儿泻停颗粒治疗小儿急性腹泻(湿热泻)的临床综合评价  

Clinical comprehensive evaluation of Erxieting Granules for treatment of acute pediatric diarrhea(damp-heat diarrhea)

作　　者：曾静 胡思源[1] 白思远 李梅芳[1] 牛丽青 张梦也 许玥 蔡秋晗 ZENG Jing;HU Siyuan;BAI Siyuan;LI Meifang;NIU Liqing;ZHANG Mengye;XU Yue;CAI Qiuhan(First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center of Acupuncture and Moxibustion,Tianjin 300380,China)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津300380

出　　处：《药物评价研究》2024年第7期1611-1618,共8页Drug Evaluation Research

基　　金：中华中医药学会求实项目(儿科专项)“儿童中成药临床综合评价技术及示范案例研究”(2020ZX09201-008);天津市教委科研计划项目(2021KJ138)。

摘　　要：目的对儿泻停颗粒治疗小儿急性腹泻(湿热泻)进行临床综合评价,判断其临床价值,为临床合理用药提供参考。方法通过课题组专家讨论,围绕安全性、有效性、经济性、适宜性、可及性、创新性6个维度,选择《儿童中成药临床综合评价指标框架》中的评价指标,基于文献资料(公开/未公开)、证据性信息、临床调查问卷等,通过现存统计资料分析法、内容分析法、系统性文献综述法等收集证据,应用《儿童中成药临床综合评价工具》进行综合价值判断,对儿泻停颗粒开展评价。结果(1)安全性维度:儿泻停颗粒的不良反应发生率较低,未发现严重不良反应,安全性良好且风险可控,证据充分,得分24.47分。(2)有效性维度:Meta分析和前瞻性队列研究结果均提示,本品治疗小儿急性腹泻,具有显著疗效,在同类品种中成药疗效排序为第2位,得分31.94分;(3)经济性维度:本品日药品费用为3.1~24.6元,每增加1个单位有效率,仅需多花费0.40~3.14元,具有经济学优势,得分3.63分。(4)适宜性维度:本品药物信息和药品使用方面都具有较好的适宜性,得分7.87分。(5)可及性维度:本品在可负担性与可获得性方面均具有较好的可及性,得分6.34分。(6)创新性维度:本品在技术创新方面,优化了工艺、提高和修订质量标准;并获得多项国家专利,具有良好创新性,得分2.73分。(7)综合评价结果:儿泻停颗粒的综合价值指数为76.98。结论儿泻停颗粒综合价值指数≥75,其治疗小儿急性腹泻(湿热泻)临床综合价值较好。Objective To evaluate the clinical value of Erxieting Granule in treating acute pediatric diarrhea and to provide reference for rational drug use.Methods Through the discussion of experts in the research group,the evaluation indicators in the Clinical Comprehensive Evaluation Index Framework of proprietary Chinese Medicines for Children were selected based on six dimensions including safety,effectiveness and economy,and the evidence was collected based on literature(open/undisclosed),evidential information,clinical questionnaires,etc.,by means of existing statistical data analysis,content analysis,systematic literature review,etc.The evaluation of Erxieting Granules was carried out by using Clinical Comprehensive Evaluation Tool of Children's proprietary Chinese Medicine.Result(1)Security dimension.The incidence of adverse reactions of Erxieting Granules was low,no serious adverse reactions were found,and the safety was good and the risk was controllable,with sufficient evidence,and the score was 24.466 points.(2)Validity dimension.The results of meta-analysis and prospective cohort study both suggested that this product had significant efficacy in the treatment of acute diarrhea in children,ranking second in the efficacy of similar varieties of proprietary Chinese medicines,with a score of 31.94 points.(3)The daily drug cost of this product is 3.1—24.6 yuan,and each additional unit of efficiency costs 0.40—3.14 yuan,which has an economic advantage,and the score is 3.63 points.(4)Suitability dimension.This product has good suitability in terms of drug information and drug use,with a score of 7.87.(5)Accessibility dimension.This product has good accessibility in terms of affordability and availability,scoring 6.34 points.(6)Innovation dimension.In terms of technological innovation,the product has optimized the process,improved and revised the quality standards.And obtained a number of national patents,with good innovation,score 2.73 points.(7)Comprehensive evaluation results.The comprehensive value index of Er

关 键 词：儿泻停颗粒 小儿 急性腹泻 湿热泻 临床综合评价 

分 类 号：R975[医药卫生—药品]