阿克他利治疗68例类风湿关节炎病人的随机双盲对照试验

Actarit in treating 68 patients with rheumatoid arthritis: a double-blind randomized controlled study

目的 :评估阿克他利治疗类风湿关节炎(RA)的疗效和安全性。方法 :采用随机双盲对照试验入选 10 5例RA病人 ,完成观察 10 3例 ,分为 2组。阿克他利组 6 8例 ,予阿克他利 10 0mg ,po ,tid ;甲氨蝶呤组 35例 ,予甲氨蝶呤 10mg ,po ,qw ;疗程均为 12wk。 12wk后揭盲 ,31例阿克他利组病人继续疗程至 2 4wk。结果 :阿克他利组 12wk的有效率为 6 8% ,与甲氨蝶呤组的疗效 (74 % )相近 ,P >0 .0 5 ,阿克他利组 2 4wk的有效率为 84 %。阿克他利组的不良反应发生率为 7% ,明显低于甲氨蝶呤组 (2 8% ) ,P <0 .0 1。结论 :阿克他利作为一种新型抗风湿二线药物治疗RA有较好的疗效 ,且不良反应轻微。

AIM: To observe the efficacy and safety of actarit in treating rheumatoid arthritis (RA). METHODS: One hundred and five patients with RA were randomly divided into two groups in a double-blind, randomized controlled study. Actarit group of 68 patients ((M 9,F 59;age(44±s 12)a) was treated with actarit, 100 mg,po,tid for 12 wk. Methotrexate group of 35 patients ((M 5,F 30;age (46±11)a) was treated with methotrexate, 10 mg,po,qw,for 12 wk. Thirty-one patients of actarit group continued the treatment up to 24 wk. RESULTS: The clinical effective rates of actarit and methotrexate group were 68 % and 74 %(P> 0.05). That of actarit group of 24 wk was 84 %. The adverse reaction of actarit group was more lower than that of methotrexate group (P<0.01). CONCLUSION: Actarit shows the similar effects to methotrexate in treating RA, but the adverse reaction of the former is less than that of the latter.