PMS & Pharmacoepidemiology Department, Shionogi Pharmacovigilance Center Co, Ltd, Osaka, Japan.
Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Clin Infect Dis. 2021 Sep 7;73(5):e1181-e1190. doi: 10.1093/cid/ciaa1870.
Baloxavir marboxil (baloxavir) is a single-dose, oral antiinfluenza drug with a novel mechanism of action. We compared the incidence of hospitalization in patients treated with baloxavir vs neuraminidase inhibitors.
In this retrospective, observational, cohort study, we used real-world patient data extracted from a Japanese health insurance claims database. The enrollment period was 1 October 2018 to 17 April 2019. On day 1, eligible patients (N = 339 007) received baloxavir, oseltamivir, zanamivir, or laninamivir. Baseline characteristics were standardized using the inverse probability of treatment weighting method. The primary end point was the incidence of hospitalization (days 2-14). Secondary end points included antibacterial use, secondary pneumonia, and additional antiinfluenza drug use.
Compared with the baloxavir group, the incidence of hospitalization was greater in the oseltamivir group (risk ratio [RR] and 95% confidence interval [CI], 1.41 [1.00-2.00]; risk difference [RD] and 95% CI, 0.06 [.01-.12]) and zanamivir group (RR, 1.85 [1.23-2.78]; RD, 0.11 [.02-.20]). Oseltamivir-treated patients were less likely to require antibacterials than baloxavir-treated patients (RR, 0.87 [.82-.91]). However, oseltamivir-treated patients were more likely to be hospitalized with antibacterials (RR, 1.70 [1.21-2.38]) or antibacterial injection (RR, 1.67 [1.17-2.38]) than baloxavir-treated patients (post hoc analysis). Compared with baloxavir-treated patients, additional antiinfluenza drug use was greater in oseltamivir-, zanamivir-, and laninamivir-treated patients (RR, 1.51 [1.05-2.18], 2.84 [2.04-3.96], and 1.68 [1.35-2.10], respectively).
Baloxavir is an efficacious antiinfluenza treatment that may reduce hospitalization compared with oseltamivir and zanamivir.
University hospital Medical Information Network Clinical Trials Registry (UMIN000038159).
巴洛沙韦马波西利（baloxavir marboxil，baloxavir）是一种具有新型作用机制的单剂量口服抗流感药物。我们比较了巴洛沙韦与神经氨酸酶抑制剂治疗患者的住院发生率。
在这项回顾性、观察性队列研究中，我们使用了从日本健康保险索赔数据库中提取的真实患者数据。入组时间为 2018 年 10 月 1 日至 2019 年 4 月 17 日。第 1 天，符合条件的患者（N=339007 人）接受了巴洛沙韦、奥司他韦、扎那米韦或拉尼米韦治疗。使用逆概率治疗加权法对基线特征进行了标准化。主要终点是住院（第 2-14 天）的发生率。次要终点包括抗菌药物使用、继发性肺炎和额外的抗流感药物使用。
与巴洛沙韦组相比，奥司他韦组（风险比[RR]和 95%置信区间[CI]，1.41[1.00-2.00]；风险差[RD]和 95%CI，0.06[0.01-0.12]）和扎那米韦组（RR，1.85[1.23-2.78]；RD，0.11[0.02-0.20]）的住院发生率更高。与巴洛沙韦组相比，奥司他韦治疗组更不可能需要抗菌药物（RR，0.87[0.82-0.91]）。然而，与巴洛沙韦治疗组相比，奥司他韦治疗组因需要抗菌药物（RR，1.70[1.21-2.38]）或抗菌药物注射（RR，1.67[1.17-2.38]）而住院的可能性更高（事后分析）。与巴洛沙韦治疗组相比，奥司他韦、扎那米韦和拉尼米韦治疗组的额外抗流感药物使用更多（RR，1.51[1.05-2.18]、2.84[2.04-3.96]和 1.68[1.35-2.10]）。
巴洛沙韦是一种有效的抗流感治疗药物，与奥司他韦和扎那米韦相比，可能降低住院率。
大学医院医学信息网临床试验注册（UMIN000038159）。
