5597例非甾体抗炎药的不良反应报告分析

Analysis of 5597 Reports of Adverse Reactions to NSAIDs

目的:了解非甾体抗炎药(NSAIDs)相关不良反应(ADRs)的发生情况及特点,为临床提供参考。方法:采用回顾性研究方法,调取2008~2019年解放军药品不良反应监测中心ADR数据库中所有NSAIDs相关ADRs自发报告,对其中5597例有效自发报告中的患者性别、年龄,可疑NSAIDs分类、给药途径,以及ADRs类型、诱导期和累及系统/器官等进行统计分析,比较不同性别患者各个年龄段的构成比差异。结果:5597例NSAIDs相关自发报告中,新的一般的ADR报告404例,严重的ADR报告428例,新的严重的ADR报告47例。ADRs报告中男性2965例(52.97%),女性2632例(47.03%);年龄1~116(56.53±19.37)岁,大于60岁年龄段构成比最高;40岁以下年龄段男性多于女性,>40岁年龄段女性多于男性(P<0.01);且各年龄段男女构成比差异均有统计学意义(P<0.001)。5597例ADRs涉及NSAIDs十大类别,给药途径以静脉给药为主;ADR诱导期≤1 h例数最多;累及多个系统/器官,以胃肠系统损害(26.02%)和皮肤及皮肤附件损害(23.05%)为多见;严重ADR构成比最高为肝胆系统损害(17.67%);例数最多的品种为氟比洛芬酯,共686例(12.26%),相关严重ADR主要为肝功能异常等。结论:临床使用中应重视NSAIDs安全性问题,及时识别并处理ADR;有必要开展氟比洛芬酯相关用药风险评价研究。

Objective:To understand the occurrence and characteristics of adverse reactions(ADRs) associated with non-steroidal anti-inflammatory drugs(NSAIDs) for clinical reference. Methods:Using a retrospective study, all spontaneous reports of ADRs related to NSAIDs in the ADR database of the PLA Adverse Drug Reaction Monitoring Center in 2008-2019 were retrieved, and among these 5 597 valid spontaneous reports, the gender and age of patients, the classification of suspected NSAIDs, route of administration, and the type of ADRs, induction period, and systems/organ involved were statistically analyzed and compared the differences in the composition ratios of patients by gender in each age group. Results:Of the 5 597 spontaneous reports associated with NSAIDs, 404 new general ADRs were reported, 428 serious ADRs were reported, and 47 new serious ADRs were reported. ADRs were reported in 2 965(52.97%) males and 2 632(47.03%) females;age 1-116(56.53±19.37) years, with the highest composition ratio in the >60 years age group;more males than females in the under-40 years age group and more females than males in the >40 years age group(P<0.01);and the difference between male and female composition ratios in each age group was statistically significant(P<0.001). The 5 597 ADRs involved the ten major categories of NSAIDs, and the route of administration was mainly intravenous;maximum number of cases with ADR induction period ≤1 h;multiple systems/organ were involved, with gastrointestinal system damage(26.02%) and skin and skin adnexal damage(23.05%) being the most common;the highest composition of serious ADRs was hepatobiliary system damage(17.67%);the species with the largest number of cases was flurbiprofen axetil, with 686 cases(12.26%), and the related serious ADRs were mainly liver function abnormalities. Conclusion:Clinical use should pay attention to NSAIDs safety issues, timely identification and treatment of ADR;it is necessary to carry out flurbiprofen axetil-related dosing risk evaluation studies.