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2506例类风湿关节炎不同病程患者中医证型分布特点及中医药疗效评价——一项真实世界回顾性研究

Distritution Characteristics of TCM Syndromes and Evaluation of Traditional Chinese Medicine Efficacy in 2506 Rheumatoid Arthritis Patients with Different Course of Disease:A Real-World Retrospective Study
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摘要 目的 探讨类风湿关节炎(RA)患者不同病程的证型演变规律、中药使用特点及疗效差异。方法 基于中国中医风湿病注册研究信息平台(CERTAIN)回顾性纳入经过中医药治疗的2506例RA病案,按基线病程将患者分为<6个月组166例、6个月~<5年组1063例、5~<20年组1067例、≥20年组210例。对各组患者中医药治疗前后进行辨证分型(分为湿热痹阻证、风湿痹阻证、寒湿痹阻证、瘀血阻络证、痰瘀痹阻证、肝肾不足证、气血两虚证、气阴两虚证),并计算高频证型治疗前后证型演变率;分析各组首诊时排名前20位的中药使用情况;根据治疗前后基于红细胞沉降率的28个关节疾病活动度(DAS28-ESR)及基于C反应蛋白的28个关节疾病活动度(DAS28-CRP)分别判定DAS28-ESR临床疗效、DAS28-CRP临床疗效;采用多因素Logistic回归分析中医药治疗疗效的影响因素。结果 治疗前病程<6个月组以寒湿痹阻证、风湿痹阻证、湿热痹阻证为主[分别占29.5%(49/166)、27.7%(46/166)、25.9%(43/166)],6个月~<5年组、5~<20年组以湿热痹阻证为主[分别占30.5%(324/1063)、29.8%(318/1067)],≥20年组肝肾不足证和湿热痹阻证并重[均占25.2%(53/210)]。患者治疗前超过100例的证型且经治疗后证型演变率>10%的证型分别是湿热痹阻证[27.2%(201/738)]、肝肾不足证[32.4%(119/367)]、痰瘀痹阻证[42.4%(73/172)],故为高频证型。治疗后湿热痹阻证、肝肾不足证主要向风湿痹阻证转化,痰瘀痹阻证向湿热痹阻证、寒湿痹阻证转化。各组排名前两位的中药均是甘草和白芍,病程<6个月组和6个月~<5年组患者高频中药还包括防风、独活、川芎、羌活等,5~<20年组和≥20年组黄芪、茯苓、牛膝、当归等占比升高,而防风、独活等占比下降。各组治疗后DAS28-ESR和DAS28-CRP均较本组治疗前明显降低(P<0.05)。各组患者DAS28-ESR临床疗效及DAS28-CRP临床疗效差异均具有统计学意义(P<0.01)。多因素Logistic回归分析显示,较<6个月组,6个月~<5年组、5~<20年组、≥20年组临床疗效明显降低(OR分别为0.4、0.5、0.4,P<0.01)。结论 RA患者随病程进展呈现由实转虚的动态演变规律,中药干预由祛邪转向扶正,中医药治疗可明显降低RA患者疾病活动度,且以病程<6个月的患者疗效更优。 Objective To investigate the syndrome evolution patterns,characteristics of the used herbal medicinals,and efficacy variations across different stages of rheumatoid arthritis(RA)progression.Methods Based on the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine(CERTAIN),2,506 RA patients were retrospectively enrolled and categorized into<6 months group(166 cases),6 months to<5 years group(1063 cases),5 to<20 years group(1067 cases),and≥20 years group(210 cases).Syndromes were differentiated before and after traditional Chinese medicine(TCM)treatment,including damp-heat obstruction,wind-damp obstruction,cold-damp obstruction,blood stasis obstructed in the collaterals,phlegm-stasis obstruction,liver-kidney insufficiency,qi and blood deficiency,and qi-yin deficiency.The syndrome evolution rate was calculated for high-frequency syndromes before and after treatment.Analysis was conducted on top 20 frequently used Chinese herbs at the first diagnosis.Clinical efficacy of the 28-joint disease activity score based on erythrocyte sedimentation rate(DAS28-ESR)and 28-joint disease activity score based on C-reactive protein(DAS28-CRP)before and after treatment were assessed.A multivariate logistic regression analysis was performed to identify factors affecting the efficacy of TCM treatment.Results Patients with course of disease shorter than 6 months predominantly presented with cold-dampness obstruction syndrome(49/166,29.5%),wind-dampness obstruction syndrome(46/166,27.7%),and dampness-heat obstruction syndrome(43/166,25.9%).For patients with course of disease logner than 6 months and shorter than 5 years and those within 5 to 20 years,the dominant syndrome was dampness-heat obstruction syndrome(324/1063,30.5%and 318/1067,29.8%,respectively).In patients with disease duration≥20 years,liver-kidney insufficiency syndrome and dampness-heat obstruction syndrome both predominated,each accounting for 25.24%(53/210).The syndromes with more than 100 cases before treatment and a syndrome evolution rate greater than 10%after treatment were dampness-heat obstruction(201/738,27.2%),liver-kidney insufficiency(119/367,32.4%),and phlegm-stasis obstruction syndromes(73/172,42.4%).These were classified as high-frequency syndromes.After treatment,damp-heat obstruction syndrome and liver-kidney insufficiency syndrome primarily evolved into wind-damp obstruction syndrome,while phlegm-stasis obstruction syndrome evolved into damp-heat obstruction and cold-damp obstruction syndrome.The top two commonly used Chinese herbs across all groups were Gancao(Radix et Rhizoma Glycyrrhizae)and Baishao(Radix Paeoniae Alba).In the<6 months group and the 6 months to<5 years group,high-frequency herbs also included Fangfeng(Radix Saposhnikoviae),Duhuo(Radix Angelicae Pubescentis),Chuanxiong(Rhizoma Chuanxiong),and Qianghuo(Radix et Rhizoma Notopterygii).In the 5 to<20 years group and the≥20 years group,the usage of Huangqi(Radix Astragali),Fuling(Poria),Niuxi(Radix Achyranthis Bidentatae),and Danggui(Radix Angelicae Sinensis)increased,while the proportion of Fangfeng and Duhuo decreased.After treatment,the DAS28-ESR and DAS28-CRP scores in all groups significantly decreased(P<0.05).There were statistically significant differences in clinical efficacy based on DAS28-ESR and DAS28-CRP across all groups(P<0.01).Multivariate logistic regression revealed significantly reduced treatment efficacy in the 6 months-5 years group(OR=0.4),5~20 years group(OR=0.5),and≥20 years group(OR=0.4)compared to the<6 months group.Conclusion RA syndromes follow a progression pattern from excess to deficiency,with corresponding transition in herbal usage from pathogen-eliminating to healthy qi-reinforcing approaches.TCM intervention can significantly reduce disease activity of RA,with superior efficacy in patients with disease duration shorter than 6 months.
作者 申钲瑶 李晶涛 杨煜辰 张淑娟 姜泉 巩勋 SHEN Zhengyao;LI Jingtao;YANG Yuchen;ZHANG Shujuan;JIANG Quan;GONG Xun(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing,100053;First Clinical School of Shandong UniversityofTraditionalChinese Medicine)
出处 《中医杂志》 北大核心 2025年第23期2453-2459,共7页 Journal of Traditional Chinese Medicine
基金 国家自然科学基金(82274507) 中央高水平中医医院临床研究和成果转化能力提升项目(HLCMHPP2023087)。
关键词 类风湿关节炎 病程 中医证型 中医药疗效 28个关节疾病活动度 rheumatoid arthritis course of disease traditional Chinese medicine sydnromes traditional Chinese medicine efficacy 28-joint disease activity score
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