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锌补充剂是否能增强羟氯喹的临床疗效?一项随机、多中心试验。

Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial.

机构信息

Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt.

Public health and Community Medicine, Menoufia University, Menoufia, Egypt.

出版信息

Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.

Abstract

No specific treatment for COVID-19 infection is available up till now, and there is a great urge for effective treatment to reduce morbidity and mortality during this pandemic. We aimed to evaluate the effect of combining chloroquine/hydroxychloroquine (CQ/HCQ) and zinc in the treatment of COVID-19 patients. This was a randomized clinical trial conducted at three major University hospitals in Egypt. One hundred ninety-one patients with a confirmed diagnosis of COVID-19 infection were randomized into two groups: group I (96) patients received both HCQ and zinc, and group II (95) received HCQ only. The primary endpoints were the recovery within 28 days, the need for mechanical ventilation, and death. The two groups were matched for age and gender. They had no significant difference regarding any of the baseline laboratory parameters or clinical severity grading. Clinical recovery after 28 days was achieved by 79.2% in the zinc group and 77.9% in zinc-free treatment group, without any significant difference (p = 0.969). The need for mechanical ventilation and the overall mortality rates did not show any significant difference between the 2 groups either (p = 0.537 and 0.986, respectively). The age of the patient and the need for mechanical ventilation were the only risk factors associated with the patients' mortality by the univariate regression analysis (p = 0.001 and < 0.001, respectively). Zinc supplements did not enhance the clinical efficacy of HCQ. More randomized studies are needed to evaluate the value of adding zinc to other therapies for COVID 19. ClinicalTrials.gov Identifier: NCT04447534.

摘要

目前尚无针对 COVID-19 感染的特定治疗方法,因此迫切需要有效的治疗方法来降低大流行期间的发病率和死亡率。我们旨在评估氯喹/羟氯喹(CQ/HCQ)和锌联合治疗 COVID-19 患者的效果。这是在埃及三家主要大学医院进行的一项随机临床试验。191 名确诊为 COVID-19 感染的患者被随机分为两组:组 I(96 名)患者接受 HCQ 和锌联合治疗,组 II(95 名)患者仅接受 HCQ 治疗。主要终点是 28 天内康复、需要机械通气和死亡。两组在年龄和性别方面相匹配。他们在任何基线实验室参数或临床严重程度分级方面均无显着差异。28 天后,锌组有 79.2%的患者临床康复,而无锌组为 77.9%,无显着差异(p=0.969)。两组之间也没有显着差异需要机械通气和总体死亡率(分别为 p=0.537 和 0.986)。单因素回归分析显示,患者的年龄和需要机械通气是与患者死亡相关的唯一危险因素(p=0.001 和 <0.001)。锌补充剂并未增强 HCQ 的临床疗效。需要更多的随机研究来评估在 COVID-19 治疗中添加锌的价值。ClinicalTrials.gov 标识符:NCT04447534。

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