目的 通過系統(tǒng)方法對(duì)四磨湯口服液治療成人功能性消化不良（氣滯食積證）進(jìn)行多維度價(jià)值評(píng)估，促進(jìn)中成藥回歸臨床價(jià)值，提高中成藥科學(xué)使用水平。方法 按照中成藥臨床綜合評(píng)價(jià)指南（2022年版試行），使用循證證據(jù)分析、藥物經(jīng)濟(jì)學(xué)、問卷調(diào)查等方法，對(duì)四磨湯口服液治療成人功能性消化不良（氣滯食積證）的安全性、有效性、經(jīng)濟(jì)性、創(chuàng)新性、適宜性、可及性、中醫(yī)藥特色“6＋1”維度開展綜合評(píng)價(jià)，采用多準(zhǔn)則決策分析模型（MCDA）進(jìn)行綜合評(píng)分。結(jié)果 安全性方面，綜合文獻(xiàn)報(bào)道不良反應(yīng)、國家不良反應(yīng)監(jiān)測中心數(shù)據(jù)、毒理研究等內(nèi)容，綜合得出四磨湯口服液不良反應(yīng)較輕。有效性方面，Meta分析結(jié)果顯示，相比于常規(guī)治療，四磨湯及四磨湯＋常規(guī)治療的總有效率更優(yōu)（P＜0.05）。經(jīng)濟(jì)性方面，與多潘立酮比較，在改善噯氣、呃逆的癥狀方面，四磨湯更具有經(jīng)濟(jì)性。創(chuàng)新性方面，在企業(yè)服務(wù)體系及產(chǎn)業(yè)方面均有創(chuàng)新。適宜性方面，問卷調(diào)查結(jié)果提示四磨湯口服液醫(yī)護(hù)及患者的適宜性均高?？杉靶苑矫?，物品覆蓋面廣，醫(yī)?？蓤?bào)銷，且可持續(xù)性佳。中醫(yī)藥特色評(píng)價(jià)方面，四磨湯口服液組方來源于《痘疹金鏡錄》，組方符合中醫(yī)理論，源自明代經(jīng)典方，中醫(yī)藥特色明顯。結(jié)論 各維度評(píng)價(jià)結(jié)果及MCDA綜合評(píng)價(jià)分?jǐn)?shù)均提示四磨湯口服液在治療成人功能性消化不良（氣滯食積證）方面臨床價(jià)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

湖南省中醫(yī)藥管理局專項(xiàng)——中藥大品種臨床綜合評(píng)價(jià)研究（D2023021）