Häuselmann H J, Caravatti M, Seifert B, Wang K, Bruckner P, Stucki G, Michel B A
Department of Rheumatology and Physical Medicine, University Hospital Zürich, Switzerland.
Br J Rheumatol. 1998 Oct;37(10):1110-7.
Based on the results of two recently published, randomized, double-blind and placebo-controlled studies, a possible improvement in rheumatoid arthritis disease activity after oral tolerization with triple helical collagen type II has been suggested. The goal of this study was to go one step further and ask the question whether collagen type II can sustain the therapeutic effect induced by methotrexate, the most widely accepted disease-modifying anti-rheumatic drug in patients with long-standing rheumatoid arthritis.
Ninety-two patients with rheumatoid arthritis on stable therapy with methotrexate were enrolled in a 3 month double-blind, randomized and comparative study to examine the efficacy of oral triple helical collagen type II as compared to continuing methotrexate. The dose of methotrexate (or the respective placebo drug) and of concomitant corticosteroids was not changed and intra-articular corticosteroids were not allowed during the 3 months. The primary study endpoint was disease activity as measured by physician and patients.
While patients under ongoing therapy with methotrexate had, as expected, no change in disease activity, almost all parameters of disease activity and outcome in patients under a daily oral dose of 0.5 mg triple helical collagen type II worsened significantly (highly significant difference in swollen joints, between the two groups, P < 0.0001). No significant differences in side-effects between the two groups during the study period could be demonstrated.
Substitution of methotrexate with daily 0.5 mg of triple helical collagen type II in patients with rheumatoid arthritis leads to a significant increase in disease activity, suggesting that oral collagen type II at the given dose is not capable of sustaining the methotrexate-induced anti-inflammatory effect in patients with long-standing rheumatoid arthritis.
基于最近发表的两项随机、双盲、安慰剂对照研究结果，有人提出口服II型三螺旋胶原后类风湿关节炎疾病活动度可能得到改善。本研究的目的是更进一步，探讨II型胶原能否维持甲氨蝶呤（在长期类风湿关节炎患者中最广泛接受的改善病情抗风湿药物）所诱导的治疗效果。
92例接受甲氨蝶呤稳定治疗的类风湿关节炎患者参与了一项为期3个月的双盲、随机、对照研究，以检验口服II型三螺旋胶原与继续使用甲氨蝶呤相比的疗效。甲氨蝶呤（或相应的安慰剂药物）及同时使用的皮质类固醇剂量不变，且在这3个月内不允许使用关节内皮质类固醇。主要研究终点是由医生和患者评估的疾病活动度。
正如预期的那样，持续接受甲氨蝶呤治疗的患者疾病活动度没有变化，而每日口服0.5mg II型三螺旋胶原的患者，几乎所有疾病活动度参数和结局指标都显著恶化（两组间肿胀关节数差异极显著，P<0.0001）。研究期间两组间副作用无显著差异。
类风湿关节炎患者用每日0.5mg II型三螺旋胶原替代甲氨蝶呤会导致疾病活动度显著增加，这表明给定剂量的口服II型胶原不能维持长期类风湿关节炎患者中甲氨蝶呤诱导的抗炎作用。
Zotero 插件