QT Interval Prolongation in People Treated With Bedaquiline for Drug-Resistant Tuberculosis Under Programmatic Conditions: A Retrospective Cohort Study.
QT Interval Prolongation in People Treated With Bedaquiline for Drug-Resistant Tuberculosis Under Programmatic Conditions: A Retrospective Cohort Study.
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DOI：
10.1093/ofid/ofab413
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发表时间：
2021-08
影响因子：
4.2
通讯作者：
Millard J
中科院分区：
文献类型：
--
作者：
Isralls S;Baisley K;Ngam E;Grant AD;Millard J
贝达喹啉有心律失常和猝死风险的黑框警告。本研究旨在确定在计划条件下接受贝达喹啉治疗耐药结核病（DR-TB）的患者中QTc间期延长和心脏事件的发生率。2017年9月至2019年2月在南非夸祖鲁纳塔尔的一家耐药结核病医院接受贝达喹啉治疗的患者的回顾性队列研究。主要结局，使用Fridericia公式校正的QT间期延长（QTcF），定义为QTcF >500 ms，QTcF较基线变化>60 ms，或两者兼而有之。在420例患者（66.2%为男性，中位年龄36岁）中，基线时的中位QTcF为406.4（四分位距[IQR]，389.1-421.3）ms，3个月时增加至430.5（IQR，414.4-445.1）ms，6个月时增加至434.0（IQR，419.0-447.9）ms。420例患者中有18例（4.3%）QTcF >500 ms，110例（26.2%）QTcF变化>60 ms。未记录到心律失常或心源性死亡。伴随使用唑类药物时，QTcF延长的几率增加（调整后的比值比[aOR]，5.61 [95%置信区间（CI），2.26-13.91]; P < .001），与HIV阳性状态呈负相关（aOR，0.34 [95%CI，0.15 - 0.75]; P = 0.008）和高血压（aOR，0.13 [95%CI，0.02 - 0.86]; P = 0.02）。延长后，QTcF下降至<500 ms，无论是否中断药物。我们观察到QTcF适度延长，在第15周达到最大值;未记录到心律失常或相关死亡。在南非夸祖鲁-纳塔尔的项目条件下，在接受贝达喹啉治疗耐药结核病的患者中观察到QTcF中度延长，最长为15周。未记录心律失常或相关死亡。
Bedaquiline has a black-box warning of the risk of arrhythmias and sudden death. This study aimed to determine the incidence of QTc prolongation and cardiac events in patients receiving bedaquiline for drug-resistant tuberculosis (DR-TB) under programmatic conditions. Retrospective cohort study of patients receiving bedaquiline at a DR-TB hospital in KwaZulu Natal, South Africa from September 2017 to February 2019. The primary outcome, a prolonged QT interval corrected using the Fridericia formula (QTcF), was defined as QTcF >500 ms, QTcF change >60 ms from baseline, or both. Among 420 patients (66.2% male, median age 36 years), the median QTcF was 406.4 (interquartile range [IQR], 389.1–421.3) ms at baseline, increasing to 430.5 (IQR, 414.4–445.1) ms by 3 months and 434.0 (IQR, 419.0–447.9) ms at 6 months. Eighteen of 420 patients (4.3%) had a QTcF >500 ms and 110 of 420 patients (26.2%) had a QTcF change >60 ms. There were no recorded arrhythmias or cardiac deaths. Odds of prolonged QTcF were increased with concomitant azoles (adjusted odds ratio [aOR], 5.61 [95% confidence interval (CI), 2.26–13.91]; P < .001) and an inverse association with HIV-positive status (aOR, 0.34 [95% CI, .15–.75]; P = .008) and hypertension (aOR, 0.13 [95% CI, .02–.86]; P = .02). After prolongation, the QTcF declined to <500 ms, whether drugs were interrupted or not. We observed a modest prolongation of QTcF, maximal at week 15; there were no recorded arrhythmias or related deaths. A modest QTcF prolongation, maximal at 15 weeks, was observed in patients receiving bedaquiline treatment for drug-resistant tuberculosis under programmatic conditions in KwaZulu-Natal, South Africa. There were no recorded arrhythmias or related deaths.
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影响因子：
24.3
作者：
Pym, Alexander S.;Diacon, Andreas H.;Dannemann, Brian
通讯作者：
Dannemann, Brian
DOI：
10.5588/ijtld.14.0944
发表时间：
2015-08-01
影响因子：
4
作者：
Ndjeka, N.;Conradie, F.;Pillay, Y.
通讯作者：
Pillay, Y.
影响因子：
76.2
作者：
Schnippel, Kathryn;Ndjeka, Norbert;Conradie, Francesca
通讯作者：
Conradie, Francesca
影响因子：
158.5
作者：
Diacon, Andreas H.;Pym, Alexander;Dannemann, Brian
通讯作者：
Dannemann, Brian
DOI：
10.1016/0735-1097(95)00426-2
发表时间：
1996-01-01
影响因子：
24
作者：
Molnar, J;Zhang, F;Rosenthal, JE
通讯作者：
Rosenthal, JE