阿莫西林钠和氨苄西林钠分别与舒巴坦钠联合治疗急性细菌性感染临床研究

A randomized, single blind controlled clinical trial of amoxacillin/sulbactam versus ampicillin/sulbactam for treating acute bacteria infections

目的 本研究对阿莫西林钠 /舒巴坦钠与氨苄西林钠 /舒巴坦钠随机单盲对照治疗中、重度急性细菌性感染 ,评价阿莫西林钠 /舒巴坦钠的有效性与安全性。方法 采用区组随机单盲对照试验设计 ,完成试验药 2 0例及对照药1 9例感染患者的临床试验。结果 两组病例的一般项目基本相似 ,阿莫西林钠 /舒巴坦钠和氨苄西林 /舒巴坦钠治疗各种细菌感染的临床有效率分别为 85.0 0 %与 89.47% ,细菌学有效率为分别为 80 .0 0 %和 86.67% ,细菌清除率为93.33%与 1 0 0 % ,临床分离细菌的产酶率均为 66.67%。两组病例的不良反应发生率分别为 1 0 .0 0 %和 1 0 .53% ,不良反应轻微 ,不需特殊处理 ,停药后可自行恢复正常。 结论 阿莫西林钠 /舒巴坦钠是一种安全有效治疗细菌感染的药物 ,对β-内酰胺酶产生菌也同样有较好疗效 。

Objective To evaluate the clinical efficacy and safety of amoxacillin and ampicillin combined with sulbactam for treating mild and severe bacteria infections.method A randomized, single blind controlled clinical design was used to accomplish the clinical trial which included 20 cases in amoxacillin/sulbactam group and 19 cases in ampicillin/sulbactam group.Results The common data of patients in the two groups were similar. The clinical effective rates of amoxaxillin/sulbactam and ampicillin/sulbactam were 85.00% and 89.47%, respectively, and the bacterilogical effective rates were 80.00% and 86.67%, bacteria eradicating rates were 93.33% amd 100%, respectively. The β lactamase producing rate of these isolates was 66.67%. The rates of adverse reaction in the two groups were 10.00% and 10.53%, respectively.The side effects were mild and required no treatment. They would disappear after stopping administration of drugs.Conclusion Amoxacillin/sulbactam are effective and safe antimicrobial agents for treating acute bacteria infections, especially for the β lactamases producing isolates infections. It can be used to treat various infections caused by many bacteria.