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 Controlle

Fanfan Wang,1,2 Jian Liu,1,2 Yuan Wang,1,2 Yue Sun,2 Jianting Wen,1,2 Mingyu He1,2 1The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, 230031, People’s Republic of China; 2Department of Rheumatism Immunity, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, 230031, People’s Republic of ChinaCorrespondence: Jian Liu, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, 230031, People’s Republic of China, Email [email protected]: 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.Keywords: rheumatoid arthritis, Xinfeng Capsule, post hoc analysis, DAS28, SAS, SDS