他克莫司与霉酚酸联用的药物不良反应分析

Analysis of adverse drug reactions induced by tacrolimus combined with mycophenolic acid

目的通过美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)挖掘分析他克莫司(Tac)与霉酚酸(MPA)联合使用的药物不良反应(ADR)信号,为联合用药提供参考。方法用OpenVigil 2.1平台检索2004年第一季度至2023年第一季度FAERS数据库中有关Tac与MPA联合使用的不良事件报告,用比例失衡分析法进行ADR信号挖掘。分析不良事件上报的人群特征,比较两药联合应用与其说明书中报告的ADR差别,筛选新的ADR。结果共获取Tac与MPA联合使用的ADR报告32866例,涉及男性患者17455例(53.11%),女性患者11445例(34.82%);40~<65岁患者占多数(13174例,40.08%)。发生频次较高的ADR主要有发热、感染和肾损害;信号强度较强的ADR主要有感染和皮肤毒性等;新发的ADR主要有血甲状旁腺素升高、心瓣膜关闭不全和急性精神病等。结论联合使用Tac与MPA时,应对发生频次较高、信号强度较强及新发的ADR予以重视和监护。

Objective To mine and analyze the adverse drug reaction(ADR)signals caused by tacrolimus(Tac)combined with mycophenolic acid(MPA)based on Food and Drug Administration(FDA)adverse event reporting system(FAERS)database,so as to provide reference for clinical drug combination.Methods OpenVigil 2.1 platform was used to collect adverse events reports related to Tac and MPA between the first quarter of 2004 and the first quarter of 2023.Disproportionality analysis methods were used to mine the ADR risk signals.Characteristics of the population reporting adverse events were analyzed.ADR that arose from the combination of the two drugs were compared with those specified in the instructions of the two drugs in order to screen out new ADR.Results A total of 32866 ADR reports of Tac and MPA used in combination were retrieved,in which 17455 cases(53.11%)were males,11445cases(34.82%)were females.Cases were major in age from 40 to 65years old(13174 cases,40.08%).ADR with high frequency mainly included pyrexia,infections and renal impairment;ADR with strong signal strength mainly included infections and skin toxicity;new ADR mainly included blood parathyroid hormone increased,heart valve incompetence and acute psychosis.Conclusion When using Tac and MPA in combination,attention and care should be paid to the high frequency,strong signal strength and new signal of ADR.