Fan H W, Han Y, Liu W, Li X W, Li L Z, Yao H Y, Wang Y, Su Z Q, Ye W X, Huang J, Lu W Z, Li G W, Li H L, Wang S Y, Wu H, Lu Q F, Zhu G F, Liu S M, Chen G, Zhang W H, Li T S
Department of Infectious Disease, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
Department of Respiratory, Liuzhou Worker's Hospital, Liuzhou 545005, China.
Zhonghua Nei Ke Za Zhi. 2019 Aug 1;58(8):560-565. doi: 10.3760/cma.j.issn.0578-1426.2019.08.003.
To evaluate the effectiveness and safety of peramivir trihydrate in patients with influenza. This was a randomized, double-blind, double-dummy, placebo and positive control, multicenter clinical trial, comparing peramivir trihydrate with oseltamivir and placebo. The inclusive criteria were 15-70 years old, onset within 48 h, positive rapid influenza antigen test, and febrile (>38℃) accompanied with at least two associated symptoms. The severe cases complicated with chronic pulmonary and cardiac diseases, malignancies, organ transplantation, hemodialysis, uncontrolled diabetes, immunocompromised status, pregnancy and coexistence of bacterium infections were excluded. All patients were randomized 2∶2∶1 to receive peramivir, oseltamivir and placebo respectively. The primary endpoint was the disease duration, the secondary endpoints included time to normal axillary temperature and normal living activities, viral response, and adverse effects. Following informed consent, 133 patients were included in this study. Four patients were exclude due to missing medical records, not fitting inclusion or exclusion criteria and poor compliance. A total of 129 patients were finally analyzed, including 49 cases, 54 cases and 26 cases in peramivir group, oseltamivir group and placebo group. The median disease duration were 96 (76, 120) hours, 105 (90,124) hours, and 124 (104, 172) hours in three groups respectively (0.05) . The time to normal axillary temperature, normal living activities and viral response were not significantly different in three groups (0.05) . The value of antiviral therapy in patients with mild influenza needs to be further determined.
评估三水合帕拉米韦治疗流感患者的有效性和安全性。这是一项随机、双盲、双模拟、安慰剂和阳性对照的多中心临床试验，比较三水合帕拉米韦与奥司他韦及安慰剂。纳入标准为年龄15 - 70岁、发病48小时内、快速流感抗原检测呈阳性、发热（>38℃）并伴有至少两种相关症状。排除合并慢性肺和心脏疾病、恶性肿瘤、器官移植、血液透析、未控制的糖尿病、免疫功能低下状态、妊娠及合并细菌感染的重症病例。所有患者按2∶2∶1随机分组，分别接受帕拉米韦、奥司他韦和安慰剂治疗。主要终点为疾病持续时间，次要终点包括腋温恢复正常和生活活动恢复正常的时间、病毒反应及不良反应。在获得知情同意后，133例患者纳入本研究。4例患者因病历缺失、不符合纳入或排除标准及依从性差而被排除。最终共129例患者纳入分析，帕拉米韦组、奥司他韦组和安慰剂组分别为49例﹑54例和26例。三组的疾病持续时间中位数分别为96（76，120）小时、105（90,124）小时和124（104，172）小时（P>0.05）。三组腋温恢复正常时间、生活活动恢复正常时间及病毒反应差异均无统计学意义（P>0.05）。轻度流感患者抗病毒治疗的价值尚需进一步确定。
