药品不良反应信号检测中的Meta分析

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (3): 148-150.

• 药品不良反应信号检测 • 上一篇下一篇

药品不良反应信号检测中的Meta分析

叶小飞, 钱维, 贺佳^*

第二军医大学卫勤系卫生统计学教研室,上海 200433

收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-03-08 发布日期:2016-02-19
通讯作者: 贺佳,女,博士生导师,药物流行病学与新药评价的统计分析。E-mail：hejia@smmu.edu.cn
作者简介:叶小飞,男,在读博士研究生,药物流行病学。
基金资助:
国家自然科学基金资助项目(No.30872186),上海市优秀学科带头人计划(A类)(No.09XD1405500)

Application of Meta-analysis in the Adverse Drug Reaction Signal Detection

YE Xiao-fei, QIAN Wei, HE Jia^*

Department of Health Statistics, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China

Received:2016-02-19 Revised:2016-02-19 Online:2010-03-08 Published:2016-02-19

摘要/Abstract

摘要： Meta分析是系统综述中数据的定量统计分析方法,目前已涌现出一些关于Meta分析在药物流行病学中的研究,Meta分析应用于药品不良反应有其独特优势。通过介绍Meta分析的概念、研究步骤,结合噻唑烷二酮类药物引起的心血管事件、药品不良反应发生率及种族差异间的Meta分析实例,指出在药品不良反应信号检测的Meta分析时,应注意灵敏度分析、亚组分析及选择正确的模型。

关键词: meta分析, 药品不良反应

Abstract: Meta-analysis is a statistical technique for summarizing previous quantitative research with its unique advan-tages. In this article we gave a brief introduction about the concept, steps about meta-analysis. And also illustrated several examples including cardiovascular events caused by TZDs, the incidence of adverse drug reactions(ADR) in hospitalized patients and ethnic differences in risks of adverse reactions. In addition, we also suggested that sensitive analysis, sub-group analysis and model selection should not be ignored while applying Meta-analysis in ADR signal detection.

Key words: Meta-analysis, adverse drug reaction(ADR)

中图分类号:

叶小飞, 钱维, 贺佳. 药品不良反应信号检测中的Meta分析[J]. 中国药物警戒, 2010, 7(3): 148-150.

YE Xiao-fei, QIAN Wei, HE Jia. Application of Meta-analysis in the Adverse Drug Reaction Signal Detection[J]. Chinese Journal of Pharmacovigilance, 2010, 7(3): 148-150.

参考文献

[1] 周文.药物流行病学[M].1版.北京:人民卫生出版社,2007:7-8.
[2] 詹思延.药物流行病学研究新方法概述-药物流行病学研究新方法系列讲座（一）[J].中国药物应用与监测,2009;6(1):59-62.
[3] 闫永平,陈薇.临床流行病学[M].1版.北京:人民卫生出版社,2009:245.
[4] Lago R M, Singh P P, Nesto R W. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials[J]. Lancet, 2007, 370(9593): 1129-1136.
[5] Singh S, Loke Y K, Furberg C D. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis[J]. JAMA, 2007, 298(10): 1189-1195.
[6] Nissen S E, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes[J]. N Engl J Med, 2007;356(24): 2457-2471.
[7] 中华医学会糖尿病学分会,中华医学会内分泌学分会.中华糖尿病学分会内分泌学分会:关于文迪雅心脏安全性的联合共识[EB/OL]. 2008-5-17 [2009-12-28]. http://www. diab. net.cn / news_show.jsp?id=24.html.
[8] Home P D, Pocock S J, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial [J]. Lancet, 2009, 373(9681):2125-2135.
[9] Loke Y K, Singh S, Furberg C D. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis[J]. CMAJ, 2009, 180(1): 32-39.
[10] Lazarou J, Pomeranz B H, Corey P N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies[J]. JAMA, 1998, 279(15): 1200-1205.
[11] McDowell S E, Coleman J J, Ferner R E. Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine[J]. BMJ, 2006, 332(7551):1177-1181.
[12] Hernandez A V, Walker E, Ioannidis J P, et al. Challenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazone[J]. Am Heart J, 2008,
156(1):23-30.
[13] Rucker G, Schumacher M. Simpson's paradox visualized: the example of the rosiglitazone meta-analysis[J]. BMC Med Res Meth- odol, 2008,8:34.
[14] Shuster J J, Jones L S, Salmon D A. Fixed vs random effects meta-analysis in rare event studies: the rosiglitazone link with myocardial infarction and cardiac death [J]. Stat Med, 2007, 26(24):4375-4385.
[15] Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement[J]. J Clin Epidemiol, 2009,62(10):1006-1012.
[16] Papanikolaou P N, Ioannidis J P. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials[J]. Am J Med, 2004, 117(8):582-589.
[17] Ioannidis J P, Evans S J, Gotzsche 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.

药品不良反应信号检测中的Meta分析

Application of Meta-analysis in the Adverse Drug Reaction Signal Detection

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	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.
[2]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[3]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[4]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[5]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[6]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[7]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[8]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[9]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[10]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.
[11]	陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明. 326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析[J]. 中国药物警戒, 2024, 21(1): 107-110.
[12]	刘赛月, 吕小琴, 周耘. 疑似药品不良反应死亡病例调查及报告实施要点[J]. 中国药物警戒, 2023, 20(9): 971-974.
[13]	里筱竹, 王蔷, 逄瑜, 张轶菁. 个例药品不良反应报告管理浅析与思考[J]. 中国药物警戒, 2023, 20(9): 975-977.
[14]	逄瑜, 刘博, 吕少俐, 王涛, 邢颖, 秦星宇, 田月洁, 吴文宇. 基于国际药物警戒经验探讨收集患者报告的意义[J]. 中国药物警戒, 2023, 20(9): 978-981.
[15]	刘文东, 崔欢欢, 王晓晗, 苏娴, 王海学. 我国儿童用药临床试验期间药物警戒监管体系现状及思考[J]. 中国药物警戒, 2023, 20(9): 1002-1006.