左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的多中心临床研究  

Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections

作　　者：马玲[1] 张元珍[1] 郑漪霖[2] 王泽华[3] 徐友娣[4] 孔丽娜[5] 

机构地区：[1]武汉大学中南医院妇产科,430071 [2]南京医科大学第一附属医院妇产科 [3]华中科技大学同济医学院附属协和医院妇产科 [4]南京市第一医院妇产科 [5]皖南医学院弋矶山医院妇产科

出　　处：《中华妇产科杂志》2010年第10期754-756,共3页Chinese Journal of Obstetrics and Gynecology

基　　金：国家重大新药创制项目（2008ZX09101-101）

摘　　要：目的 评价左奥硝唑氯化钠注射液（其他名称：优诺安）治疗厌氧菌引起的盆腔感染的临床有效性及安全性.方法 2007年2至10月,采用多中心、随机、双盲、阳性药物、平行对照试验设计方法,将武汉大学中南医院、南京医科大学第一附属医院、华中科技大学同济医学院附属协和医院,南京市第一医院、皖南医学院戈矶山医院就诊的、经筛选符合厌氧菌性盆腹腔感染标准的143例患者随机分为观察组70例,对照组73例.观察组患者用左奥硝唑氯化钠注射液0.5 g,静脉滴注,0.5～1 h内滴完,每天两次,5～7 d为一疗程;对照组用奥硝唑氯化钠注射液静脉滴注,用药剂量及疗程同观察组.比较两组患者用药后的临床治愈率、细菌清除率和不良反应发生率.结果 疗程结束时,临床治愈率观察组为80%（56/70）,对照组为81%（59/73）,两组比较,差异无统计学意义（P＞0.05）;观察组厌氧菌细菌清除率为97%（36/37）,对照组厌氧菌细菌清除率为92%（22/24）,两组比较,差异也无统计学意义（P＞0.05）;不良反应发生率观察组为3%（2/70）,对照组为22%（16/73）,两组比较,差异有统计学意义（P＜0.05）.结论 左奥硝唑氯化钠注射液用于厌氧菌性盆腔感染的治疗有效、安全.Objective To evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. Methods A multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0. 5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. Results At the endpoint, the rate of clinical efficacy were 80% （56/70） in study group and 81% （59/73） in control group, which did not reach significant difference （P＞0. 05）. The rate of bacteria clearance were 97% （36/37） in study group and 92% （22/24） in control group, which also did not reach significant difference（P ＞0. 05）. The rate of adverse reaction of 3% （20/70） in study group was significantly lower than 22% （ 16/73 ） in control group （ P ＜ 0. 05 ）. Conclusion It is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

关 键 词：奥硝唑 细菌 厌氧 盆腔感染 多中心研究 

分 类 号：R686[医药卫生—骨科学]