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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 sodium in the treatment of acute bacterial infections. Methods Ampicillin / sulbactam sodium was used as a control, and 113 cases were treated by randomized multicenter clinical trial. Among them, 58 cases in the test group and 55 cases in the control group. Amoxicillin / sulbactam sodium daily 4.5-6.0g, ampicillin / sulbactam sodium 4.5-12.0g daily, the two drugs were divided into two sub-intravenous infusion, treatment 7-14 days. Results The cure rate and effective rate of the experimental group and the control group were 75.86% and 80.0% (P> 0.05) and 94.83% and 98.18% respectively (P> 0.05). The rates of bacterial production in the two groups were 67.35% and 69.57%, respectively (P> 0.05). Bacterial clearance rates were 93.88% and 95.65% respectively. No serious adverse reactions were seen in both groups. Conclusion Amoxicillin / sulbactam sodium is effective and safe in the treatment of acute bacterial infections.