摘要
目的:评价消癥丸治疗乳腺增生、子宫肌瘤的临床综合价值。方法:以消癥丸为评价对象,以《中成药临床综合评价指南(2022年版试行)》为准则,通过梳理文献及其他相关资料,围绕有效性、安全性、经济性、传承与创新性、适宜性和可及性6个维度进行综合评价。结果:在有效性方面,消癥丸可提高乳腺增生、子宫肌瘤的总有效率;在安全性方面,消癥丸的不良反应发生率低,以胃肠道、皮肤反应为主;在经济性方面,消癥丸的增量成本-效果比优于乳癖消胶囊等对照药;在传承与创新性方面,消癥丸获得国家二级中药保护品种和3项发明专利;在适宜性方面,消癥丸临床使用方便,其药品说明书符合现行规定;在可及性方面,消癥丸在多个省/直辖市/自治区均有销售,原料可持续供应。结论:消癥丸在治疗乳腺增生、子宫肌瘤2种疾病中呈现“疗效-安全-经济”多维优势,具有显著临床综合价值。建议后续开展真实世界大样本研究与长期成本-效用模型构建,为药品遴选提供高阶证据支持。
OBJECTIVE:To evaluate the clinical comprehensive value of Xiaozheng pills in the treatment of hyperplasia of mammary gland and hysteromyoma.METHODS:Taking Xiaozheng pills as the evaluation object and the Guidelines for Clinical Comprehensive Evaluation of Chinese Patent Medicines(2022 Trial Version)as the criterion,comprehensive evaluation was carried out around six dimensions of effectiveness,safety,economy,inheritance and innovation,suitability and accessibility by sorting out literature and other relevant materials.RESULTS:In terms of effectiveness,Xiaozheng pills could improve the total effective rate of hyperplasia of mammary gland and hysteromyoma.In terms of safety,Xiaozheng pills had low incidence of adverse drug reactions,mainly for gastrointestinal tract and skin reactions.In terms of economy,the incremental cost-effectiveness of Xiaozheng pills was superior to that of the control drugs such as Rupixiao capsules.In terms of inheritance and innovation,Xiaozheng pills had obtained national second-class protected varieties and three invention patents.In terms of suitability,Xiaozheng pills was easy to use and the drug instructions met the current regulations.In terms of accessibility,Xiaozheng pills was available for sale in multiple provinces,municipalities directly under the Central Government and autonomous regions,and the raw materials were consistently available.CONCLUSIONS:Xiaozheng pills demonstrates multi-dimensional advantages of“efficacy,safety and economy”in the treatment of hyperplasia of mammary gland and hysteromyoma,with significant clinical comprehensive value.Future large-scale real-world studies and long-term cost-utility modeling are recommended to strengthen evidence quality and inform clinical decision-making.
作者
郭媛媛
李慧
李佳怡
张然
马丽娜
顾媛媛
赵薇
李旨君
郑长辉
冷怡林
徐阳
郭丹丹
曹俊岭
何婷
GUO Yuanyuan;LI Hui;LI Jiayi;ZHANG Ran;MA Lina;GU Yuanyuan;ZHAO Wei;LI Zhijun;ZHENG Changhui;LENG Yilin;XU Yang;GUO Dandan;CAO Junling;HETing(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100029,China;Dept.of Oncology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Pharmaceutical Association,Beijing 100120,China;Dept.of Pharmacy,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Dept.of Pharmacy,Luoyang Hospital,Dongzhimen Hospital,Beijing University of Chinese Medicine,Henan Luoyang 471934,China;Dept.of Pharmacy,Beijing Gulou Hospital of Traditional Chinese Medicine,Beijing 100009,China;Dept.of Pharmacy,Beijing Royal Integrative Medicine Hospital,Beijing 102209,China;Caojunling National Veteran Pharmaceutical Worker Inheritance Studio,Henan Luoyang 471934,China)
出处
《中国医院用药评价与分析》
2025年第8期980-983,988,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
北京市中医管理局-中药临床应用评价项目(2022)
河南省临床中药学重点学科建设项目(No.豫卫中医药科教〔2024〕1号)。
关键词
消癥丸
乳腺增生
子宫肌瘤
临床综合评价
Xiaozheng pills
Hyperplasia of mammary gland
Hysteromyoma
Clinical comprehensive evaluation
