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.
维普
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