Objectives: To evaluate the effectiveness and safety of peramivir trihydrate in patients with influenza. Methods: 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. Results: 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 (P>0.05) . The time to normal axillary temperature, normal living activities and viral response were not significantly different in three groups (P>0.05) . Conclusion: The value of antiviral therapy in patients with mild influenza needs to be further determined.
目的： 评价帕拉米韦三水合物注射液治疗无并发症的急性流行性感冒（流感）的有效性和安全性。 方法： 随机、双盲双模拟、安慰剂和阳性药平行对照、多中心临床试验。纳入年龄15~70岁，起病在48 h内，流感病毒快速抗原检测阳性，体温超过38 ℃，至少有两个流感伴随症状，流感症状体征（influenza symptoms and signs, ISS）严重程度评分≥2分者。重症流感患者、合并慢性心肺疾病、恶性肿瘤、器官移植、血液透析、控制不佳的糖尿病、免疫功能缺陷，有合并细菌感染临床表现患者以及孕妇除外。受试者采用随机数字表法按照2∶2∶1随机分配进入帕拉米韦组、奥司他韦组和安慰剂组。疾病持续时间是主要研究终点，次要研究终点包括体温恢复正常所需时间、恢复正常生活起居所需时间、流感病毒阴转率以及不良反应。 结果： 133例受试者纳入本研究，4例被剔除（1例没有医疗记录，2例违背入排标准，1例没有服药），全分析集人群共129例，其中帕拉米韦组49例，奥司他韦组54例，安慰剂组26例。帕拉米韦组、奥司他韦组和安慰剂组疾病持续时间[M(P(25),P(75))]分别为96（76，120）h、105（90，124）h和124（104，172）h，差异无统计学意义（P>0.05）。三组间的体温恢复正常所需时间、恢复正常生活起居所需时间和病毒学阴转率差异也没有统计学意义（P>0.05）。 结论： 确诊的轻症流感患者抗病毒治疗的临床价值仍需进一步研究。.
Keywords: Influenza; Oseltamivir; Peramivir.