阿克他利/甲氨喋呤治疗类风湿关节炎双盲随机对照研究  

A Double-blind, Randomized, Controlled Clinical Study on Actarit/Methotrxate for Treatment of Rheumatoid Arthritis

作　　者：徐建华[1] 丁长海[2] 倪立青 周嘉陵 帅宗文[1] 王芬[1] 徐胜前[1] 孙桂华[1] 徐叔云[2] 

机构地区：[1]安徽医科大学附属医院风湿科,合肥230022 [2]安徽医科大学临床药理研究所,合肥230023 [3]上海市光华医院,上海200052

出　　处：《中国临床药理学杂志》2001年第1期22-26,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的：比较研究阿克他利治疗类风湿关节炎的疗效和安全性。方法：随机、双盲比较研究。共完成病例１３５例，试验组６７例，口服阿克他利１００ｍｇ，每天三次；对照组６８例，口服甲氨喋呤（ＭＴＸ） １０ ｍｇ，每周一次，疗程１２周。结果：治疗６周、１２周后，总有效率：ＡＣＴ组为３５．８２％，６２．６９％；ＭＴＸ组为４５．５９％，７２．０６％（Ｐ＜０．０５）。两药均能明显改善患者的症状和体征，１２周时能降低血沉，Ｃ－反应蛋白和类风湿因子水平。ＭＴＸ在改善患者的休息痛、关节压痛数及压痛指数、双手握力、医师评价、病人评价及降低血沉方面优于ＡＣＴ（Ｐ＜０．０５）。安全性评价：药物不良反应发生率：ＡＣＴ组８．９６％（６／６７）ＭＴＸ组２３．５３％（１６／６８），ＡＣＴ的耐受性优于ＭＴＸ（Ｐ＜０．０５）。结论：阿克他利是一个安全性好且较有效的治疗类风湿关节炎的新型抗风湿药。OBJECTIVE: To evaluate the efficacy and safety of actarit(ACT) in the treatment of patients with rheumatoid arthritis. METHODS: Double- blind, randomized, controlled clinical trial of ACT versus MTX was performed. 135 patients (ACT 67cases,MTX 68cases) were given po with ACT 100mg three times daily or MTX 10mg one time weekly for 12 weeks. RESULTS: ACT and MTX could improve the symptoms and signs of rheumatoid arthritis, decrease ESR. Creactive protein(CRP) and rheumatoid factor(RF) levels. The total efficacy rates of ACT were 35.82%; 62.69%, and the MTX were 45.59%; 72.06% after 6 and 12 weeks treatment, respectively (P>0.05). MTX improved rest paint, enderness joint count(TJC), tenderness joint score(TJS) grasp strength of two hands, patient assessment. physician assessment and decreased ESR better than those of ACT(P <0.05). The incidence of adverse effects of ACT were 8.96%; and the MTX were 23.53%(P<0.05). The tolerance of ACT is better than that of MTX. Main adverse effects of ACT were that one patient's SGOT increased mildly and other patient happened asthma. Others were symptoms of gastrointestinal tract. None ceased treatment due to adverse effects. CONCLUSION: ACT is a safe, effective drug in treating rheumatoid arthritis.

关 键 词：阿克他利 甲氨喋呤 类风湿性关节炎 药物治疗 双盲试验 

分 类 号：R593.220.5[医药卫生—内科学]