Randomized controlled clinical trial of domestic oseltamivir in patients with influenza / 中华传染病杂志

ABSTRACT

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.