中药复方临床随机对照试验报告规范2017: CONSORT声明的扩展、说明与详述(附全文下载)

2017-07-07 MedSci MedSci原创

2017年6月27日是一个值得纪念的日子。中医方剂随机对照试验报告国际标准当日通过美国《内科学年鉴》正式向全球发布，以简体中文、繁体中文、英文三种文字同期发表，并配发编者社论。该标准历时十年余，由中国、加拿大、英国学者组成的国际核心团队共同完成，包括香港浸会大学协理副校长、中医药学院临床部主任、我分会副会长卞兆祥教授，四川大学华西医院、我分会顾问李幼平教授、吴泰相副教授，北京中医药大学东直门医院、

2017年6月27日是一个值得纪念的日子。中医方剂随机对照试验报告国际标准当日通过美国《内科学年鉴》正式向全球发布，以简体中文、繁体中文、英文三种文字同期发表，并配发编者社论。该标准历时十年余，由中国、加拿大、英国学者组成的国际核心团队共同完成，包括香港浸会大学协理副校长、中医药学院临床部主任、我分会副会长卞兆祥教授，四川大学华西医院、我分会顾问李幼平教授、吴泰相副教授，北京中医药大学东直门医院、我分会创会会长商洪才研究员，香港浸会大学中医药学院临床部郑颂华医生，以及CONSORT学术组织创始人David Moher教授和Doug Altman教授。该国际标准的制定将提高中医方剂随机对照临床试验的报告质量，提升中医药临床研究的国际认可度。

CONSORT CHM formula 2017是在CONSORT声明的基础上，加入了中医药的核心元素“证”和中医方剂质量控制的具体內容而制定；期望可向国内外的中医药研究人员、同行审议员和期刊编辑等目标读者推广使用，切实改善中医方剂临床试验报告的质量，以及对其研究设计和实施方法等有积极的影响。这也是《内科学年鉴》自1927年创刊以來，首次以英文、中文繁体和简体版同时发表一个研究类文章，说明国际医学界对中医药研究的重视。

中药复方是传统中医药(TCM)临床治疗最主要的形式，但临床试验报告的统一标准(Consolidated Standards of Reporting Trials, CONSORT)声明(简称CONSORT声明)及其草药及针刺的扩展版，均未能有效提升中药复方临床随机对照试验报告的质量。由中医药临床专家、方法学家、流行病学家和医学期刊编辑组成的工作组，草拟并发表了报告规范初稿，经广泛征求意见及修订后，制订了中药复方临床试验报告的统一标准 (CONSORT–CHM Formulas)(下称CONSORT–中药复方)。

CONSORT–中药复方是在CONSORT 2010声明的基础上，加入中医证候和针对中药复方特点的条目内容，新增了1项子条目“关键词”，便于中药复方临床试验报告的索引及文献检索，并对其中7项条目的内容进行扩展，包括文题和摘要、背景和目的、受试者、干预措施、结局指标、可推广性和解释, 另针对中药复方的危害说明进行了修改，同时提供了报告实例和详尽的解说。工作组希望借着CONSORT–中药复方 2017的出版，能够改善中药复方临床随机对照试验的报告质量。

临床研究分会期待相关领域的专家学者，在推广使用CONSORT CHM formula 2017的同时，切实提升中医方剂临床研究的水平，共同提高中医方剂临床研究的价值。

报告规范中文版下载：中药复方临床随机对照试验报告规范2017: CONSORT声明的扩展、说明与详述

原始出处：
Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017 Jun 27. doi: 10.7326/M16-2977

Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version). Ann Intern Med. 2017 Jun 27. doi: 10.7326/IsTranslatedFrom_M17-2977_2

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2018-01-04 amyloid

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2017-12-19 般若傻瓜

#对照试验#

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encodeId=a5712194242d, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Fri Jul 07 08:22:42 CST 2017, time=2017-07-07, status=1, ipAttribution=)]
2017-07-08 tomyang91

#CONSORT#

59 0
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beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Jul 07 18:20:52 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219558, encodeId=4cbc2195588c, content=厉害了, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Fri Jul 07 16:00:55 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219424, 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2017-07-08 tomyang91

#CONSORT#

80 0
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beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Jul 07 18:20:52 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219558, encodeId=4cbc2195588c, content=厉害了, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Fri Jul 07 16:00:55 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219424, encodeId=a5712194242d, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Fri Jul 07 08:22:42 CST 2017, time=2017-07-07, status=1, ipAttribution=)]
2017-07-08 lisa438

#随机对照试验#

66 0
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beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Jul 07 18:20:52 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219558, encodeId=4cbc2195588c, content=厉害了, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Fri Jul 07 16:00:55 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219424, encodeId=a5712194242d, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Fri Jul 07 08:22:42 CST 2017, time=2017-07-07, status=1, ipAttribution=)]
2017-07-08 mhm289

#报告规范#

90 0
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2017-07-08 lou.minghong

"证"怎么加入呢？

109 0
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2017-07-07 131****1460

学习了受益匪浅

137 0
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2017-07-07 天地飞扬

厉害了

137 0
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beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Fri Jul 07 18:20:52 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219558, encodeId=4cbc2195588c, content=厉害了, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Fri Jul 07 16:00:55 CST 2017, time=2017-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=219424, encodeId=a5712194242d, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Fri Jul 07 08:22:42 CST 2017, time=2017-07-07, status=1, ipAttribution=)]
2017-07-07 龙胆草

学习谢谢分享

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