环吡酮胺治疗外阴阴道假丝酵母菌病的随机对照研究
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第四军医大学西京医院妇产科

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Ciclopirox olamine in treatment of vulvovaginal candidiasis: a randomized controlled study
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    摘要:

    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5 g/d(有效成分环吡酮胺0.05 g/d),连用7 d;对照组阴道给予硝酸咪康唑栓,200 mg/d,连用7 d。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24 h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。

    Abstract:

    Objective To investigate the efficacy of ciclopirox olamine vaginal cream for treatment of vulvovaginal candidiasis(VVC). Methods According to the inclusion and exclusion criteria, 605 patients were enrolled in the present study from Jan. 2012 to Oct. 2013. The patients were randomly assigned to experimental group and the control group. Patients in the experimental group were given ciclopirox olamine ointment 5 g/d (ciclopirox olamine 0.05 g/d) for 7 days by vaginal delivery, and those in the control group were given miconazole nitrate suppositories 200 mg/d for 7 days in the same manner. The clinical efficacies of the two groups were compared. Results A total of 586 patients completed the study and the two groups had a good balance. The symptom remission rates 24 h after medication in the experimental group and the control group were 78.25% (223/285) and 41.86% (126/301), respectively, showing significant difference (P<0.01); and the total effective rates one week after treatment were 91.93% (262/285) and 85.05% (256/301), respectively, also showing significant difference between the two groups (P<0.01). The recurrence rates in 204 patients of the experimental group at 3 and 6 months after discontinuation were 0.49% (1/204) and 3.92% (8/204), while in 205 patients of the control group were 7.32% (15/205) and 14.15% (29/205), respectively, showing significant differences between the two groups at both time points(P<0.01). Conclusion Ciclopirox olamine vaginal cream is more effective than miconazole nitrate in treating VVC, and it can significantly reduce the recurrence rate.

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  • 收稿日期:2015-07-15
  • 最后修改日期:2015-09-28
  • 录用日期:2015-10-29
  • 在线发布日期: 2015-11-20
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