Adverse drug reaction prevalence and mechanisms of action of first-line anti-tubercular drugs,Saudi Pharmaceutical Journal

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Adverse drug reaction prevalence and mechanisms of action of first-line anti-tubercular drugs
Saudi Pharmaceutical Journal ( IF 4.1 ) Pub Date : 2020-01-31 , DOI: 10.1016/j.jsps.2020.01.011
Faisal Imam ₁ , Manju Sharma ₂ , Khalid Umer Khayyam ₃ , Naif O Al-Harbi ₁ , Mohd Khan Rashid ₁ , Mohammad Daud Ali ₄ , Ayaz Ahmad ₄ , Wajhul Qamar _{1,

5}

Affiliation

Purpose

Understanding the appearance of anti-tubercular drug-related adverse drug reactions (ADRs) in patients receiving tuberculosis (TB) treatment is important, and may be related to morbidity and mortality if not recognized early. Here, we aimed to characterize the mechanisms underlying adverse drug reactions due to combination anti-tuberculosis therapy of the Revised National Tuberculosis Control Program (RNTCP).

Methods

This was a prospective observational study conducted in 9 DOTS centers of New Delhi, India. All enrolled TB patients receiving first-line tuberculosis treatment as per RNTCP guidelines were monitored for ADRs. All ADRs that appeared during the treatment were recorded and analyzed.

Results

The study included 1011 TB patients on anti-TB treatment under DOTS. According to Naranjo’s probability scale, of a total 351 (34.72%) reported adverse events, 102 (10.09%) were definite, 59 (5.83%) probable, 123 (12.17%) possible, and 67 (6.63%) doubtful. On the Hartwig severity scale, of the 351 adverse drug events, 225 (22.26%) were mild, 105 (10.38%) were moderate, and 21 (2.08%) were severe. Out of 102 reported adverse drug reactions, 81 (79.41%) were moderate and 21 (20.59%), while 65.28% did not experience any ADRs.

Conclusions

Directly Observed Treatment (DOT) is effective and safe compared to daily treatment regimens. Patients receiving DOTS therapy needed close monitoring for adverse events. Therefore, a pharmacovigilance program should be added at the National level to accesses the adverse event incidence.

中文翻译：

一线抗结核药物不良反应发生率及作用机制

目的

了解接受结核病 (TB) 治疗的患者中抗结核药物相关药物不良反应 (ADR) 的出现很重要，如果不及早发现，可能与发病率和死亡率有关。在这里，我们旨在描述由于修订的国家结核病控制计划 (RNTCP) 的联合抗结核治疗引起的药物不良反应的机制。

方法

这是一项在印度新德里的 9 个 DOTS 中心进行的前瞻性观察性研究。根据 RNTCP 指南，对所有接受一线结核病治疗的入组 TB 患者进行 ADR 监测。记录和分析治疗期间出现的所有 ADR。

结果

该研究包括在 DOTS 下接受抗结核治疗的 1011 名结核病患者。根据 Naranjo 的概率量表，在总共 351 例（34.72%）报告的不良事件中，102 例（10.09%）是确定的，59 例（5.83%）可能，123 例（12.17%）可能，67 例（6.63%）可疑。在 Hartwig 严重程度量表中，351 起药物不良事件中，225 起（22.26%）为轻度，105 起（10.38%）为中度，21 起（2.08%）为重度。在报告的 102 例药物不良反应中，81 例（79.41%）为中度，21 例（20.59%），而 65.28% 未出现任何 ADR。