基于FDA不良事件数据库和指定医疗事件对氯喹和羟氯喹不良反应信号的检测与评价
首发时间:2020-03-25
摘要:目的: 挖掘和评价新型冠状病毒肺炎治疗方案(试行第七版)中加入的药物"磷酸氯喹"和《上海市2019冠状病毒病综合救治专家共识》中推荐加入的"硫酸羟氯喹"上市后的安全信号,为临床合理用药提供参考。方法检索美国FDA不良事件报告系统(FDA adverse event reporting system,FAERS)数据库2004年1月1日至2019年12月31日收录以"氯喹"及"羟氯喹"为怀疑药物的不良事件(Adverse drug events,ADEs)报告,提取排名前200位药物不良反应(Adverse Drug Reaction,ADR)报告进行指定医疗事件(Designated Medical Event,DME)筛选,采用报告比值比法(ROR)和比例报告比值比法(PRRs)检测ADR信号,重点评估和比较出现DME的系统器官分类(SOC)中的安全信号,并对DME进行分析。结果提取FAERS数据库得到氯喹与羟氯喹ADEs报告数量分别为1128、29639;氯喹严重不良事件(Serious Adverse Event,SAE)占比57.89%,羟氯喹占比26.60%。经DME筛选,共涉及7种SOC,其中眼部疾病与呼吸系统相关ADR中,羟氯喹检出的信号较多;皮肤和皮下组织类疾病,两种药物信号关联性均较高;心脏、血液及肝胆系统相关ADR中,信号主要集中在氯喹;耳部系统相关ADR中,信号检出较少。另外,发现在中毒性表皮坏死松解症、尖端扭转型室速、全血细胞减少症以及耳聋这4种共同检出的DME中氯喹的信号关联性高于羟氯喹。结论基于真实世界的ADR信号检测有助于新冠疫情中氯喹与羟氯喹的安全性评价,降低临床用药风险。
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Detection and evaluation of Adverse Drug Reaction signals of Chloroquine and Hydroxychloroquine based on FDA adverse event database and Designated Medical Event
Abstract:OBJECTIVE To mine and evaluate the postmarketing safety signals of Chloroquine Phosphate that recommended for trial in the novel coronavirus pneumonia treatment plan (trial version seventh) and Hydroxychloroquine Sulfate that recommended by《Expert consensus on comprehensive treatment of 2019 coronavirus disease in Shanghai》, provide reference for clinical rational drug use. METHODS From January 1, 2004 to December 31, 2019, "Chloroquine " and "Hydroxychloroquine " were included in the database of the U.S. FDA Adverse Event Reporting system (FAERS), and extracted the top 200 ADR reports for screening of Designated Medical Event (DME), ADR signals were detected by ROR and PRR. The safety signals in system organ classification (SOC) with DME were evaluated and compared, and the DME is analyzed. RESULTS 1128 cases were reported with Chloroquine, 29639 with Hydroxychloroquine. The proportion of Chloroquine SAE was 57.89%, and Hydroxychloroquine was 26.60%. After DME screening, there were 7 kinds of SOC involved, among which, Hydroxychloroquine detected more signals in ADR related to eye diseases and respiratory system; skin and subcutaneous tissue diseases, both drug signals were highly correlated; in ADR related to heart, blood and hepatobiliary system, Chloroquine was the main signal set; in ADR related to ear system, less signals were detected. In addition, the signal correlation of Chloroquine in DME was higher than that of Hydroxychloroquine, these signals are toxic epidermal necrolysis, torsade de pointes, pancytopenia and deafness. CONCLUSION The detection of ADR signal based on the real world may help to evaluate the safety of Chloroquine and Hydroxychloroquine in the Novel Coronavirus Pneumonia and reduce the risk of clinical medication.
Keywords: novel coronavirus pneumonia chloroquine hydroxychloroquine designated medical event signal detection
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基于FDA不良事件数据库和指定医疗事件对氯喹和羟氯喹不良反应信号的检测与评价
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