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目的研究环吡酮胺阴道乳膏治疗外阴阴道假丝酵母菌病(vulvovaginal candidiasis,VVC)的疗效。方法根据纳入标准和排除标准,于2012年1月至2013年10月共入选VCC患者605例,随机分配进入试验组和对照组。试验组阴道给予环吡酮胺乳膏5g/d(有效成分环吡酮胺0.05g/d),连用7d;对照组阴道给予硝酸咪康唑栓,200mg/d,连用7d。比较两组临床应用效果。结果最终共有586例患者完成试验,两组的均衡性良好。试验组和对照组用药24h内的症状缓解率分别为78.25%(223/285)和41.86%(126/301),差异有统计学意义(P<0.01);停药1周后总有效率分别为91.93%(262/285)和85.05%(256/301),差异有统计学意义(P<0.01)。试验组204例治愈患者在停药后3、6个月的复发率分别为0.49%(1/204)和3.92%(8/204),而对照组205例治愈患者的相应复发率分别为7.32%(15/205)和14.15%(29/205),两组比较差异有统计学意义(P<0.01)。两组不良反应均轻微。结论环吡酮胺阴道乳膏治疗VVC较硝酸咪康唑更为有效,且可明显降低复发率。
Objective To investigate the efficacy of Ciclopirox vaginal cream in the treatment of vulvovaginal candidiasis (VVC). Methods According to inclusion criteria and exclusion criteria, 605 patients with VCC were enrolled from January 2012 to October 2013 and randomly assigned to the experimental group and the control group. The test group was given ciclopirox olamine vaginally 5g / d (ciclopirox olamine 0.05g / d) for 7d; the control group was given miconazole nitrate suppositories, 200mg / d for 7d. The clinical effects of two groups were compared. Results A total of 586 patients eventually completed the trial, with good balance between the two groups. The remission rates of the experimental group and the control group within 24 hours of treatment were 78.25% (223/285) and 41.86% (126/301), respectively, with statistical significance (P <0.01) 91.93% (262/285) and 85.05% (256/301) respectively, the difference was statistically significant (P <0.01). The recurrence rates of 204 cured patients in trial group were 0.49% (1/204) and 3.92% (8/204) respectively at 3 and 6 months after discontinuation, while the corresponding recurrence rates of 205 cured patients in control group were 7.32 % (15/205) and 14.15% (29/205), respectively. The difference between the two groups was statistically significant (P <0.01). Adverse reactions were mild in both groups. Conclusion Ciclopirox ointment vaginal cream treatment of VVC than miconazole nitrate is more effective, and can significantly reduce the recurrence rate.