目的 从“6+1”个维度开展坤泰胶囊治疗更年期综合征（阴虚火旺证）的临床综合评价，以期系统评估其临床价值，为中成药资源的优化配置与促进临床合理用药提供科学参考。方法 融合循证医学、药物经济学、卫生技术评估（HTA）等多学科方法整合主、客观数据，通过问卷调查、文献二次研究、真实世界数据分析等途径构建评价体系，并运用多准则层决策分析模型与中成药临床证据和价值评估软件（CSC v2.0）进行量化评分。结果 上市前急毒/长毒试验、临床研究、国家药品不良反应监测中心（SRS）收集数据等显示坤泰胶囊不良反应主要包括恶心、呕吐、胃胀、头晕、皮疹等相关症状，已知风险较小，且预后良好，标准化分数为0.75分，评级为A，安全性良好。Meta分析结果显示，坤泰胶囊联合激素药物治疗更年期综合征具有一定疗效，能进一步改善更年期综合征患者的心理症状、神经系统功能紊乱、及泌尿生殖道症状，评级为A。基于2020年人均可支配收入作为患者意愿支付阈值的假设，使用坤泰胶囊联合激素类药物治疗方案比单用激素类药物方案更具有经济性，评级为B。坤泰胶囊化裁于经典名方，是国内首个被批准用于治疗卵巢功能衰退相关病症的中成药，填补了基药目录中妇女卵巢衰退治疗药物的空白，具有较好的创新性，评级为A。坤泰胶囊中成药信息服务信息齐全，坤泰胶囊用法简便，无需特殊时间给药，无需特殊储藏，对医患双方均具有较好的适宜性，评级为B。坤泰胶囊临床运用广泛，销售范围涉及28个省市自治区，覆盖上万家等级医院，可及性较好，评价为B。坤泰胶囊化裁于医圣张仲景《伤寒论》的经方“黄连阿胶汤”，上市后开展了多项临床试验，人用经验丰富，中医药特色显著，评级为B。综合以上分析数据，最终得出坤泰胶囊对更年期综合征（阴虚火旺证）的临床综合评分为0.81，评级为A。结论 综合“6+1”维度及临床价值综合评价的结果，坤泰胶囊对于更年期综合征（阴虚火旺证）临床证据充足，临床价值好，具备良好的安全性、有效性和创新性，建议纳入基本临床用药管理的相关政策范畴。

Objective To conduct a comprehensive clinical evaluation of Kuntai Capsule in treating menopausal syndrome（yin deficiency and effulgent fire syndrome） from “6 + 1” dimensions. The aim was to systematically assess its clinical value and provide a scientific reference for optimizing the allocation of Chinese patent medicine resources and promoting rational clinical drug use. Methods An evaluation system was constructed by integrating multidisciplinary methodologies, including evidence-based medicine, pharmacoeconomics, and health technology assessment（HTA）. This involved synthesizing both subjective and objective data gathered through questionnaires, secondary literature research, and real-world data analysis. Quantification was achieved using a multi-criteria decision analysis（MCDA） model and CSC（v2.0） software. Results Safety（Grade A）: Data from pre-clinical toxicity studies, clinical trials, and the National Center for ADR Monitoring indicate that adverse reactions to Kuntai Capsule are primarily mild（e.g., nausea, vomiting, abdominal distension, dizziness, rash）. The known risks are low with a favorable prognosis, yielding a standardized score of 0.75. Effectiveness（Grade A）: Meta-analysis results demonstrate that Kuntai Capsule combined with hormone therapy offers significant benefits, further improving vasomotor symptoms, neuropsychological symptoms, and urogenital symptoms in patients with menopausal syndrome. Economy（Grade B）: Based on the assumption of using the 2020 per capita disposable income as the patient willingness-to-pay threshold, the combination therapy of Kuntai Capsule and hormones is more cost-effective than hormone therapy alone. Innovativeness（Grade A）: Derived from a classic formula, Kuntai Capsule is the first Chinese patent medicine approved in China for conditions related to ovarian function decline, filling a gap in the National Essential Drug List for treating female ovarian. Suitability（Grade B）: The drug information for this Chinese patent medicine is complete. Kuntai Capsule is easy to administer, requires no specific timing for intake or special storage conditions, showing good suitability for both clinicians and patients. Accessibility（Grade B）: Kuntai Capsule is widely used clinically, with distribution covering 28 provinces/municipalities/autonomous regions and availability in over ten thousand hospitals of various grades, indicating good accessibility. Characteristics of Traditional Chinese Medicine（Grade B）: Kuntai Capsule is based on the classical formula “Huanglian Ejiao Tang” from Zhang Zhongjing’s “Treatise on Cold Damage Diseases”. Multiple clinical trials have been conducted post-marketing, affirming its extensive human use experience and significant TCM characteristics. Comprehensive Score: The overall clinical evaluation score for Kuntai Capsule in treating menopausal syndrome（yin deficiency and effulgent fire syndrome） was 0.81, corresponding to a Grade A rating. Conclusion The comprehensive evaluation across the “6 + 1” dimensions indicates that Kuntai Capsule possesses sufficient clinical evidence and demonstrates good clinical value for menopausal syndrome（yin deficiency and effulgent fire syndrome）. It exhibits favorable safety, effectiveness, and innovativeness, which is recommended to be included in the scope of relevant policies for basic clinical medication management.

R984

全国名老中医药专家传承工作室建设项目[国中医药人教函(2022)75]; 2021年岐黄学者支持项目[国中医药人教函(2022)6]; 中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003);中国中医科学院中央级公益性科研院所基本科研业务费专项(ZYJGKX202408)