PDF(Pubmed)
Abstract：
Some anti-mycobacterial drugs are known to cause QT interval prolongation, potentially leading to life-threatening ventricular arrhythmia. However, the highest leprosy and tuberculosis burden occurs in settings where electrocardiographic monitoring is challenging. The feasibility and accuracy of alternative strategies, such as the use of automated measurements or a mobile electrocardiogram (mECG) device, have not been evaluated in this context. As part of the phase II randomized controlled BE-PEOPLE trial evaluating the safety of bedaquiline-enhanced post-exposure prophylaxis (bedaquiline and rifampicin, BE-PEP, versus rifampicin, SDR-PEP) for leprosy, all participants had corrected QT intervals (QTc) measured at baseline and on the day after receiving post-exposure prophylaxis. The accuracy of mECG measurements as well as automated 12L-ECG measurements was evaluated. In total, 635 mECGs from 323 participants were recorded, of which 616 (97%) were of sufficient quality for QTc measurement. Mean manually read QTc on 12L-ECG and mECG were 394 ± 19 and 385 ± 18 ms, respectively (p < 0.001), with a strong correlation (r = 0.793). The mean absolute QTc difference between both modalities was 11 ± 10 ms. Mean manual and automated 12L-ECG QTc were 394 ± 19 and 409 ± 19 ms, respectively (n = 636; p < 0.001), corresponding to moderate agreement (r = 0.655). The use of a mECG device for QT interval monitoring was feasible and yielded a median absolute QTc error of 8 ms. Automated QTc measurements were less accurate, yielding longer QTc intervals.
摘要：
已知一些抗分枝杆菌药物会导致QT间期延长，可能导致危及生命的室性心律失常.然而,麻风病和结核病负担最高发生在心电图监测具有挑战性的地区.替代策略的可行性和准确性，例如使用自动测量或移动心电图（mECG）设备，没有在这种情况下进行评估。作为II期随机对照BE-PEOPLE试验的一部分，评估贝达奎林增强暴露后预防的安全性（贝达奎林和利福平，BE-PEP,对抗利福平,SDR-PEP)用于麻风病，所有参与者在基线时和接受暴露后预防后当天测量了校正的QT间期(QTc).评估了mECG测量以及自动12L-ECG测量的准确性。总的来说,记录了323名参与者的635个mECGs，其中616人（97%）具有足够的QTc测量质量。12L-ECG和mECG的平均手动读取QTc分别为394±19和385±18ms，分别(p<0.001)，具有很强的相关性(r=0.793)。两种模式之间的平均绝对QTc差为11±10ms。平均手动和自动12L-ECGQTc为394±19和409±19ms，分别为(n=636；p<0.001)，对应于中等一致性(r=0.655)。使用mECG设备进行QT间期监测是可行的，并且产生的绝对QTc误差中位数为8ms。自动QTc测量精度较低，产生较长的QTc间隔。
