比较耐药结核病患者接受含地拉马尼治疗方案与短程治疗方案的 QTc 间期变化。

Pub Date : 2024-01-01 DOI:10.3233/JRS-230024
H Y Jefman Efendi Marzuki, Nafrialdi Nafrialdi, Neni Sawitri, Yani Jane Sugiri, I Gusti Agung Ayu Putu Sri Darmayani, Purwantyastuti Ascobat
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引用次数: 0

摘要

背景:地拉那米(DLM)是一种治疗耐药性结核病(DR-TB)的相对较新的药物,尽管其安全性数据有限,但自2019年以来一直在印度尼西亚使用。众所周知,DLM可抑制hERG钾通道,可能导致QT延长,最终导致Torsades de pointes(TdP):本研究旨在分析与短期治疗方案(STR)相比,使用 DLM 方案的 DR-TB 患者 QTc 间期的变化:方法:根据从两家参与研究的医院获得的二手数据进行回顾性队列研究。方法:根据从两家参与医院获得的二级数据进行回顾性队列,在 24 周内每 4 周评估一次 QTc 间期和 QTc 间期与基线相比的变化(ΔQTc):结果:DLM 组 QTc 间期和 ΔQTc 间期的最大增幅较小,平均差异分别为 18.6 毫秒(95%CI 0.3 至 37.5)和 31.6 毫秒(95%CI 14.1 至 49.1)。DLM组QTc间期延长的比例小于STR组(RR=0.62;95%CI 0.42至0.93):本研究表明,与 STR 相比,DLM 方案增加 QTc 间期的可能性较小。结论:本研究表明,与 STR 相比,DLM 方案不易导致 QTc 间期延长,但在使用 QT 间期延长的抗结核药物时,需要密切监测 QT 间期延长的风险。
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Comparison of QTc interval changes in drug-resistant tuberculosis patients on delamanid-containing regimens versus shorter treatment regimens.

Background: Delamanid (DLM) is a relatively new drug for drug-resistant tuberculosis (DR-TB) that has been used in Indonesia since 2019 despite its limited safety data. DLM is known to inhibit hERG potassium channel with the potential to cause QT prolongation which eventually leads to Torsades de pointes (TdP).

Objective: This study aims to analyse the changes of QTc interval in DR-TB patients on DLM regimen compared to shorter treatment regimens (STR).

Methods: A retrospective cohort was implemented on secondary data obtained from two participating hospitals. The QTc interval and the changes in QTc interval from baseline (ΔQTc) were assessed every 4 weeks for 24 weeks.

Results: The maximum increased of QTc interval and ΔQTc interval were smaller in the DLM group with mean difference of 18,6 (95%CI 0.3 to 37.5) and 31.6 milliseconds (95%CI 14.1 to 49.1) respectively. The proportion of QTc interval prolongation in DLM group were smaller than STR group (RR=0.62; 95%CI 0.42 to 0.93).

Conclusion: This study has shown that DLM regimens are less likely to increase QTc interval compared to STR. However, close monitoring of the risk of QT interval prolongation needs to be carried out upon the use of QT interval prolonging antituberculoid drugs.

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