口服Ⅱ型胶原治疗类风湿关节炎的临床研究  

Clinical study on the treatment of rheumatoid arthritis with oral type Ⅱ collagen

作　　者：徐建华[1] 孙桂华[1] 帅宗文[1] 王芬[1] 徐胜前[1] 刘爽[1] 丁长海[2] 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230032

出　　处：《安徽医药》2001年第1期14-16,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的　研究和比较不同剂量Ⅱ型胶原治疗类风湿关节炎的疗效和安全性。方法　为随机比较的临床试验。共完成病例 6 6例 ,口服Ⅱ型胶原 2 0 μg、6 0 μg、10 0 μg和 15 0μg ,每天一次 ,疗程 8周。 结果　总有效率 :4周 2 0 μg、6 0μg、10 0 μg和 15 0 μg组分别为 2 8 5 7%、5 0 0 0 %、46 6 2 %和46 6 7% ;8周 6 0 μg、10 0 μg和 15 0 μg组分别为 6 2 5 0 %、6 0 0 0 %和 5 7 14%。不同剂量组之间疗效总有效率无明显差异 (P >0 0 5 )。但 2 0 μg组仅能改善患者的关节压痛和手握力 ,对晨僵、关节肿胀、关节功能等不能改善 ;而 6 0 μg、10 0μg和 15 0 μg能明显改善患者以上的症状和体征 ,降低血沉。安全性评价 :3例患者有轻度腹胀 ,1例患者偶有少量鼻出血 ,不良反应发生率 :6 0 6 % (4 / 6 6例 )。结论　Ⅱ型胶原可以改善类风关患者的关节症状且无毒副作用 ,值得推荐的剂量为 6 0 μg、10 0AIM To evaluate the efficacy and dosages of type Ⅱ collagen(C Ⅱ) in the treatment of patients with rheumatoid arthritis(RA). METHODS 66 patients with RA were enrolled by randomized clinical preliminary trial to receive four dosages (20, 60, 100, 150 μg·d -1 ) of oral C Ⅱ for eight week. RESULTS The total efficacy rates of 20, 60, 100, 150 μg groups were 28 57%? 50 00%? 46 62% and 46 67% after four week, respectively; after treatment eight week, 60 μg? 100 μg? 150 μg groups were 62 50%? 60 00% and 57 14%, respectively, no significant statistic difference in four groups. The 60 μg? 100 μg? 150 μg groups could improve the symptoms and signs of RA, but 20 μg? only could improve part the symptoms of RA. CONCLUSION The present study has shown that this novel therapy is clinically beneficial and safe in patients with RA.

关 键 词：Ⅱ型胶原 类风湿性关节炎 口服耐受 临床试验 

分 类 号：R593.22[医药卫生—内科学]