Purpose

The aim of this meta-analysis is to compare the clinical efficacy and safety of baloxavir with other anti-influenza agents or placebo in the treatment of influenza.

Methods

PubMed, Embase, Web of Science, Google Scholar, Scopus, CINAHL, Cochrane databases and clinical registration were searched from inception until February 15 2021 for relevant randomized controlled trials (RCTs). Only phase 3 RCTs evaluating the usefulness of baloxavir in the treatment of influenza were included.

Results

Three RCTs enrolling 3771 patients (baloxavir group, n = 1451; oseltamivir group, n = 1288; placebo group, n = 1032) were included. Compared with oseltamivir, baloxavir had an insignificantly shorter time to the alleviation of symptoms (mean difference [MD], −1.29 h; 95% CI, −6.80 to 4.21; I² = 0%). In contrast, baloxavir had a significantly shorter time to the alleviation of symptoms than placebo (MD, −26.32 h; 95% CI, −33.78 to −18.86; I² = 0%). Baloxavir was associated with a significant decline in influenza virus titers and viral RNA load compared to oseltamivir and placebo. Baloxavir was associated with a lower risk of any adverse events than oseltamivir (OR, 0.82; 95% CI, 0.69–0.98; I² = 0%) and placebo (OR, 0.79; 95% CI, 0.66–0.96; I² = 0%).

Conclusions

The findings of this meta-analysis suggested that baloxavir is superior to placebo in the treatment of influenza in both clinical outcome and virological response. Moreover, baloxavir was found to have a better virological response than oseltamivir and to be as effective as oseltamivir clinically. Compared with oseltamivir and placebo, baloxavir appears to be a relatively safe anti-influenza agent.

中文翻译：

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baloxavir marboxil 治疗流感的临床疗效和安全性：随机对照试验的系统评价和荟萃分析

目的

本荟萃分析的目的是比较巴洛沙韦与其他抗流感药物或安慰剂治疗流感的临床疗效和安全性。

方法

PubMed、Embase、Web of Science、Google Scholar、Scopus、CINAHL、Cochrane 数据库和临床注册从开始到 2021 年 2 月 15 日进行了相关随机对照试验 (RCT) 的搜索。仅包括评估巴洛沙韦治疗流感的有用性的 3 期 RCT。

结果

三项随机对照试验纳入了 3771 名患者（巴洛沙韦组，n = 1451；奥司他韦组，n = 1288；安慰剂组，n = 1032）。与奥司他韦相比，巴洛沙韦缓解症状的时间略短（平均差异 [MD]，-1.29 小时；95% CI，-6.80 至 4.21；I ²  = 0%）。相比之下，baloxavir 的症状缓解时间明显短于安慰剂（MD，-26.32 小时；95% CI，-33.78 至 -18.86；I ²  = 0%）。与奥司他韦和安慰剂相比，Baloxavir 与流感病毒滴度和病毒 RNA 载量显着下降有关。与奥司他韦相比，巴洛沙韦与任何不良事件的风险较低相关（OR，0.82；95% CI，0.69–0.98；I ² = 0%）和安慰剂（OR，0.79；95% CI，0.66–0.96；I ²  = 0%）。

结论

该荟萃分析的结果表明，baloxavir 在治疗流感方面的临床结果和病毒学反应均优于安慰剂。此外，发现巴洛沙韦比奥司他韦具有更好的病毒学反应，并且在临床上与奥司他韦一样有效。与奥司他韦和安慰剂相比，巴洛沙韦似乎是一种相对安全的抗流感药物。