阿比多尔片治疗流行性感冒有效性和安全性的开放性临床试验研究

Open clinical trial of arbidol tablet in the treatment of naturally acquired influenza

目的:评价阿比多尔治疗流行性感冒有效性和安全性。方法:共入选50例流行性感冒患者为研究对象,所用患者给予阿比多尔200mg,每日3次,共5 d。在治疗前和治疗后第3、7天共访视3次,评价其症状缓解情况和安全性。结果:50例患者中有15例病毒检测阳性,阳性率为30%。流感患者的临床痊愈率和有效率分别为88%和98%。治疗第3天和治疗结束后总症状积分较治疗前有显著下降(P<0.01)。50例患者发热症状均得到缓解,发热缓解时间中位数23.60h,其他症状75%以上得到缓解。不良反应发生率为6%,主要不良反应表现为消化道症状,无严重不良事件。结论:阿比多尔治疗流行性感冒是相对安全有效的。

Objective：To evaluate the efficacy and safety of Arbidol in the treatment of naturally acquired influenza.Methods：Accepting the 50 cases of infected patients as subjects.All patients were given Arbidol 200mg,3 times a day,a total of 5 day.Before treatment,3 days and 7 days after treatment,all patients were interviewed 3 times to evaluate the symptoms and adverse events.Results：Among the 50 cases,15 cases of patients with virus positive detection,virus positive rate was 30%.The clinical cure rate and clinical efficacy rate of arbidol was 88% and 98% respectively.the individual symptom and total symptom scores on 3th day and after whole therapy were significantly lower than those in pretherapy（P 〈0.01）.Fever response rate was 100%,alleviate time was 23.6h,other symptoms response rates were more than 75%.The incidence of adverse reaction was 6%,gastrointestinal symptoms were the main adverse reactions,there are no serious adverse events.Conclusion：Application of arbidol in the treatment of acute simple uncomplicated influenza is relatively safe and effective.