阿克他利治疗类风湿关节炎随机对照研究  

A randomized controlled clinical trial of actarit in the treatment of r heumatoid arthritis

作　　者：高世明[1] 徐建华[1] 丁长海[2] 徐叔云[2] 

机构地区：[1]安徽医科大学第一附属医院,安徽合肥230022 [2]安徽医科大学临床药理研究所,安徽合肥230032

出　　处：《中国药学杂志》2002年第12期951-953,共3页Chinese Pharmaceutical Journal

摘　　要：目的　研究新型抗风湿病药阿克他利 (ACT)治疗类风湿关节炎 (RA)的疗效和安全性。方法　采用甲氨蝶呤 (MTX)为阳性对照药 ,进行双盲、单盲、随机对照平行性的临床试验。ACT组为 31 3例 ,其中 67例为双盲试验 ;MTX组 1 67例 ,其中 68例为双盲试验 ;余为单盲试验。共完成病例数 480例。口服ACT 1 0 0mg·d- 1 ,一天 3次 ,或MTX 1 0mg·周 - 1 ;疗程 3个月。结果　①治疗 3个月后 ,ACT组 (31 3例 )总有效率为 68.0 6 % ;MTX组 (1 67例 )总有效率为 76 .65 % (P >0 .0 5)。②ACT和MTX均能显著改善RA患者症状、体征和关节功能 ,降低血沉、C 反应蛋白 (CRP)和类风湿因子 (RF) ;但ACT组对晨僵、握力、关节压痛数、血沉和RF的改善程度低于MTX(P <0 .0 5)。③ACT组和MTX组的不良反应发生率分别为 7.0 3 %和2 2 .35 % (P <0 .0 1 )。ACT不良反应主要为胃肠道不良反应 ,眩晕、失眠、皮疹及谷丙转氨酶轻度升高。结论　ACT对RA有较好的治疗作用 ,其疗效稍低于MTX ,但耐受性好于MTX。OBJECTIVE: To evaluate the efficacy and safety of actarit and methotrexate in the treatment of patients with rheumatoid arthritis (RA). METHODS: Randomized, double or single blind, controlled and multi-center clinical trial of actarit versus methotrexate was performed. The 313 patients were given po with actarit 100 mg tid and another 167 patients were given po with methotrexate 10 mg once weekly for 12 weeks. Naproxen or oxaprozin was gived together in the first 4 - 6 weeks. RESULTS: The total efficacy rates of actarit and methotrexate were 68.06% and 76.65% after 12 weeks treatment, respectively(P>0.05). Actarit and methotrexate improved the symptoms and signs of rheumatoid arthritis, decreased ESR, C-reactive protein and rheumatoid factor(RF) level respectively. Methotrexate improved morning stiffness, grasp strength of two hand, tenderness joint count (TJC), ESR and RF level better than those of actarit(P<0.05). The incidences of adverse effects of actarit and methotrexate were 7.03% and 22.35% (P<0.05). The adverse effects of actarit were gastrointestinal effects, SGPT increased slightly and etc. CONCLUSION: Actarit is a safe and effective antirhematic drug in the treatment of RA. The efficacy of actarit was lower than that of methotrexate, while the tolerance of actarit is better than that of methotrexate.

关 键 词：治疗 类风湿关节炎 阿克他利 甲氨蝶呤 类风湿关节炎 疗效 

分 类 号：R593.22[医药卫生—内科学] R969[医药卫生—临床医学]