Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea.
J Korean Med Sci. 2022 Apr 25;37(16):e128. doi: 10.3346/jkms.2022.37.e128.
Adverse drug reactions (ADRs) to first-line anti-tuberculosis (TB) drugs are common; however, there have been few reports of nationwide epidemiologic studies on ADRs to anti-TB drugs in Korea. This study aimed to investigate the clinical characteristics of various ADRs to first-line anti-TB drugs using a nationwide database of ADRs.
We used the Korea Adverse Event Reporting System (KAERS) database (2009-2018). The study subjects were selected using the Korean Standard Classification of Diseases codes for pulmonary and extrapulmonary TB and electronic data interchange codes for isoniazid (INH), rifampicin (RIF), ethambutol (ETB), and pyrazinamide (PZA). The causality assessment of "possible," "probable," or "certain" by World Health Organization-Uppsala Monitoring Center System causality category was selected.
A total of 1,562,024 ADRs were reported in the KIDS-KAERS database from 2009 to 2018, where ADRs to first-line anti-TB drugs were 17,843 cases (1.14%). The most common causative drugs were RIF (28.7%), INH (24.0%), ETB (23.4%), and PZA (23.9%) in that order. 48.5% of cases were reported in the older patients (≥ 60 years). According to organ system, gastro-intestinal system disorder was most common (32.0%), followed by skin and appendage (25.9%), liver and biliary system (14.2%). Nausea was the most common ADR (14.6%), followed by hepatic enzyme elevation (14.2%), rash (11.7%), pruritus (9.1%), vomiting (8.9%), and urticaria (4.2%). Most ADRs appeared within 1 month, but ADRs such as neuropathy, paresthesia, hematologic abnormalities, renal function abnormalities and liver enzyme abnormality were also often reported after 2 months.
Our data are clinically informative for recognizing and coping with ADRs of anti-TB drugs.
一线抗结核（TB）药物的不良反应（ADRs）很常见；然而，韩国针对抗 TB 药物 ADR 的全国性流行病学研究报告甚少。本研究旨在使用全国性的 ADR 数据库，调查一线抗结核药物 ADR 的各种临床特征。
我们使用了韩国不良事件报告系统（KAERS）数据库（2009-2018 年）。研究对象是使用肺结核和肺外结核的韩国标准疾病分类代码和异烟肼（INH）、利福平（RIF）、乙胺丁醇（ETB）和吡嗪酰胺（PZA）的电子数据交换代码选择的。选择了世界卫生组织-乌普萨拉监测中心系统因果关系类别为“可能”、“很可能”或“肯定”的因果关系评估。
2009 年至 2018 年，KIDS-KAERS 数据库共报告了 1562024 例 ADR，其中一线抗 TB 药物 ADR 为 17843 例（1.14%）。最常见的致病药物依次为 RIF（28.7%）、INH（24.0%）、ETB（23.4%）和 PZA（23.9%）。48.5%的病例发生在老年患者（≥60 岁）中。根据器官系统，胃肠系统紊乱最为常见（32.0%），其次是皮肤和附属器（25.9%）、肝和胆道系统（14.2%）。恶心是最常见的 ADR（14.6%），其次是肝酶升高（14.2%）、皮疹（11.7%）、瘙痒（9.1%）、呕吐（8.9%）和荨麻疹（4.2%）。大多数 ADR 出现在 1 个月内，但神经病变、感觉异常、血液学异常、肾功能异常和肝酶异常等 ADR 也常在 2 个月后报告。
我们的数据为识别和应对抗结核药物的 ADR 提供了临床信息。
