头孢哌酮/舒巴坦钠与头孢噻肟随机对照及开放治疗细菌性感染182例临床评价

A randomized controlled clinical trial of cefoperazone versus cefotaxime in the treatment of 182 cases of bacterial infections

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。

Object To evaluate the safety and efficacy of the domestic cefoperazone/sulbactam. Method Randomized comparative controlled and open, clinical trial. Results Altogether 128 patients were evaluable for safety and efficacy in the controlled group, 66 of who received cefoperazone/sulbactam and 62 cefotaxime. The patients, who were 18 to 65 years of age, were treated for respiratory tract infections, urinary tract infections, skin and soft tissue infections, and other moderate to severe nosocomial infections. For the cefoperazone/sulbactam and cofotaxime treatment groups, response rates were 95.45% and 88.71% among all the patients. The bacterial eradication rate for both treatment groups was 95.38% and 93.44% respectively. Both regimens were well tolerated, with 4.55% and 6.45% of patients respectively in the cefoperazone/sulbactam and cofotaxime treatment groups, experiencing adverse reactions. In the open group, the response rate was 92.31% . The bacteria eradication rate were 92.45% and the adverse reaction rate was 3.70%. Conclusion Domestic cefoperazone/sulbactam is safe and effective in the treatment of moderate to severe bacterial infections including nosocomial infections.