国产奥司他韦治疗流行性感冒的随机对照临床研究

目的 评价国产奥司他韦治疗流行性感冒(流感)的有效性与安全性.方法 采用随机单盲对照试验,国产组采用国产奥司他韦治疗,进口组采用进口奥司他韦治疗,用法均为75 mg/次,每日2次口服,疗程5 d.对两组治疗前、后的各项指标进行评价,以此判断疗效.两组基线和不良反应比较采用卡方检验,疗效差异性比较采用配对t检验.结果 共入选209例患者,其中国产组98例,进口组111例.两组在体温动态变化方面比较,差异无统计学意义(t=0.061,P>0.05).进口组症状评分在24～48 h内下降速度快于国产组,但至72 h时接近同一水平,两组比较差异无统计学意义(t=0.875,P>0.05).两组在不良反应方面比较,差异无统计学意义(X2=0.197,P>0.05).结论 国产奥司他韦治疗流感与进口奥司他韦同样安全、有效.

Randomized controlled clinical trial of domestic oseltamivir in patients with influenza

Objective To investigate the efficacy and safety of domestic oseltamivir in patients with influenza. Methods A randomized, single-blinded, controlled clinical trial was performed.Patients in the study group received domestic oseltamivir, while the patients in control group received foreign oseltamivir. The doses were both 75 mg every time, twice a day. The treatment durations in both groups were 5 days. Chi square test was performed to compare baseline characteristics and the difference of side effects. Paired t test was used to compare the efficacy. Results Two hundred and nine patients were enrolled in this study (98 cases in study group. 111 cases in control group). The trend in body temperature change was similar in the two groups (t = 0. 061, P>0. 05). The score of symptom severity decreased more quickly in patients treated with foreign oseltamivir compared to those treated with domestic oseltamivir during the period from 24 h to 48 h. However, the difference between the two groups diminished gradually and was not statistically significant at 72 h (t=0. 875,P>0. 05). The safety of the domestic and foreign oseltamivir were comparable(X2 = 0. 197,P>0. 05). Conclusion The domestic oseltamivir is as effective and safe as the foreign oseltamivir.