2022 年第 12 期 第 17 卷

抗结核药物不良反应报告分析

Analysis of adverse reactions report of anti tuberculosis drugs

作者：梁艳蓉 张爱洁 俞南 徐伟

英文作者：Liang Yanrong Zhang Aijie Yu Nan Xu Wei

单位：北京市朝阳区疾病预防控制中心结防科，北京100021

英文单位：Department of Tuberculosis Prevention， Chaoyang Center for Disease Prevention and Control Beijing 100021 China

关键词：肺结核；抗结核药物；药物不良反应

英文关键词：Tuberculosis;Antituberculosisdrugs;Adversedrugreactions

• 摘要：

• 目的  分析结核患者服用抗结核药物后药物不良反应（ADR）的发生情况。方法  回顾性分析2016年3月至2020年6月北京市朝阳区疾病预防控制中心管理的服用抗结核药物治疗后出现ADR的156例结核病患者的病历资料，统计患者的年龄、性别、ADR发生时间、所致ADR类型、怀疑引起ADR的药物种类等指标。结果  156例患者中男90例、女66例，年龄（55±7）岁。ADR发生时间为用药后1～330 d，其中，151例（96.8%）患者集中在用药后30 d内，用药后4～10 d为ADR高发期，共出现100例，占64.1%。男性ADR占比高于女性，60岁及以上患者占比高于其他年龄段，但不同年龄段ADR占比比较差异无统计学意义（P>0.05）。ADR类型表现为胃肠道反应146例（93.6%）、尿酸升高137例（87.8%）、肝脏毒性125例（80.1%）、神经系统反应117例（75.0%）、过敏反应111例（71.2%）等，其中出现1种不良反应者58例、2种不良反应者49例、3种不良反应者36例、4种及以上者13例。引发ADR的药品以异福酰胺为主，67例（42.9%），其次为异烟肼+利福平+吡嗪酰胺+乙胺丁醇、异烟肼+利福平+吡嗪酰胺联用方案，分别为17例（10.9%）、14例（9.0%）。结论  抗结核药物导致的ADR主要为胃肠道反应、高尿酸、肝脏损害、神经系统疾病及过敏反应，用药4～10 d为其高发期，且多见于男性、60岁及以上患者，异福酰胺、异烟肼+利福平+吡嗪酰胺+乙胺丁醇、异烟肼+利福平+吡嗪酰胺联用方案所致ADR占比较大，临床用药过程中应重点关注高发期及多发人群，并注意选取合适的用药方案，以降低ADR风险。

• Objective  To analyze the incidence of adverse drug reactions(ADR) of tuberculosis patients taking anti tuberculosis drugs. Methods  The data of 156 tuberculosis patients were analyzed retrospectively. All the patients had ADR after taking anti tuberculosis drugs in Beijing Chaoyang Center for Disease Prevention and Control from March 2016 to June 2020. The age, gender, occurrence time of ADR, types of ADR and drugs suspected to cause ADR were recorded. Results  The age of 156 patients were (55±7) years, including 90 males and 66 females. The occurrence time of ADR was 1-330 d after administration. There were 151 cases(96.8%) of ADR onset concentrated with the first 30 d after administration, of which 100 cases  occurred at 4-10 d after administration, accounting for 64.1%. The incidence of ADR in male was significantly higher than that in female, the incidence of ADR in patients over 60 years was higher than that in other age groups, but there was no significant difference among different age groups(P>0.05). The common types of ADR were gastrointestinal reaction in 146 cases(93.6%), elevated uric acid in 137 cases(87.8%), hepatic toxicity in 125 cases(80.1%), nervous system reaction in 117 cases(75.0%) and allergic reaction in 111 cases(71.2%). Among them, 58 cases had 1 kind of adverse reaction, 49 cases had 2 kinds, 36 cases had 3 kinds and 13 cases had 4 kinds or more. The drugs that caused ADR were mainly rifampicin, isoniazid and pyrazinamide, accounting for 67 cases(42.9%), followed by isoniazid+rifampicin+pyrazinamide+ethambutol, and isoniazid+rifampicin+pyrazinamide, accounting for 17 cases(10.9%) and 14 cases(9.0%), respectively. Conclusion  ADR induced by anti tuberculosis drugs are mainly gastrointestinal reaction, hyperuricemia, hepatic damage, nervous system diseases and allergic reaction, and the high incidence period of ADR was 4-10 d after administration. Those are common in male and patients over 60 years, and are mainly caused by rifampicin, isoniazid and pyrazinamide, isoniazid+rifampicin+pyrazinamide+ethambutol, and isoniazid+rifampicin+pyrazinamide. We should pay more attention to the population who are on the high incidence period and have multiple ADR. It is necessary to select appropriate drug regimens to reduce the risk of ADR.