磷酸奥司他韦治疗流行性感冒的临床疗效和安全性

Efficacy and safety of oseltamivir in the treatment of naturally acquired influenza in China

目的 验证磷酸奥司他韦在自然获得流行性感冒 (流感 )患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临床试验设计。 95例患者随机接受磷酸奥司他韦 75mg或安慰剂治疗。 结果 证实流感患者 (即ITTI总体 ) 6 0例 ,治疗组 2 9例 ,对照组 31例。ITTI总体治疗组疾病持续时间中位数为 74.5h( 95 %可信区间为 5 7.0～ 10 4.3h) ,对照组疾病持续时间中位数为 119.0h( 95 %可信区间为 90 .4～ 138.8h) ,两组疾病缓解率在统计学上差异有显著性(P =0 .0 13 5 )。ITTI总体治疗组症状总分下降值的曲线下面积中位数为 15 15 .2 ,高于对照组的12 33 .8,但无统计学意义 (P =0 .12 76 )。共 91例可进行安全性分析 ,总结不良反应的发生率 ,治疗组和对照组无统计学差异。不良反应主要为消化系统症状。结论 磷酸奥司他韦在流感发病后早期使用 ,可以明显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。

Objective To evaluate the efficacy and safety of oseltamivir in the treatment of naturally acquired influenza in China. Methods A randomized,double-blinded, placebo controlled trial were conducted in Beijing. Individuals were randomized to oseltamivir group(75 mg twice daily for 5 days ) or placebo group. Results 95 individuals were enrolled into the study, and 60 individuals who were infected with influenza were included to intent-to-treat infected group(ITTI) (29 oseltamivir and 31 placebo). In ITTI population, the median duration of illness was significantly shorter in the oseltamivir group than in the placebo group, which were 74.5 hours(95% CI 57.0～104.3 hours) and 119.0 hours(95% CI 90.4～138.8 hours) respectively.The median total area under curve of decreased symptom scores were slightly higher in the oseltamivir group than in the placebo group, which were 1 515.2 and 1 233.8 respectively(P= 0.127 6). 91 individuals were included for safety analysis. Adverse events reported were similar in oseltamivir group and in placebo group. The main adverse events were gastrointestial symptoms. Conclusions Oseltamivir was effective and well tolerated in the treatment of early naturally acquired influenza.