Clinical Efficacy of Yuxuebi Capsule in the Treatment of Rheumatoid Arthritis with Blood Stasis
Objective To observe the clinical efficacy of Yuxuebi Capsule in treating rheumatoid arthritis(RA)patients with blood stasis and to assess its impact on cardiovascular risk factors.Methods A total of 2,108 RA patients from Guang'anmen Hospital,China Academy of Chinese Medical Sciences from May 2020 to December 2021 were en-rolled.Patients were divided into an exposure group(1,082 cases,Yuxuebi Capsule+standard treatment)and a non-ex-posure group(1,026 cases,standard treatment alone)based on Yuxuebi Capsule intake.Primary outcome measures includ-ed DAS28-ESR and DAS28-CRP.The baseline data at the 24th week of treatment were compared between groups to as-sess the improvement in disease activity and cardiovascular risk factors after treatment.Secondary outcomes included tradi-tional Chinese medicine(TCM)syndrome index(blood stasis syndrome score),inflammatory indexes[white blood cell count(WBC),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),and high-sensitivity C-reactive protein(hs-CRP)],immune indexes[rheumatoid factor(RF),serum Immunoglobulin G(IgG),Immunoglobulin M(IgM),Immuno-globulin A(IgA),antinuclear antibody(ANA)],platelet count(PLT),hemoglobin(HGB),and blood lipid indexes[(total cholesterol[TC],triglycerides[TG],high-density lipoprotein cholesterol[HDL-C],low-density lipoprotein cholesterol[LDL-C]).Safety indexes were vital signs(body temperature,respiratory rate,heart rate,blood pressure),adverse events or reactions,which were monitored at all times,and laboratory tests(alanine aminotransferase(ALT),aspartate aminotrans-ferase(AST),gamma-glutamyltransferase(GGT),urea,creatinine,and direct bilirubin.Results By the 24th week of treatment,patients receiving Yuxuebi Capsule and standard treatment showed significant improvements compared with those receiving standard treatment alone in reducing DAS28 scores,ESR,CRP,RF,IgG,and ANA,suggesting a notable enhance-ment in overall disease condition and daily living capabilities.Additionally,Yuxuebi Capsule combined with standard treat-ment significantly outperformed standard treatment in lowering blood stasis syndrome scores,PLT,TG,and HDL-C at the 24th week,suggesting a decrease in cardiovascular risk factors.No definitive evidence was found linking Yuxuebi Capsule to abnormal liver and kidney function,and no evidence indicated serious adverse reactions when treating RA patients.Con-clusion Yuxuebi Capsule combined with standard treatment can increase the clinical response rate in RA patients and shows improvements in cardiovascular risk factors,with high safety.