摘要
目的:开展复方金钱草颗粒治疗泌尿系结石(UC)湿热下注证的临床综合评价研究。方法:综合应用临床流行病学、循证医学、卫生技术评估、问卷调查等方法,对本品治疗UC的安全性、有效性、经济学等维度进行评价,并利用多准则决策分析框架进行临床综合评价。结果:本评价开展了自发呈报系统(SRS)数据分析、上市后随机对照试验(RCT)、Meta分析等,安全证据较充分,已知风险较小,安全性评价为B级。本品联合常规西药治疗UC术后或非手术治疗均可提高痊愈率,加快结石排出,有效性评价为A级。成本-效果分析显示,增量成本效果比(ICER)为2 270元,敏感性分析结果稳健;价格与同类产品相比,属于中等,经济学评价为B级。本品是国家专利品种,企业注重服务体系和产业创新,创新性评价为B级。本品对医护人员、患者的适宜性较好,适宜性评价为B级。本品药品价格较低,可负担性好,其城镇居民和农村居民可负担性分别为7.32%和19.44%,药材资源丰富,可及性评价为A级。本品组方针对湿热下注病机而设,上市后有超过2000例的人用经验,中医药特色评价为B级。结论:复方金钱草颗粒治疗UC湿热下注证临床综合评价为B级。
Objective:To conduct a comprehensive clinical evaluation of Compound Jinqiancao Granules for the treatment of urinary calculi(UC) with dampness-heat pouring down syndrome.Methods:A multidisciplinary approach integrating clinical epidemiology,evidence-based medicine,health technology assessment,and questionnaire surveys was employed to evaluate the safety,efficacy,economic value,and other relevant aspects of Compound Jinqiancao Granules for the treatment of UC.A multi-criteria decision analysis framework was applied for comprehensive clinical assessment.Results:The evaluation included spontaneous reporting system(SRS) data analysis,post-marketing randomized controlled trials(RCTs),and meta-analyses,indicating sufficient safety evidence with minimal known risks,resulting in a B-grade safety rating.This product,when combined with conventional Western medicine,improved the cure rate and accelerated stone expulsion in both postoperative and non-surgical treatment of UC,with an A-grade efficacy rating.Cost-effectiveness analysis showed an incremental cost-effectiveness ratio(ICER) of 2 270 CNY,with stable sensitivity analysis results.The product′s price was moderate compared to similar treatments,leading to a B-grade economic evaluation.As a patented product,the manufacturer emphasizes service systems and industrial innovation,receiving a B-grade innovation rating.The product demonstrated good suitability for both healthcare providers and patients,earning a B-grade suitability rating.With a relatively low price and good affordability 7.32% for urban residents and 19.44% for rural residents—the product benefits from abundant medicinal resources,leading to an A-grade accessibility rating.Designed specifically for the dampness-heat pouring down syndrome,the formulation has accumulated post-marketing human experience exceeding 2 000 cases,receiving a B-grade TCM characteristics rating.Conclusion:The comprehensive clinical evaluation of Compound Jinqiancao Granules for UC with dampness-heat pouring down syndrome is B-grade.
作者
付常宽
刘峘
席俊羽
谢雁鸣
黎元元
FU Changkuan;LIU Huan;XI Junyu;XIE Yanming;LI Yuanyuan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《世界中医药》
北大核心
2025年第5期833-838,842,共7页
World Chinese Medicine
基金
国家重点研发计划项目(2018YFC1707400)
中国中医科学院科技创新工程重大攻关项目(CI2021A00702)
中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)
2021年岐黄学者支持项目(国中医药人教函[2022]6号)。
关键词
中成药
复方金钱草颗粒
泌尿系结石
湿热下注证
多准则决策分析
临床综合评价
中药上市后评价
循证评价
Chinese patent medicine
Compound Jinqiancao Granules
Urinary calculi
Dampness-heat pouring down syndrome
Multi-criteria decision analysis
Clinical comprehensive evaluation
Post-marketing evaluation of Chinese medicine
Evidence-based evaluation
