优得康与舒氨西林随机对照临床试验

 目的：评价氨苄西林/舒巴坦（优得康）的安全性及临床疗效。方法：172例感染患者被入选随机对照及开放试验，与氨苄西林/舒巴坦（舒氨西林）比较。用药方法:两药均为（1.5～3g/次Q8 h静脉点滴，疗程7～10 d）。结果：随机对照治疗呼吸道和泌尿道感染，两组各65例。临床疗效试验药与对照药分别为90.8%与86.2%。细菌清除率分别为88.1%与81.7%。不良反应发生率分别为10.8%与13.8%。上述结果经统计学检验无显著性差异（P>0.05）。开放组临床有效率为88.1%。细菌清除率88.6%。不良反应发生率9.5%。结论：氨苄西林/舒巴坦为治疗临床常见的呼吸道和泌尿道感染的安全有效的抑酶增效联合制剂。 

A randomized controlled open study of ampicillin/sulbactum in the treatment of 172 cases with bacterial infections

OBJECTIVE：To evaluate the safety and efficacy of a mpicillin/sulbactum in the treatment of bacterial infections. METHOD：172 patients with infections were enrolled in a rando mized controlled open clinical trial. Two generic products of ampicillin/sulbac tum (AMP+SUL) was given intravenously 1.5～3.0 g each time, three times a day for 7～10 days. RESULTS：In the randomized controlled study, the clinical eff icacy rates of the trialed AMP+SUL and controlled AMP+SUL were 90.8% and 86.2% , the bacterial clearance rates were 88.1% and 81.7%, Adverse drug reactions o ccurred in 10.8% and 13.8% in the two groups respectively. There were no stat istical difference between the two groups with respect to clinical efficacy, bac terial clearance and adverse reaction. The results of the opened clinical trial showed the clinical efficacy rate of trialed APM+SUL were 88.1%, the bacterial eradication were 88.6%, the incidence of adverse drug reactions were 9.5%. CONCLUSION：Ampicillin/sulbactum is a safe and effective comb ination in treating bacterial infections.