注射用头孢噻肟钠配舒巴坦钠预防和治疗妇产科感染的多中心临床对照研究

目的：评价注射用头孢噻肟钠配舒巴坦钠预防和治疗妇产科感染的安全性、有效性及不良反应．方法：用多中心随机对照的方法，比较注射用头孢噻肟钠配舒巴坦钠每次1．5g，每12h或8h1次，预防治疗妇产科感染的临床疗效和安全性．结果：试验组的痊愈率（80．8％）高于对照组（75．2％），其差异具有统计学意义（P〈0，05）．两组的有效率分别为95．5％和94．1％，细菌清除率分别为和96．4％和95．2％，两组有效率和细菌清除率之间差异无统计学意义（P〉0．05）．试验中未发现应用注射用头孢噻肟钠配舒巴坦钠的严重药物不良反应．结论：国产注射用头孢噻肟钠配舒巴坦钠对预防和治疗妇产科感染的和手术后预防感染安全有效药物，临床疗效好、且药物不良反应少．

Multicenter clinical trial on injection of cefotaxime sodium and sulbactam sodium in prevention and treatment of bacterial infections in obstetrics and gynecology

AIM: To evaluate the clinical efficacy, safety and adverse drug reaction of cefotaxime sodium and sulbactam sodium in the prevention and treatment of bacterial infections in obstetrics and gynecology. METHODS: A randomized controlled multicenter clinical trial on the efficacy and safety of China-made cefotaxime sodium and sulbactam sodium at 1.5 g every 12 h (mild), 3.0 g every 12 h (moderate) and 3.0 g every 8 h (serious) was conducted to prevent or treat bacterial infections. RESULTS: The curative rate (80.8%) in the test group increased significantly (P<0.05) compared with that of control group (75.2%), while no significant differences were found in the efficacy rate (95.5% vs 94.1% ) and the bacterial clearance rate ( 96.4% vs 95.2%) between the 2 groups (P>0.05). There was no serious adverse drug reactions to cefotaxime sodium and sulbactam sodium in the clinical trial. CONCLUSION: The injection of cefotaxime sodium and sulbactam sodium is effective and safe for the prevention and treatment of bacterial infections in obstetrics and gynecology.