摘要
目的 观察瘀血痹胶囊治疗血瘀证类风湿关节炎(Rheumatoid Arthritis,RA)患者的临床疗效及对其心血管事件风险因素的影响.方法 选取2020年5月-2021年12月期间中国中医科学院广安门医院收治的RA患者作为研究对象,共纳入2108例RA患者,以服用瘀血痹胶囊为暴露因素,纳入暴露组(瘀血痹胶囊+基础治疗)1082例与非暴露组(基础治疗)1026例.主要结局指标为DAS28-ESR、DAS28-CRP,分别分析基线数据及在治疗后第24周较基线的改善值的组间比较,以评估治疗后患者疾病活动度及心血管相关风险因素的改善情况.次要结局指标:(1)中医证候指标:血瘀证评分;(2)炎症指标:白细胞计数(White blood cell,WBC)、血沉(Erythrocyte sedimentation Rate,ESR)、C 反应蛋白(C-reactive protein,CRP)、超敏 C 反应蛋白(high sensitivity C-reactive protein,hsCRP);(3)免疫指标:类风湿因子(Rheumatoid factor,RF)、血清免疫球蛋白 G(Immunoglobulin G,IgG)、血清免疫球蛋白 M(Immunoglobulin M,IgM)、血清免疫球蛋白 A(Immunoglobulin A,IgA)、抗核抗体(Anti-Nuclear Antibody,ANA);(4)血小板计数(Platelet,PLT)、血红蛋白(Hemoglobin,HGB)及血脂指标[总胆固醇(Total cholesterol,TC)、甘油三酯(Triglyceride,TG)、高密度脂蛋白(High Density lipoprotein cholesterol,HDL-C)、低密度脂蛋白(Low density lipoprotein cholesterol,LDL-C)]o安全性指标:(1)生命体征:体温、呼吸、心率、血压;(2)不良事件或不良反应:随时观测;(3)实验室检查:谷丙转氨酶、谷草转氨酶、谷氨酰转移酶、尿素、肌酐、直接胆红素.结果 (1)在治疗第24周后,瘀血痹胶囊联合基础治疗在降低DAS28评分、ESR、CRP、RF、lgG、ANA方面显著优于单用基础治疗,提示可明显患者疼痛症状及疾病整体状态,提高日常生活能力;(2)在治疗后第24周,瘀血痹胶囊联合基础治疗在降低血瘀证评分、PLT、TG、HDL-C方面显著优于单用基础治疗,提示可降低心血管事件风险因素;(2)在肝肾功异常方面,无确定性证据表明由瘀血痹胶囊引起的肝肾功能异常,暂无证据表明瘀血痹胶囊治疗RA患者存在严重不良反应.结论 瘀血痹胶囊联合基础治疗可以提高RA患者的临床达标率,同时能改RA患者心血管风险因素相关指标,且安全性较好.
Abstract
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.
基金项目
国家重点研发计划(2018YFC1705202)
中国中医科学院科技创新工程重大攻关项目(CI2021A01501)
国家自然科学基金(82230121)
维普
万方数据