国内期刊中药临床试验安全性报告分析

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (1): 20-24.

国内期刊中药临床试验安全性报告分析

李迅¹, 李昕雪¹, 刘智君¹, 马立新¹, 刘建平^1,2*

1北京中医药大学循证医学中心,北京 100029;
2特罗瑟姆大学挪威国家补充与替代医学研究中心,挪威特罗瑟姆 9037

收稿日期:2016-02-18 修回日期:2016-02-18 出版日期:2010-01-08 发布日期:2016-02-18
通讯作者: *通讯作者：刘建平,男,教授,循证医学在中医临床评价中的应用。
作者简介:李迅,女,在读硕士研究生,循证医学在中医药临床疗效中的评价。

Analysis of Safety Reporting in Clinical Trials on Herbal Medicine Published in Chinese Journals

LI Xun¹, LI Xin-xue¹, LIU Zhi-jun¹, MA Li-xin¹, LIU Jian-ping^1,2,*

1Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China;
2National Research Center in Complementary and Alternative Medicine(NAFKAM), University of Tromso, Tromso 9037, Norway

Received:2016-02-18 Revised:2016-02-18 Online:2010-01-08 Published:2016-02-18

摘要/Abstract

摘要： 目的对2005~2009年中药随机对照临床试验中安全性报告的情况进行评价,并与既往的分析结果进行对比,观察报告现状是否改善。方法检索《中医杂志》、《福建中医药》、《成都中医药大学学报》近5年刊登的有关中药的随机对照试验,对每一篇临床试验文章的方法、结果和讨论部分分别提取涉及中药安全性报告相关的信息和数据。结果近5年,3种期刊药物临床试验的文章中,分别只有37%（204/550篇）、38%（140/364篇）和38%（29/76篇）对安全性进行了报告,从数量和报告的质量上与以往15年（跨度25年）的40%（354/879篇）、38%（173/452篇）和33%（40/123篇）相比并没有明显改善。结论中药安全性在临床试验报告中重视不够,需要进行规范的测量、分析和报告。

关键词: 中药, 临床试验, 安全性, 期刊, 报告

Abstract: Objective To evaluate the safety reporting in randomized clinical trials（RCT） on Chinese herbal medicine published between 2005 to 2009 and compare with the previous Results to find out whether there is any improve-ment. Methods Searched Journal of Traditional Chinese Medicine, Fujian Journal of Traditional Chinese Medicine and Journal of Chengdu University of Chinese Medicine for all the RCTs on herbal meidicne published in the recent 5 years, extracted data about safety reporting in method, result and discussion. Results In the three journals reviewed, only 37%（204/550）、38%（140/364）and 38%（29/76）respectively reported safety data, which did not demonstrate im-provement compared with the previous data from 15 years （over arching 25 years in total） as 40%（354/879）, 38%（173/452）, and 33%（40/123）, respectively. Conclusion The awareness of safety observation and reporting in herbal trials is still far away from their sufficient reporting.

Key words: Chinese herbal medicine, clinical trial, safety, Chinese journals, reporting

中图分类号:

R286

李迅, 李昕雪, 刘智君, 马立新, 刘建平. 国内期刊中药临床试验安全性报告分析[J]. 中国药物警戒, 2010, 7(1): 20-24.

LI Xun, LI Xin-xue, LIU Zhi-jun, MA Li-xin, LIU Jian-ping. Analysis of Safety Reporting in Clinical Trials on Herbal Medicine Published in Chinese Journals[J]. Chinese Journal of Pharmacovigilance, 2010, 7(1): 20-24.

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