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_0.docVIP

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 【关键词】 ,头孢噻肟 Multicenter clinical trial on injection of cefotaxime sodium and sulbactam sodium in prevention and treatment of bacterial infections in obstetrics and gynecology 　　【Abstract】 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 Chinamade 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 (P0.05) 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 (P0.05). 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. 　　【Keywords】 cefotaxime; sulbactam; bacterial infections 　　【摘要】 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1.5 g，每12 h或8 h 1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（P0.05）. 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（P0.05）. 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. 　　【关键词】 头孢噻肟；舒巴克坦；细菌感染 　　0引言 　　注射用头孢噻肟钠配舒巴坦钠 （cefotaxime sodium and sulbactam sodium for injection）（商品名： 新治君），头孢噻肟是第三代头孢菌素，通过抑制细菌细胞壁合成而产生杀菌作用；舒巴坦对耐药菌产生的β内酰胺酶可产生不可逆的抑制作用. 两者合用时可增强头孢噻肟的抗酶作用和杀菌能力［1-2］. 为了评价新药注射用头孢噻肟钠配舒巴坦钠的临床疗效和安全性，我们用阿莫西林/克拉维酸钾对照药，进行多中心甘情愿随机对照临床 研究 . 　　1对象和方法 　　1.1对象 　　入选标准： 2003/2004中山市博爱 医院 妇