基于上海市临床药事质量控制中心数据库的药物心脏毒性不良反应信号挖掘研究  

Signal Mining of Cardiotoxic Drug Adverse Reactions Based on Shanghai Quality Control Center of Hospital Pharmaceutical Administration Database

作　　者：颜明明[1] 郑晗 吴舒珊 张千 邱晓燕[1] Yan Mingming;Zheng Han;Wu Shushan;Zhang Qian;Qiu Xiaoyan(Huashan Hospital,Fudan University,Shanghai 200040,China;College of Pharmacy,University of Nebraska Medical Center)

机构地区：[1]复旦大学附属华山医院,上海200040 [2]内布拉斯加大学医学中心药学院

出　　处：《药物流行病学杂志》2022年第5期309-313,共5页Chinese Journal of Pharmacoepidemiology

基　　金：上海市2019年度“科技创新行动计划”软科学研究领域重点项目(编号:19692107000);上海市优秀青年临床药师培养计划(编号:201801-202012);上海市“医苑新星”青年医学人才培养资助计划-临床药师项目[编号:沪卫人事(2021)99]。

摘　　要：目的:采用报告比值比(ROR)法对药品不良反应(ADR)信号进行监测,挖掘可能的心脏毒性药物信号。方法:采用上海市临床药事质量控制中心数据库中2018年上海市44家医疗机构报告的ADR数据共13911条,按照数据挖掘一般步骤进行数据处理,采用ROR法对ADR数据的心脏毒性药物信号进行挖掘,计算不同药物心脏毒性风险的粗ROR值及其95%置信区间(CI),并计算性别、年龄校正后的ROR值及其95%CI。结果:共挖掘出6个潜在的心脏毒性风险药物信号:阿利沙坦酯[校正ROR=98.64,95%CI(10.22,952.13)]、氨溴索[校正ROR=6.78,95%CI(2.80,16.41)]、消癌平注射液[校正ROR=6.37,95%CI(1.84,21.99)]、间苯三酚[校正ROR=5.85,95%CI(1.71,20.04)]、碳酸锂[校正ROR=3.64,95%CI(1.10,12.07)]、丙戊酸[校正ROR=2.99,95%CI(1.37,6.54)]。年龄对目标ADR发生的影响有统计学意义(P=0.021)。结论:阿利沙坦酯、氨溴索、消癌平注射液、间苯三酚、碳酸锂、丙戊酸可能与心脏毒性的风险相关,信号的可信度和强弱易受混杂因素、数据量大小的影响,该信号还需要进一步临床研究予以证实。Objective:To detect signals of potentially cardiotoxic drugs in the database of adverse drug reactions(ADR)through the method of reporting odds ratio(ROR).Methods:A total of 13911 ADR reports in 2018 were extracted from Shanghai Quality Control Center of Hospital Pharmaceutical Administration database.The concept of ROR,a conventional data mining method,was empolyed to calculate the crude ROR with 95%confidence interval(CI),and the ROR adjusted by age and gender with 95%CI,in order to mining the cardiotoxic drug signals.Results:Six signals of drugs that potentially caused heart damage were detected:allisartanisoproxil(adjusted ROR=98.64,95%CI 10.22 to 952.13),ambroxol(adjusted ROR=6.78,95%CI 2.80 to 16.41),Xiaoaiping injection(adjusted ROR=6.37,95%CI 1.84 to 21.99),phloroglucinol(adjusted ROR=5.85,95%CI 1.71 to 20.04),lithium carbonate(adjusted ROR=3.64,95%CI 1.10 to 12.07),valproic acid(adjusted ROR=2.99,95%CI 1.37 to 6.54).Age had significant influence on the incidence of target ADR(P=0.021).Conclusion:Allisartanisoproxil,ambroxol,Xiaoaiping injection,phloroglucinol,lithium carbonate,and valproic acid may be associated with the risk of cardiotoxicity.Although other existing confounding factors and the limited number of ADR reports included may undermine the reliability of these signals detected,further clinical studies are required to explore a better understanding of this phenomenon.

关 键 词：药物心脏毒性 信号挖掘 报告比值比法 多因素回归分析 

分 类 号：R595.3[医药卫生—内科学]