Cai Jianpeng, Wang Hongyu, Ye Xiaoting, Lu Shengjia, Tan Zhili, Li Zhonghua, Lin Dan, Qian Jiancheng, Lu Xiaoxian, Wan Jiaolong, Wang Jie, Ai Jingwen, Pu Yonglan, Qu Lihong, Wang Sen
Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Department of Infectious Diseases, The Third Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Front Microbiol. 2024 Jul 23;15:1428095. doi: 10.3389/fmicb.2024.1428095. eCollection 2024.
Baloxavir Marboxil is a per oral small-molecule antiviral for the treatment of influenza. While the efficacy and safety of Baloxavir Marboxil have been thoroughly characterized across an extensive clinical trial, studies on the effectiveness of Baloxavir Marboxil in a real-world setting are still scarce.
We conducted an ambispective, observational, multi-center study that enrolled uncomplicated in-fluenza outpatients treated with Baloxavir Marboxil or Oseltamivir in East China. The primary endpoint was time from treatment to alleviation of all influenza symptoms (TTAIS). The secondary endpoints included time from treatment to alleviation of fever (TTAF) and household transmission during the duration of influenza.
A total of 509 patients were enrolled. The median TTAIS in the Baloxavir Marboxil group and the Oseltamivir group was 28.0 h (IQR, 20.0 to 50.0) and 48.0 h (IQR, 30.0 to 67.0), respectively. The median TTAF in the Baloxavir Marboxil group and the Oseltamivir group was 18 h (IQR, 10.0-24.0) and 30.0 h (IQR, 19.0-48.0). In the COX multivariable analysis, Baloxavir Marboxil reduced the duration of influenza symptoms (HR = 1.36 [95%CI:1.12-1.64], = 0.002) and the duration of fever (HR = 1.93 [95%CI:1.48-2.52], < 0.001) compared to Oseltamivir. When antiviral drugs were given within 12-48 h after symptom onset, the Baloxavir Marboxil group had a significantly shorter TTAIS compared to the Oseltamivir group. There was no significant difference in the rate of adverse events between the two group ( = 0.555).
Baloxavir Marboxil was superior to Oseltamivir in alleviating influenza symptoms in outpatients with uncomplicated influenza. Our findings suggested that compared to Oseltamivir, Baloxavir Marboxil might be more appropriate for patients with influenza 12- 48 h after symptom onset.
巴洛沙韦酯是一种用于治疗流感的口服小分子抗病毒药物。虽然巴洛沙韦酯的疗效和安全性已在广泛的临床试验中得到充分表征，但关于巴洛沙韦酯在实际临床环境中的有效性研究仍然较少。
我们开展了一项回顾性、观察性、多中心研究，纳入了中国东部地区接受巴洛沙韦酯或奥司他韦治疗的无并发症流感门诊患者。主要终点为从治疗到所有流感症状缓解的时间（TTAIS）。次要终点包括从治疗到发热缓解的时间（TTAF）以及流感期间的家庭传播情况。
共纳入509例患者。巴洛沙韦酯组和奥司他韦组的TTAIS中位数分别为28.0小时（IQR，20.0至50.0）和48.0小时（IQR，30.0至67.0）。巴洛沙韦酯组和奥司他韦组的TTAF中位数分别为18小时（IQR，10.0 - 24.0）和30.0小时（IQR，19.0 - 48.0）。在COX多变量分析中，与奥司他韦相比，巴洛沙韦酯缩短了流感症状持续时间（HR = 1.36 [95%CI：1.12 - 1.64]，P = 0.002）以及发热持续时间（HR = 1.93 [95%CI：1.48 - 2.52]，P < 0.001）。当在症状出现后12 - 48小时内给予抗病毒药物时，巴洛沙韦酯组的TTAIS显著短于奥司他韦组。两组不良事件发生率无显著差异（P = 0.555）。
在缓解无并发症流感门诊患者的流感症状方面，巴洛沙韦酯优于奥司他韦。我们的研究结果表明，与奥司他韦相比，巴洛沙韦酯可能更适合症状出现后12 - 48小时的流感患者。
