羁押人员应用抗感染药物所致的158例不良反应分析

目的分析上海市监狱总医院抗感染类药物所致不良反应的特点及规律,为羁押人员合理用药和药物警戒提供依据。方法收集本院2011年1月至2018年10月呈报国家药品不良反应监测中心的抗感染类药物ADR病例,应用帕累托图分析法研究导致ADR的抗感染药物的种类、累及器官和(或)系统的主要及次要因素。结果共收集158例抗感染药物所致的ADR病例,男性143例(90.51%),集中在20~59岁。经帕累托图分析发现,ADR主要涉及8类抗感染药物(抗结核药物、头孢菌素类药物、磺胺类药物、抗病毒类药物、青霉素类药物、氨基糖苷类药物、氟喹诺酮类和硝基咪唑类药物),ADR主要累及肝胆系统、皮肤及其附件、全身性反应和血液系统,以肝功能异常、肝功能损害、皮疹和过敏反应最为常见。结论应用帕累托图法揭示的“关键的少数和次要的多数”来分析羁押人员抗感染药物所致的ADR,重点关注抗结核药物及头孢菌素类药物的治疗,减少或避免ADR的发生。

Analysis on 158 detainees with adverse reactions due to anti-infective drugs

Objective To analyze the characteristics and trends of adverse drug reactions (ADR) induced by anti-infective drugs in Shanghai Prison General Hospital and provide a guideline of rational drug use and pharmacovigilance for detainees.Methods The anti-infective drug induced ADR cases reported to the national ADR monitoring center in our hospital from January 2011 to October 2018 were collected. The primary and secondary factors of types, organs and (or) systems affected by anti-infective drugs that lead to ADR were studied with Pareto diagram.Results 158 ADR cases caused by anti-infective drugs were collected. 143 cases (90.51%) were male in 20-59 years old. Pareto diagram analysis showed that ADRs mainly involved eight kinds of anti-infective drugs (antituberculosis drugs, cephalosporins, sulfonamides, antiviral drugs, penicillin, aminoglycosides, fluoroquinolones and nitroimidazoles). ADRs mainly involved in hepatobiliary and blood system. Both topical and systemic reactions were reported. Abnormal liver function, liver injury, rash and allergic reaction were the most common.Conclusion Pareto diagram method reflected the "critical minority and minor majority" analysis on detainees with ADRs caused by anti-infective drug. It was recommended to focus on anti-tuberculosis drugs and cephalosporin drugs to reduce or avoid the occurrence of ADR.