阿莫西林克拉维酸钾颗粒(8∶1)治疗呼吸系统细菌感染多中心随机对照研究

A multicenter,randomized controlled clinical trial of amoxicillin and clavulanate potassium granules(8∶1) in the treatment of acute infection of respiratory system

目的:评价注射用阿莫西林克拉维酸钾颗粒(8∶1)治疗急性呼吸道感染的有效性和安全性。方法:采用多中心、随机、双盲、平行对照试验设计,共入选病例136例,其中试验组[阿莫西林克拉维酸钾颗粒(8∶1)]69例;对照组[阿莫西林克拉维酸钾片(7∶1)]69例;一般疗程均为7～14 d,最短疗程不少于5 d。结果:试验组治疗有效病例69例,治愈59例,临床痊愈率为89.39%;对照组治疗有效病例69例,治愈61例,临床治愈率为92.42%。细菌清除率:试验组为95.45%,对照组为92.91%,药物不良反应发生率均为4.35%。结论:阿莫西林克拉维酸钾颗粒(8∶1)治疗各种敏感菌所引起的呼吸道感染,安全、有效,使用方便,耐受性好。

Objective：To evaluate the efficacy and safety of amoxicillin and clavulanate potassium granules（8∶1） in the treatment of acute infection of respiratory system.Methods： A multicenter,randomized,double-blind,controlled clinical trial was conducted in the treatment of 138 patients with acute infection of respiratory system.There were 69 cases in the trial group：amoxicillin and clavulanate potassium granules（8∶1）,while 65 cases were in the control group：amoxicillin and clavulanate potassium gispersible tablets（7∶1）.The treatment duration for both groups was from 7 to 14 days（at least 5 days）.Results： The effective rate for the trial and control group was 89.39% and 92.42% respectively.The bacterial eradication rate was 95.45% and 92.91% respectively.The incidence of adverse reactions was 4.35% in both groups.Conclusion： Amoxicillin and clavulanate potassium granules（8∶1） is effective and safe in the treatment of acute infectin of respiratory system.