阿比朵尔治疗流行性感冒的随机、双盲、安慰剂对照、多中心临床研究

目的验证盐酸阿比朵尔在中国自然获得流行性感冒受试者中的临床疗效并观察其安全性和耐受性.方法采用随机、双盲和安慰剂对照的多中心临床试验设计.共入组232人,入组条件为年龄≥18岁,≤65岁;发热≥37.8℃;符合流感疑似病例诊断标准;出现症状后不超过36 h.合格的受试者随机接受盐酸阿比朵尔200mg或安慰剂治疗,每日3次,共5 d.结果疗效分析总体为PPi,即指按规定服用药物并完成所有随访且实验室检查证明为流感病毒感染的病例,试验组59例,对照组66例.两组疾病缓解率经生存分析Logrank检验,试验组缓解率高于对照组.试验组疾病持续时间中位数为72.00h(95%可信区间为66.00～78.00h),对照组疾病持续时间中位数为96.00h(95%可信区间为87.46～104.54 h),两组比较差异有显著性(P=0.0083).试验组症状总分下降值的曲线下面积中位数为780.00(95%可信区间为700.77～859.23),对照组中位数为684.00(95%可信区间为559.81～808.19),两组经Wilcoxon检验差异有显著性(P=0.005).共有232例可用于安全性分析,试验组113例,对照组119例.共有20例不良事件可能与研究药物有关,其中试验组7例(6.19%),对照组13例(10.9%),两组间差异无显著性(P=0.245).不良反应主要为消化系统症状和血清转氨酶升高.结论盐酸阿比朵尔在流感发病后早期使用可以缩短疾病的持续时间,减轻症状的严重程度,而且其安全性和耐受性好,适合在临床推广使用.

Efficacy and safety of arbidol in treatment of naturally acquired influenza

OBJECTIVE: To evaluate the efficacy and safety of Arbidol in the treatment of naturally acquired influenza. METHODS: A randomized, double-blinded, placebo controlled trial was conducted. Subjects were enrolled. The inclusion criteria included: aged 18 to 65 years, presented within 36 hours of onset of influenza symptoms; and had documented temperature of 37.8 degrees C or higher during an influenza outbreak in the community. Individuals were randomly divided Arbidol group (200 mg three times daily for 5 days) or placebo group. RESULTS: Totally 232 individuals were recruited and received medication and follow-up. All of them were qualified to be analyzed for safety as intent-to-treat population (ITT) (113 Arbidol, 109 placebo). Twenty-two (9.48%) were during follow-up or refused to continue the trial, and 210 completed as schecule and identified as PP population (102 Arbidol, 108 placebo). Totally 125 individuals were identified as influenza-infected through laboratory test, which was defined as PPi population (59 Arbidol, 66 placebo). In PPi population, the cumulative alleviation proportion of Arbidol group was significantly higher than that of placebo group. The median duration of illness was 72.0 hours (95% confident interval (CI) 66.00-78.00 hours) in Arbidol group and 96.0 hours (95% CI 87.46-104.54 hours) in placebo group. The median area under the curve (AUC) of decreased total score were significantly higher in Arbidol group than in placebo group, which were 780.00 and 684.00 score-hours respectively. For PP population, similar results were seen. Adverse events reported were similar in Arbidol group and in placebo group. The main adverse events were gastrointestial symptoms and increased transaminase. CONCLUSION: Arbidol was effective and well tolerated in the treatment of early naturally acquired influenza.