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四磨汤口服液治疗功能性消化不良临床综合评价

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目的 以药品临床价值为导向，对四磨汤口服液治疗功能性消化不良开展临床综合评价，为四磨汤口服液的合理定价、合理用药以及药品目录遴选提供科学依据。方法 基于当前可获得数据以及调研数据，围绕四磨汤口服液与两种对照药治疗功能性消化不良的有效性、安全性、经济性、创新性、适宜性和可及性6个维度开展临床综合评价。结果 有效性方面，四磨汤口服液可提高临床有效率，药理作用机制明确。安全性方面，未见毒性反应，不良反应较轻，预后良好。经济性方面，日均费用略高于对照药，具有一定成本效果优势。创新性方面，获中国专利授权，并作为中药创新药上市。适宜性方面，方便服用，在药物技术特性和药品使用方面都具有较好的适宜性。可及性方面，医院覆盖较广，产能充足，患者负担较低，长期应用无较大环境风险。3种中成药的综合价值分数从高到低依次为四磨汤口服液(92。01分)＞对照药A(85。11分)＞对照药B(77。51分)。专家组推荐意见为A类(21/23)，建议可直接转化为决策使用。结论 四磨汤口服液治疗功能性消化不良的临床综合价值较高，可为药品合理定价、合理用药以及药品目录遴选提供参考依据。
Clinical Comprehensive Evaluation of Simo Decoction Oral Liquid(四磨汤口服液)in Treatment of Functional Dyspepsia
Objective To carry out the clinical comprehensive evaluation of Simo Decoction Oral Liquid(四磨汤口服液)in the treatment of functional dyspepsia guided by the clinical value of drugs and provide scientific basis for the rational pricing,ra-tional use of drugs and drug catalog selection of Simo Decoction Oral Liquid.Methods Based on the currently available evidence and survey data,a comprehensive clinical evaluation is carried out around the six dimensions of effectiveness,safety,economics,innovation,suitability and accessibility of Simo Decoction Oral Liquid and two control drugs in the treatment of functional dyspep-sia.Results In terms of effectiveness,Simo Decoction Oral Liquid can improve the cure rate,and the pharmacological mechanism was clear.In terms of safety,there was no toxic reaction.The adverse effects were mild and had favorable prognosis.In terms of economics,the average daily cost was slightly higher than that of the control drug,and had certain cost-effectiveness advantages.In terms of innovation,it has obtained Chinese patent authorization and listed as an innovative traditional Chinese medicine.In terms of suitability,it was convenient to take,and it had good suitability in terms of drug technical characteristics and drug usage.In terms of accessibility,it had a wide coverage in hospital,sufficient capacity,low patient burden and no major environmental risk for long-term application.The comprehensive value scores of the three Chinese patent medicines were Simo Decoction Oral Liq-uid(92.01 points)＞control drug A(85.11 points)＞control drug B(77.51 points)from the highest to the lowest.The recom-mendations of the expert panel were Class A(21/23),which can be directly converted into decision-making.Conclusion The clinical comprehensive value of Simo Decoction Oral Liquid in the treatment of functional dyspepsia is high,which can provide a reference basis for the rational pricing of drugs,the rational use of drugs and the selection of drug catalogue.

Simo Decoction Oral Liquid(四磨汤口服液)functional dyspepsiaclinical comprehensive evaluationtradition-al Chinese patent medicine

戴泽琦、万楚川、李文爽、孙庆冉、唐旭东、廖星

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中国中医科学院中医临床基础医学研究所循证医学基础研究室,北京 100700

中国药科大学国家药物政策与医药产业经济研究中心,江苏南京 211198

中国中医科学院,北京 100700

四磨汤口服液 功能性消化不良 临床综合评价 中成药

国家自然科学基金中国中医科学院科技创新工程项目中国中医科学院科技创新工程项目中国中医科学院科技创新工程项目中国中医药循证医学中心业务研究室主任专项中华中医药学会青年求实项目(第一批)(2022)中华中医药学会青年求实项目(第一批)(2022)

82174239CI2021A00701-3CI2021A05501CI2021A055032020YJSZX-22022-QNQSLCL-02-012022-QNQSLCL-02-02

2024

10.13193/j.issn.1673-7717.2024.03.029

中华中医药学刊
中华中医药学会 ,辽宁中医药大学

中华中医药学刊

CSTPCD北大核心
影响因子：1.007
ISSN：1673-7717
年,卷(期)：2024.42(3)
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