Vaman Raman Swathy, Thomas George Dilu, Kalyanasundaram Madhanraj, Soman Surabhi, Valamparampil Mathew J, Puroshothama Bhat Susheela Rakesh, Murhekar Manoj V
District Hospital, Kanhangad, India.
FETP-MPH programme, ICMR-NIE, Chennai, India.
IJID Reg. 2025 Mar 1;15:100615. doi: 10.1016/j.ijregi.2025.100615. eCollection 2025 Jun.
We conducted a study to estimate the incidence of adverse drug reactions (ADRs) in the drug-resistant tuberculosis (DR-TB) cohort in Kerala in 2020 and describe the characteristics of the reported ADRs.
A non-concurrent cohort study was conducted among all patients with DR-TB across 14 districts in Kerala from January 1, 2020 to December 31, 2020. We collected data on ADRs from patients, "Nikshay" web-portal, treatment cards, case sheets, and registers. We described ADRs by organ system, causality, severity, preventability, predictability, and seriousness of the reaction using standard tools.
Of the 364 persons initiated on treatment, 304 (83.5%) had at least one of the 28 listed adverse reactions, with an incidence of 27.6 ADR per 100 person-months of treatment. Gastrointestinal disorders had the highest incidence 365 per 1046 (35%). A total of 1001 of 1046 (95.7%) ADRs were non-predictable, and 405 of 1046 (39%) were definitely preventable. A total of 83 of 304 (27.3%) patients had severe ADR, and 56 of 304 (18.4%) had serious ADR. A total of 87 of 304 (28.6%) patients with ADR required interruption of the probable offending drug, with 64 of 87 (73.6%) temporary and 23 of 87 (26.4%) permanent interruptions.
Four-fifths of all patients on therapy had at least one of the 28 listed adverse reaction and one-fifth had serious ADR. ADRs can lead to treatment interruptions. Early detection and prompt management is essential for improving treatment outcomes in patients with DR-TB.
我们开展了一项研究，以估算2020年喀拉拉邦耐多药结核病（DR-TB）队列中药物不良反应（ADR）的发生率，并描述所报告的ADR的特征。
2020年1月1日至2020年12月31日期间，在喀拉拉邦14个区的所有耐多药结核病患者中进行了一项非同期队列研究。我们从患者、“Nikshay”网络门户、治疗卡、病历和登记册中收集了ADR的数据。我们使用标准工具按器官系统、因果关系、严重程度、可预防性、可预测性和反应的严重性来描述ADR。
在开始治疗的364人中，304人（83.5%）至少出现了28种列出的不良反应中的一种，治疗每100人月ADR的发生率为27.6。胃肠道疾病的发生率最高，每1046例中有365例（35%）。在1046例ADR中，共有1001例（95.7%）不可预测，1046例中有405例（39%）肯定可预防。304例患者中共有83例（27.3%）出现严重ADR，304例中有56例（18.4%）出现严重不良反应。304例发生ADR的患者中共有87例（28.6%）需要中断可能引起问题的药物，87例中有64例（73.6%）为暂时中断，87例中有23例（26.4%）为永久中断。
接受治疗的所有患者中有五分之四至少出现了28种列出的不良反应中的一种，五分之一出现了严重ADR。ADR可导致治疗中断。早期发现和及时处理对于改善耐多药结核病患者的治疗结局至关重要。
