{"id":39716,"date":"2016-11-17T07:08:17","date_gmt":"2016-11-17T01:38:17","guid":{"rendered":"https:\/\/new.editage.cn\/insights\/%e4%b8%ba%e4%bd%95%e6%94%b9%e5%8f%98%e6%88%90%e6%95%88%e4%bc%9a%e8%ae%a9%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e5%a4%b1%e5%8e%bb%e6%84%8f%e4%b9%89"},"modified":"2026-01-07T16:25:05","modified_gmt":"2026-01-07T10:55:05","slug":"wei-he-gai-bian-cheng-xiao-hui-rang-lin-chuang-shi-yan-shi-qu-yi-yi-2694","status":"publish","type":"post","link":"https:\/\/www.editage.cn\/insights\/wei-he-gai-bian-cheng-xiao-hui-rang-lin-chuang-shi-yan-shi-qu-yi-yi-2694\/","title":{"rendered":"\u4e3a\u4f55\u6539\u53d8\u6210\u6548\u4f1a\u8ba9\u4e34\u5e8a\u8bd5\u9a8c\u5931\u53bb\u610f\u4e49"},"content":{"rendered":"<p>\u4e34\u5e8a\u8bd5\u9a8c\u88ab\u8ba4\u4e3a\u662f\u53d1\u73b0\u65b0\u7684\u836f\u54c1\uff0c\u65b0\u7684\u6cbb\u7597\u65b9\u6848\u548c\u6539\u826f\u533b\u5b66\u5668\u6750\u7684\u91cd\u8981\u7814\u7a76\u5de5\u5177\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u4ee5\u5728\u4ed6\u4eec\u88ab\u5e7f\u6cdb\u4f7f\u7528\u524d\u6d4b\u8bd5\u5176\u5b89\u5168\u6027\u548c\u6548\u7528\u3002\u7814\u7a76\u5458\u5fc5\u987b\u5728\u89c4\u5b9a\u7684\u65f6\u95f4\u5185<a href=\"https:\/\/www.editage.cn\/insights\/what-every-medical-researcher-should-know-about-registering-clinical-trials\" target=\"_blank\">\u767b\u8bb0\u4e34\u5e8a\u8bd5\u9a8c<\/a>\u548c<a href=\"https:\/\/www.editage.cn\/insights\/who-calls-for-researchers-to-report-the-findings-of-all-clinical-trials\" target=\"_blank\">\u62a5\u544a\u6210\u6548<\/a>\u3002\u867d\u7136\u7814\u7a76\u5458\u6709\u8ddf\u4ece\u8fd9\u4e9b\u6700\u4f73\u5b9e\u8df5\uff0c\u4f46\u5f88\u591a\u4e5f\u9676\u9189\u5728\u6240\u8c13\u300c\u6539\u53d8\u6210\u6548\u300d\u7684\u884c\u4e3a\u4e2d\u3002\u5f53\u4e00\u4e2a\u5b9e\u9a8c\u62a5\u544a\u4e0d\u5305\u62ec\u5df2\u767b\u8bb0\u7684\u6210\u6548\uff0c\u6216\u8005\u5728\u6ca1\u6709\u4efb\u4f55\u6839\u672c\u89e3\u91ca\u4e0b\u516c\u5e03\u65b0\u7684\u6210\u6548\uff0c\u8bd5\u9a8c\u5c31\u53ef\u4ee5\u88ab\u8ba4\u4e3a\u662f\u6539\u53d8\u4e86\u6210\u6548\u3002\u6539\u53d8\u6210\u6548\u503c\u5f97\u5173\u6ce8\u56e0\u4e3a\u5b83\u5f71\u54cd\u4e86\u7814\u7a76\u7684\u900f\u660e\u5ea6\uff0c\u5e76\u4e14\u504f\u79bb\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u539f\u672c\u7684\u62a5\u544a\u5e38\u6001\uff0c\u56e0\u6b64\u4f1a\u5a01\u80c1\u533b\u5b66\u7814\u7a76\u7684\u8bda\u4fe1\u3002\u6b64\u5916\uff0c\u4e0d\u51c6\u786e\u62a5\u544a\u8bd5\u9a8c\u53ef\u4ee5\u5bf9\u533b\u7597\u4fdd\u5065\u6709\u5f88\u5927\u5f71\u54cd\uff0c\u6240\u4ee5\u8fd9\u4e2a\u73b0\u8c61\u5f88\u503c\u5f97\u5f15\u8d77\u6ce8\u610f\u3002<\/p>\n<p><a href=\"https:\/\/compare-trials.org\/blog\/are-your-results-unusual-or-how-often-are-outcomes-switched\/\" rel=\"nofollow\" target=\"_blank\">Study 329<\/a> \u662f\u5176\u4e2d\u4e00\u4e2a\u6539\u53d8\u6210\u6548\u6700\u6709\u540d\u7684\u4f8b\u5b50\u3002\u5b83\u662f\u5728\u5317\u7f8e\u7531\u845b\u5170\u7d20\u53f2\u514b\uff08GlaxoSmithKline\uff09\u505a\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u76ee\u7684\u662f\u7814\u7a76\u836f\u7269\u5e15\u7f57\u897f\u6c40\uff08paroxetine\uff09\u5bf9\u6cbb\u7597\u9752\u5c11\u5e74\u7684\u5fe7\u90c1\u75c7\u7684\u6210\u6548\u3002\u8bd5\u9a8c\u7ed3\u679c\u5448\u9633\u6027\uff0c\u6240\u4ee5\u8fd9\u79cd\u836f\u7269\u4e5f\u88ab\u5f88\u591a\u533b\u62a4\u4eba\u5458\u91c7\u7528\uff1a\u5728 2002 \u5e74\uff0c\u7f8e\u56fd\u5171\u8ba1\u5f00\u5904\u65b9 2 \u767e\u4e07\u6b21\u5e15\u7f57\u897f\u6c40\u7ed9\u9752\u5c11\u5e74\u548c\u513f\u7ae5\u3002\u7136\u800c\u90e8\u5206\u7814\u7a76\u5458\u8868\u793a\u8981\u8fdb\u4e00\u6b65\u5173\u6ce8\u8be5\u836f\u7269\u7684\u6210\u6548\uff0c\u8fdb\u4e00\u6b65\u8c03\u67e5\u8bd5\u9a8c\u7684\u8d44\u6599\u540e\u53d1\u73b0\u6210\u6548\u66fe\u88ab\u6539\u53d8\u7684\u8bc1\u636e\u3002\u7814\u7a76\u5458\u53d1\u73b0\u867d\u7136\u8bd5\u9a8c\u9884\u5148\u767b\u8bb0\u4e862\u4e2a\u4e3b\u8981\u6210\u6548\u800c 6 \u4e2a\u6b21\u8981\u6210\u6548\uff0c\u8bd5\u9a8c\u4e5f\u91cf\u5ea6\u4e86\u989d\u5916 19 \u4e2a\u4e0d\u5728\u9884\u5148\u767b\u8bb0\u540d\u5355\u5185\u7684\u6210\u6548\u3002\u5728\u8fd9\u4e9b\u6210\u6548\u4e2d\uff0c\u53ea\u6709 4 \u4e2a\u4e3a\u9633\u6027\uff0c\u4f46\u8bd5\u9a8c\u62a5\u544a\u5374\u628a\u4ed6\u4eec\u5f62\u5bb9\u6210\u597d\u50cf\u662f\u4e3b\u8981\u6210\u6548\u4e00\u6837\uff0c\u800c\u8d1f\u9762\u5f71\u54cd\u5219\u7740\u58a8\u4e0d\u591a\u3002\u7814\u7a76\u5458\u60ca\u5947\u7684\u53d1\u73b0\u5176\u5b9e\u8fd9\u79cd\u836f\u7269\u5bf9\u6cbb\u7597\u5fe7\u90c1\u75c7\u6ca1\u6709\u6210\u6548\uff0c\u4e8b\u5b9e\u4e0a\u53cd\u800c\u4f1a\u589e\u52a0\u81ea\u6740\u7684\u503e\u5411\u3002\u4f9d\u636e\u8fd9\u4e9b\u7ed3\u679c\uff0c\u533b\u62a4\u4eba\u5458\u88ab\u7981\u6b62\u5904\u65b9\u5e15\u7f57\u897f\u6c40\u3002\u5c3d\u7ba1\u8fd9\u79cd\u836f\u7269\u53ea\u5728\u4e00\u4e2a\u7279\u5b9a\u7684\u5730\u533a\u88ab\u5904\u65b9\uff0c\u4f46\u662f\u5f53\u6211\u4eec\u8eab\u5904\u5728\u516c\u5171\u536b\u751f\u5371\u673a\u65f6\uff0c\u7814\u7a76\u6d4b\u8bd5\u6cbb\u7597\u75ab\u75c7\uff0c\u5982\u732a\u6d41\u611f\u548c\u57c3\u535a\u62c9\u75c5\u6bd2\u7684\u836f\u7269\uff0c\u6539\u53d8\u7814\u7a76\u7684\u6210\u6548\u53ef\u4ee5\u5bf9\u56fd\u9645\u95f4\u6709\u5de8\u5927\u5f71\u54cd\u3002<\/p>\n<p>\u56e0\u4e3a\u8bd5\u9a8c\u7ed3\u679c\u53ef\u4ee5\u5e2e\u52a9\u533b\u62a4\u4eba\u5458\u548c\u516c\u4f17\u4f5c\u51fa\u5173\u4e8e\u4ed6\u4eec\u6cbb\u7597\u65b9\u6848\u660e\u667a\u7684\u51b3\u5b9a\uff0c\u4e0d\u540c\u673a\u6784\u5df2\u64b0\u5199\u76f8\u5173\u6307\u5f15\u53bb\u786e\u4fdd\u6240\u6709\u8bd5\u9a8c\u7b26\u5408\u5df2\u6709\u7684\u6807\u51c6\u3002\u4f8b\u5982 <a href=\"https:\/\/www.consort-statement.org\/\" rel=\"nofollow\" target=\"_blank\">CONSORT<\/a>\u00a0\u4e00\u79cd\u7528\u4e8e\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c (Randomized Control Trials, RCTs)\uff0c<a href=\"https:\/\/strobe-statement.org\/\" rel=\"nofollow\" target=\"_blank\">STROBE<\/a> \u662f\u4e3a\u89c2\u5bdf\u6027\u7814\u7a76\u800c\u8bbe\uff0c\u800c <a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/stard\/\" rel=\"nofollow\" target=\"_blank\">STARD<\/a>\u00a0\u5219\u4e3a\u8bca\u65ad\u7814\u7a76\u800c\u8bbe\u3002\u7814\u7a76\u5458\u5e94\u8be5\u8ddf\u968f\u76f8\u5173\u6307\u5f15\uff0c\u800c\u671f\u520a\u5e94\u8be5\u63a5\u53d7\u7b26\u5408\u6307\u5f15\u7684\u6587\u7ae0\u3002\u4f46\u5b9e\u9645\u60c5\u51b5\u662f\u8fd9\u6837\u5417\uff1f 2015 \u5e74 5 \u6708\u5728\u671f\u520a PLOS ONE \u4e0a\u520a\u767b\u7684\u4e00\u7bc7<a href=\"https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0127495\" rel=\"nofollow\" target=\"_blank\">\u6587\u7ae0<\/a>\u5ba1\u6838\u4e86\u5728\u77e5\u540d\u533b\u5b66\u671f\u520a\u4e2d\u53d1\u8868\u7684\u6587\u7ae0\uff0c\u4f5c\u8005\u6bd4\u8f83\u4e86\u8fd9\u4e9b\u7814\u7a76\u4e2d\u767b\u8bb0\u8bb0\u5f55\u548c\u53d1\u8868\u62a5\u544a\u51fa\u73b0\u6539\u53d8\u6210\u6548\u548c\u9009\u62e9\u6027\u62a5\u544a\u7684\u7a0b\u5ea6\u3002\u8be5\u6587\u7684\u4f5c\u8005\u62a5\u544a\u4e86\u5728 6 \u4e2a\u6708\u65f6\u95f4\u4e2d\u51fa\u7248\u7684 137 \u4e2a RCTs\uff0c18% \u8ddf\u4e3b\u8981\u6210\u6548\u6709\u5dee\u5f02\uff0c15% \u6539\u53d8\u4e86\u4e3b\u8981\u6210\u6548\uff0c\u800c64%\u51fa\u73b0\u4e86\u5df2\u767b\u8bb0\u7684\u975e\u4e3b\u8981\u6210\u6548\u548c\u65b0\u589e\u975e\u4e3b\u8981\u6210\u6548\u4e4b\u95f4\u7684\u5dee\u5f02\u3002\u5373\u4f7f\u662f\u5728\u6392\u540d\u8f83\u9ad8\u7684\u671f\u520a\u4e0a\u53d1\u8868\u7684\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u88ab\u4fee\u6539\u5230\u8fd9\u4e2a\u7a0b\u5ea6\u5b9e\u5728\u4ee4\u4eba\u5fe7\u8651\u3002<\/p>\n<p>\u4e0d\u6309\u7167\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5f15\u4f1a\u5e26\u6765\u98ce\u9669\uff0c\u597d\u5728\u4e1a\u5185\u5df2\u7ecf\u6709\u4eba\u52aa\u529b\u53bb\u627e\u51fa\u6539\u53d8\u6210\u6548\u7684\u4e2a\u6848\uff0c\u5e76\u5c1d\u8bd5\u66f4\u6b63\u79d1\u5b66\u8bb0\u5f55\u3002<a href=\"https:\/\/en.wikipedia.org\/wiki\/Centre_for_Evidence-Based_Medicine\" rel=\"nofollow\" target=\"_blank\">\u5faa\u8bc1\u533b\u5b66\u4e2d\u5fc3<\/a>\uff08Centre for Evidence-Based Medicine\uff09\u9ad8\u7ea7\u7814\u7a76\u5458\u66a8 <a href=\"https:\/\/en.wikipedia.org\/wiki\/AllTrials\" rel=\"nofollow\" target=\"_blank\" title=\"AllTrials\">AllTrials<\/a> \u8ba1\u5212\u7684\u521b\u529e\u4eba Ben Goldacre \u53d1\u8d77\u4e86\u4e00\u4e2a\u540d\u4e3a <a href=\"https:\/\/compare-trials.org\/\" rel=\"nofollow\" target=\"_blank\">COMPare Project<\/a> \u7684\u884c\u52a8\u3002\u4ed6\u548c\u4ed6\u7684\u56e2\u961f\u5c1d\u8bd5\u627e\u51fa\u5728\u5df2\u516c\u5e03\u7684\u8bd5\u9a8c\u767b\u8bb0\u8bb0\u5f55\u4e2d\u548c\u7814\u7a76\u62a5\u544a\u7684\u6210\u6548\u4e4b\u95f4\u4e0d\u543b\u5408\u7684\u5730\u65b9\uff0c\u800c\u5f53\u4ed6\u4eec\u5fd9\u4e8e\u8fd9\u9879\u5de5\u4f5c\u65f6\uff0c\u4ed6\u4eec\u4f1a\u5411\u76f8\u5173\u671f\u520a\u70b9\u51fa\u95ee\u9898\u3002\u5230\u73b0\u65f6\u4e3a\u6b62\uff0c\u4ed6\u4eec\u5ba1\u6838\u4e86 67 \u4e2a\u5728\u6392\u540d\u9ad8\u7684\u671f\u520a\u53d1\u8868\u7684\u8bd5\u9a8c\uff1a\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b (New England Journal of Medicine, NEJM)\u3001\u300a\u7f8e\u56fd\u533b\u5b66\u4f1a\u6742\u5fd7\u300b(JAMA)\u3001\u300a\u523a\u80f3\u9488\u300b(Lancet)\u3001\u300a\u82f1\u56fd\u533b\u5b66\u6742\u5fd7\u300b(BMJ) \u548c\u300a\u5185\u79d1\u533b\u5b66\u5e74\u9274\u300b(\u00a0Annals of Internal Medicine)\u3002\u5728\u8fd9 67 \u4e2a\u8bd5\u9a8c\u62a5\u544a\u4e2d\uff0c\u5171\u6709 301 \u4e2a\u9884\u8bbe\u7684\u6210\u6548\u672a\u88ab\u62a5\u544a\uff0c\u800c\u6709 357 \u4e2a\u975e\u9884\u8bbe\u7684\u6210\u6548\u88ab\u52a0\u5165\uff0c\u5374\u7f3a\u4e4f\u4efb\u4f55\u6570\u636e\u652f\u6301\u3002\u5f53 Goldacre \u7684\u56e2\u961f\u63d0\u9192\u671f\u520a\u7f16\u8f91\u5173\u4e8e\u5728\u4ed6\u4eec\u671f\u520a\u4e0a\u5df2\u53d1\u8868\u7684\u6587\u7ae0\u7684\u95ee\u9898\uff0c\u7f16\u8f91\u7684\u53cd\u5e94\u5404\u5f02\u3002\u6709\u4e9b\u7f16\u8f91\u5f88\u5feb\u5c31\u53d1\u8868\u4e86\u4fee\u6b63\u901a\u77e5\uff0c\u6709\u4e9b\u5219\u62b1\u6000\u7591\u6001\u5ea6\uff0c\u751a\u81f3\u4e0d\u7406\u4f1a\u63d0\u9192\u3002\u5c3d\u7ba1 Goldacre \u8d5e\u540c\u5927\u90e8\u5206\u671f\u520a\u90fd\u6709\u51b3\u5fc3\u6539\u5584\u8bd5\u9a8c\u62a5\u544a\u7684\u6807\u51c6\uff0c\u7136\u800c\u57fa\u672c\u4e0a\u6ca1\u6709\u671f\u520a\u6709\u4e25\u683c\u8ddf\u968f\u6807\u51c6\u7684\u65b9\u9488\u3002\u4ed6\u63d0\u5230\uff0c\u300c<a href=\"https:\/\/retractionwatch.com\/2016\/02\/26\/top-journals-give-mixed-response-to-learning-published-trials-didnt-proceed-as-planned\/\" rel=\"nofollow\" target=\"_blank\">\u5bf9\u4e8e\u6253\u51fb\u6539\u53d8\u6210\u6548\u7684\u73b0\u8c61\uff0c\u4f3c\u4e4e\u5b58\u5728\u4e00\u79cd\u5947\u602a\u7684\u6587\u5316\u76f2\u70b9<\/a>\u3002\u300d<\/p>\n<p>\u6539\u53d8\u6210\u6548\u662f\u4e00\u4e2a\u4ee4\u4eba\u5173\u6ce8\u7684\u8bae\u9898\uff0c\u8fd9\u4e2a\u95ee\u9898\u4e5f\u9700\u8981\u6025\u5207\u5904\u7406\u3002\u79d1\u7814\u4f5c\u8005\uff0c\u671f\u520a\u7f16\u8f91\u548c\u8bd5\u9a8c\u8d5e\u52a9\u673a\u6784\u90fd\u5e94\u8be5\u627f\u8bfa\u8ddf\u968f\u62a5\u544a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6700\u4f73\u5b9e\u8df5\u3002\u8003\u8651\u5230\u4ed6\u4eec\u51fa\u7248\u7684\u7ed3\u679c\u5728\u79d1\u5b66\uff0c\u4f26\u7406\u548c\u9053\u5fb7\u65b9\u9762\u7684\u5f71\u54cd\uff0c\u4f5c\u8005\u4eec\u5e94\u8be5\u5728\u62a5\u544a\u8bd5\u9a8c\u8d44\u6599\u65f6\u4fdd\u6301\u900f\u660e\u5ea6\u548c\u51c6\u786e\u5ea6\u3002\u81f3\u4e8e\u671f\u520a\u7f16\u8f91\uff0c\u4ed6\u4eec\u5e94\u8be5\u79ef\u6781\u5f80\u786e\u4fdd\u4f5c\u8005\u8ddf\u4ece\u6307\u5f15\u7684\u65b9\u5411\u52aa\u529b\u5e76\u5728\u53d1\u73b0\u5dee\u5f02\u65f6\u4f5c\u51fa\u5b9e\u9645\u884c\u52a8 \u2014 \u53d1\u8868\u66f4\u6b63\u6216\u64a4\u56de\u6587\u7ae0\u7684\u901a\u77e5 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