中华传染病杂志
中華傳染病雜誌
중화전염병잡지
CHINESE JOURNAL OF INFECTIOUS DISEASES
2010年
5期
282-285
,共4页
杜蓉%冯琦%陈斌%曾春芳%龙波%赵新华%尹华%蒋奕%司果%李文君
杜蓉%馮琦%陳斌%曾春芳%龍波%趙新華%尹華%蔣奕%司果%李文君
두용%풍기%진빈%증춘방%룡파%조신화%윤화%장혁%사과%리문군
流感,人%奥司他韦%随机对照试验
流感,人%奧司他韋%隨機對照試驗
류감,인%오사타위%수궤대조시험
Influenza,human%Oseltamivir%Randomized controlled trial
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.
目的 評價國產奧司他韋治療流行性感冒(流感)的有效性與安全性.方法 採用隨機單盲對照試驗,國產組採用國產奧司他韋治療,進口組採用進口奧司他韋治療,用法均為75 mg/次,每日2次口服,療程5 d.對兩組治療前、後的各項指標進行評價,以此判斷療效.兩組基線和不良反應比較採用卡方檢驗,療效差異性比較採用配對t檢驗.結果 共入選209例患者,其中國產組98例,進口組111例.兩組在體溫動態變化方麵比較,差異無統計學意義(t=0.061,P>0.05).進口組癥狀評分在24～48 h內下降速度快于國產組,但至72 h時接近同一水平,兩組比較差異無統計學意義(t=0.875,P>0.05).兩組在不良反應方麵比較,差異無統計學意義(X2=0.197,P>0.05).結論 國產奧司他韋治療流感與進口奧司他韋同樣安全、有效.
목적 평개국산오사타위치료류행성감모(류감)적유효성여안전성.방법 채용수궤단맹대조시험,국산조채용국산오사타위치료,진구조채용진구오사타위치료,용법균위75 mg/차,매일2차구복,료정5 d.대량조치료전、후적각항지표진행평개,이차판단료효.량조기선화불량반응비교채용잡방검험,료효차이성비교채용배대t검험.결과 공입선209례환자,기중국산조98례,진구조111례.량조재체온동태변화방면비교,차이무통계학의의(t=0.061,P>0.05).진구조증상평분재24～48 h내하강속도쾌우국산조,단지72 h시접근동일수평,량조비교차이무통계학의의(t=0.875,P>0.05).량조재불량반응방면비교,차이무통계학의의(X2=0.197,P>0.05).결론 국산오사타위치료류감여진구오사타위동양안전、유효.
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.
