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机构地区:[1]中国中医科学院广安门医院风湿病科,北京100053
出 处:《国际中医中药杂志》2011年第10期872-875,共4页International Journal of Traditional Chinese Medicine
基 金:首都医学发展科研基金、北京医学卫生科技联合攻关项目(项目编号:2005-SF-I-010)
摘 要:目的比较清热活血方药(中药组)和清热活血方药联合甲氨蝶呤片(中药+MTX组)改善类风湿关节炎(RA)湿热瘀阻证临床症状的有效性和安全性。方法采用随机多中心平行对照试验设计,将142例湿热瘀阻证RA患者随机分为中药组71例和中药+MTX组71例,以临床症状/体征为疗效评价指标,观察期为12周,采用全数据集(FAS)和符合方案数据集(PP)进行统计分析。结果两组均可减轻关节疼痛[分别为(4.82±1.98)分、(4.31±1.85)分],减少关节压痛数[分别为(8.72±6.24)个、(7.14±5.03)个]及肿胀数[分别为(4.87±4.05)个、(4.20±3.36)个]、缩短晨僵时间[分别为[(39.56±46.68)min、(36.65±42.58)min],并可减轻疲乏症状[分别为(4.13±2.34)分、(3.74±2.20)分],且安全性较好,但组间比较差异无统计学意义(P〉0.05)。结论在改善湿热瘀阻证RA患者临床症状方面,中药+MTX组较中药组无明显疗效优势。但清热活血方药可较好改善湿热瘀阻证RA患者的临床症状。Objective To Evaluate the efficacy and safety of Qingre-Huoxue Recipe (QHR), Qingre -Huoxue Recipe and Methotrexate(QHR±MTX) in improving clinical symptoms of dampness-heat and blood-stasis syndrome of rheumatoid arthritis. Methods According to multi-center, randomized, and control intervention design, 142 RA patients were randomly divided into QHR group (71 cases) and QHRq-MTX group (71 cases) . With clinical symptoms as evaluation indexes, FAS set and PP set were adapted for analysis. Results FAS set analysis: Both groups can significantly reduce pain VAS score [ (4.82 ± 1.98) vs (4.31 ± 1.85) ], reduce tenderness and swollen joint number [ (4.87 ± 4.05) vs (4.20 ± 3.36), (8.72 ± 6.24) vs (7.14 ± 5.03) respectively], shorten morning stiffness[ (39.56±46.68)rain vs (36.65±42.58)mini and significantly reduce the symptoms of fatigue [ (4.13 ± 2.34) vs (3.74 ± 2.20) ], also with good security. But there was no statistically significant difference between the two groups. Conclusion Qingre-Huoxue Recipe with MTX had no significant advantage in improving clinical symptoms in patients with the dampness-heat and blood-stasis syndrom of RA than without MTX.
分 类 号:R259[医药卫生—中西医结合]
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