摘要
目的:通过对阿奇霉素不良反应(ADR)信号进行挖掘和评价,为临床安全使用阿奇霉素提供参考与指导。方法:对烟台市药品不良反应数据库收集的阿奇霉素ADR的病例报告进行数据清洗、统计,通过报告比值比(ROR)法挖掘出与阿奇霉素相关的ADR信号,并对ADR信号进行分析与评价。结果:共提取出以阿奇霉素为怀疑药物的报告数为1146份,分类并数据清洗后共得1555例次ADR。按照系统器官分类(SOC)的阿奇霉素ADR共涉及8个系统或器官,数量较多的有胃肠系统损害(1036例次)、皮肤及其附件损害(223例次)、用药部位损害(95例次)、全身性损害(83例次)。ROR法挖掘出阿奇霉素的ADR信号11个,分别是腹泻、疼痛、恶心、腹胀、血管炎、呕吐、胃肠道反应、厌食、注射部位疼痛、哭闹、腹部疼痛,其中血管炎和哭闹在说明书中未具体说明。结论:通过对数据库中阿奇霉素ADR进行信号挖掘与分析,为降低临床用药风险提供借鉴。
Objective:To provide reference and guidance for the rational use of azithromycin by excavating and evaluating the adverse reaction signals of azithromycin.Methods:Data cleaning and statistics were performed on the case report of azithromycin adverse reactions collected by the spontaneous reporting system of adverse reactions in Yantai.Reporting odds ratio(ROR)method was used to detect adverse reactions related to azithromycin,and analyzing and evaluating the adverse reaction signals.Results:A total of 1146 suspected reports of azithromycin were extracted from the statistical data,and 1555 adverse reactions were recorded after classifying and cleaning the data.According to the system organ classification(SOC),azithromycin adverse reactions involve a total of 8 systems or organs.There were 1036 cases of stomach and intestines damage,223 cases of skin and its appendages disorders,95 cases of drug site damage and 83 cases of systemic damage.Eleven adverse reaction signals of azithromycin were detected by ROR method,including diarrhea,pain,nausea,abdominal distention,vasculitis,vomiting,gastrointestinal reaction,anorexia,pain at injection site,crying and abdominal pain.Vasculitis and crying were not specified in the instructions.Conclusion:Signal mining and analysis of azithromycin adverse reactions in the database can reduce the risk of clinical use of drugs.
作者
冷维萍
李硕硕
丁月霞
唐启令
Leng Weiping;Li Shuoshuo;Ding Yuexia;Tang Qiling(Department of Pharmacy,Yantaishan Hospital,Yantai 264001,Shandong,China;School of Pharmacy,Yantai University;Department of Pharmacy,Yantai Yuhuangding Hospital)
出处
《药物流行病学杂志》
CAS
2020年第3期170-173,共4页
Chinese Journal of Pharmacoepidemiology
关键词
阿奇霉素
数据清洗
药品不良反应
信号挖掘
药物警戒
Azithromycin
Data cleaning
Adverse drug reactions
Signal mining
Pharmacovigilance
作者简介
通讯作者:唐启令,Tel:13791205166,E-mail:yttql@163.com
