重庆医科大学学报
重慶醫科大學學報
중경의과대학학보
UNIVERSITATIS SCIENTIAE MEDICINAE CHONGQING
2009年
12期
1743-1746
,共4页
阿莫西林氟氯西林钠胶囊%阿莫西林%克拉维酸钾片%随机试验%双盲双模拟法%呼吸道细菌感染
阿莫西林氟氯西林鈉膠囊%阿莫西林%剋拉維痠鉀片%隨機試驗%雙盲雙模擬法%呼吸道細菌感染
아막서림불록서림납효낭%아막서림%극랍유산갑편%수궤시험%쌍맹쌍모의법%호흡도세균감염
Amoxicillin floxacillin%Amoxicillin potassium clavulanate%Randomized controlled trials%Double-blind method%Bacterial infections in respiratory tract
目的:评价阿莫丙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(阿莫两林氟氯西林钠胶囊)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5～14 d.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.
目的:評價阿莫丙林氟氯西林鈉膠囊治療呼吸道細菌性感染的療效及安全性.方法:採用隨機雙盲雙模擬平行暘性藥臨床試驗設計,選用75例18～65歲的病人隨機分配到試驗組(阿莫兩林氟氯西林鈉膠囊)37例和對照組(阿莫西林剋拉維痠鉀片)38例.給藥方案為試驗組2粒阿莫西林氟氯西林鈉膠囊+1片阿莫西林,剋拉維痠鉀片的安慰劑,口服3次/d.對照組1片阿莫西林,剋拉維痠鉀片+2粒阿莫西林氟氯西林鈉膠囊的安慰劑,口服3次/d.試驗藥物與對照藥物療程均為5～14 d.結果:試驗組與對照組的痊愈率與有效率分彆為56.8%,58.3%與94.6%,91.7%,細菌暘性率分彆為81.3%與83.3%.細菌清除率分彆為100%與100%,不良反應髮生率分彆為2.7%與5.3%(P>0.05).結論:阿莫西林氟氯西林鈉膠囊是治療呼吸道細菌感染的有效和安全的藥物,與阿莫西林/剋拉維痠鉀片相噹.
목적:평개아막병림불록서림납효낭치료호흡도세균성감염적료효급안전성.방법:채용수궤쌍맹쌍모의평행양성약림상시험설계,선용75례18～65세적병인수궤분배도시험조(아막량림불록서림납효낭)37례화대조조(아막서림극랍유산갑편)38례.급약방안위시험조2립아막서림불록서림납효낭+1편아막서림,극랍유산갑편적안위제,구복3차/d.대조조1편아막서림,극랍유산갑편+2립아막서림불록서림납효낭적안위제,구복3차/d.시험약물여대조약물료정균위5～14 d.결과:시험조여대조조적전유솔여유효솔분별위56.8%,58.3%여94.6%,91.7%,세균양성솔분별위81.3%여83.3%.세균청제솔분별위100%여100%,불량반응발생솔분별위2.7%여5.3%(P>0.05).결론:아막서림불록서림납효낭시치료호흡도세균감염적유효화안전적약물,여아막서림/극랍유산갑편상당.
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 multicenter, 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 pilles 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 well-tolerated as amoxicillin clavulanic acid for the treatment of bacterial infections in respiratory tract.
