消结安胶囊治疗子宫肌瘤气滞血瘀证药品临床综合评价  

Comprehensive Clinical Evaluation of Xiaojie'an Capsules in Treatment of Uterine Fibroids with Qi Stagnation and Blood Stasis Syndrome

作　　者：马雨彤 路振凯 谢雁鸣[1] MA Yutong;LU Zhenkai;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国实验方剂学杂志》2025年第8期235-243,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局岐黄学者支持项目(国中医药人教函[2022]6号);全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]175号)。

摘　　要：目的:通过“6+1”维度的临床证据评估和综合价值分析,对消结安胶囊治疗子宫肌瘤的相关研究进行系统整理,凸显消结安胶囊的疗效与特点。方法:该研究基于循证医学、流行病学、药物经济学、卫生技术评估(HTA)等方法学,采用定性与定量相结合的评价方法,通过问卷调查、官网数据信息、已发表文献和真实世界数据的二次评估等,对中成药的安全性、有效性、经济性、创新性、适宜性、可及性及中医药特色,共计“6+1”维度构建评价体系。结果:(1)安全性:消结安胶囊2009年1月至2023年3月期间,国家不良反应监测中心报告一般不良反应159例(248例次),严重不良反应4例,经专家判读后均为一般不良反应。通过文献检索,使用消结安胶囊患者共计6 865例,其中报道消结安胶囊不良反应文献26篇,不良反应共计244例次。消结安胶囊不良反应临床表现包括恶心、呕吐、胃部不适、腹泻、皮疹、瘙痒、头晕、头痛、失眠等,且预后良好,药物警戒体系健全。根据已知风险和证据充分性两方面进行评价,在已知风险评价方面,根据自发呈报系统(SRS)监测结果,消结安胶囊共发现4例严重不良反应(ADR),经专家讨论后,最终将4例ADR判定为一般ADR,结合已知风险评价标准认为已知风险小。根据消结安胶囊已开展的研究类型(随机对照试验及其系统评价、SRS数据分析、真实世界人用经验研究、非临床安全性研究),参照证据充分性评价标准,认为消结安胶囊证据比较充分。该品种安全性证据充足,结果确定。(2)有效性:Meta分析结果显示,消结安胶囊联合米非司酮片与米非司酮片比较具有较好的临床疗效,在缩小最大子宫肌瘤体积方面效果更优,受降级因素局限性和不精确性的影响,证据质量评价为C级。综合有效性证据与价值评价,该品种有效性证据比较充分,结果明确。(3)经济性:经济学评价结�Objective:To systematically organize the relevant research on the treatment of uterine fibroids with Xiaojie'an capsules through clinical evidence evaluation and comprehensive value analysis in the"6+1"dimension,highlighting the efficacy and characteristics of Xiaojie'an capsules.Methods:Based on evidence-based medicine,epidemiology,pharmacoeconomics,health technology assessment(HTA),and other methodologies,this study adopted qualitative and quantitative evaluation methods.Through a questionnaire survey,official website data information,published literature,and secondary evaluation of real world data,a total of"6+1"dimensions were used to build an evaluation system for the safety,effectiveness,economy,innovation,suitability,accessibility of Chinese patent medicines,and characteristics of traditional Chinese medicines.Results:①Safety:From January 2009 to March 2023,the National Adverse Drug Reaction Monitoring Center reported 159 cases(248 cases)of general adverse reactions and four cases of serious adverse reactions to Xiaojie'an capsules,all of which were classified as general adverse reactions after expert judgment.Through literature search,a total of 6865 patients were treated with Xiaojie'an capsules,of which 26 articles reported adverse reactions to Xiaojie'an capsules,resulting in a total of 244 adverse reactions.The clinical manifestations of adverse reactions to Xiaojie'an capsules include nausea,vomiting,stomach discomfort,diarrhea,rash,itching,dizziness,headache,insomnia,etc.The prognosis was good,and the drug surveillance system was sound.Based on the evaluation of known risks and sufficient evidence,in terms of known risk assessment,according to the monitoring results of the spontaneous reporting system(SRS),there were four cases of serious adverse reactions to Xiaojie'an capsules.After expert discussion,the four cases of serious adverse reactions were finally judged as general adverse reactions,and the known risks were considered to be small in combination with the known risk evaluation criteria.Ac

关 键 词：消结安胶囊 子宫肌瘤 气滞血瘀证 临床综合评价 多准则决策分析 

分 类 号：R259[医药卫生—中西医结合] R271.1[医药卫生—中医内科学] R711[医药卫生—中医学]