头孢哌酮钠/舒巴坦钠防治妇产科感染531例疗效观察

Clinical Observation on 531 Cases of Infections in Obstetrics and Gynecology Treated with Cefoperazon Sodium/Sulbactam Sodium.

目的评价注射用头孢哌酮钠/舒巴坦钠预防和治疗妇产科感染的安全性和有效性。方法按照卫生部颁发的"抗菌药物临床研究指导原则"进行临床观察,与头孢他啶随机对照,比较注射用头孢哌酮钠/舒巴坦钠每次1.5g每12h 1次(轻度);1.5g每8h 1次(中度);3.0g每8h 1次(重度);预防治疗妇产科感染的临床疗效和安全性。结果试验组的临床痊愈率57.06%(303/531)高于对照组49.02%(225/459),其差异具有统计学意义(P<0.05),两组有效率分别为91.53%(486/531)和84.10%(386/459),细菌清除率分别为90.59%(414/457)和81.06%(321/396),(P<0.05),临床研究中未发现试验药物的严重不良反应。结论注射用头孢哌酮钠/舒巴坦钠对预防和治疗妇产科感染和手术后预防感染安全有效。

Objective To evaluate the clinical efficacy and safety of cefoperazone sodium and Sulbactam Sodium in the prevention and treatment of bacterial infections in obstetrics and gynecology. Methods The clinical observation was done according to the criteria for clinical research of antibiotics issued by the National Health Ministry. A randomized controlled clinical trial on efficacy and safety of cefoperazone sodium and sulbactam sodium vs ceftazidime at 1.5g every 12h （mild） and 1.5g every 8h （moderate） and 3.0g every 8h （serious） was conducted to prevent or treat bacterial infections. Results The curative rate of 57.06% （303/531） in the test group increased significantly （P 〈 0.05 ） as comparted with 49.02% （225/459） in control group. While significant differences were found in the efficacy rate 91.53% （486/531） vs 84.10% （386/459） and the bacterial clearance rate 90.59% （414/457） vs 81.06% （321/396） between the two groups （ P 〈 0.05 ）. There was no serious adverse drug reaction associated with trial drug in the clinical trial. Conclusion The injection of cefoperazone sodium and sulbactam sodium is effective and safe for the prevention and treatment of bacterial infections in obstetrics and gynecology.