Institute of Clinical Pharmacology, Anhui Medical University, Key Laboratory of Anti-inflammatory and Immunopharmacology of Education Ministry, 81 Meishan Road, Hefei 230032, PR China.
Arthritis Res Ther. 2009;11(6):R180. doi: 10.1186/ar2870. Epub 2009 Dec 1.
Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA).
Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII.
Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically significant difference between the two treatment groups (P < 0.05). Gastrointestinal complaints were common in both groups, but there were fewer and milder side effects in the CCII group than in the MTX group. The incidence of adverse events between the two groups was statistically significant (P < 0.05).
CCII is effective in the treatment of RA and is safe for human consumption. CCII exerts its beneficial effects by controlling inflammatory responses through inducing oral tolerance in RA patients.
ChiCTR-TRC-00000093.
鸡 II 型胶原蛋白（CCII）是从鸡胸软骨中提取的一种蛋白质，具有通过诱导口服耐受来治疗自身免疫性疾病的潜力。本研究开展了一项为期 24 周、双盲、双模拟、随机、甲氨蝶呤（MTX）对照的研究，旨在评估 CCII 治疗类风湿关节炎（RA）的疗效和安全性。
共有 503 例 RA 患者入组该研究。患者接受每日 0.1mg 的 CCII（n=326）或每周 10mg 的 MTX（n=177）治疗 24 周。在基线（第 0 周）、第 12 周和第 24 周时，每位患者都使用标准工具评估疼痛、晨僵、压痛关节计数、肿胀关节计数、健康评估问卷（HAQ）、研究者和患者评估、红细胞沉降率（ESR）和 C 反应蛋白（CRP）。此外，在第 0 周和第 24 周时还评估了类风湿因子（RF）。检测血清中一系列生化参数、血液学参数和尿液分析，以评估 CCII 的安全性。
454 例患者（94.43%）完成了 24 周的随访。两组患者的疼痛、晨僵、压痛关节计数、肿胀关节计数、HAQ 和研究者及患者评估均有下降，所有差异均有统计学意义。MTX 组的 ESR 和 CRP 下降。两组 RF 均无变化。24 周时，CCII 组有 41.55%的患者达到美国风湿病学会 20%改善标准（ACR-20），MTX 组有 57.86%的患者达到该标准，CCII 组有 16.89%的患者达到 ACR 50%改善标准（ACR-50），MTX 组有 30.82%的患者达到该标准。CCII 组的 ACR-20 和 ACR-50 反应率均低于 MTX 组，差异有统计学意义（P<0.05）。计算了两组治疗后的 DAS28（使用 28 个关节计数的疾病活动评分）值，两组间有统计学差异（P<0.05）。两组均常见胃肠道不适，但 CCII 组的不良反应较 MTX 组少且较轻。两组不良事件的发生率有统计学差异（P<0.05）。
CCII 治疗 RA 有效，且可安全应用于人体。CCII 通过诱导 RA 患者的口服耐受来控制炎症反应，从而发挥其有益作用。
ChiCTR-TRC-00000093。
