阿莫西林钠/舒巴坦钠与氨苄西林钠/舒巴坦钠随机对照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 in Treatment of Bacteriav 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 19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 4 7% ,细菌学有效率为分别为 80 0 0 %和 86 6 7% ,细菌清除率为 93 33%与 10 0 % ,临床分离细菌的产酶率均为 6 6 6 7%。两组病例的不良反应发生率分别为 10 0 0 %和 10 5 3% ,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.Result:The common data of patients in the two groups was similar.The clinical effective rates of amoxacillin/sulbactam and ampicillin/sulbactam were 85 00% and 89 47%,bacteriological effective rates were 80 00% and 86 67%,bacteria eradicate rates were 93 33% and 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% separately.The side effects were mild and not required to treat.They could disappear after stopping administering drugs.Conclusion:Amoxacillin/sulbactam is a 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 due to many bacteria.