摘要
目的 评价阿莫西林/舒巴坦钠治疗急性细菌性感染的有效性和安全性。方法 以氨苄西林/舒巴坦钠为对照,采用多中心随机对照临床试验治疗急性细菌性感染113例,其中试验组58例、对照组55例。阿莫西林/舒巴坦钠每日4.5-6.0g、氨苄西林/舒巴坦钠每日4.5-12.0g,两药均分次静脉滴注,疗程7-14日。结果 试验组与对照组的痊愈率和有效率分别为75.86%与80.0%(P>0.05)和94.83%与98.18%(P>0.05)。两组细菌产酶率分别为67.35%与69.57%(P>0.05)。细菌清除率分别为93.88%与95.65%。两组均未见严重不良反应。结论 阿莫西林/舒巴坦钠治疗急性细菌性感染临床疗效确切,使用安全。
Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections.Method A multicentre randomized controlled clinical trial was conducted.Ampicillin/sulbactam (AMP/ SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group) .AMX/SUL and AMP/SUL were administered 4.5-6.0g and 4.5- 12.0g every day respectively.Both drugs were given intravenously for 7- 14 days. Results The cure rates and the efficacy rates of the two groups were 75.86% , 80.0% and 94.83 % , 98.18 % respectively. The β - lactamase producing rates were 67.35 % , 69.57 % and the bacterial clearance rates were 93.88 % , 95 .65 % . There were no significant differences of the above results between the two groups ( P > 0.05) .There was no serious adverse drug reaction in AMX/SBT groups.Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.