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法匹拉韦与羟氯喹治疗 COVID-19 的安全性和有效性:一项随机对照试验。

Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomised controlled trial.

机构信息

Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Ramsis Street, Abbassia Square, Cairo, 11591, Egypt.

Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Centre (MASRI-CRC), Cairo, Egypt.

出版信息

Sci Rep. 2021 Mar 31;11(1):7282. doi: 10.1038/s41598-021-85227-0.

Abstract

Favipiravir is considered a potential treatment for COVID-19 due its efficacy against different viral infections. We aimed to explore the safety and efficacy of favipiravir in treatment of COVID-19 mild and moderate cases. It was randomized-controlled open-label interventional phase 3 clinical trial [NCT04349241]. 100 patients were recruited from 18th April till 18th May. 50 patients received favipiravir 3200 mg at day 1 followed by 600 mg twice (day 2-day 10). 50 patients received hydroxychloroquine 800 mg at day 1 followed by 200 mg twice (day 2-10) and oral oseltamivir 75 mg/12 h/day for 10 days. Patients were enrolled from Ain Shams University Hospital and Assiut University Hospital. Both arms were comparable as regards demographic characteristics and comorbidities. The average onset of SARS-CoV-2 PCR negativity was 8.1 and 8.3 days in HCQ-arm and favipiravir-arm respectively. 55.1% of those on HCQ-arm turned PCR negative at/or before 7th day from diagnosis compared to 48% in favipiravir-arm (p = 0.7). 4 patients in FVP arm developed transient transaminitis on the other hand heartburn and nausea were reported in about 20 patients in HCQ-arm. Only one patient in HCQ-arm died after developing acute myocarditis resulted in acute heart failure. Favipiravir is a safe effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.

摘要

法匹拉韦被认为是治疗 COVID-19 的一种潜在药物,因为它对不同的病毒感染有效。我们旨在探讨法匹拉韦治疗 COVID-19 轻症和中度病例的安全性和疗效。这是一项随机对照、开放标签的 3 期临床试验[NCT04349241]。从 4 月 18 日至 5 月 18 日,共招募了 100 名患者。50 名患者在第 1 天接受法匹拉韦 3200mg,然后每天两次(第 2 天至第 10 天)接受 600mg。50 名患者在第 1 天接受羟氯喹 800mg,然后每天两次(第 2 天至第 10 天)和口服奥司他韦 75mg/12h,持续 10 天。患者从艾因夏姆斯大学医院和阿西尤特大学医院招募。在人口统计学特征和合并症方面,两组均具有可比性。HCQ 组和法匹拉韦组的 SARS-CoV-2 PCR 阴性平均出现时间分别为 8.1 天和 8.3 天。在诊断后第 7 天或之前,HCQ 组有 55.1%的患者转为 PCR 阴性,而法匹拉韦组有 48%的患者转为 PCR 阴性(p=0.7)。法匹拉韦组有 4 例患者出现短暂性转氨基酶升高,而 HCQ 组约有 20 例患者出现胃灼热和恶心。HCQ 组只有 1 例患者因急性心肌炎导致急性心力衰竭而死亡。法匹拉韦是治疗 COVID-19 轻症或中度感染患者的一种安全有效的羟氯喹替代药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9ec/8012649/d4388bc45eb4/41598_2021_85227_Fig1_HTML.jpg

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