国产与进口azithromycin随机对照试验的临床评价  

Clinical evaluation of domestic and imported azithromycin in a randomized comparative study

作　　者：杨惠芬[1,2,3] 何屏[1,2,3] 胡文芝 温毅[1,2,3] 韩晓文 王增贵[1,2,3] 刘铁忱 姚春华[1,2,3] 韩秀君 

机构地区：[1]天津医科大学第二医院 [2]河北省人民医院 [3]河北医科大学附属第二医院

出　　处：《中国抗生素杂志》1998年第1期36-40,共5页Chinese Journal of Antibiotics

摘　　要：为评价国产ａｚｉｔｈｒｏｍｙｃｉｎ（ＡＺＭ）在临床治疗急性细菌性感染病人的有效性与安全性，我们以进口ＡＺＭ为对照药，进行随机对照试验治疗细菌性感染２００例。国产与进口ＡＺＭ组各１００例，治疗呼吸系统和皮肤软组织感染均为每日１次，首次５００ｍｇ，以后每次２５０ｍｇ，疗程７ｄ，治疗淋病均为单次口服１ｇ即可。两组痊愈率分别为８０．０％及８４．０％，有效率分别为９３．０％及９１．０％，细菌清除率分别为９３．３％及９２．１％，不良反应发生率分别为７％及６％，以上结果经统计学处理无显著性差异。国产ＡＺＭ临床疗效肯定，使用安全、方便。100 patients with the acute bacterial infections (50 patients with respiratory tract infections, 25 with skinsoft tissue infections, 25 with gonorrhoea) as a group were treated with domestic azithromycin compared with imported azithromycin in a randomized controlled trial for efficacy and safety of the domestic azithromycin. For respiratory tract and skinsoft tissue infections, an alternative given over 7 days with 500mg on day 1, then 250mg on days 2 to 7. For gonorrhoea, the dose is 1g given as a single dose. The results showed that the cure rate of domestic azithromycin was 80%, the effective rate was 93%. The bacterial eradication rate was 93.3%. The adverse reaction rate was 7%. There were no statistically significant difference between domestic azithromycin and imported one in overall results.

关 键 词：AZITHROMYCIN 细菌性感染 药物疗法 临床试验 

分 类 号：R978.15[医药卫生—药品] R515.05[医药卫生—药学]