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羟氯喹在沙特阿拉伯 COVID-19 门诊患者批准治疗方案内的安全性结果。

Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia.

机构信息

Saudi Centre for Disease Prevention and Control, 70 SCDC Building, Al Aarid, King Abdulaziz Rd, Riyadh, 13354, Saudi Arabia.

King Fahad Medical City, 59046, Riyadh, 11525, Saudi Arabia.

出版信息

Int J Infect Dis. 2021 Jan;102:110-114. doi: 10.1016/j.ijid.2020.10.031. Epub 2020 Oct 17.

Abstract

BACKGROUND

Global healthcare is challenged following the COVID-19 pandemic, since late 2019. Multiple approaches have been performed to relieve the pressure and support existing healthcare. The Saudi Arabian Ministry of Health (MOH) launched an initiative to support the National Healthcare System. Since the 5 of June 2020, 238 outpatient fever clinics were established nationwide. This study aimed to assess the safety outcome and reported adverse events from hydroxychloroquine use among suspected COVID-19 patients.

METHOD

A cross-sectional study included 2,733 patients subjected to MOH treatment protocol (hydroxychloroquine) and followed-up within 3-7 days after initiation. Data was collected through an electronic link and cross-checked with the national database (Health Electronic Surveillance Network, HESN) and reports from the MOH Morbidity and Mortality (M&M) Committee.

RESULTS

240 patients (8.8%) discontinued treatment because of side effects (4.1%) and for non-clinical reasons in the remaining (4.7%). Adverse effects were reported among (6.7%) of all studied participants, including mainly cardiovascular (2.5%, 0.15% with QTc prolongation), and gastrointestinal (2.4%). No Intensive Care Unit admission or death were reported among these patients.

CONCLUSION

Our results show that hydroxychloroquine for COVID-19 patients in mild to moderate cases in an outpatient setting, within the protocol recommendation and inclusion/exclusion criteria, is safe, highly tolerable, and with minimum side effects.

摘要

背景

自 2019 年底 COVID-19 大流行以来,全球医疗保健面临挑战。已经采取了多种方法来缓解压力并支持现有的医疗保健。沙特阿拉伯卫生部 (MOH) 发起了一项倡议,以支持国家医疗保健系统。自 2020 年 6 月 5 日以来,全国范围内设立了 238 个门诊发热诊所。本研究旨在评估疑似 COVID-19 患者使用羟氯喹的安全性结果和报告的不良事件。

方法

一项横断面研究包括 2733 名接受 MOH 治疗方案(羟氯喹)的患者,并在开始后 3-7 天内进行随访。通过电子链接收集数据,并与国家数据库(电子卫生监测网络,HESN)和 MOH 发病率和死亡率(M&M)委员会的报告进行交叉核对。

结果

240 名患者(8.8%)因副作用(4.1%)和其他非临床原因(4.7%)停止治疗。在所有研究参与者中,报告了 6.7%的不良事件,主要包括心血管(2.5%,0.15%伴有 QTc 延长)和胃肠道(2.4%)。这些患者中没有报告进入重症监护病房或死亡。

结论

我们的结果表明,在门诊环境中,根据方案建议和纳入/排除标准,对轻度至中度 COVID-19 患者使用羟氯喹是安全的,具有高度耐受性,并且副作用最小。

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