目的 明确宁泌泰胶囊治疗慢性前列腺炎（湿热蕴结证）的临床综合价值、优势特点及治疗定位，为国家医药管理部门决策及临床合理用药提供参考。方法 基于安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6＋1”维度构建评价体系，整合问卷调查、官方网站数据、文献二次评价、真实世界数据等多源证据，采用多准则层决策分析（multi-criteria decision analysis model，MCDA）模型度量各维度，通过中成药临床证据和软件CSCv2.0计算价值总分。结果 宁泌泰胶囊安全性、有效性均评为A级（无严重不良反应，抗感染、缓解疼痛及排尿异常效果显著）；经济性、创新性、适宜性、可及性、中医药特色均评为B级（有经济性证据支持，获1项发明专利，适用人群接受度高，资源可及性好，苗药组方独特）；临床价值综合评价为A级。结论 宁泌泰胶囊治疗慢性前列腺炎临床价值显著，建议进一步开展药效机制研究及高质量循证研究，优化生产工艺，完善药品说明书，充分发挥其临床优势。

Objective To clarify the comprehensive clinical value, advantages, characteristics and therapeutic positioning of Ningmitai Capsules (宁泌泰胶囊) in the treatment of chronic prostatitis (damp-heat accumulation syndrome), and to provide references for decision-making of national medical and health administrative departments and rational clinical drug use. Methods An evaluation system was constructed based on the “6 + 1” dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics. Multi-source evidence including questionnaire surveys, official website data, secondary evaluation of literature, and real-world data was integrated. The multi-criteria decision analysis (MCDA) model was used to measure each dimension, and the total value score was calculated based on TCM clinical evidence using software CSCv2.0. Results Ningmitai Capsules were rated Grade A for both safety and effectiveness (no serious adverse reactions, significant effects in anti-infection, relieving pain and alleviating urinary abnormalities); Grade B for economy, innovation, suitability, accessibility, and TCM characteristics (supported by economic evidence, obtained 1 invention patent, high acceptance among target populations, good resource accessibility, and a unique Miao medicine formula); the comprehensive evaluation of clinical value was Grade A. Conclusion Ningmitai Capsules have significant clinical value in the treatment of chronic prostatitis. It is recommended to further conduct pharmacological mechanism research and high-quality evidence-based research, optimize the production process, improve the drug insert, and give full play to its clinical advantages.

R285.64

国家重点研发计划项目（2018YFC1707400）