在类风湿性关节炎的现有治疗方案中添加口服牛II型胶原蛋白后疗效欠佳。
Lack of efficacy of oral bovine type II collagen added to existing therapy in rheumatoid arthritis.
作者信息
McKown K M, Carbone L D, Kaplan S B, Aelion J A, Lohr K M, Cremer M A, Bustillo J, Gonzalez M, Kaeley G, Steere E L, Somes G W, Myers L K, Seyer J M, Kang A H, Postlethwaite A E
机构信息
Department of Medicine, The University of Tennessee, Department of Veterans Affairs Medical Center, Memphis 38163, USA.
出版信息
Arthritis Rheum. 1999 Jun;42(6):1204-8. doi: 10.1002/1529-0131(199906)42:6<1204::AID-ANR17>3.0.CO;2-U.
OBJECTIVE
To investigate the efficacy of oral type II collagen (CII) in the treatment of rheumatoid arthritis (RA), when added to existing therapy.
METHODS
Patients with active RA (n = 190) were randomized into a 6-month, double-blind, placebo-controlled trial. Patients continued to take their current arthritis medications. Patients received either placebo or bovine CII, 0.1 mg/day for 1 month, then 0.5 mg/day for 5 months.
RESULTS
There were no significant differences between the baseline characteristics of either group. The primary response parameter was the American College of Rheumatology (ACR) preliminary definition of improvement in RA (ACR 20). There was no statistically significant difference in the ACR 20 after 6 months (20.0% of placebo patients; 16.84% of bovine CII patients). There were significant differences in several clinical variables after treatment, all favoring the placebo group.
CONCLUSION
Oral solubilized bovine CII, added to existing therapy, did not improve disease activity in patients with RA.
目的
研究在现有治疗基础上加用口服II型胶原蛋白（CII）治疗类风湿关节炎（RA）的疗效。
方法
将190例活动期RA患者随机分为一项为期6个月的双盲、安慰剂对照试验。患者继续服用其当前的关节炎药物。患者接受安慰剂或牛CII治疗，0.1毫克/天，持续1个月，然后0.5毫克/天，持续5个月。
结果
两组的基线特征无显著差异。主要反应参数是美国风湿病学会（ACR）对RA改善的初步定义（ACR 20）。6个月后ACR 20无统计学显著差异（安慰剂组为20.0%；牛CII组为16.84%）。治疗后几个临床变量存在显著差异，均有利于安慰剂组。
结论
在现有治疗基础上加用口服可溶性牛CII并不能改善RA患者的疾病活动度。
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