基于FDA不良事件报告系统数据库的奥马环素不良事件信号挖掘

Data-mining and analysis of adverse events signals for omacycline based on FDA adverse event reporting system database

目的 基于FDA不良事件报告系统(FAERS)数据库对奥马环素相关不良事件进行信号挖掘与分析,为防范奥马环素的用药风险提供参考。方法 从FAERS数据库提取奥马环素2018年10月1日至2022年12月31日的不良事件报告,利用报告比值比法(ROR)、比例报告比法、英国药品和健康产品管理局综合标准法和贝叶斯可信区间递进神经网络法进行数据挖掘,利用国际医学用语词典术语集进行不良事件系统归类。结果 共获得319份奥马环素为首要怀疑药物的不良事件报告,涉及1049条不良事件。通过4种方法综合分析,筛选获得与奥马环素相关的有效不良反应阳性风险信号24个,主要累及胃肠系统、各类检查、皮肤及皮下组织疾病等,其中阳性风险信号的不良事件按发生频次排名前5位的依次为恶心、呕吐、住院治疗、上腹痛和腹部不适;阳性风险信号按ROR排名前5位的依次为牙齿变色(ROR=263.40)、喷射性呕吐(ROR=75.89)、伤口分泌(ROR=56.23)、粪便松软(ROR=19.98)和AST升高(ROR=13.03)。结论 奥马环素引起牙齿变色、肝损伤以及胃肠系统等不良事件风险信号强度较高,用药期间应关注相关不良反应,及时干预,保证用药安全。

Objective To detect and analyze the adverse events signals related to omacycline based on the FDA adverse event reporting system(FAERS) database,so as to provide reference for the prevention of medication risks of omacycline.Methods The adverse event reports on omacycline from October 1 2018 to December 31 2022 were extracted from FAERS database.Data mining was performed using reporting odds ratio(ROR),proportional report ratio,Medicines and Healthcare products Regulatory Agency method and Bayesian Confidence Propagation Neural Network method,and the obtained risk signals were translated and systematically classified by Medical Dictionary for Regulatory Activities term set.Results A total of 319 case reports on omacycline as the primary suspected drug were collected,involving 1049 adverse events.Totally 24positive risk signals were obtained by the four kinds of data mining methods.Organ system classifications of adverse events mainly included gastrointestinal disorders,investigations,skin and subcutaneous tissue disorders.The top 5 positive risk signals in the number of adverse events were nausea,vomiting,hospitalization,abdominal pain upper,and abdominal discomfort.The top 5 positive risk signals with great ROR values were tooth discolouration(ROR=263.40),vomiting projectile(ROR=75.89),wound secretion(ROR=56.23),faeces soft(ROR=19.98) and aspartate aminotransferase increase(ROR=13.03).Conclusion The risk signal intensity of adverse events such as tooth discoloration,liver damage,and gastrointestinal system caused by omacycline is high.During the medication period,attention should be paid to related adverse reactions and timely intervention should be taken to ensure medication safety.