b5\u4e0b\uff0c\u7814\u7a76\u624d\u53ef\u80fd\u91c7\u7528\u5b89\u6170\u5242\u5bf9\u7167\uff0c\u800c\u6709\u5173\u5b89\u6392\u987b\u7ecf\u4f26\u7406\u5ba1\u67e5\uff0c\u5e76\u5728\u77e5\u60c5\u540c\u610f\u8fc7\u7a0b\u4e2d\u6e05\u695a\u4ea4\u4ee3\u3002<\/p>\n\n\n\n<p>\u968f\u673a\u5206\u7ec4\uff08randomisation\uff09\u4e00\u822c\u7531\u7535\u8111\u7cfb\u7edf\u6309\u7814\u7a76\u65b9\u6848\u5206\u914d\uff0c\u60a3\u8005\u53ca\u533b\u751f\u5747\u4e0d\u80fd\u81ea\u884c\u9009\u62e9\u7ec4\u522b\u3002\u6797\u533b\u751f\u63d0\u9192\uff0c\u65b0\u7597\u6cd5\u662f\u5426\u4f18\u4e8e\u73b0\u6709\u6cbb\u7597\uff0c\u6b63\u662f\u7814\u7a76\u8981\u56de\u7b54\u7684\u95ee\u9898\uff0c\u56e0\u6b64\u4e0d\u80fd\u9884\u5148\u4fdd\u8bc1\u8bd5\u9a8c\u7ec4\u6548\u679c\u8f83\u4f73\uff0c\u4e5f\u4e0d\u80fd\u4fdd\u8bc1\u6bcf\u4f4d\u53c2\u52a0\u8005\u90fd\u4f1a\u53d7\u76ca\u3002<\/p>\n\n\n\n<p><strong>\u56db\u3001\u4e0d\u53ea\u665a\u671f\u65e9\u671f\u4e73\u764c\u4e5f\u6709\u7814\u7a76<\/strong><\/p>\n\n\n\n<p>\u95ee\uff1a\u53ea\u6709\u665a\u671f\u6216\u5df2\u6ca1\u6709\u5176\u4ed6\u6cbb\u7597\u9009\u62e9\u7684\u75c5\u4eba\uff0c\u624d\u9002\u5408\u53c2\u52a0\uff1f<\/p>\n\n\n\n<p>\u6797\u533b\u751f\u6307\u51fa\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u6db5\u76d6\u764c\u75c7\u6cbb\u7597\u7684\u4e0d\u540c\u9636\u6bb5\uff0c\u5e76\u975e\u53ea\u4e3a\u665a\u671f\u6216\u5df2\u7528\u5c3d\u6807\u51c6\u6cbb\u7597\u7684\u60a3\u8005\u800c\u8bbe\u3002\u4ed6\u4e3e\u4f8b\uff0c\u5728\u65e9\u671f\u4e73\u764c\u65b9\u9762\uff0c\u6709\u7814\u7a76\u63a2\u8ba8\u65b0\u8f85\u52a9\u6cbb\u7597\uff08neoadjuvant therapy\uff09\uff0c\u5373\u5728\u624b\u672f\u524d\u4f7f\u7528\u836f\u7269\uff0c\u4ee5\u7f29\u5c0f\u80bf\u7624\u53ca\u8bc4\u4ef7\u6cbb\u7597\u53cd\u5e94\uff1b\u4ea6\u6709\u7814\u7a76\u8bc4\u4ef7\u8f85\u52a9\u6cbb\u7597\uff08adjuvant therapy\uff09\uff0c\u5373\u624b\u672f\u540e\u7684\u836f\u7269\u6cbb\u7597\uff0c\u4ee5\u964d\u4f4e\u590d\u53d1\u98ce\u9669\u3002\u6b64\u5916\uff0c\u4e5f\u6709\u7814\u7a76\u63a2\u7d22\u5982\u4f55\u51cf\u5c11\u6cbb\u7597\u526f\u4f5c\u7528\u3001\u7ebe\u7f13\u75c7\u72b6\u53ca\u6539\u5584\u751f\u6d3b\u7d20\u8d28\u3002<\/p>\n\n\n\n<p>\u4ed6\u63d0\u9192\uff0c\u662f\u5426\u9002\u5408\u53c2\u52a0\uff0c\u987b\u7efc\u5408\u8003\u8651\u80bf\u7624\u7684\u75c5\u7406\u53ca\u5206\u5b50\u7279\u5f81\u3001\u8fc7\u5f80\u6cbb\u7597\u3001\u8eab\u4f53\u72b6\u51b5\uff0c\u4ee5\u53ca\u60a3\u8005\u7684\u6cbb\u7597\u76ee\u6807\u548c\u610f\u613f\u3002\u4e34\u5e8a\u8bd5\u9a8c\u6216\u9700\u989d\u5916\u68c0\u67e5\u53ca\u8f83\u9891\u5bc6\u590d\u8bca\uff0c\u60a3\u8005\u9664\u8861\u91cf\u6cbb\u7597\u7684\u53ef\u80fd\u6548\u76ca\u53ca\u98ce\u9669\uff0c\u4ea6\u5e94\u8003\u8651\u4ea4\u901a\u3001\u5de5\u4f5c\u3001\u5bb6\u5ead\u7167\u987e\u53ca\u65f6\u95f4\u7b49\u5b9e\u9645\u8d1f\u62c5\u3002<\/p>\n\n\n\n<p><strong>\u4e94\u3001\u8de8\u5883\u53c2\u52a0\u95ee\u6e05\u695a\u518d\u5b89\u6392\u884c\u7a0b<\/strong><\/p>\n\n\n\n<p>\u95ee\uff1a\u5185\u5730\u5c45\u6c11\uff0c\u53ef\u4ee5\u53c2\u52a0\u9999\u6e2f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5417\uff1f<\/p>\n\n\n\n<p>\u6797\u533b\u751f\u8868\u793a\uff0c\u662f\u5426\u63a5\u53d7\u5185\u5730\u5c45\u6c11\uff0c\u987b\u89c6\u4e4e\u4e2a\u522b\u8bd5\u9a8c\u53ca\u7814\u7a76\u673a\u6784\u7684\u5b89\u6392\uff0c\u4e0d\u80fd\u4e00\u6982\u800c\u8bba\uff1b\u6301\u6709\u6709\u6548\u6765\u6e2f\u8bc1\u4ef6\uff0c\u4ea6\u4e0d\u7b49\u4e8e\u5df2\u7b26\u5408\u53c2\u52a0\u8d44\u683c\u3002<\/p>\n\n\n\n<p>\u4ed6\u5efa\u8bae\uff0c\u6709\u610f\u53c2\u52a0\u8005\u5b9c\u5148\u8054\u7edc\u7814\u7a76\u4e2d\u5fc3\uff0c\u63d0\u4f9b\u75c5\u5386\u3001\u75c5\u7406\u62a5\u544a\u3001\u56fe\u50cf\u53ca\u57fa\u56e0\u68c0\u6d4b\u7ed3\u679c\uff08\u4f8b\u5982HER2\u3001BRCA\u3001PIK3CA\u7b49\uff09\uff0c\u8ba9\u7814\u7a76\u56e2\u961f\u521d\u6b65\u8bc4\u4ef7\u7814\u7a76\u662f\u5426\u63a5\u53d7\u5883\u5916\u60a3\u8005\u3001\u60a3\u8005\u662f\u5426\u53ef\u80fd\u7b26\u5408\u5165\u7ec4\u6761\u4ef6\uff0c\u7136\u540e\u624d\u5b89\u6392\u6765\u6e2f\u3002<\/p>\n\n\n\n<p>\u5185\u5730\u5c45\u6c11\u4ee5\u5c31\u533b\u76ee\u7684\u6765\u6e2f\uff0c\u987b\u6309\u89c4\u5b9a\u6301\u6709\u6548\u5f80\u6765\u6e2f\u6fb3\u901a\u884c\u8bc1\u53ca\u5408\u9002\u7684\u300c\u5176\u4ed6\u300d\u7b7e\u6ce8\uff0c\u5177\u4f53\u8981\u6c42\u5e94\u5411\u76f8\u5173\u51fa\u5165\u5883\u90e8\u95e8\u786e\u8ba4\u3002\u6797\u533b\u751f\u63d0\u9192\uff0c\u8de8\u5883\u53c2\u52a0\u8bd5\u9a8c\uff0c\u4e0d\u53ea\u8981\u8003\u8651\u9996\u6b21\u5c31\u8bca\uff0c\u4e5f\u8981\u786e\u4fdd\u80fd\u914d\u5408\u540e\u7eed\u590d\u8bca\u3001\u62bd\u8840\u3001\u56fe\u50cf\u68c0\u67e5\u53ca\u5b89\u5168\u76d1\u6d4b\u3002\u60a3\u8005\u5e94\u4e8b\u5148\u4e86\u89e3\u51fa\u73b0\u4e0d\u9002\u65f6\u7684\u8054\u7edc\u53ca\u6c42\u533b\u5b89\u6392\uff0c\u4ee5\u53ca\u533b\u7597\u3001\u4ea4\u901a\u548c\u4f4f\u5bbf\u7b49\u5f00\u652f\uff1b\u7814\u7a76\u836f\u7269\u53ca\u68c0\u67e5\u7684\u8d44\u52a9\u8303\u56f4\uff0c\u4ea6\u987b\u5411\u7814\u7a76\u56e2\u961f\u9010\u9879\u786e\u8ba4\u3002<\/p>\n\n\n\n<p><strong>\u516d\u3001\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u4e94\u90e8\u66f2<\/strong><\/p>\n\n\n\n<p>\u6797\u533b\u751f\u4ecb\u7ecd\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u987b\u9075\u5faa\u300c\u4f18\u826f\u4e34\u5e8a\u8bd5\u9a8c\u89c4\u8303\u300d\uff08Good Clinical Practice\uff0cGCP\uff09\u53ca\u76f8\u5173\u6cd5\u89c4\uff0c\u4ee5\u4fdd\u969c\u53c2\u52a0\u8005\u6743\u76ca\u53ca\u7814\u7a76\u6570\u636e\u7d20\u8d28\u3002\u5b9e\u9645\u7a0b\u5e8f\u56e0\u8bd5\u9a8c\u800c\u5f02\uff0c\u4e00\u822c\u53ef\u6982\u62ec\u4e3a\u4ee5\u4e0b\u4e94\u6b65\uff1a<\/p>\n\n\n\n<p>1. \u521d\u6b65\u4e86\u89e3\u4e0e\u8bc4\u4ef7<\/p>\n\n\n\n<p>\u60a3\u8005\u63d0\u4f9b\u75c5\u5386\u3001\u75c5\u7406\u53ca\u68c0\u67e5\u62a5\u544a\uff0c\u7531\u533b\u751f\u521d\u6b65\u8bc4\u4ef7\u662f\u5426\u6709\u53ef\u80fd\u9002\u5408\u7684\u7814\u7a76\u3002<\/p>\n\n\n\n<p>2. \u4e86\u89e3\u7814\u7a76\uff0c\u81ea\u613f\u540c\u610f<\/p>\n\n\n\n<p>\u7814\u7a76\u56e2\u961f\u89e3\u91ca\u7814\u7a76\u76ee\u7684\u3001\u6cbb\u7597\u53ca\u5206\u7ec4\u5b89\u6392\u3001\u53ef\u80fd\u6548\u76ca\u548c\u98ce\u9669\u3001\u66ff\u4ee3\u6cbb\u7597\u3001\u6240\u9700\u68c0\u67e5\u53ca\u8d39\u7528\u3002\u60a3\u8005\u6709\u8db3\u591f\u65f6\u95f4\u63d0\u95ee\u53ca\u8003\u8651\uff0c\u624d\u51b3\u5b9a\u662f\u5426\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\u3002<\/p>\n\n\n\n<p>3. 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