阿莫西林氟氯西林钠胶囊与阿莫西林/克拉维酸钾片随机对照治疗呼吸道细菌性感染75例

Amoxicillin floxacillin and amoxicillin clavulanic acid in the treatment of 75 cases of bacterial infections in respiratory tract

目的:评价阿莫西林氟氯西林钠胶囊治疗呼吸道细菌性感染的疗效及安全性。方法:采用随机双盲双模拟平行阳性药临床试验设计,选用75例18～65岁的病人随机分配到试验组(阿莫西林氟氯西林钠胶囊)37例和对照组(阿莫西林克拉维酸钾片)38例。给药方案为试验组2粒阿莫西林氟氯西林钠胶囊+1片阿莫西林/克拉维酸钾片的安慰剂,口服3次/d。对照组1片阿莫西林/克拉维酸钾片+2粒阿莫西林氟氯西林钠胶囊的安慰剂,口服3次/d。试验药物与对照药物疗程均为5～14d。结果:试验组与对照组的痊愈率与有效率分别为56.8%,58.3%与94.6%,91.7%,细菌阳性率分别为81.3%与83.3%,细菌清除率分别为100%与100%,不良反应发生率分别为2.7%与5.3%(P>0.05)。结论:阿莫西林氟氯西林钠胶囊是治疗呼吸道细菌感染的有效和安全的药物,与阿莫西林/克拉维酸钾片相当。

Objective：To evaluate the clinical efficacy and safety of amoxicillin floxacillin in the treatment of bacterial infections in respiratory tract. Methods：A total of seventy-five patients with respiratory infections were enrolled into this muhicenter, randomized controlled clinical study. Thirty-seven patients received amoxicillin floxacillin as trial group and thirty-eight patients received amoxicillin clavulanic acid as control group. Trial group were given amoxicillin floxacillin two pilles and one pill placebo of amoxicillin clavulanic acid thrice daily, while control group were give amoxicillin clavulanic acid one pill and two piiles placebo of amoxicillin floxacillin thrice daily, Duration of therapy was 5 to 14 days. Results： The cure and effective rates were 56.8% and 94.6% respectively in amoxicillin floxacillin group, 58.3% and 1.7% respectively in amoxicillin clavulanic acid group. The bacterial culture-positive rates,the bacterial eradication rates, and the adverse event rates in trial and control group were 81.3% and 83.3%, 100% and 100%, 2.7% and 5.3%, respectively. There were no significant differences between the two groups （P〉0.05）. Conclusion：Amoxicillin floxacillin is as effective and welltolerated as amoxicillin clavulanic acid for the treatment of bacterial infections in respiratory tract.