塞克硝唑片治疗滴虫阴道炎随机双盲双模拟临床研究  

Double-blind double-simulate randomized controlled clinical trial on secnidazole tablet in the treatment of trichomonal vaginitis

作　　者：董晓静[1] 胡丽娜[2] 刘宏伟[2] 周应芳[3] 张淑兰[4] 

机构地区：[1]重庆医科大学附属第二医院妇产科,重庆400010 [2]四川大学华西第二医院,四川成都610041 [3]北京大学第一医院,北京100034 [4]中国医科大学附属第二医院,辽宁沈阳110002

出　　处：《中国临床药理学杂志》2006年第2期83-86,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 评价塞克硝唑片（抗阴道滴虫药）治疗滴虫阴道炎的疗效和安全性.方法 用随机双盲双模拟对照试验,试验组64例,对照组58例,分别给予塞克硝唑片和替硝唑片顿服;于停药后3～7天和停药后月经来潮干净3～7天,观察外阴瘙痒、尿路刺激症状、白带和体征变化,进行阴道分泌物病原学检查.结果 停药后3～7天,试验组和对照组临床治愈率分别为48.44%和50.00%,有效率分别为93.75%和98.28%;滴虫阴转率分别为92.19%和98.28%.停药后、月经来潮干净后3～7天,临床治愈率分别为57.81%和58.62%,有效率分别为92.19%和89.66%;滴虫阴转率分别为92.19%和89.66%.2组比较差异均无统计学意义（P＞0.05）.未见明显药物不良反应.结论 塞克硝唑片治疗滴虫阴道炎安全、有效.Objective To evaluate the efficacy and safety of secnidazole tablet in the treatment of trichomonal vaginitis. Methods A double - blind double -simulate randomized controlled clinical trail was conducted. Sixty four cases in trial group were given secnidazole tablet and 58 cases in control group were given tinidazole tablet at draught. Vulva pruritus, symptoms of urethritis, leucorrhea, signs as well as pathogens were observed respectively 3 -7 day after the end of treatment and 3 to 7 day after menorrhea. Results After treatment, the cure rates were 48.44% in trial group, and 50.00% in control group; the efficacy rates were 93.75% and 98.28%, the eradicated rates of pathogen were 92.19% and 98.28% respectively. Three to 7 days after menorrhea, the cure rates were 57.81% in test group, and 58.62% in control group, the efficacy rates were 92.19% and 89.66%, the eradicated rates of pathogen were 92.19% and 89.66%, respectively. There was no significant statistic difference between these two groups in efficacy and safety （P 〉 0.05 ）. Conclusion Secnidazole tablet is an effective and safe preparation in the treatment of trichomonal vaginitis.

关 键 词：塞克硝唑片 替硝唑片 滴虫阴道炎 

分 类 号：R711.31[医药卫生—妇产科学] R984.3[医药卫生—临床医学]