期刊文献+

对几种中医药期刊发表的中药临床试验中副反应报告的评价 被引量:2

下载PDF
导出
摘要 目的对中药临床试验中副反应报告的情况进行评价,以期改进中药临床试验安全性的报告。方法手工检索《中医杂志》、《福建中医药》、《成都中医药大学学报》1980~2004年期间3个五年刊登的有关中药的随机对照试验和对照临床试验文章。对每篇临床试验文章的方法、结果和讨论部分分别提取相关的数据。结果15年间(跨度25年)3种期刊中药临床试验的文章中,分别只有40%(354/879篇)、38%(173/452篇)和33%(40/123篇)对副反应进行了报告,其质量和数量虽呈上升趋势,依然存在报告不充分、不规范的问题,所下结论证据不足。结论中药临床试验报告对安全性观察和报告重视不够,对规范报告副反应提出了相应建议。
出处 《中医杂志》 CSCD 北大核心 2007年第9期791-793,共3页 Journal of Traditional Chinese Medicine
基金 国家重点基础研究发展计划资助(2006CB504602)
  • 引文网络
  • 相关文献

参考文献8

  • 1The CONSORT Statement:Revised recommendations for improving the quality of reports of parallel-group randomized trials.[2007-07-31].http://www.consort-statement.org/Statement/jama.pdf.
  • 2International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Definitions and terminology associated with clinical safety experience.ICH Street Committee,1994-10-27[2006-12-10].http://www.ccchina.net/article.asp? articleid=286.
  • 3Brief Introduction to Journal of Traditional Chinese Medicine[2006-12-10].http://www.jtcm.net.cn/include.asp.
  • 4Ioannidis JP,Lau J.Completeness of safety reporting in randomized trials:an evaluation of 7 medical areas.JAMA,2001,285(4):437-443.
  • 5Papanikolaou PN,Churchill R,Wahlbeck K,et al.Safety reporting in randomized trials of mental health interventions.Am J Psychiatry,2004,161(9):1692-1697.
  • 6Derry S,Loke YK,Aronson JK.Incomplete evidence:the inadequacy of databases in tracing published adverse drug reactions in clinical trials.BMC Med Res Methodol,2001,1:7.
  • 7Loke YK,Derry S.Reporting of adverse drug reactions in randomised controlled trials-a systematic survey.BMC Clin Pharmacol,2001,1:3.
  • 8Good Clinical Practice.http://www3.interscience.wiley.com/cgi-bin/homepage/?isbn=0470842520.

同被引文献21

  • 1魏建江.从中药不良反应的客观性探讨建立药物警戒系统[J].中国现代药物应用,2009,3(4):190-191. 被引量:3
  • 2EDWARS JE, MCOUAY HJ, MOORE RA, et al. Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain [ J ]. J Pain Symptom Manage, 1999,18:427 - 437.
  • 3IOANNIDIS JPA, LAU J. Completeness of safety reporting in randomized Trials - an evaluation of seven medical areas [J]. J Am Med Assoc,2001, 285:437 -443.
  • 4DERRY S, LOKE YK, ARONSON JK. Incomplete evidence : the inadequacy of databases in tracing published ad- verse drug reactions in clinical trials [ J ]. BMC Med Res Methodol, 2001,1:7.
  • 5LOKE YK, DERRY S. Reporting of adverse drug reactions in randomised controlled trials - a systematic survey [ J ]. BMC Clin Pharmacol, 2001, 1:3.
  • 6JOEL J GAGNIER, HEATHER Boon, PAULA Rochon, et al. For the CONSORT Group. Reporting Randomized, Controlled Trials of Herbal Interventions:An Elaborated CONSORT Statement[ J]. Ann Intern Med,2006,144:36 - 38.
  • 7JOHN P A, STEPHEN J W, EVANS P C, et al. Better Reporting of Harms in Randomized Trials : An Extension of the CONSORT Statement [ J ]. Ann Intern Med, 2004,141 : 781 - 788.
  • 8Moher D, Schulz K F, Altman D G. CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. J Am Podiatr Med Assoc, 2001 Sep,91(8):437-442.
  • 9Ioannidis J P, Evans S J , Gotzsehe P C, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement[J]. Ann Intern Med,2004,141(10):781-788.
  • 10ICH Street Committee. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Definitions and term inology associated w ith clinical safety experience[EB/OL]. 1994-10-27[2009-12-12]. http://www. ccchina.net/article.asp?articleid=286.

引证文献2

二级引证文献18

;
使用帮助 返回顶部