基于真实世界研究类风湿关节炎患者的中医证候与临床特点

Analysis of TCM Syndromes and Clinical Manifestations of Rheumatoid Arthritis Patients Based on Real-world Study

目的 基于真实世界研究我国类风湿关节炎(RA)患者的证候分型及临床特点。方法 收集2015年9月-2020年1月全国10家医院2 650例RA患者临床资料,分析其临床特点。结果 2 650例RA患者肝肾阴虚证最多(1 280例,48.3%);平均发病年龄(51.33±14.20)岁,男女比例1∶4.4;有风湿病相关家族史者135例(5.1%),肝肾阴虚证(81例,6.3%)与湿热痹阻证(18例,3.1%)比较差异有统计学意义(P=0.003)。RA患者多于春季发病,不同证型RA患者发病季节比较差异无统计学意义(P>0.05)。中位病程72(28,145)月,其中湿热痹阻证病程在各证型中最短,与肝肾阴虚证及痰瘀互结证比较差异有统计学意义(P<0.005)。RA患者中位晨僵时间30(2,60)min,寒湿阻络证晨僵时间30(10,60)min,与其他证型比较差异有统计学意义(P<0.005)。中位红细胞沉降率(ESR)28.0 mm/h,湿热痹阻证ESR最高。类风湿因子(RF)有效数据811例,其中RF阳性患者680例(83.8%),气血亏虚证患者RF阳性率最高(32例,88.9%)。抗环瓜氨酸肽抗体(抗CCP抗体)有效数据699例,抗CCP抗体阳性患者574例(82.1%),湿热痹阻证患者抗CCP抗体阳性率最高(118例,83.1%)。各证型RF和抗CCP抗体阳性率比较差异无统计学意义(P>0.05)。中位28个关节的疾病活动度(DAS28-ESR)评分4.10(3.17,5.08)分,DAS28-ESR达标(DAS28-ESR评分≤3.2分)685例(25.8%)。结论 目前RA患者大多为中年起病,女性比例较高,多数RA患者处于疾病活动期,以中高疾病活动度为主,肝肾阴虚证最常见,寒湿阻络证晨僵时间最长,不同证型间抗CCP抗体、RF差异无统计学意义。

Objective To investigate the syndrome classification and clinical manifestations of Chinese patients with rheumatoid arthritis(RA) in the real world.Methods The clinical data of 2 650 patients with RA in 10 hospitals in China from September 2015 to January 2020 were collected and their clinical manifestations were analyzed.Results Among the 2 650 RA patients,the maximum syndrome is liver-kidney yin deficiency(1 280 cases,48.3%);the average age at onset was(51.33±14.20) years old,and the male to female ratio is 1∶ 4.4;there are 135 cases(5.1%) with a family history of rheumatism,and there is a statistically significant difference between the liver-kidney yin deficiency syndrome(81 cases,6.3%) and damp-heat impediment syndrome(18 cases,3.1%),with significant difference(P=0.003).Although the incidence of RA is mostly in spring,but there is no significant difference in the incidence of RA with different syndromes in different seasons(P>0.05).The median course of disease are 72(28,145) months,and the duration of damp-heat impediment syndrome is the lowest among the five groups,which is significantly different from that of liver-kidney yin deficiency syndrome and phlegm-blood stasis syndrome(P<0.005).The median duration of morning stiffness is 30(2,60) min,and the median duration of cold-damp impediment syndrome is 30(10,60) min and the longest,which is significantly different from other syndrome(P<0.005).The median level of ESR in patients is 28.00 mm/h,and the level of ESR in patients with damp-heat impediment syndrome is the highest.There are 811 patients with RF valid data,including 680 patients with RF positive(83.8%),Qi-blood deficiency syndrome patients with positive RF rate is the highest(32 cases,88.9%).There are 699 patients with anti-CCP antibody valid data,including 574 patients with anti-CCP antibody positive(82.1%).Dampness-heat impediment syndrome with positive anti-CCP antibody rate is the highest(118 cases,83.1%).There is no significant difference in positive RF and anti-CCP antibody rate of RA with different syndromes(P>0.05).The median DAS28-ESR level is 4.10(3.17,5.08),and the DAS28-ESR meet the criterion(DAS28-ESR≤3.2) in 685cases(25.8%).Conclusion At present,the onset of RA in patients most commonly occurred in middle age,and the higher proportion is female.Most RA patients in active stage are in the middle stage of disease activity.The most common syndrome of RA is liver-kidney yin deficiency.The median duration of morning stiffness of cold-damp impediment syndrome is the longest,and there are no significant differences in positive RF and anti-CCP antibody rates among different syndromes.