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

作　　者：张紫寒 史宏晖[1] 郎景和[1] 徐涛[2] 熊巍[1] 李晓燕[1] 桂婷[1] 陶陶[1] 瞿红[3] 詹宇新[3] 刘崇东[3] 程素敏 孙霭萍[4] 邹杰 李茜[4] 程娇影[4] 潘红炬 廖志刚 ZHANG Zi-han;SHI Hong-hui;LANG Jing-he;XU Tao;XIONG Wei;LI Xiao-yan;GUI Ting;TAO Tao;QU Hong;ZHAN Yu-xin;LIU Chong-dong;CHENG Su-min;SUN Ai-ping;ZOU Jie;LI Qian;CHENG Jiao-ying;PAN Hong-ju;LIAO Zhi-gang(Department of Obstetrics and Gynecology,Peking Union Medical College Hospital,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院妇产科,北京100730 [2]中国医学科学院基础医学研究所流行病及统计学教研室,北京100730 [3]首都医科大学附属北京朝阳医院妇产科,北京100020 [4]中日友好医院妇产科,北京100029 [5]广东省外用药工程技术研究开发中心,广东佛山528300

出　　处：《中国实用妇科与产科杂志》2020年第6期555-558,共4页Chinese Journal of Practical Gynecology and Obstetrics

摘　　要：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.

关 键 词：外阴阴道假丝酵母菌病 克霉唑乳膏 克霉唑片剂 

分 类 号：R711[医药卫生—妇产科学]