目的 通过系统、多学科的方法对肝爽颗粒治疗肝硬化（肝郁脾虚证）进行多维度价值评估。方法 按照《药品临床证据和价值评估管理指南》标准，基于循证医学证据，结合问卷调查、卫生技术评估、药物经济学评价等方法，利用多准则决策分析模型，从有效性、安全性、经济性、创新性、适宜性、可及性、中医药特色“6＋1”维度对该药治疗肝硬化（肝郁脾虚证）的临床证据和临床价值进行综合评估，最终形成“临床证据和价值评估指数”。结果 基于证据充分性结果和已知风险评价结果，肝爽颗粒安全性等级为B，认为风险可控、安全性较好；基于证据质量评价和证据价值评价结果，提示肝爽颗粒联合恩替卡韦在改善肝硬化患者丙氨酸氨基转移酶、天冬氨酸氨基转移酶、总胆红素、白蛋白、层黏连蛋白、Ⅲ型前胶原、透明质酸、Ⅳ型胶原蛋白方面优于单用恩替卡韦治疗（P<0.05），有效性等级为A，认为该药有效性好、临床意义大；肝爽颗粒在临床、企业、产业3方面均具有一定创新性，创新性等级为B；根据肝爽颗粒治疗肝硬化的成本-效果结果显示，认为该药经济性较好，经济性等级B；综合医护人员和患者问卷得分情况，适宜性等级为B；与同类药相比，肝爽颗粒价格适中合理，可负担性好，覆盖全国26个省市自治区的2636家医院，可及性等级为B；基于中医药特色评定规则，中医药特色等级为B，认为该药中医药特色较为突出。综合“6＋1”维度结果，运用CSC V2.0软件计算得出肝爽颗粒治疗肝硬化（肝郁脾虚证）的综合衡量价值为B类。结论 基于肝爽颗粒各维度评价结果及综合评价分数，表明肝爽颗粒临床价值较好，建议进一步开展药效机制研究，提高循证证据质量，充分发挥肝爽颗粒的临床价值优势。

Objective To evaluate the multi-dimensional value of Ganshuang Granules (肝爽颗粒) by systematic and multidisciplinary methods. Methods According to the "Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs" standard, based on the evidence of evidence-based medicine and combined with questionnaire survey, health technology assessment (HTA), pharmacoeconomic evaluation and other research methods, the multi-criteria decision analysis model(MCDA) was used to comprehensively evaluate the clinical evidence and clinical value of the drug from the "6 + 1" dimensions of effectiveness, safety, economy, innovation, suitability, accessibility and characteristics of traditional Chinese medicine, and finally the "clinical evidence and value evaluation index" were formed. Results Based on the results of evidence adequacy and known risk assessment, the safety level of Ganshuang Granules is B, which is considered to be controllable and safe. Based on the results of evidence quality evaluation and evidence value evaluation, it is suggested that the efficacy of Ganshuang Granules combined with was superior to entecavir alone in improving alanine aminotransferase, aspartate aminotransferase, total bilirubin, albumin, laminin, type III procollagen, hyaluronic acid and type IV collagen in patients with cirrhosis (P < 0.05), and the effectiveness level is A, which is considered to be effective and of great clinical significance. Ganshuang granules have certain innovation in clinical, enterprise and industry, and the innovation level is B; According to the cost-effectiveness results of Ganshuang Granules in the treatment of liver cirrhosis, it is considered that the drug is economical and economy grade is B; Based on the medical staff and patient questionnaire scores, suitability level is B; Compared with similar drugs, the price of Ganshuang granules is moderate and reasonable, and the affordability is good. It covers 2636 hospitals in 26 provinces, municipalities and autonomous regions across the country, and the accessibility level is B; Based on the evaluation rules of traditional Chinese medicine characteristics, the characteristic grade of traditional Chinese medicine is B, which is considered to be more prominent. Based on the results of "6 + 1" dimension, CSC V2.0 software was used to calculate the comprehensive measurement value of Ganshuang granules in the treatment of liver cirrhosis (liver stagnation and spleen deficiency syndrome) as category B. Conclusion Based on the evaluation results and comprehensive evaluation scores of each dimension of Ganshuang Granules, it is shown that the clinical value of Ganshuang Granules is good. It is suggested to further carry out research on the pharmacodynamic mechanism, improve the quality of evidence-based evidence, and give full play to the clinical value advantages of Ganshuang Granules.

R285.64

国家重点研发计划项目（2018YFC1707400）