目的 开展苦参凝胶治疗外阴阴道假丝酵母菌病(VVC,湿热下注证)的临床综合评价。方法 经过系统梳理苦参凝胶治疗VVC(湿热下注证)的现有研究,采用定性和定量的相结合的评价方法,基于多准则决策(MCDA)模型,应用CSC v2.0软件,从“6+1”维度对苦参凝胶进行临床综合评价。结果 苦参凝胶开展了自发呈报系统(SRS)监测数据、随机对照试验(RCT)、真实世界研究、Meta分析和非临床安全研究,尚未发现严重不良反应,安全性评为A级;Meta分析显示苦参凝胶和抗真菌药物(氟康唑胶囊、克霉唑阴道片、克霉唑阴道泡腾片、酮康唑片)联合使用在假丝酵母菌转阴率、复发率、临床症状改善时间方面优于抗真菌药,有效性评为A级;采用决策树模型,根据增量效应水平分析,苦参凝胶联合克霉唑阴道片治疗方案更具有经济性,经济性评为B级;苦参凝胶联用抗真菌药可显著降低VVC的复发率,为国内首个阴道用卡波姆凝胶剂(专利号:ZL031151981),创新性评为B级;一般不需要个体化治疗方案,供应贮运方便较高,政策宣传促销信息和药品信息规范,医护、患者都易操作;中成药信息齐全,符合国家标准的规定,比较规范,准确;适宜性评为B级;药品价格属于中等,可负担性和可获得性均较好,可及性评为B级;来源于《金匮要略》的苦参汤,人用经验丰富,中医药特色评为B级。结论 综合“6+1”维度,采用CSC v2.0软件计算得出,苦参凝胶的临床价值评价为A类,建议可直接按程序转化为基本临床用药管理的相关政策结果。

Objective To evaluate the clinical effect of Kushen Gel(Kunlishu^®) on vulvovaginal candidiasis(damp-heat syndrome).Method This study through the system combing Kushen Gel(Kunlishu^®) treating vulvovaginal candidiasis(dampness-heat syndrome) of existing research, using the combination of qualitative and quantitative evaluation method, based on multiple criteria decision making(MCDA) model, the application of CSC v2.0, the clinical comprehensive evaluation of Kushen Gel(Kunlishu^®)was carried out from the dimension of "6+1".Results Kushen Gel(Kunlishu^®) has carried out self-reporting system(SRS)monitoring data, RCT, real world studies, Meta-analysis and non-clinical safety studies. No serious adverse reactions have been found, and its safety is rated as GRADE A. Meta-analysis showed that the combined use of Kushen Gel(Kunlishu^®) and antifungal drugs(fluconazole capsules, clotrimazole vaginal tablets, clotrimazole vaginal effervescent tablets, ketoconazole tablets) was superior to antifungal drugs in terms of candida negative conversion rate, recurrence rate and clinical symptom improvement time,and the effectiveness was rated as GRADE A. According to the analysis of incremental effect level, the treatment plan of Kushen Gel(Kunlishu^®) combined with clotrimazole vaginal tablet was more economical by decision tree model. However, due to the availability of data, this study only calculated direct medical costs, which is rated B for economy. Kushen Gel(Kunlishu^®) combined with antifungal drugs can significantly reduce the recurrence rate of VVC, which is the first vaginal carpod gel in China(patent no.ZL031151981), rated as B grade for innovation. Generally, there is no need for individual treatment plan, the supply, storage and transportation are relatively convenient, and the policy publicity and promotion information and drug information are standardized,which are easy to operate for doctors and patients. Chinese patent medicine information is complete, in line with the provisions of national standards, relatively standardized, accurate, Suitability rated as B. The price of drugs is medium, with good affordability and availability. Rated B for accessibility. It comes from the Golden Chamber synopsis, and people are experienced in using it. Chinese medicine features rated B.Conclusion Based on the "6 + 1" dimension, the CSC V2.0 software was used to calculate the clinical value of Kushen Gel(Kunlishu^®), and it was suggested that it could be translated directly into relevant policy results of basic clinical medication management according to the program.

R984

国家中医药管理局2021年岐黄学者支持项目(国中医药人教函[2022]6号); 中国中医科学院科技创新工程重大攻关项目(CI2021A00702)