国产硝呋太尔制霉素阴道软胶囊治疗阴道炎的临床研究

Effect of China made Nifuratel and Nysfungin Vaginal Soft Capsules on the treatment of vulvovaginal infections

目的 评价国产硝呋太尔制霉素阴道软胶囊治疗滴虫性阴道炎、细菌性阴道病、外阴阴道念珠菌病的临床疗效和安全性。方法 随机盲法平行对照多中心临床试验，进口麦咪康帕阴道栓为对照药。结果 有效病例为滴虫性阴道炎62例、细菌性阴道病65例、外阴阴道念珠菌病65例，各适应证的试验组及对照组受试者的临床症状、体征及妇科实验检查在用药前后均有明显改善（P〈0．01），各适应证的总有效率为90．0％～96．8％，试验组与对照组的疗效相似（P〉0．05），无严重不良事件发生，对肝肾功能血尿常规等均无影响，仅个别患者有轻微的阴道局部的刺激症状。结论 临床试验结果提示，国产硝呋太尔制霉素阴道软胶囊是一种可供选择的、能用于治疗细菌性阴道病、滴虫性阴道炎及外阴阴道念珠菌病的阴道局部药物。

Objective To evaluate the effect and safety of China made Nifuratel and Nysfungin Vaginal Soft Capsules in treating trichomoniasis, bacterial vaginosis （BV） and vulvovaginal candidiasis （VVC）. Methods Multicenter random control clinical trial was conducted on China made Nifuratel and Nysfungin Vaginal Soft Capsules, which was given to the women with trichomoniasis （n=62）, BV （n= 65） or VVC （n= 66）. Nifuratel - Nystatin Vaginal Suppositories （MACMIROR） served as control. Results The effective rates of China made Nifuratel and Nysfungin Vaginal Soft Capsules on trichomoniasis, BV and VVC were from 99. 0% to 96.8%, similar to the control groups （P〉0. 05）. Only a few of them complained of irritation in vulva and vagina. Conclusions The China made Nifuratel and Nysfungin Vaginal Soft Capsules can be an option in treatment of trichomoniasis, VVC and BV.