Rouamba Toussaint, Barry Houreratou, Ouédraogo Esperance, Tahita Marc Christian, Yaméogo Nobila Valentin, Poda Armel, Diendéré Arnaud Eric, Ouedraogo Abdoul-Salam, Valea Innocent, Koné Amariane M, Thiombiano Cherileila, Traoré Isidore, Tarnagda Zekiba, Sawadogo Serge A, Gansané Zakaria, Kambiré Yibar, Sanou Idrissa, Barro-Traoré Fatou, Drabo Maxime K, Tinto Halidou
Institut de Recherche en Sciences de la Santé (CNRST-IRSS), Nanoro, Burkina Faso.
Institut National de Santé Publique, Centre Muraz, Bobo-Dioulasso, Burkina Faso.
Ther Clin Risk Manag. 2021 Nov 15;17:1187-1198. doi: 10.2147/TCRM.S330813. eCollection 2021.
Though chloroquine derivatives are used in the treatment of coronavirus disease 2019 (COVID-19) in many countries worldwide, doubts remain about the safety and efficacy of these drugs, especially in African communities where published data are scarce.
We conducted an observational prospective cohort study from April 24 to September 03, 2020, in Burkina Faso to assess (as primary outcome) the clinical, biological, and cardiac (electrocardiographic) safety of chloroquine or hydroxychloroquine plus azithromycin administered to COVID-19 patients. The main secondary outcomes were all-cause mortality and median time of viral clearance.
A total of 153 patients were enrolled and followed for 21 days. Among patients who took at least one dose of chloroquine or hydroxychloroquine (90.1% [138/153]), few clinical adverse events were reported and were mainly rash/pruritus, diarrhea, chest pain, and palpitations. No statistically significant increase in hepatic, renal, and hematological parameters or electrolyte disorders were reported. However, there was a significant increase in the QTc value without exceeding 500ms, especially in those who received chloroquine phosphate. Three adverse events of special interest classified as serious (known from chloroquine derivatives) were recorded namely pruritus, paresthesia, and drowsiness. One case of death occurred. The average onset of SARS-CoV-2 PCR negativity was estimated at 7.0 (95% CI: 5.0-10.0) days.
Hydroxychloroquine appeared to be well tolerated in treated COVID-19 patients in Burkina Faso. In the absence of a robust methodological approach that could generate a high level of scientific evidence, our results could at least contribute to guide health decisions that should be made based on different sources of scientific evidence including those from our study.
尽管氯喹衍生物在世界许多国家被用于治疗2019冠状病毒病（COVID-19），但这些药物的安全性和有效性仍存疑虑，尤其是在已发表数据稀少的非洲社区。
2020年4月24日至9月3日，我们在布基纳法索进行了一项观察性前瞻性队列研究，以评估（作为主要结局）给予COVID-19患者氯喹或羟氯喹加阿奇霉素的临床、生物学和心脏（心电图）安全性。主要次要结局是全因死亡率和病毒清除的中位时间。
共纳入153例患者并随访21天。在至少服用一剂氯喹或羟氯喹的患者中（90.1%[138/153]），报告的临床不良事件较少，主要是皮疹/瘙痒、腹泻、胸痛和心悸。未报告肝、肾、血液学参数或电解质紊乱有统计学意义的增加。然而，QTc值有显著增加，但未超过500毫秒，尤其是接受磷酸氯喹的患者。记录了3例被归类为严重的特殊不良事件（已知与氯喹衍生物有关），即瘙痒、感觉异常和嗜睡。发生1例死亡。SARS-CoV-2 PCR转阴的平均开始时间估计为7.0（95%CI：5.0-10.0）天。
在布基纳法索接受治疗的COVID-19患者中，羟氯喹似乎耐受性良好。在缺乏能够产生高水平科学证据的有力方法的情况下，我们的结果至少可以有助于指导应基于包括我们研究在内的不同科学证据来源做出的健康决策。
