国际Cochrane协作网有关药品安全性评价的证据概括

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (4): 208-210.

国际Cochrane协作网有关药品安全性评价的证据概括

夏芸¹, 李昕雪¹, 刘建平^1,2*

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

收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-04-08 发布日期:2016-02-19
通讯作者: 刘建平,男,研究生导师,循证中医药临床研究。Email: jianping_liu@fagmed.uit.no
作者简介:夏芸,女,在读博士研究生,循证医学在中医临床评价中的应用。

The Evidence Summary of Drug Safety Evaluation in the Cochrane Collaboration

XIA Yun¹, LI Xin-xue¹, 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:2016-02-19 Revised:2016-02-19 Online:2010-04-08 Published:2016-02-19

摘要/Abstract

摘要： 目的对当前可获得的Cochrane协作网有关药品安全性评价的证据进行概括。方法电子检索Cochrane图书馆（光盘版）2009年第3期。检索词包括“药品不良反应”和“药品安全性”。结果与结论检索结果涉及Cochrane系统评价、非Cochrane系统评价、临床试验、方法学研究、技术评估和经济学评价六个方面的文章,药品安全性的评价主要与疗效评价同期进行,目前Cochrane协作网尚无专门评价药品安全性的系统评价。

关键词: Cochrane协作网, 药品安全性, 评价, 证据, 概括

Abstract: Objective To summarize the evidence related to drug safety available from the Cochrane Collaboration. Methods Electronic searching on the Cochrane Library(2009 Issue 3), the searching terms included adverse drug reaction and drug safety. Results ＆Condusion Articles related to 6 aspects including Cochrane systematic review, abstracts of non-Cochrane systematic review, clinical trials, methodological study, health technology assessment and economical evaluation, respectively, were reviewed. The safety was evaluated along with efficacy or effectiveness of drugs. Currently, there has been no specific systematic review focusing on drug safety in the Cochrane Collaboration.

Key words: The Cochrane Collaboration, drug safety, evaluation, evidence, summary

中图分类号:

R954

夏芸, 李昕雪, 刘建平. 国际Cochrane协作网有关药品安全性评价的证据概括[J]. 中国药物警戒, 2010, 7(4): 208-210.

XIA Yun, LI Xin-xue, LIU Jian-ping. The Evidence Summary of Drug Safety Evaluation in the Cochrane Collaboration[J]. Chinese Journal of Pharmacovigilance, 2010, 7(4): 208-210.

参考文献

[1] http://www.interscience.wiley.com/cgi-bin/mrwhome/106568753/home.
[2] http://www.mrw.interscience.wiley.com/cochrane/cochrane_clabout_contents_fs.html .
[3] Loke Y K, Price D, Herxheimer A. Chapter 14: Adverse effects. In: Higgins JPT, Green S(editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1(updated September 2008)[S]. The Cochrane Collaboration, 2008.
[4] Zhang W Y. Evidence from case-control and cohort studies for adverse drug reaction - a case study of analgesic nephropathy[R].9th Annual Cochrane Colloquium Abstracts, 2001.
[5] Golder S, Loke Y, McIntosh H. Going beyond MEDLINE - what information might reviewers find from searching databases of adverse drug reactions?[J].XIV Cochrane Colloquium, 2006, 10: 23-26;Dublin, Ireland. 2006,44.
[6] Nilsson BS. Evaluation of methods for recording adverse drug reactions in clinical trials[J]. European Journal of Clinical Microbio-logy & Infectious Disease, 1990,89(7):534-536.
[7] Wallin J, Sjovall J. Detection of adverse drug reactions in a clinical trial using two types of questioning [J]. Clinical Therapeutics, 1981,3(6):450-452.
[8] Agbabiaka T B, Savovic J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review[J]. Drug safety, 2008,31(1):21-37.
[9] Aronson J K, Derry S, Loke Y K. Adverse drug reactions: keeping up to date[J]. Fundamental & Clinical Pharmacology, 2002,16(1):49-56.
[10] Venulet J, Blattner R, Von Bulow J, et al. How good are articles on adverse drug reactions?[J]BMJ,1982,284(6311):252-254.
[11] Loke Y K, Price D, Derry S, et al. Case reports of suspected adverse drug reactions-systematic literature survey of followup[J]. BMJ, 2006,332(7573):335-339.
[12] Hazell L, Shakir S A. Under-reporting of adverse drug reactions: a systematic review[J]. Drug Safety, 2006,29(5):385-396.

[1]	贾茵茵, 张财树, 周颖, 刘丽, 耿颖, 魏宁漪, 钮思静, 陈华, 许卉. 吸入制剂微细粒子空气动力学粒径分布评价方法研究[J]. 中国药物警戒, 2024, 21(2): 141-146.
[2]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[3]	张建, 方慧华. 某院活血化瘀类中药注射剂使用评价标准建立的探索[J]. 中国药物警戒, 2024, 21(2): 185-189.
[4]	詹姆斯·布坎南. 用 nR 改良海氏法则及 P_ALT 评估药物性肝损伤研究进展[J]. 中国药物警戒, 2024, 21(1): 117-120.
[5]	王然, 李轶凡, 刘小艳, 冯欣. 1例妊娠期药物暴露风险的药学监护[J]. 中国药物警戒, 2023, 20(8): 933-934.
[6]	张蕾, 吕健, 谢雁鸣. 厚朴排气合剂治疗术后早期肠麻痹有效性和安全性的Meta分析[J]. 中国药物警戒, 2023, 20(7): 799-806.
[7]	陈婕, 秦侃. 肠外营养个体化给药实践评价[J]. 中国药物警戒, 2023, 20(7): 812-816.
[8]	潘喆敏, 徐圣, 郑轶, 陈晨鑫, 刘永梅, 张朋朋, 叶小飞, 贺佳. 上市后不良反应评价中似然比检验方法的比较[J]. 中国药物警戒, 2023, 20(6): 655-660.
[9]	于乐成, 郝坤艳, 范晔. 中草药肝损伤的临床诊断[J]. 中国药物警戒, 2023, 20(5): 481-488.
[10]	聂晓璐, 唐少文, 喻锦扬, 宋海波, 符祝, 孙凤. 药品风险最小化评价研究报告规范解读[J]. 中国药物警戒, 2023, 20(5): 524-529.
[11]	岳小林, 鲁松, 张兰. 药品临床综合评价体系建设研究[J]. 中国药物警戒, 2023, 20(5): 530-535.
[12]	成冯镜茗, 吕健, 谢雁鸣. 复方丹参喷雾剂/气雾剂治疗冠心病心绞痛有效性与安全性的Meta分析[J]. 中国药物警戒, 2023, 20(5): 536-543.
[13]	刘欢, 袁慧, 尹晶晶, 刘梦雅, 秦秀军, 李建国. 薏芽健脾凝胶幼龄大鼠的一般毒理学研究[J]. 中国药物警戒, 2023, 20(4): 416-422.
[14]	苏鑫鑫, 吕健, 谢雁鸣. 头痛宁胶囊治疗慢性头痛的有效性及安全性Meta分析[J]. 中国药物警戒, 2023, 20(4): 433-440.
[15]	刘静, 刘燕, 郑笑为, 汪祺, 何风艳, 王菲菲, 王亚丹, 何轶, 聂黎行, 胡晓茹, 戴忠, 马双成. 基于国家药品抽检的骨刺片质量分析[J]. 中国药物警戒, 2023, 20(3): 292-295.