1.中国中医科学院广安门医院,北京市西城区北线阁5号,100053
2.山东中医药大学第一临床医学院
通信作者:gongxun8269@163.comm
收稿:2025-07-10,
修回:2025-11-10,
纸质出版:2025-12-02
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申钲瑶,李晶涛,杨煜辰等.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[J].中医杂志,2025,66(23):2453-2459.
SHEN Zhengyao,LI Jingtao,YANG Yuchen,et al.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[J].Journal of Traditional Chinese Medicine,2025,66(23):2453-2459.
申钲瑶,李晶涛,杨煜辰等.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[J].中医杂志,2025,66(23):2453-2459. DOI: 10.13288/j.11-2166/r.2025.23.011.
SHEN Zhengyao,LI Jingtao,YANG Yuchen,et al.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[J].Journal of Traditional Chinese Medicine,2025,66(23):2453-2459. DOI: 10.13288/j.11-2166/r.2025.23.011.
目的
2
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
2
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
2
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
2
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
2
To investigate the syndrome evolution patterns, characteristics of the used herbal medicinals, and efficacy variations across different stages of rheumatoid arthritis (RA) progression.
Methods
2
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
2
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
2
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.
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