红核妇洁洗液治疗单纯性外阴阴道假丝酵母菌病的随机对照研究

目的:评价红核妇洁洗液治疗单纯性外阴阴道假丝酵母菌病(VVC)的有效性和安全性。方法:2014年6月至2016年6月在复旦大学附属妇产科医院门诊募集单纯性VVC患者,随机分为研究组(红核妇洁洗液组)和对照组(硝酸咪康唑软胶囊组),分别在治疗前和治疗结束后1~2周、4周、8周进行真菌检测、瘙痒评价、VVC评分、BV五项检测及安全性评估。结果:治疗后1~2周,研究组和对照组的瘙痒阳性率、真菌阳性率、VVC评分均呈显著下降趋势,两组比较无显著差异。两组治疗后4周与基线相比,p H值、唾液酸苷酶、白细胞脂酶、脯氨酸氨基肽酶阳性率显著下降,但两组无显著差异。治疗后8周,研究组的白细胞脂酶阳性率、VVC评分显著低于对照组。两组患者在治疗前后血常规、生化指标、心电图等无显著差异,无明显不良反应。结论:红核妇洁洗液治疗单纯性VVC有效、安全,在临床上值得进一步应用。

A randomised,case-control study of Honghe Fujie lotion for treating uncomplicated vulvovaginal candidiasis

Objective:To evaluate the efficiency and the safety of Honghe Fujie lotion for treating uncomplicated vulvovaginal candidiasis(VVC).Methods:Women with uncomplicated VVC were recruited in the clinic of the Obstetrics and Gynecology Hospital of Fudan University from June 2014 to June 2016,then were randomly divided into the experimental group (treated by Honghe Fujie lotion) and the control group (treated by miconazole nitrate soft capsule).Before and after treatment(one-two weeks,four weeks,eight weeks)we made fungal detection and tested the five indexes of bacterial vaginosis(BV),evaluated the itching,the VVC score and the safety.Results:One to two weeks after treatment both groups showed the significant downtrend in the positive rate of funguses,itching and the VVC score.There were no significant differences between two groups.Four weeks after treatment both groups showed the significant downtrend in the positive rate of pH,neuraminidase,leucocyte esterase and proline aminopeptidase.There were also no significant differences between two groups.In the 8th week follow-up after treatment,the experimental group had lower VVC score and the positive rate of leucocyte esterase than the control group.Patients in both groups had the similar results of blood test,biochemical indicators,electrocardiogram before and after treatment.In this study,there wasn't significant adverse effect.Conclusion:The Honghe Fujie lotion is effective and safe for treating uncomplicated VVC.It's worthy of further promotion in clinical practice.