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目的：评价国产头孢哌酮／舒巴坦钠的安全性及有效性。方法：随机对照及开放临床试验。结果：随机对照治疗呼吸道感染及泌尿系感染１２８ 例，其中试验药６６ 例，对照药６２例，两组痊愈率分别为７２．７３％和６２．９０％ ，总有效率分别为９５．４５％ 和８８．７１％ ；头孢哌酮／舒巴坦钠与头孢噻肟对各种致病菌感染的痊愈率分别为７２．３１％ 和６３．９３％ ，有效率分别为９５．３８％ 和８８．５２％ ；两组细菌阳性率分别为９８．４８％ （６５／６６）和９８．３９％ （６１／６２），治疗后细菌清除率为９５．３８％ 与９３．４４％ ；头孢哌酮／舒巴坦钠不良反应发生率为４．５５％ ，头孢噻肟不良反应发生率为６．４５％ ，以上结果均无统计学显著差异（Ｐ＞ ０．０５）。开放治疗呼吸道感染及皮肤感染５４例，临床痊愈率６４．８１％ ，有效率９０．７４％ 。开放组对各种细菌感染的痊愈率与有效率分别为６７．３１％ 与９２．３１％ ，细菌清除率为９２．４５％ ，不良反应发生率为３．７０％ 。结论：头孢哌酮／舒巴坦钠，临床疗效好，不良反应轻微，对于临床常见中至重度呼吸道、泌尿道及皮肤软组织感染是一个安全、有效的药物
Objective: To evaluate the safety and efficacy of domestic cefoperazone / sulbactam sodium. Methods: Randomized controlled and open clinical trials. Results: Randomized controlled treatment of respiratory tract infection and urinary tract infection in 128 cases, of which 66 cases of test drugs, 62 cases of control drug, the cure rate was 72.73% and 62.90%, the total effective rate was 95.45% And 88.71%, respectively. The cure rates of cefoperazone / sulbactam and cefotaxime on various pathogenic bacteria were 72.31% and 63.93% respectively, the effective rates were 95.38% and 88 .52%. The positive rates of bacteria in the two groups were 98.48% (65/66) and 98.39% (61/62) respectively, the bacterial clearance rates were 95.38% and 93.44% / Sulbactam sodium adverse reaction rate was 4.55%, cefotaxime adverse reaction rate was 6.45%, the above results were no statistically significant difference (P> 0.05). Open treatment of respiratory infections and skin infections in 54 cases, the clinical cure rate was 64.81%, the effective rate was 90.74%. In the open group, the cure rate and effective rate of various bacterial infections were 67.31% and 92.31% respectively, the bacterial clearance rate was 92.45% and the adverse reaction rate was 3.70%. Conclusion: Cefoperazone / sulbactam sodium has good clinical curative effect and mild adverse reactions. It is a safe and effective drug for clinical common moderate to severe respiratory tract, urinary tract and skin and soft tissue infections