Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, South Korea.
Lung Research Institute, Hallym University College of Medicine, Chuncheon, South Korea.
Pharmacoepidemiol Drug Saf. 2022 Nov;31(11):1153-1163. doi: 10.1002/pds.5513. Epub 2022 Aug 9.
In tuberculosis (TB) treatment, adverse drug reactions (ADRs) can interrupt treatment and decrease the quality of life (QoL). We aimed to prospectively investigate the incidence of ADRs to first-line anti-TB drugs and related outcomes and QoL.
Adult patients with TB who had been treated with first-line anti-TB drugs in five Korean hospitals were enrolled. ADR questionnaire surveys and blood tests were performed four times serially, and QoL was assessed on the fourth TB treatment week (±2 weeks).
Of 410 enrolled patients with TB (males, 62%; mean age, 52.1 ± 18.1 years [those aged ≥65 years, 26.6%]), 67.8% experienced any ADRs (≥ grade 2) to TB drugs. The most common ADR was fatigue (53.2%), followed by itching (42.7%) and anorexia (41.7%). Older adult patients experienced relatively more ADRs, including anorexia, dyspepsia, rash, dizziness, anemia, abnormal hepatic/renal function tests, and increased uric acid levels (p < 0.05). Treatment regimens changed for 9.5% of patients owing to ADRs to anti-TB drugs. Patients with any ADRs and older adult patients had significantly lower QoL than their counterparts (p < 0.05). Old age (odds ratio [OR], 1.02) and being male (OR 2.65) were independently associated with ADRs, whereas active smoking (OR 4.73) and a relatively long treatment phase (OR 5.13) were independently associated with hepatotoxicity.
ADRs to first-line anti-TB drugs were common and related to relatively low QoL, especially among older adults. Although 9.5% of patients had ADR-related regimen changes, most patients with ADRs completed treatments successfully.
在结核病（TB）治疗中，药物不良反应（ADR）可能会中断治疗并降低生活质量（QoL）。我们旨在前瞻性调查一线抗结核药物的 ADR 发生率及其相关结局和 QoL。
在韩国的五家医院中，纳入接受一线抗结核药物治疗的成年 TB 患者。四次连续进行 ADR 问卷调查和血液检查，并在第四次 TB 治疗周（±2 周）评估 QoL。
在纳入的 410 例 TB 患者中（男性占 62%；平均年龄为 52.1±18.1 岁[≥65 岁者占 26.6%]），67.8%的患者出现任何（≥2 级）TB 药物 ADR。最常见的 ADR 是疲劳（53.2%），其次是瘙痒（42.7%）和食欲不振（41.7%）。老年患者出现的 ADR 相对更多，包括食欲不振、消化不良、皮疹、头晕、贫血、肝/肾功能异常和尿酸水平升高（p<0.05）。由于对 TB 药物的 ADR，有 9.5%的患者改变了治疗方案。有任何 ADR 和老年患者的 QoL 明显低于无 ADR 和年轻患者（p<0.05）。年龄较大（比值比 [OR]，1.02）和男性（OR，2.65）与 ADR 独立相关，而主动吸烟（OR，4.73）和相对较长的治疗阶段（OR，5.13）与肝毒性独立相关。
一线抗结核药物的 ADR 很常见，与相对较低的 QoL 相关，尤其是在老年患者中。尽管有 9.5%的患者因 ADR 改变了治疗方案，但大多数 ADR 患者仍成功完成了治疗。
