优得康与舒氨西林随机对照临床试验  

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

作　　者：吕媛[1] 李家泰[1] 张永龙[1] 陈扬 李淑芬[2] 顾俊明[3] 王慧玲[3] 何巧洁[3] 

机构地区：[1]北京医科大学第一医院临床药理研究所,北京100034 [2]卫生部北京医院呼吸内科,北京100006 [3]大连医科大学第二附属医院,大连116027

出　　处：《中国药学杂志》2000年第1期56-57,共2页Chinese Pharmaceutical Journal

摘　　要：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Q8h静脉点滴 ,疗程 7～ 10d)。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 0 5 )。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。OBJECTIVE: To evaluate the safety and efficacy of ampicillin/sulbactum in the treatment of bacterial infections METHOD: 172 patients with infections were enrolled in a randomized controlled open clinical trial Two generic products of ampicillin/sulbactum (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 efficacy 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 occurred in 10 8% and 13 8% in the two groups respectively There were no statistical difference between the two groups with respect to clinical efficacy, bacterial 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 combination in treating bacterial infections

关 键 词：氨苄西林 舒巴坦 细菌性感染 临床试验 

分 类 号：R515.05[医药卫生—内科学] R978.11[医药卫生—临床医学]