目的 開展苦參凝膠治療外陰陰道假絲酵母菌病(VVC,濕熱下注證)的臨床綜合評價。方法 經(jīng)過系統(tǒng)梳理苦參凝膠治療VVC(濕熱下注證)的現(xiàn)有研究,采用定性和定量的相結(jié)合的評價方法,基于多準則決策(MCDA)模型,應用CSC v2.0軟件,從“6+1”維度對苦參凝膠進行臨床綜合評價。結(jié)果 苦參凝膠開展了自發(fā)呈報系統(tǒng)(SRS)監(jiān)測數(shù)據(jù)、隨機對照試驗(RCT)、真實世界研究、Meta分析和非臨床安全研究,尚未發(fā)現(xiàn)嚴重不良反應,安全性評為A級;Meta分析顯示苦參凝膠和抗真菌藥物(氟康唑膠囊、克霉唑陰道片、克霉唑陰道泡騰片、酮康唑片)聯(lián)合使用在假絲酵母菌轉(zhuǎn)陰率、復發(fā)率、臨床癥狀改善時間方面優(yōu)于抗真菌藥,有效性評為A級;采用決策樹模型,根據(jù)增量效應水平分析,苦參凝膠聯(lián)合克霉唑陰道片治療方案更具有經(jīng)濟性,經(jīng)濟性評為B級;苦參凝膠聯(lián)用抗真菌藥可顯著降低VVC的復發(fā)率,為國內(nèi)首個陰道用卡波姆凝膠劑(專利號:ZL031151981),創(chuàng)新性評為B級;一般不需要個體化治療方案,供應貯運方便較高,政策宣傳促銷信息和藥品信息規(guī)范,醫(yī)護、患者都易操作;中成藥信息齊全,符合國家標準的規(guī)定,比較規(guī)范,準確;適宜性評為B級;藥品價格屬于中等,可負擔性和可獲得性均較好,可及性評為B級;來源于《金匱要略》的苦參湯,人用經(jīng)驗豐富,中醫(yī)藥特色評為B級。結(jié)論 綜合“6+1”維度,采用CSC v2.0軟件計算得出,苦參凝膠的臨床價值評價為A類,建議可直接按程序轉(zhuǎn)化為基本臨床用藥管理的相關(guān)政策結(jié)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

國家中醫(yī)藥管理局2021年岐黃學者支持項目(國中醫(yī)藥人教函[2022]6號); 中國中醫(yī)科學院科技創(chuàng)新工程重大攻關(guān)項目(CI2021A00702)