Madioko Makanzu Brady, Makulo Jean-Robert, Ndona Mandina Madone, Wumba Dimosi Roger, Mashi Longokolo Murielle, Situakibanza Hippolyte, Odio Ossam, Sonzi Mangala Donat, Mihigo Bashengezi Constantin, Kabwe Mwilambwe Benjamin, Kabanda Kurhenga Gilbert, Longo-Mbenza Benjamin, Mwimba Mbungu Roger
Department of Cardiology, Kinshasa University Hospital, Kinshasa, DR Congo, Kinshasa University Hospital, Kinshasa 11, Congo.
Nephrology Unit, Kinshasa University Hospital, Kinshasa, Democratic Republic of the Congo, Kinshasa 11, Kinshasa, Congo.
World J Virol. 2024 Jun 25;13(2):90668. doi: 10.5501/wjv.v13.i2.90668.
QTc interval prolongation with an increased risk of torsade de pointes (Tsd) has been described in coronavirus disease 2019 (COVID-19) patients treated with hydroxychloroquine (HCQ) and azithromycin (AZI) in Western countries. In the DR Congo, few studies have evaluated the safety of this association or proposed new molecules.
To determine the incidence of QTc prolongation and Tsd in COVID-19 patients treated with HCQ-AZIs doubase C (new molecule).
In present randomized clinical trial, we have included patients with mild or moderate COVID-19 treated with either HCQ-AZI or doubase C. Electrocardiogram (ECG) changes on day 14 of randomization were determined based on pretreatment tracing. Prolonged QTc was defined as ≥ 500 ms on day 14 or an increase of ≥ 80 ms compared to pretreatment tracing. Patients with cardiac disease, those undergoing other treatments likely to prolong QTc, and those with disturbed ECG tracings were excluded from the study.
The study included 258 patients (mean age 41 ± 15 years; 52% men; 3.4% diabetics, 11.1% hypertensive). Mild and moderate COVID-19 were found in 93.5% and 6.5% of patients, respectively. At baseline, all patients had normal sinus rhythm, a mean heart rate 78 ± 13/min, mean PR space 170 ± 28 ms, mean QRS 76 ± 13 ms, and mean QTc 405 ± 30 ms. No complaints suggesting cardiac involvement were reported during or after treatment. Only four patients (1.5%) experienced QTc interval prolongation beyond 500 ms. Similarly, only five patients (1.9%) had an increase in the QTc interval of more than 80 ms. QTc prolongation was more significant in younger patients, those with high viral load at baseline, and those receiving HCQ-AZI ( < 0.05). None of the patients developed Tsd.
QTc prolongation without Tsd was observed at a lower frequency in patients treated with HCQ-AZI doubase C. The absence of comorbidities and concurrent use of other products that are likely to cause arrhythmia may explain our results.
在西方国家，接受羟氯喹（HCQ）和阿奇霉素（AZI）治疗的2019冠状病毒病（COVID-19）患者中，已发现QTc间期延长且尖端扭转型室速（Tsd）风险增加。在刚果民主共和国，很少有研究评估这种联合用药的安全性或提出新的药物。
确定接受HCQ-AZIs双碱基C（新药物）治疗的COVID-19患者中QTc延长和Tsd的发生率。
在目前的随机临床试验中，我们纳入了接受HCQ-AZI或双碱基C治疗的轻度或中度COVID-19患者。根据治疗前的心电图记录确定随机分组第14天的心电图变化。QTc延长定义为第14天≥500毫秒或与治疗前记录相比增加≥80毫秒。患有心脏病、正在接受其他可能延长QTc的治疗以及心电图记录异常的患者被排除在研究之外。
该研究纳入了258名患者（平均年龄41±15岁；52%为男性；3.4%为糖尿病患者，11.1%为高血压患者）。分别在93.5%和6.5%的患者中发现轻度和中度COVID-19。基线时，所有患者窦性心律正常，平均心率78±13次/分钟，平均PR间期170±28毫秒，平均QRS波群76±13毫秒，平均QTc 405±30毫秒。治疗期间或治疗后均未报告提示心脏受累的症状。只有4名患者（1.5%）的QTc间期延长超过500毫秒。同样，只有5名患者（1.9%）的QTc间期增加超过80毫秒。QTc延长在年轻患者、基线病毒载量高的患者以及接受HCQ-AZI治疗的患者中更为显著（<0.05）。没有患者发生Tsd。
接受HCQ-AZI双碱基C治疗的患者中，QTc延长但无Tsd的发生率较低。无合并症以及未同时使用其他可能导致心律失常的药物可能解释了我们的研究结果。
