目的 通过系统方法对四磨汤口服液治疗成人功能性消化不良（气滞食积证）进行多维度价值评估，促进中成药回归临床价值，提高中成药科学使用水平。方法 按照中成药临床综合评价指南（2022年版试行），使用循证证据分析、药物经济学、问卷调查等方法，对四磨汤口服液治疗成人功能性消化不良（气滞食积证）的安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6＋1”维度开展综合评价，采用多准则决策分析模型（MCDA）进行综合评分。结果 安全性方面，综合文献报道不良反应、国家不良反应监测中心数据、毒理研究等内容，综合得出四磨汤口服液不良反应较轻。有效性方面，Meta分析结果显示，相比于常规治疗，四磨汤及四磨汤＋常规治疗的总有效率更优（P＜0.05）。经济性方面，与多潘立酮比较，在改善嗳气、呃逆的症状方面，四磨汤更具有经济性。创新性方面，在企业服务体系及产业方面均有创新。适宜性方面，问卷调查结果提示四磨汤口服液医护及患者的适宜性均高。可及性方面，物品覆盖面广，医保可报销，且可持续性佳。中医药特色评价方面，四磨汤口服液组方来源于《痘疹金镜录》，组方符合中医理论，源自明代经典方，中医药特色明显。结论 各维度评价结果及MCDA综合评价分数均提示四磨汤口服液在治疗成人功能性消化不良（气滞食积证）方面临床价值好。

Objective To evaluate the multi-dimensional value of Simo Decoction Oral Liquid in the treatment of adult functional dyspepsia (qi stagnation and food retention syndrome) through a systematic method, promote the return of proprietary Chinese medicines to clinical value, and improve the scientific use level of proprietary Chinese medicines. Methods According to the Guidelines for the Comprehensive Evaluation of Proprietary Chinese Medicines (Trial Version 2022), using evidence-based analysis, pharmacoeconomics, questionnaire surveys, etc., a comprehensive evaluation of the safety, efficacy, cost-effectiveness, innovation, suitability, accessibility, and traditional Chinese medicine characteristics (6+1 dimensions) of Simo Decoction Oral Liquid in the treatment of adult functional dyspepsia (qi stagnation and food retention syndrome) was conducted, and a multi-criteria decision analysis model (MCDA) was used for comprehensive scoring. Results In terms of safety, based on comprehensive literature reports of adverse reactions, data from the National Adverse Reaction Monitoring Center, toxicological studies, etc., it is concluded that Simo Decoction Oral Liquid has relatively mild adverse reactions. In terms of efficacy, Meta-analysis results show that compared with conventional treatment, the total effective rate of Simo Decoction Oral Liquid and Simo Decoction Oral Liquid + conventional treatment is better (P < 0.05). In terms of cost-effectiveness, compared with domperidone, Simo Decoction Oral Liquid is more costeffective in improving symptoms such as belching and hiccupping. In terms of innovation, there are innovations in the enterprise service system and industry. In terms of suitability, questionnaire survey results suggest that Simo Decoction Oral Liquid has high suitability for both medical staff and patients. In terms of accessibility, the product has a wide coverage, is reimbursable by medical insurance, and has good sustainability. In terms of traditional Chinese medicine characteristics evaluation, the prescription of Simo Decoction Oral Liquid comes from "Dou Zhen Jin Jing Lu", the prescription conforms to traditional Chinese medicine theory, originates from classic prescriptions of the Ming Dynasty, and has obvious traditional Chinese medicine characteristics. Conclusion The evaluation results of each dimension of Simo Decoction Oral Liquid and the comprehensive score of MCDA all indicate that Simo Decoction Oral Liquid has good clinical value in the treatment of adult functional dyspepsia (qi stagnation and food retention syndrome).

R969.4

湖南省中医药管理局专项——中药大品种临床综合评价研究（D2023021）