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目的:评价阿莫西林克拉维酸钾咀嚼片(8∶1)治疗各种急性细菌感染的有效性和安全性。方法:采用随机、双盲、多中心、平行对照临床试验的方法,共纳入病例204例,试验组102例,给予阿莫西林克拉维酸钾咀嚼片(8∶1)2片,b id,同时服用阳性对照药模拟剂2片,tid。对照组102例,给予阿莫西林克拉维酸钾咀嚼片(4∶1)2片,tid,同时服用试验药模拟剂2片,b id,疗程均为7~14 d。结果:试验组和对照组的痊愈率分别为83.33%(85/102)和76.47%(78/102),有效率分别为92.16%(94/102)和89.22%(91/102),两组细菌清除率均为90.70%,阴转率均为84.71%。两组不良反应发生率分别为5.17%(6/116)和9.48%(11/116),以上结果两组组间比较均无统计学意义。结论:阿莫西林克拉维酸钾咀嚼片(8∶1)治疗各种急性细菌感染的疗效确切,安全性好。
Objective: To evaluate the efficacy and safety of amoxicillin and clavulanate potassium chewable tablets (8: 1) in the treatment of various acute bacterial infections. Methods: Randomized, double-blind, multicenter and parallel controlled clinical trials were performed. A total of 204 patients were enrolled and 102 patients in the test group were given 2 tablets of amoxicillin potassium clavulanate (8: 1) At the same time taking a positive control drug simulant 2, tid. Control group of 102 cases, given amoxicillin clavulanate potassium chewable tablets (4: 1) 2 tablets, tid, while taking two test drug simulants, b id, treatment were 7 to 14 days. Results: The cure rates of the two groups were 83.33% (85/102) and 76.47% (78/102) respectively, the effective rates were 92.16% (94/102) and 89.22% (91/102), respectively Bacterial clearance rates were 90.70%, the negative conversion rate was 84.71%. The incidence of adverse reactions in the two groups were 5.17% (6/116) and 9.48% (11/116), respectively. There was no significant difference between the two groups in the above results. Conclusion: Amoxicillin clavulanate chewable tablets (8: 1) is effective and safe for the treatment of various acute bacterial infections.