阿比多尔治疗急性病毒性上呼吸道感染的随机双盲对照临床研究

目的评价国产阿比多尔片治疗急性病毒性上呼吸道感染的疗效与安全性.方法采用随机双盲对照试验设计,将急性病毒性上呼吸道感染病人分为两组,试验组每次服用阿比多尔片200 mg,对照组每次服用利巴韦林片150 mg,用法均为口服,每日3次,疗程5～7天.结果66例病人入组并完成试验,试验组33例,对照组33例.试验组临床控制率、有效率在治疗第4天分别为27.3%、97.0%,治疗结束后分别为97.0%、100%;对照组治疗第4天分别为33.3%、84.9%,治疗结束后分别为78.8%、90.9%;两组临床控制率和有效率比较差异无显著性.试验组出现2例不良反应,包括1例中度口干和1例轻度嗜睡,3天内自行消失.两组不良反应发生率比较差异无显著性.结论阿比多尔片治疗急性病毒性上呼吸道感染疗效确切,不良反应轻,可以临床推广.

A randomized controlled clinical trial of arbidol in patients with acute viral upper respiratory infection

Objective To determine the efficacy and safety of arbidol in patients with acute viral upper respiratory infection(URI).Methods Patients with URI were divided into two groups according to randomized double-blinded controlled clinical trial principle.Patients in two groups were administrated with arbidol,200mg,tid or ribavirin 150mg,tid for 5 to 7 days respectively.Results 66 patients were enrolled and completed in the study,each group has 33 patients.The rate of cute and efficiency were 27.3% and 97.0% on 4th day and 97.0% and 100% after whole therapy respectively in the study group.The rate of cute and efficiency were 33.3% and 84.9% on 4th day and 78.8% and 90.9% after whole therapy respectively in the control group.There was no significant difference between the two groups(P>0.05).Two adverse events were found out in study group.One patient felt moderate thirsty and another felt mild sleepy.These adverse events were disappeared three days later without taken any action.There was no significant difference in the rate of adverse events between the two groups(P>0.05).Conclusion Arbidol is an effective and safe medicine for patients with URI.