国内药物不良反应信号检测文献研究设计问题的调查和分析  

Investigation and analysis on research design problems in adverse drug reaction signal detection study in China

作　　者：戴睿 张青霞[3] 胡扬[1] 王焕玲 赵彬[1] 合理用药国际网络中国中心组临床安全用药组 Dai Rui;Zhang Qingxia;Hu Yang;Wang Huanling;Zhao Bin;Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs(Department of Pharmacy,Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences,Beijing 100730,China;Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Pharmacy,Xuanwu Hospital,Capital Medical University,National Clinical Research Center for Geriatric Disease,Beijing 100053,China;不详)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [2]中国医学科学院北京协和医学院北京协和医院临床药理研究中心,北京100730 [3]首都医科大学宣武医院药学部,国家老年疾病临床医学研究中心,北京100053 [4]不详

出　　处：《药物不良反应杂志》2023年第8期475-481,共7页Adverse Drug Reactions Journal

基　　金：北京协和医院中央高水平医院临床科研专项(2022⁃PUMCH⁃B⁃058);中国药学会医院药学专业委员会人才专项资助项目(CPA⁃Z05⁃ZC⁃2022⁃003)。

摘　　要：目的了解我国当前药物不良反应(ADR)信号检测研究设计的现状及相关问题。方法检索中国生物医学文献服务系统、中国知网、万方医学和维普网关于ADR信号检测类研究的文献(截至2022年5月30日)。对文献的研究目的、研究方向(目标药物、目标ADR)、信号来源数据库、目标药物角色及对照药物、信号检测算法和偏倚控制等问题逐条进行描述性分析。结果共纳入165篇文献,146篇(88.5%)文献发表在核心期刊;2013至2022年(2022年1~5月)分别发表4、3、2、7、8、11、20、29、55和26篇。6.7%(11/165)的文献研究目的不明确,80.6%(133/165)目标ADR选择为非针对性,国内数据库利用较少[9.7%(16/165)],33.9%(56/165)未提及目标药物角色的选择范围,36.4%(60/165)仅采用单一算法进行信号检测,85.5%(141/165)未进行偏倚分析。结论国内已发表的ADR信号检测文献在研究设计方面存在研究目的和方向不明确、研究项目不全面等规范性欠佳问题。我国学者应在加强ADR信号检测研究的同时,进一步提高研究设计的质量。Objective To understand the current situation and problems of research design in adverse drug reaction(ADR)signal detection study in China.Methods The literature on ADR signal detection study in SinoMed,CNKI,WanFang Data and VIP databases were retrieved(up to May 30,2022).The research purpose,research direction(target drug,target ADR),source database of signals,target drug role,reference drug,signal detection algorithm,and bias control of the literature were analyzed descriptively one by one.Results A total of 165 articles were included,of which 146(88.5%)were published in core journals.From 2013 to 2022(January to May,2022),there were 4,3,2,7,8,11,20,29,55,and 26 rele⁃vant articles,respectively.Problems in these studies were as follows:research purposes were not clear in 6.7%(11/165)of the literature;target ADRs were selected as non targeted in 80.6%(133/165)of the literature;the domestic database was less utilized[only 9.7%(16/165)];did the selection range of the target drug role were not mentioned in 33.9%(56/165)of the literature;only a single algorithm for signal detection was used in 36.4%(60/165)of the literature;bias analysis was not conducted in 85.5%(141/165)of the litera⁃ture.Conclusions The domestic literature on ADR signal detection has problems of poor standardiza⁃tion in research design,such as unclear research purpose and direction,incomplete research items,etc.Chinese scholars should further improve the quality of research design while strengthening the research on ADR signal detection.

关 键 词：药物警戒 药物相关副作用和不良反应 药物不良反应报告系统 信号检测 评价性研究 研究设计 

分 类 号：R95[医药卫生—药学]