克霉唑乳膏治疗外阴阴道假丝酵母菌病随机多中心前瞻性临床研究

A prospective randomized multicenter clinical study of clotrimazole cream in the treatment of vulvovaginal candidiasis

目的探讨克霉唑乳膏与克霉唑阴道片剂治疗外阴阴道假丝酵母菌病(VVC)的临床效果,为VVC的规范化治疗提供依据。方法根据非劣效界值为15%计算有效样本量,选取2016年3月至2019年3月北京协和医院、北京朝阳医院、中日友好医院门诊就诊女性按随机对照表随机入组,设定研究组与对照组各入组158例。研究组使用克霉唑乳膏治疗,对照组使用克霉唑阴道片剂治疗。观察两组患者治疗前后临床症状、临床治疗效果及不良反应。结果轻度VVC者的治疗痊愈率研究组为73.6%(78/106),对照组为69.0%(80/116);重度VVC者的治疗痊愈率研究组为68.8%(33/48),对照组为72.2%(26/36)。结论克霉唑乳膏可有效治疗轻度VVC,且更易融化、吸收,不良反应少;片剂更适合重症患者。

Objective To explore the clinical therapeutic effect of clotrimazole cream and clotrimazole tablets on vulvovaginal candidiasis(VVC)so as to provide evidence for standardized treatment.Methods The effective sample capacity is calculated according to 15%of the non-inferiority margin value,the patients with VVC treated in Peking Union Medical College Hospital,Beijing Chaoyang Hospital and China-Japan Friendship Hospital from March 2016 to March 2019 were randomized into a treatment group and a control group,with 158 patients in each group.In the treatment group clotrimazole cream was used.In the control group,clotrimazole tablets were used.The clinical symptoms,clinical efficacy and adverse reactions were observed in the two groups.Results For mild VVC,the cure rate by clotrimazole cream and tablets was 73.6%(78/106)in treatment group and 69.0%(80/116)in control group;For severe VVC,the cure rate by clotrimazole cream and tablets was 68.8%(33/48)in treatment group and 72.2%(26/36)in control group.Conclusion Clotrimazole cream is effective in the treatment of mild VVC,which is easy to dissolve and be absorbed,and has less adverse reactions.clotrimazole tablet is more suitable for severe VVC.