艾拉莫德在老年类风湿关节炎患者中应用的安全风险性分析

Safety risk analysis of iguratimod in elderly rheumatoid arthritis population

目的分析艾拉莫德(iguratimod,IGU)在老年类风湿关节炎(rheumatoid arthritis,RA)患者中的安全性数据,为临床合理使用艾拉莫德提供参考。方法分析我国药品不良反应(adverse drug reaction,ADR)监测中心数据库、国内外文献中有关艾拉莫德治疗老年RA患者的安全性资料,对ADR的临床表现、发生时间、关联性、预后及单药或联合治疗后ADR发生率等主要指标进行统计分析。结果国家药品不良反应监测中心数据库共报告153例应用艾拉莫德发生ADR的老年RA患者,其中严重ADR占比为12.4%,高于非老年RA患者的6.4%,其中最常见ADR为胃肠系统损害,皮肤及其附件损害以及肝胆系统损害。ADR主要发生在服药后1~8周,停药后大部分可痊愈或好转。国内外文献资料中共316例使用艾拉莫德治疗的老年RA患者,其中发生ADR共计69例。其中单药治疗者6例出现ADR,ADR发生率为20.0%,联合治疗者63例出现ADR,ADR发生率根据联合用药不同为5.6%~21.7%。联合艾拉莫德治疗没有增加ADR发生率,且无严重ADR报道。文献报道的主要ADR为胃肠道反应、肝酶升高和白细胞减少。结论老年RA患者使用艾拉莫德安全性良好,与其他年龄群体无显著性差异。

Objective To analyze the safety data of iguratimod in elderly patients with rheumatoid arthritis(RA)and provide reference for the clinical rational use of iguratimod.Methods Analyze the safety of iguratimod in the treatment of elderly RA patients based on the data from national center for adverse drug reaction(ADR)monitoring of China,and domestic and foreign literature.The main indicators of ADR,such as clinical manifestations,occurrence time,relevance,prognosis,and ADR incidence after single drug or combination therapy,were statistically analyzed.Results One hundred and fifty-three cases of elderly RA with ADRs were reported in the database of national center for ADR monitoring.The proportion of serious ADRs of elderly RA patients was 12.4%,higher than non-elderly RA patients(6.4%),mainly related to gastrointestinal system disorders,skin and appendages disorders and hepatobiliary system disorders.ADRs mainly occur 1-8 weeks after taking the medicine,and most of them can be cured or improved after stopping the medicine.A total of 316 cases of elderly RA who have used iguratimod were involved in the domestic and foreign literature,among them 69 people arose ADRs.Among them,6 patients treated with monotherapy had ADRs with the incidence rate of ADRs of 20.0%,and 63 patients treated with combination therapy had ADRs with the incidence rate of ADRs ranging from 5.6%to 21.7%according to different drugs combined.The data suggested that combination ofiguratimod treatment did not increase the incidence rate of ADRs.No serious ADRs were reported.Literature showed that the main ADRs of iguratimod in elderly RA patients were gastrointestinal reactions,elevated transaminasesand leukopenia.Conclusion Elderly patients with rheumatoid arthritis are safe to use iguratimod,and there is no significant difference from other age groups.