口服Ⅱ型胶原治疗类风湿关节炎的临床研究  

Effectiveness and Safety of Oral Administration of Type Ⅱ Collagen on Patients with Active Rheumatoid Arthritis

作　　者：帅宗文[1] 丁长海[2] 徐建华[1] 孙桂华[1] 王芬[1] 徐淑云[2] 

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

出　　处：《中国医师杂志》2001年第7期510-512,共3页Journal of Chinese Physician

摘　　要：目的　初步探讨口服Ⅱ型胶原 (CⅡ )治疗类风湿关节炎的疗效和安全性。方法　用随机双盲和安慰剂对照的方法 ,70例活动性类风湿关节炎患者随机分为试验组和对照组各 3 5例 ,分别口服Ⅱ型胶原每日0 1mg和安慰剂 ,随访 12周 ,比较观察二组的疗效 ,并记录不良反应。结果　用药 12周 ,有效率试验组和对照组分别为 54 55%和 12 12 % (P <0 0 1) ,显效率两组分别为 18 18%和 3 13 % (P <0 0 1) ,试验组明显高于对照组 ;口服CⅡ治疗有效患者的病程明显短于无效患者 ;两组不良反应表现为轻度可耐受的胃肠道反应 ,试验组和对照组发生率分别为 15 15%和 12 50 % ,差异无显著性。结论　口服Ⅱ型胶原蛋白治疗类风湿关节炎安全有效 ,不良反应轻 ,发病早期使用可提高有效率。Objective To assess the effectiveness and safety of oral administration of type Ⅱ collagen(C Ⅱ) versus placebo in patients with active rheumatoid arthritis(RA).Methods Seventy patients with active RA were randomly divided into receive placebo(n=35) or bovine CⅡ(n=35) at 0 1mg/day for 12 weeks,in a double-blind study.The cumulative response rates were analyzed by utilizing the American College of Rheumatology(ACR) criteria for improvement in RA,and the requirement for ≥50% improvement of outcome measures in ACR criteria.Results After the 12-week course of treatment,much more outcome was significantly improved in C Ⅱ group than in placebo group.The rates of improvement and remarkable improvement in CⅡ group were increased significantly,as compared with placebo group(54 55% vs 12 12% and 18 18% vs 3 13%,respectively,P<0 01).The course of disease for RA patients improved with CⅡ was shorter than those of inefficacy cases,CⅡ main adverse events(AES) were slight gastrointestinal symptom,AES incidence was not statistically difference tolerantable between the two groups(15 15% vs 12 50%,P>0 05).Conclusions Oral administration of CⅡ in treating RA was significantly effective and has slight side effects.Further investigation in the field is worthwhile.

关 键 词：类风湿性关节炎 胶原 治疗 临床试验 

分 类 号：R593.22[医药卫生—内科学]