类风湿关节炎患者凝血及血小板参数与临床结局的相关性分析及健脾化湿通络方-新风胶囊的干预作用：基于一项随机对照试验的事后分析

Correlation Analysis of Coagulation and Platelet Parameters with Clinical Outcomes in Rheumatoid Arthritis Patients and the Interventional Effect of Jianpi Huashi Tongluo Formula - Xinfeng Capsule: A Post Hoc Analysis Based on an Randomized Controlled Trial.

作者信息

Wang Fanfan, Liu Jian, Wang Yuan, Sun Yue, Wen Jianting, He Mingyu

机构信息

The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, 230031, People's Republic of China.

Department of Rheumatism Immunity, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, 230031, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Apr 29;19:3477-3495. doi: 10.2147/DDDT.S512338. eCollection 2025.

DOI:10.2147/DDDT.S512338

PMID:40322027

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12049676/

Abstract

BACKGROUND

Rheumatoid arthritis (RA) patients frequently present coagulation and platelet abnormalities. Jianpi Huashi Tongluo Prescription - Xinfeng Capsule (XFC), a traditional Chinese medicine compound preparation, has demonstrated efficacy in improving RA disease activity and inflammation in clinical trials (Clinical Trial.gov: NCT01774877), but its effects on coagulation and platelet parameters remain unclear.

OBJECTIVE

To explore the relationship between coagulation/platelet parameters and RA disease activity, quality of life, and inflammatory indicators, and to assess the improvement effect of XFC treatment over 12 weeks.

METHODS

A post-hoc analysis of 304 RA patients assessed disease activity (DAS28), quality of life (SAS/SDS), and coagulation/platelet parameters. Spearman correlation, logistic regression, restricted cubic spline (RCS), and ROC analyses explored relationships between parameters. Mediation analysis was performed to explore the mediating effects of inflammatory indicators. XFC and leflunomide (LEF) were compared for coagulation and platelet parameters improvements after 12 weeks.

RESULTS

Coagulation and platelet parameters were significantly correlated with immune-inflammatory indicators, as well as with DAS28, SAS, and SDS scores. Logistic regression identified ESR/CRP as DAS28 risk factors, FBG/DD/PLT/PCT/CRP as SAS risks, and FBG/CRP as SDS risks. Specific combinations of parameter levels significantly increased the risks of DAS28, SAS, and SDS. RCS revealed non-linear relationships. Mediation analysis indicated that CRP/ESR mediated the relationship between coagulation parameters and disease activity, as well as quality of life. ROC indicated CRP best predicted DAS28, PLT for SAS, and ESR for SDS. The XFC group exhibited significant improvements in APTT, TT, PLT, PCT, and PDW, while the LEF group showed improvements in APTT, TT, FBG, and MPV. XFC outperformed LEF in improving FBG, PLT, PCT, PDW, and MPV.

CONCLUSION

Coagulation/platelet parameters in RA patients are closely associated with increased disease activity and decreased quality of life. Furthermore, XFC exhibits significant advantages over LEF in improving FBG, PLT, PCT, PDW, and MPV.

摘要

背景

类风湿关节炎（RA）患者常出现凝血和血小板异常。健脾化湿通络方——新风胶囊（XFC），一种中药复方制剂，在临床试验（Clinical Trial.gov：NCT01774877）中已证明对改善RA疾病活动度和炎症有效，但其对凝血和血小板参数的影响仍不清楚。

目的

探讨凝血/血小板参数与RA疾病活动度、生活质量及炎症指标之间的关系，并评估XFC治疗12周后的改善效果。

方法

对304例RA患者进行事后分析，评估疾病活动度（DAS28）、生活质量（SAS/SDS）及凝血/血小板参数。采用Spearman相关性分析、逻辑回归分析、限制性立方样条（RCS）分析及ROC分析探讨各参数之间的关系。进行中介分析以探讨炎症指标的中介作用。比较XFC组和来氟米特（LEF）组治疗12周后凝血和血小板参数的改善情况。

结果

凝血和血小板参数与免疫炎症指标以及DAS28、SAS和SDS评分显著相关。逻辑回归分析确定ESR/CRP为DAS28的危险因素，FBG/DD/PLT/PCT/CRP为SAS的危险因素，FBG/CRP为SDS的危险因素。参数水平的特定组合显著增加了DAS28、SAS和SDS的风险。RCS分析显示存在非线性关系。中介分析表明，CRP/ESR介导了凝血参数与疾病活动度以及生活质量之间的关系。ROC分析表明，CRP对DAS28的预测最佳，PLT对SAS的预测最佳，ESR对SDS的预测最佳。XFC组的APTT、TT、PLT、PCT和PDW有显著改善，而LEF组的APTT、TT、FBG和MPV有改善。XFC在改善FBG、PLT、PCT、PDW和MPV方面优于LEF。