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目的评价特康唑阴道栓治疗外阴阴道假丝酵母菌病(vulvovaginal candidiasis,VVC)的有效性和安全性。方法采用多中心、随机、双盲对照的研究方法,将2004年5月至8月在复旦大学附属妇产科医院等4家医院就诊并确诊的139例外阴阴道假丝酵母菌病患者随机分为治疗组(特康唑组70例)和对照组(硝酸咪康唑组69例)。连续用药7d,分别于给药后1周和4周进行临床疗效、微生物疗效和复发率比较。结果两组VVC患者治疗后症状和体征均得到有效控制,但治疗组在给药4周后的临床症状和微生物学检查的复发率均为0,对照组的复发率分别为10.17%、16.67%,差异有统计学意义(P<0.05)。两组的不良反应发生率分别为5.7%和5.8%,差异无统计学意义(P>0.05),均未见严重不良事件。结论特康唑阴道栓抗真菌谱广、复发率低、安全性好,可作为治疗VVC的一个新选择。
Objective To evaluate the efficacy and safety of terconazole vaginal suppository in the treatment of vulvovaginal candidiasis (VVC). METHODS: A total of 139 patients with vulvovaginal candidiasis who were diagnosed and diagnosed in 4 hospitals including Obstetrics and Gynecology Hospital of Fudan University from May to August 2004 were randomized into two groups according to a multicenter, randomized and double-blind controlled study. For the treatment group (70 cases of the conazole group) and the control group (miconazole nitrate group 69 cases). Continuous treatment for 7 days, respectively, after administration of 1 week and 4 weeks for clinical efficacy, microbial efficacy and recurrence rate. Results The symptoms and signs of VVC in both groups were effectively controlled after treatment. However, the recurrence rates of clinical symptoms and microbiological examination in the treatment group after 4 weeks of treatment were both 0. The recurrence rates of the control group were 10.17% and 16.67% , The difference was statistically significant (P <0.05). Adverse reactions in both groups were 5.7% and 5.8%, respectively, with no significant difference (P> 0.05). No serious adverse events occurred in both groups. Conclusion It is a new choice for the treatment of VVC.