黄芪总甙治疗类风湿关节炎临床研究

Clinical study on astragalosides for treatment of rheumatoid arthritis

目的 观察黄芪总甙 (AST)治疗类风湿关节炎 (RA)临床疗效和安全性。方法 随机、开放性的临床试验 ,治疗前后自身对照。选择RA患者 11例 ,男性 2例 ,女性 9例 ;年龄为 2 9～ 6 5岁 ,平均 (47± 14 )岁 ;病程 2个月～ 3年 ,平均 (1 8± 1 2 )年。AST的起始剂量为每日 0 6 g (0 2g ,每日 3次 ) ,若疗效不明显 ,可增至每日0 9g(0 3g ,每日 3次 )。 4周为 1疗程 ,共观察 2个疗程。在试验过程中不得加用具有镇痛、抗炎、免疫调节和肌肉松弛等影响疗效评价的中西药物。结果 11例RA患者经AST治疗 4周后 ,无效 6例 ,改善 3例 ,进步 2例 ,无明显进步病例 ,总有效率 4 5 5 % ;治疗 6周后 ,无效 5例 ,改善 2例 ,进步 3例 ,明显进步 1例 ,总有效率 5 4 5 % ;9例RA患者经AST治疗 8周后 ,无效 4例 ,进步 4例 ,明显进步 1例 ,总有效率 5 5 6 %。主要观察指标的改善结果显示 :4周疗程时 ,AST能明显改善RA患者的休息痛、舌质淡和脉象细 (P <0 0 5 ) ;6周疗程时 ,能明显改善患者的休息痛、舌质淡、脉象细和肿胀关节数 (P <0 0 5 ) ;8周疗程时 ,能明显改善患者的休息痛、晨僵时间、舌质淡、脉象细、肿胀关节数和指数 (P <0 0 5 )。 8周时AST明显提高RA患者淋巴细胞的增生反应 (P <0 0 5 ) ;同时降低RA患者外?

Objective To evaluate the efficacy and safety of astragalosides (AST) in the treatment of patients with rheumatoid arthritis (RA) Methods Randomized,open,self controlled clinical study of AST was performed Eleven patients with RA participated in the study;male 2 cases,female 9 cases,aged 29 65 years,average (47±14) years,duration:2 months 3 years,average (1 8±1 2) years AST 0 6～0 9 g/d (0 2～0 3 g three times daily) for 8 weeks Other antirhumatoid drugs including nonsteroidal antiinflammatory agents,and slow acting antirheumatic agents;analgesics,immunomodulators,and muscle relaxants can not be used in the study Results The total efficacy rates of AST were 45 5%,54 5%and 55 6%respectively for 4,6 and 8 week treatments AST relieved rest pain,morning stiffness;improved swollen joint count,appearances of pale tongue and conditions of weak pulse ( P <0 05),meanwhile increased the lymphocyte multiplication and reduced IL 1 which was produced by mononuclear cells of peripheral blood No adverse reactions were observed except only one patient having mild swallow pain Conclusion AST is a safe,effective drug in treating RA