基于真实世界数据的五味温通除痹胶囊治疗类风湿关节炎寒湿痹阻证临床研究  

Clinical Study of Wuwei Wentong Chubi Capsules in Treating Rheumatoid Arthritis with Cold and Dampness Obstruction Syndrome Based on Real World Data

作　　者：吴爱红 汪元[2] 杜蜀徽 孙梦雨 WU Aihong;WANG Yuan;DU Shuhui;SUN Mengyu(The First Clinical Medical College of Anhui University of Chinese Medicine,Hefei 230038,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China)

机构地区：[1]安徽中医药大学第一临床医学院,安徽合肥230038 [2]安徽中医药大学第一附属医院,安徽合肥230031

出　　处：《中国中医药信息杂志》2025年第4期146-151,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：安徽省临床医学研究转化专项(202304295107020110);国家中医药管理局高水平重点学科建设项目-中医痹病学(2023年);安徽省青年领军后备人才项目(2022年)。

摘　　要：目的基于临床病历信息系统,评价真实世界环境下五味温通除痹胶囊治疗类风湿关节炎寒湿痹阻证患者的临床疗效及安全性。方法收集2020年1月-2024年3月安徽中医药大学第一附属医院风湿病科类风湿关节炎寒湿痹阻证住院患者病史、刻下症和用药信息,根据是否使用五味温通除痹胶囊,将患者分为治疗组304例、对照组378例,完善2组患者信息及指标后建立数据库。比较2组中医证候积分、疾病活动度量表评分及实验室指标。结果与本组治疗前比较,治疗组治疗后中医证候评分(关节疼痛重着、晨僵、肿胀、遇冷疼痛加剧、关节屈伸不利、食少纳呆、少气懒言、口淡不渴、头身困重、大便稀溏及倦怠乏力)明显下降(P<0.05),疾病活动度评分、红细胞沉降率(ESR)、超敏C反应蛋白(hs-CRP)、类风湿因子(RF)、补体(C3、C4)、免疫球蛋白(Ig)G、IgM、抗环瓜氨酸肽抗体(抗CCP抗体)、促甲状腺激素(TSH)、抗甲状腺球蛋白抗体(TGAb)、抗甲状腺过氧化物酶抗体(TPOAb)明显降低(P<0.05),游离三碘甲状腺原氨酸(FT3)、游离四碘甲状腺原氨酸(FT4)升高(P<0.05);对照组治疗后中医证候评分(关节疼痛重着、晨僵、肿胀、倦怠乏力)明显降低,疾病活动度量表评分、ESR、hs-CRP、RF、抗CCP抗体、TGAb、TPOAb明显降低(P<0.05);与对照组治疗后比较,治疗组治疗后中医证候评分(关节晨僵、肿胀、屈伸不利及遇冷加剧、食少纳呆、少气懒言、口淡不渴、头身困重及倦怠乏力)改善更明显(P<0.05),疾病活动度评分、ESR、hs-CRP、RF、抗CCP抗体、C3、IgG、TSH、TPOAb指标降低更明显,FT3、FT4升高更明显(P<0.05);2组治疗前后血常规及肝肾功能均在正常范围,差异无统计学意义(P>0.05)。关联规则分析得出,使用五味温通除痹胶囊后,ESR、hs-CRP、RF、C3、IgG、TSH、FT4、TPOAb指标均有明显改善,提升度均大于1,具有强关联。结论五味温通除�Objective To evaluate the clinical efficacy and safety of Wuwei Wentong Chubi Capsules in patients with rheumatoid arthritis of cold and dampness obstruction syndrome under real world based on clinical medical record information system.Methods Medical history,symptoms and medication information of hospitalized patients with rheumatoid arthritis of cold and dampness obstruction syndrome in the Department of Rheumatology,First Affiliated Hospital of Anhui University of Chinese Medicine were collected from January 2020 to March 2024.According to whether to use Wuwei Wentong Chubi Capsules,patients were divided into treatment group(304 cases)and control group(378 cases).A database was established after improving the information and indicators of two groups of patients.TCM syndrome scores,disease activity scores and laboratory indicators of both groups were compared.Results Compared with before treatment,TCM syndrome score(severe joint pain,morning stiffness,swelling,worsening pain when encountering cold,poor joint flexion and extension,eating less and eating more,lack of breath and lazy speech,weak mouth and thirst,heavy head and body fatigue,loose stools and fatigue)in the treatment group significantly decreased after treatment(P<0.05),the disease activity score,erythrocyte sedimentation rate(ESR),high-sensitivity C-reactive protein(hs-CRP),rheumatoid factor(RF),complement(C3,C4),immunoglobulin(Ig)G,IgM,anti cyclic citrullinated peptide antibody(anti CCP antibody),thyroid stimulating hormone(TSH),anti thyroglobulin antibody(TGAb),and anti thyroid peroxidase antibody(TPOAb)were significantly reduced(P<0.05),and free triiodothyronine(FT3)and free tetraiodothyronine(FT4)increased(P<0.05);after treatment,TCM syndrome score(severe joint pain,morning stiffness,swelling,fatigue and weakness)in the control group significantly decreased,and the disease activity score,ESR,hs-CRP,RF,the levels of anti CCP antibodies,TGAb,and TPOAb were significantly reduced(P<0.05);compared with the control group after treatment,TCM syndrome s

关 键 词：五味温通除痹胶囊 类风湿关节炎 真实世界研究 临床疗效 

分 类 号：R259.932.2[医药卫生—中西医结合]