奥司他韦治疗流行性感冒的临床评价  

A Randomized, Double - blinded and Controlled Clinical Evaluation of Oseltamivir in the Treatment of Influenza

作　　者：谭伟 侯杰[1] 陈旭岩[1] 熊辉[1] 李秀清[1] 张慧琳[1] 

机构地区：[1]北京大学第一医院急诊科,北京100034

出　　处：《中国临床医学》2002年第5期528-531,共4页Chinese Journal of Clinical Medicine

摘　　要：目的:观察奥司他韦治疗流行性感冒的疗效及安全性。方法:采用随机、双盲、安慰剂对照的临床试验。入选病例80例,73例完成试验(试验组34例,对照组39例);其中47例(试验组22例,对照组25例)证实为流感可分析疗效。76例可进行安全性分析。试验组:用奥司他韦75mg,po,bid,对照组:用安慰剂胶囊1粒,po,bid,疗程均5d。结果:47例中试验组肌肉酸痛和疲劳的缓解时间中位数分别为38.67h和41.33h,明显短于对照组的各相应缓解时间38.75h和64.42h(P<0.05)。试验组用解热镇痛剂量少于对照组。不良反应发生率两组无显著差异(P>0.05)。结论:口服奥司他韦可使健康成年流感病人的疾病持续时间减少、严重程度减轻。对治疗自然获得的流行性感冒安全、有效。Objective: To investigate the efficacy and safety of oseltamivir in the treatment of influenza. Methods-. We performed a randomized, double - blinded, placebo controlled clinical trial. 80 patients were enrolled and 73 cases were finished for this trial(34 oseltamivir, 39 placebo). 47 individuals were identified as influenza - infected and could be analized(22 oseltamivir, 25 placebo). For safety analysis, 76 individuals were included. Oseltamivir group: oseltamivir, 75mgpo,bid: placebo group: one placebo capsule po.bid, both for 5 days. Results: The median durations of muscular ache and fatigue were 38.67 and 41.33 h in oseltamivir group, which were significantly shorter than those in placebo group (38.75 and 64.42 h, P <0.05). The usage of analgesic was less in oseltamivir group than that in placebo group. Adverse events were similar in the two groups (P>0.05). Conclusion: Oseltamivir is effective and well tolerated in the treatment of naturally acquired influenza.

关 键 词：奥司他韦 流行性感冒 病毒性感染 临床试验 疗效 安全性 

分 类 号：R511.7[医药卫生—内科学] R969.[医药卫生—临床医学]