国产奥硝唑栓治疗细菌性阴道病及滴虫性阴道炎的临床研究  

Clinical evaluation for ornidazole suppositories against bacterial and trichomonal vaginosis

作　　者：司延斌[1] 夏柳[1] 龚培力[1] 王泽华[2] 戴立人[2] 张怡[3] 胡华利[3] 朱付凡[4] 刘毅智[4] 

机构地区：[1]华中科技大学同济医学院临床药理研究所,武汉430030 [2]华中科技大学附属协和医院,武汉430022 [3]中南大学湘雅医院,长沙410008 [4]中南大学湘雅二医院,长沙410011

出　　处：《中国新药杂志》2006年第4期294-297,共4页Chinese Journal of New Drugs

摘　　要：目的:评价奥硝唑栓治疗厌氧菌所致阴道病及滴虫性阴道炎的临床疗效及其安全性。方法:采用多中心随机双盲对照的研究方法,共观察142例细菌性阴道病和130例滴虫性阴道炎患者。试验药为奥硝唑栓,对照药为甲硝唑栓,均为每日一次,每次500 mg,塞入阴道深处,疗程7 d。结果:奥硝唑栓和甲硝唑栓治疗细菌性阴道病痊愈率和有效率分别为62．3%,84．1%和54．8%,76．7%,细菌清除率分别为95．3%和94．1%;治疗滴虫性阴道炎的痊愈率和有效率分别为70．3%．98．4%和57．6%,97．0%。两组间比较均无统计学差异(P＞0．05)。试验组和对照组药物不良反应发生率分别为3．0%及5．0%(P＞0．05)。结论:奥硝唑栓治疗厌氧菌所致阴道病及滴虫性阴道炎安全有效,不良反应少。Objective：To evaluate the efficacy and safety of ornidazole suppositories made in China in the treatment of anaerobic bacterial and trichomonal vaginosis. Methods： A randomized, double-blind control and muhicenter clinical trial enrolled 142 patients with bacterial infection and 130 patients with trichomonal vaginosis, who were randomized to inserted high into vagina with either ornidazole suppositories （500 mg） or metronidazole suppositories （500 mg） once a day for 7 days. Resuits：For the patients with bacterial infections, ornidazole showed cure rates and overall effective rates of 62.3% and 84.1% , respectively, compared with the metronidazole of 54.8% and 76.7% ,respectively. The bacterial eradication rate was 95.3% versus 94.1%. For the patients with trichomonal vaginosis, the cure rates and overall effective rates of ornidazole and metronidazole were 70.3% vs. 57.6% , and 98.4% vs. 97.0% , respectively; the P values showed no statistical significance in both treatment groups （P 〉0.05）. The incidence rate of adverse events between two groups showed no significant difference （3.0% vs 5.0% ）. Conclusion： Ornidazole suppository is an effective and safe drug for treating anaerobic infection and trichomonal vaginosis.

关 键 词：奥硝唑栓 甲硝唑栓 随机对照盲法研究 阴道炎 

分 类 号：R969.4[医药卫生—药理学] R978.61[医药卫生—药学]