基于FDA不良事件报告系统数据库的米诺环素和多西环素在儿童用药中的安全性评价

Safety evaluation of minocycline and doxycycline in paediatric patients based on FDA adverse event reporting system database

目的对米诺环素和多西环素在儿童患者中药品不良事件(ADE)进行信号挖掘,为临床安全用药提供参考。方法使用OpenVigil 2.1平台检索FDA不良事件报告系统数据库,检索时限为2004年第1季度至2023年第1季度,年龄限制为0~17岁。采用比例失衡法中的报告比值比(ROR)法行信号检测。结果分别检索到米诺环素和多西环素相关ADE报告2965份和1431份。米诺环素报告中最多的ADE信号为腹部不适,强度最高的信号为动脉血栓形成;多西环素报告中最多的ADE信号为赫氏反应,强度最高的信号为嗜中性皮肤病。结论建议应用米诺环素和多西环素时常规监测胃肠道、肝损害和皮肤相关ADE,同时关注新的ADE。

Objective To mine the risk signals of minocycline and doxycycline in paediatric patients and provide reference for safe drug use.Methods The FDA adverse event reporting system database was queried using the OpenVigil 2.1 platform to obtain the adverse drug events(ADEs)of minocycline and doxycycline from the first quarter of 2004 to the first quarter of 2023,with an age limit of 0-17 years.Reporting odds ratios(ROR)was used to detect the risk signals.Results A total of 2965 ADE reports related to minocycline and 1431 ADE reports related to doxycycline were extracted,respectively.The most common reported ADEs of minocycline was abdominal discomfort,with the strongest signal being arterial thrombosis.The most common reported ADEs of doxycycline was Jarisch-Herxheimer reaction,with the strongest signal being neutrophilic dermatosis.Conclusion Routine monitoring of gastrointestinal,liver damage,and skin-related ADEs is recommended when using minocycline and doxycycline,and new ADEs should also be concerned.