Shiraishi Chihiro, Kato Hideo, Hagihara Mao, Asai Nobuhiro, Iwamoto Takuya, Mikamo Hiroshige
Department of Pharmacy, Mie University Hospital, Mie, Japan; Department of Clinical Pharmaceutics, Division of Clinical Medical Science, Mie University Graduate School of Medicine, Mie, Japan.
Department of Pharmacy, Mie University Hospital, Mie, Japan; Department of Clinical Pharmaceutics, Division of Clinical Medical Science, Mie University Graduate School of Medicine, Mie, Japan; Department of Clinical Infectious Diseases, Aichi Medical University, Aichi, Japan.
J Infect Chemother. 2024 Mar;30(3):242-249. doi: 10.1016/j.jiac.2023.10.017. Epub 2023 Oct 20.
Baloxavir marboxil (BXM), a newly developed cap-dependent endonuclease inhibitor, is widely used to treat influenza virus infections in inpatients and outpatients. A previous meta-analysis included only outpatients and patients suspected of having an influenza virus infection based on clinical symptoms. However, whether BXM or oseltamivir is safer and more effective for inpatients remains controversial. Therefore, we conducted a systematic review and meta-analysis validating the effectiveness and safety of BXM versus oseltamivir in inpatients with influenza virus.
The Scopus, EMBASE, PubMed, Ichushi, and CINAHL databases were systematically searched for articles published until January 2023. The outcomes were mortality, hospitalization period, incidence of BXM- or oseltamivir-related adverse events, illness duration, and changes of virus titers and viral RNA load in patients with influenza virus infections.
Two randomized controlled trials with 1624 outpatients and two retrospective studies with 874 inpatients were enrolled. No deaths occurred in outpatients treated with BXM or oseltamivir. Among inpatients, BXM reduced mortality (p = 0.06) and significantly shortened hospitalization period (p = 0.01) compared to oseltamivir. In outpatients, BXM had a significantly lower incidence of adverse events (p = 0.03), reductions in influenza virus titers (p < 0.001) and viral RNA loads (p < 0.001), and a tendency to be a shorter illness duration compared with that of oseltamivir (p = 0.27).
Our meta-analysis showed that BXM was safer and more effective in patients than oseltamivir; thus, supporting the use of BXM for the initial treatment of patients with proven influenza virus infection.
巴洛沙韦酯（BXM）是一种新开发的帽依赖性内切核酸酶抑制剂，广泛用于治疗流感病毒感染的住院患者和门诊患者。先前的一项荟萃分析仅纳入了门诊患者以及根据临床症状怀疑感染流感病毒的患者。然而，对于住院患者而言，BXM和奥司他韦哪种更安全、更有效仍存在争议。因此，我们进行了一项系统评价和荟萃分析，以验证BXM与奥司他韦在流感病毒感染住院患者中的有效性和安全性。
系统检索了Scopus、EMBASE、PubMed、Ichushi和CINAHL数据库中截至2023年1月发表的文章。结局指标为死亡率、住院时间、BXM或奥司他韦相关不良事件的发生率、疾病持续时间以及流感病毒感染患者病毒滴度和病毒RNA载量的变化。
纳入了两项包含1624例门诊患者的随机对照试验和两项包含874例住院患者的回顾性研究。接受BXM或奥司他韦治疗的门诊患者均未发生死亡。在住院患者中，与奥司他韦相比，BXM降低了死亡率（p = 0.06）并显著缩短了住院时间（p = 0.01）。在门诊患者中，与奥司他韦相比，BXM的不良事件发生率显著更低（p = 0.03），流感病毒滴度降低（p < 0.001）和病毒RNA载量降低（p < 0.001），且疾病持续时间有缩短趋势（p = 0.27）。
我们的荟萃分析表明，BXM对患者而言比奥司他韦更安全、更有效；因此，支持将BXM用于确诊流感病毒感染患者的初始治疗。
