阿莫西林／克拉维酸钾(16：1)缓释片治疗急性细菌性感染141例临床观察  

Amoxicillin clavulanate (16:1 ) sustained-release tablet treats 141 bacterial infections:a multicenter,randomized controlled,double-blind clinical study

作　　者：彭凤英[1] 唐君[1] 黄文祥[1] 刘成伟[1] 于香安[2] 陈家存[3] 朱述阳[4] 韩晓雯[5] 彭小梅[6] 郦俊生 

机构地区：[1]重庆医科大学附属第一医院感染科,重庆市传染病寄生虫病学重点实验室,重庆400016 [2]兰州大学第二医院药剂科,兰州730046 [3]徐州医学院附属医院泌尿外科,江苏徐州221005 [4]徐州医学院附属医院泌呼吸内科,江苏徐州221005 [5]河北省人民医院呼吸内科,石家庄050051 [6]广西壮族自治区人民医院肾内科,南宁530021 [7]上海徐汇区中心医院泌尿外科,上海200000

出　　处：《第三军医大学学报》2008年第9期868-870,共3页Journal of Third Military Medical University

摘　　要：目的评价国产阿莫西林/克拉维酸钾(16∶1)缓释片治疗急性细菌性感染的有效性和安全性。方法采用多中心随机、双盲双模拟、平行对照临床试验设计方法,对入组的286例病例进行观察分析,其中纳入临床疗效FAS人群分析的病例数为284例,试验组和对照组分别为141例和143例;纳入PPS人群分析的病例数为266例,试验组和对照组各133例。试验组口服阿莫西林/克拉维酸钾(16∶1)缓释片每次500mg/31.25mg,对照组口服阿莫西林/克拉维酸钾(4∶1)每次500mg/125mg,用法均为2次/d,疗程均为5～10d。结果疗程结束时,试验组和对照组的总临床痊愈率、总有效率、总细菌清除率、不良事件发生率、药物相关不良反应发生率相比较,均无统计学差异(P>0.05)。结论国产阿莫西林/克拉维酸钾(16∶1)缓释片治疗急性细菌性感染的临床疗效和安全性与进口阿莫西林/克拉维酸钾(4∶1)普通片相当。Objective To evaluate the efficacy and safety of domestic amoxicillin clavulanate （ 16：1 ） sustained-release tablet in the treatment of acute bacterial infections. Methods A muhicenter double-blind randomized clinical trail was conducted. A total of 286 patients were enrolled in the study. There were 284 patients for FAS（ Full Analysis Set） analysis, including 141 in the treatment group and 143 in control group. While 266 patients were enrolled in PPS（ Per-Protocol Set） analysis, and there were 133 patients in each group. Amoxicillin clavulanate （16：1 ） and amoxicillin clavulanate （4：1 ） were given orally at a dose of 500 mg/31.25 mg or 500 mg/125 mg respectively twice one day for 5 - 10 d. Results At the end of treatment, the cure rates and efficacy rates were 68.79% and 92.91% in the treatment group, while 74.83% and 92.31% in the control group. The bacterial eradication rates were 96.51% for each group. Adverse reactions were 9.93% in the treatment group and 8.39% in the control group, and the drug-related clinical adverse were 7.80% and 2. 78%, respectively. No statistical difference between the 2 groups was observed （P 〉0.05 ）. Conclusion Domestic amoxicillin clavulanate （16：1 ） sustained-release tablet is as effective and safe as amoxicillin clavulanate （4：1 ） in the treatment of acute bacterial infections.

关 键 词：阿莫西林/克拉维酸 随机双盲对照 临床研究 

分 类 号：R63[医药卫生—外科学] R969.4[医药卫生—临床医学]