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羟氯喹治疗轻度 SARS-CoV-2 感染医护人员的疗效和安全性:前瞻性、非随机试验。

Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: Prospective, non-randomized trial.

机构信息

Clinical Pharmacology Service, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.

Occupational Health Service, Vall d'Hebron Hospital Universitari, Barcelona, Spain.

出版信息

Enferm Infecc Microbiol Clin (Engl Ed). 2022 Jun-Jul;40(6):289-295. doi: 10.1016/j.eimce.2020.10.015.

Abstract

OBJECTIVES

To assess the efficacy and safety of hydroxychloroquine (HCQ) compared with no treatment in healthcare workers with mild SARS-CoV-2 infection.

METHODS

Prospective, non-randomized study. All health professionals with confirmed COVID-19 between April 7 and May 6, 2020, non-requiring initial hospitalization were asked to participate. Patients who accepted treatment were given HCQ for five days (loading dose of 400mg q12h the first day followed by200mg q12h). Control group included patients with contraindications for HCQ or who rejected treatment. Study outcomes were negative conversion and viral dynamics of SARS-CoV-2, symptoms duration and disease progression.

RESULT

Overall, 142 patients were enrolled: 87 in treatment group and 55 in control group. The median age was 37 years and 75% were female, with few comorbidities. There were no significant differences in time to negative conversion of PCR between both groups. The only significant difference in the probability of negative conversion of PCR was observed at day 21 (18.7%, 95%CI 2.0-35.4). The decrease of SARS-CoV-2 viral load during follow-up was similar in both groups. A non significant reduction in duration of some symptoms in HCQ group was observed. Two patients with HCQ and 4 without treatment developed pneumonia. No patients required admission to the Intensive Care Unit or died. About 50% of patients presented mild side effects of HCQ, mainly diarrhea.

CONCLUSIONS

Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.

摘要

目的

评估羟氯喹(HCQ)与不治疗相比在轻度 SARS-CoV-2 感染的医护人员中的疗效和安全性。

方法

前瞻性、非随机研究。所有在 2020 年 4 月 7 日至 5 月 6 日期间确诊 COVID-19 的卫生专业人员,且无需初始住院治疗的人员均被要求参加。接受治疗的患者给予 HCQ 治疗五天(第一天给予负荷剂量 400mg q12h,随后给予 200mg q12h)。对照组包括有 HCQ 治疗禁忌或拒绝治疗的患者。研究结局为 SARS-CoV-2 阴性转换和病毒动力学、症状持续时间和疾病进展。

结果

共有 142 名患者入组:治疗组 87 例,对照组 55 例。中位年龄为 37 岁,75%为女性,合并症较少。两组 PCR 阴性转换时间无显著差异。仅在第 21 天观察到 PCR 阴性转换的概率有显著差异(18.7%,95%CI 2.0-35.4)。两组随访期间 SARS-CoV-2 病毒载量下降情况相似。HCQ 组观察到一些症状持续时间的非显著缩短。2 名接受 HCQ 治疗的患者和 4 名未接受治疗的患者发生肺炎。无患者需要入住重症监护病房或死亡。约 50%的患者出现了 HCQ 的轻度副作用,主要为腹泻。

结论

我们的研究未能显示 HCQ 在轻度 COVID-19 医护人员的病毒动力学和临床症状缓解方面有显著获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea79/9167951/ea5d938842eb/gr1_lrg.jpg

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