School of Pharmacy and Pharmacology, University of Tasmania, Hobart, Australia.
School of Pharmacy, The University of Auckland, Auckland, New Zealand.
Infection. 2022 Feb;50(1):27-41. doi: 10.1007/s15010-021-01671-0. Epub 2021 Jul 31.
This review was aimed to synthesise the best available evidence on the effectiveness and safety of remdesivir in the treatment of moderate to severe COVID-19.
Randomised controlled trials (RCTs) and observational studies reporting the effectiveness and safety of remdesivir were searched via databases and other sources from December 2019 to December 2020. Two independent reviewers performed literature screening, data extraction and assessment of risk bias. Seven studies involving 3686 patients were included.
Treatment with remdesivir was associated with an increase in clinical recovery rate by 21% (RR 1.21; 95% CI 1.08-1.35) on day 7 and 29% (RR 1.29; 95% CI 1.22-1.37) on day 14. The likelihoods of requiring high-flow supplemental oxygen and invasive mechanical ventilation in the remdesivir group were lower than in the placebo group by 27% (RR 0.73; 95% CI 0.54-0.99) and 47% (RR 0.53; 95% CI 0.39-0.72), respectively. Remdesivir-treated patients showed a 39% (RR 0.61; 95% CI 0.46-0.79) reduction in the risk of mortality on day 14 compared to the control group; however, there was no significant difference on day 28. Serious adverse effects (SAEs) were significantly less common in patients treated with remdesivir, with an absolute risk difference of 6% (RD -0.06; 95% CI -0.09 to -0.03).
Despite conditional recommendation against its use, remdesivir could still be effective in early clinical improvement; reduction of early mortality and avoiding high-flow supplemental oxygen and invasive mechanical ventilation among hospitalised COVID-19 patients. Remdesivir was also well tolerated without significant SAEs compared to placebo, yet available evidence from clinical studies support the need to conduct close monitoring.
本综述旨在综合评估瑞德西韦治疗中重度 COVID-19 的疗效和安全性的最佳证据。
通过数据库和其他资源,检索 2019 年 12 月至 2020 年 12 月期间发表的关于瑞德西韦疗效和安全性的随机对照试验(RCT)和观察性研究。两名独立的审查员进行文献筛选、数据提取和风险偏倚评估。共纳入 7 项涉及 3686 例患者的研究。
瑞德西韦治疗组第 7 天和第 14 天的临床康复率分别增加了 21%(RR 1.21;95%CI 1.08-1.35)和 29%(RR 1.29;95%CI 1.22-1.37)。瑞德西韦组患者需要高流量补充氧和有创机械通气的可能性比安慰剂组分别降低了 27%(RR 0.73;95%CI 0.54-0.99)和 47%(RR 0.53;95%CI 0.39-0.72)。与对照组相比,瑞德西韦治疗组第 14 天的死亡率降低了 39%(RR 0.61;95%CI 0.46-0.79);然而,第 28 天无显著差异。与安慰剂组相比,瑞德西韦治疗组严重不良事件(SAEs)明显较少,绝对风险差异为 6%(RD -0.06;95%CI -0.09 至 -0.03)。
尽管有条件反对使用瑞德西韦,但它仍可能对早期临床改善有效;降低住院 COVID-19 患者的早期死亡率和避免高流量补充氧和有创机械通气。与安慰剂相比,瑞德西韦耐受性良好,无明显的严重不良事件,但来自临床研究的现有证据支持需要进行密切监测。