The safety of modified, all-oral shorter tuberculosis regimens in Armenia.

IF 0.9 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE Pub Date : 2024-01-01 DOI:10.3233/JRS-230039

Hakob Atshemyan, Naira Khachatryan, Anush Khachatryan, Narine Mirzoyan

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引用次数: 0

Abstract

Background: The implementation of modified, all-oral shorter regimens for treatment of rifampicin-resistant tuberculosis has started in Armenia since August 2020 under the conditions of operational research.

Objective: This study aims to evaluate the safety and effectiveness of shorter regimens.

Methods: We evaluated cumulative incidence rates of serious adverse events, adverse events of grade 3 and greater and events resulting in treatment modifications or suspension for 52 study participants.

Results: A new, different pattern of adverse events emerged compared with the previous evaluations of drug safety of treatment for rifampicin-resistant tuberculosis. Arthralgia (23.1%) and peripheral neuropathy (21.2%) took leading positions among the adverse events resulting in modifications of treatment. Some adverse events of interest (prolonged QT interval, elevated liver enzymes and anemia) remained relevant for the patients receiving new combinations of anti-TB drugs. The other adverse events (impaired hearing, acute kidney injury and hypokalemia) lost their significance for safety surveillance of rifampicin-resistant tuberculosis treatment. One unexpected serious adverse event (lymphoproliferative skin lesion) brought to a "failed treatment" outcome. The other serious adverse event was anemia.

Conclusion: The shorter regimens proved to be safe and effective for treatment of rifampicin-resistant tuberculosis, but proper follow-up of adverse events is necessary.

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亚美尼亚改良的全口服短期结核病治疗方案的安全性。

背景：自2020年8月起，亚美尼亚开始在业务研究条件下实施改良的全口服较短疗程治疗耐利福平结核病：本研究旨在评估缩短疗程的安全性和有效性：我们对 52 名研究参与者的严重不良事件、3 级及以上不良事件以及导致治疗调整或暂停的事件的累积发生率进行了评估：结果：与之前的耐利福平结核病治疗药物安全性评估相比，出现了一种新的、不同的不良事件模式。在导致修改治疗方案的不良反应中，关节痛（23.1%）和周围神经病变（21.2%）占首位。一些值得关注的不良反应（QT 间期延长、肝酶升高和贫血）仍然与接受新的抗结核药物组合治疗的患者有关。其他不良事件（听力受损、急性肾损伤和低钾血症）对耐利福平结核病治疗的安全性监测失去了意义。一个意外的严重不良事件（皮肤淋巴增生性病变）导致了 "治疗失败 "的结果。另一个严重不良事件是贫血：事实证明，较短疗程治疗耐利福平结核病是安全有效的，但有必要对不良事件进行适当跟踪。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

2.20

自引率

17.60%

发文量

102

期刊介绍： The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed. This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety.