目的 基于痛风（gout）真实世界研究数据，对不同证型痛风患者的中医证候疗效评价、尿酸达标率和安全性进行统计学分析，总结痛风不同证型下中医治疗的证治规律。方法 回顾性统计3287例痛风患者的临床数据，然后进行中医药治疗疗效、安全性、中药关联规则和系统聚类分析。结果 最终符合纳入标准的患者有330例，按辨证划分为湿热蕴结证224例、痰瘀互结证67例和脾虚湿阻证39例。3种证型在性别、体质量指数（body mass index，BMI）、血尿素氮（bloodurea nitrogen，BUN）、血尿酸（blood uric acid，BUA）、红细胞沉降率（erythrocyte sedimentation rate，ESR）、C反应蛋白（Creactive protein，CRP）、中医证候疗效评价、尿酸达标率和安全性上差异无统计学意义（P＞0.05）。关联规则和聚类分析显示湿热蕴结证痛风常用土茯苓、薏苡仁、苍术等中药治疗，并形成苍术-黄柏、土茯苓-威灵仙等药物组合和苍术、黄柏、川牛膝、土茯苓、薏苡仁这一新核心药方；痰瘀互结证痛风常用土茯苓、薏苡仁、茯苓等中药，形成薏苡仁-秦艽、土茯苓-威灵仙等药物组合和新核心药方为山茱萸、葛根、土茯苓、独活、防风、杜仲、威灵仙、赤芍、地龙、秦艽、川牛膝、薏苡仁、绵萆薢；脾虚湿阻证痛风常用茯苓、苍术、土茯苓等药物和苍术-威灵仙、茵陈-虎杖等药物组合，并形成伸筋草、茵陈、虎杖、陈皮、茯苓这一新核心药方。结论 在多中心真实世界研究背景下，系统阐述了中医药治疗痛风的中医证候疗效评价、安全性和证治规律，为中医药辨证论治痛风提供了一定的指导和临床应用价值。

Objective Based on the real-world research data of gout, the evaluation of traditional Chinese medicine (TCM) syndrome efficacy, uric acid standard rate and safety of patients with different syndrome types of gout were statistically analyzed, and the syndrome and treatment rules of TCM treatment under different syndrome types of gout were summarized. Methods The clinical data of 3287 patients with gout were analyzed retrospectively, and then therapeutic effect, safety, association rules of TCM and systematic cluster analysis were carried out. Results A total of 330 patients met the inclusion criteria, and were divided into 224 cases of dampness-heat accumulation syndrome, 67 cases of phlegm and blood stasis syndrome, and 39 cases of spleen deficiency and dampness retention syndrome. There were no significant differences in gender, body mass index (BMI), blood urea nitrogen (BUN), blood uric acid (BUA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), evaluation of TCM syndrome curative effect,uric acid standard rate and safety among the three syndrome types (P>0.05). Association rules and cluster analysis showed that the damp-heat accumulation syndrome of gout were commonly treated with TCM, such as Tufuling (Smilacis Glabrae Rhizoma, SGR), Yiyiren (Coicis Semen, CS), and Cangzhu (Atractylodis Rhizoma, AR), and the combination of herbs such as AR-Huangbai (Phellodendri Chinensis Cortex, PCC), SGR-Weilingxian (Clematidis Radix et Rhizoma, CRR), and the new core prescription were AR, PCC, Chuanniuxi (Cyathulae Radix, CR), SGR and CS; The phlegm and blood stasis syndrome of gout were commonly treated with TCM, such as SGR, CS and Fuling (Poria), forming drug combinations such as CS-Qinjiao (Gentianae Macrophyllae Radix, GMP), SGR-CRR, and the new core prescription were Shanzhuyu (Corni Fructus), Gegen (Puerariae Lobatae Radix), SGR, Duhuo (Angelicae Pubescentis Radix), Fangfeng (Saposhnikoviae Radix), Duzhong (Eucommiae Cortex), CRR, Chishao (Paeoniae Rubra Radix), Dilong (Pheretima), GMP, CR, CS, Mianbixie (Dioscoreae Septemlobae Rhizoma); The spleen deficiency and dampness retention syndrome of gout were commonly treated with TCM, such as Poria, AR, SGR and, and the combination of AR-CRR, Yinchen (Artemisiae Scopariae Herba, ASH)-Huzhang (Polygoni Cuspidati Rhizoma et Radix, PCRR), and new core prescription such as Shenjincao (Lycopodii Herba), ASH, PCRR, Chenpi (Citri Reticulatae Pericarpium), and Poria were formed. Conclusion In the context of multi-center real-world research, the research systematically elaborates the results of TCM syndrome efficacy evaluation, safety and the rule of syndrome and treatment under the guidance of different syndrome types of gout, which provides certain guidance and clinical application value for TCM syndrome differentiation and treatment of gout.

R285.64

国家中医药管理局区域中医(专科)诊疗中心建设项目-风湿病科(2018-2022);国家中医药管理局国家中医药循证医学研究建设项目:基本中医药循证能力建设(2019-2021);上海市卫健委华东片区中西医结合关节病专科联盟项目(2021.12-2023.12);上海申康医院发展中心重大疾病多中心临床研究项目:痛风和高尿酸血症治疗新策略(SHDC2020CR1013B)