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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 observe the clinical efficacy and safety of Astragalosides (AST) in the treatment of rheumatoid arthritis (RA). Methods Randomized, open clinical trials, self-control before and after treatment. A total of 11 RA patients were selected, including 2 males and 9 females. The mean age ranged from 29 to 65 years with an average of (47 ± 14) years. The course of disease ranged from 2 months to 3 years (mean, 18 ± 12) years. The initial dose of AST is 0.6 g daily (0 2 g, 3 times daily). If the effect is not obvious, the daily dose of AST can be increased to 0 9 g (0 3 g, 3 times daily). 4 weeks for a course of treatment, a total of 2 courses of observation. During the test shall not be added with the analgesic, anti-inflammatory, immune regulation and muscle relaxation affect the efficacy of evaluation of Chinese and Western medicines. Results After 11 weeks of treatment with AST, 6 cases were ineffective, 6 cases improved, 3 cases improved, 2 cases improved. There was no obvious progress and the total effective rate was 45.5%. After 6 weeks treatment, 5 cases were ineffective and 2 cases improved. 3 cases improved, 1 case improved obviously, and the total effective rate was 54.5%. In 9 RA patients treated with AST for 8 weeks, 4 cases were ineffective, 4 cases improved, 1 case improved obviously and the total effective rate was 55.6%. The results of the improvement of the main observation indicators showed that AST could significantly improve rest pain, pale tongue and pulse pulse (P <0 05) in RA patients during 4 weeks of treatment. Resting pain, (P <0 05). At the 8th week of treatment, the rest pain, morning stiffness, pale tongue, thin pulse, swollen joint number and index (P < 0 0 5). At 8 weeks, AST significantly increased lymphocyte proliferation in patients with RA (P <0.05)