中药干预能降低类风湿性关节炎的患病风险吗?一项单臂前瞻性研究
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广州中医药大学第二附属医院,广州510120,广东,中国

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May Traditional Chinese Medicine Reduce the Risk of Developing Rheumatoid Arthritis? An One-armed Prospective Study
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The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou 510006, Guangdong, China

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    摘要:

    背景:类风湿性关节炎(RA)的治疗是一个世界性问题,RA发病前干预和RA疾病预防是目前该领域研究的新方向。目的:该研究目的是评估中医药在RA高风险个体的疾病预防中的效果。方法:这是一项单臂前瞻性临床试验,所有受试者均来自广东省中医院,须满足抗环瓜氨酸肽抗体(anti-CCP)或类风湿因子(RF)阳性、不伴有滑膜炎、未满足2010年美国风湿病学会(ACR)和欧洲风湿病学会(EUALR)的RA分类诊断标准、未曾接受抗风湿药(DMARDs)治疗、年龄在18至65岁之间并签署书面知情同意书。受试者将口服统一煎煮的化瘀强肾通痹方(HQT)汤药,每日2次,每次200 mL,共干预24周。主要结局指标为试验期间RA的发病率,次要结局指标包括干预前后的anti-CCP、RF、超敏C-反应蛋白(CRP)、血沉(ESR)、28个关节压痛数(TJC28)、28个关节肿胀数(SJC28)、晨僵时间、休息痛(VAS)、疾病活动度(DAS28-CRP)、生活质量评价(HAQ)、患者总体评估(PtGA)、医生对患者总体评估(PGA)、关节磁共振(MRI)评分。结果:试验共纳入19例受试者,其中4例因为新冠病毒的流行(COVID-19)而脱落,15例完成24周观察。在观察期间,3例受试者(20%)发展为RA,和未发展RA的受试者相比,其在基线存在更长时间的晨僵症状(P =0.009)和更明显的MRI滑膜信号强化表现(P =0.041)。经过24周干预,受试者的SJC28、VAS、PtGA、PGA均较干预前有所改善,差异有统计学意义(P值分别为0.046,0.019,0.019,0.031);干预前后的anti-CCP、RF、ESR、CRP、晨僵时间、TJC28、HAQ和MRI评分差异无统计学意义(P > 0.05)。结论:对于RA高风险个体,口服HQT汤药具有一定的安全性和改善关节症状的效果,但其是否能有效降低RA发病风险还有待进一步研究。另外,对于RA高风险个体,晨僵和MRI滑膜信号强化表现增强可能是一种发病预警信号。

    Abstract:

    Background Rheumatoid arthritis (RA) is a worldwide public health problem. Intervention and prevention before the onset of rheumatic diseases is a new direction in current research. Objective The aim of this study was to evaluate the potential and feasibility of traditional Chinese medicine (TCM) in the prevention of RA. Methods This was a single-armed prospective clinical trial. All participants were recruited from a single center in Guangdong, China. Adults who were tested positive for anti-cyclic citrullinated peptide antibody (anti-CCP) and/or rheumatoid factor (RF), had no synovitis and never been treated with disease-modifying anti-rheumatic drugs (DMARDs), were enrolled to take the Huayu-Qiangshen-Tongbi (HQT) decoction orally twice daily, 200 mL each time for 24 weeks. Primary outcome was the proportion of patients who met 2010 ACR(American College of Rheumatology)/EULAR(European League Against Rheumatism) classification criteria of RA during observation. Secondary outcomes included levels of anti-CCP, RF, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), assessment of signs and symptoms, and radiographic progression by magnetic resonance imaging (MRI). Results 19 individuals were enrolled in the study, 4 of which withdrew because of the epidemic of COVID-19. During the observation period, 3 individuals (20%) developed RA and they had longer morning stiffness (P = 0.009) and more obvious synovial enhancement in MRI (P = 0.041) at baseline when compared with those who did not develop RA. After 24 weeks of intervention, there were improvements in 28-swollen joint count (SJC28) (P = 0.046), Visual Analog Scale (VAS) (P = 0.019), Patient's Global Assessment (PtGA) (P = 0.019) and Physician's Global Assessment (PGA) (P = 0.031), but no statistical significance was observed in the levels of anti-CCP, RF, ESR, CRP, morning stiffness, 28-tender joint count (TJC28), Health Assessment Questionnaire (HAQ) and magnetic resonance imaging (MRI) analysis (P > 0.05). Conclusion The HQT formula is safe and could improve joint symptoms and signs in these at-risk individuals, but it remains to be investigated in futher study to see if it might potentially reduce the risk of developing RA. Besides, for individuals at high risk to develop RA, morning stiffness and synovial enhancement in MRI might be predictive factors and warning signs.

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  • 在线发布日期: 2024-11-10
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