聚合物型 I 胶原对膝关节骨关节炎的影响。二、体内研究。
Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study.
机构信息
Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
出版信息
Eur J Clin Invest. 2009 Jul;39(7):598-606. doi: 10.1111/j.1365-2362.2009.02144.x. Epub 2009 Apr 23.
BACKGROUND
Polymerized-Type I Collagen (Polymerized-Collagen) is an anti-inflammatory and a tissue regenerator biodrug. The aim of the study was to evaluate the efficacy and safety of intra-articular injections of Polymerized-Collagen in patients with knee osteoarthritis (OA).
METHODS AND DESIGN
Patients (n=53) were treated with 12 intra-articular injections of 2 mL of Polymerized-Collagen (n=27) or 2 mL of placebo (n=26) during 6 months. Follow up period was 6 months. The primary endpoints included Western Ontario and McMaster University Osteoarthritis Index, Lequesne index, and pain intensity on a visual analogue scale (VAS). Secondary outcomes were patient global score, investigator global score and drug evaluation. Clinical improvement was determined if the decrease in pain exceeds 20 mm on a VAS and patients achieved at least 20% of improvement from baseline. Urinary levels of C-terminal crosslinking telopeptide of collagen type II (CTXII) and serum high-sensitivity C-reactive protein (hsCRP) were determined by enzyme immunoassays. Statistical analysis was performed by intention to treat.
RESULTS
Polymerized-Collagen was safe and well tolerated. Patients had a statistically significant improvement (P<0.05) from baseline vs. Polymerized-Collagen and vs. placebo at 6 months in: Lequesne Index (13.1+/-0.5 vs. 7.1+/-0.7 vs. 9.6+/-0.8; P=0.027), WOMAC (9.0+/-0.5 vs. 4.0+/-0.6 vs. 5.80+/-0.8; P=0.032), patient VAS (60.0+/-2.6 vs. 20.6+/-2.4 vs. 36.1+/-4.5; P=0.003), physician VAS (49.8+/-1.9 vs. 16.8+/-2.9 vs. 29.8+/-2.9; P=0.002), patient global score (1.08+/-0.1 vs. 2.7+/-0.1 vs. 1.9+/-0.2; P=0.028) and analgesic usage (30.1+/-9.4 vs. 11.0+/-3.4 vs. 17.9+/-4.9; P=0.001). This improvement was persistent during the follow up. A threefold increase in CTXII was determined in placebo group. No differences were found on hs CRP and incidence of adverse events between groups.
CONCLUSION
Polymerized-Collagen is safe and effective in the treatment of knee OA.
背景
聚合型 I 型胶原（聚合胶原）是一种具有抗炎和组织再生作用的生物药物。本研究旨在评估关节内注射聚合胶原治疗膝骨关节炎（OA）患者的疗效和安全性。
方法和设计
53 例患者（n=53）接受了 12 次 2 毫升的聚合胶原（n=27）或安慰剂（n=26）关节内注射治疗，持续 6 个月。随访时间为 6 个月。主要终点包括 Western Ontario and McMaster University Osteoarthritis Index、Lequesne 指数和视觉模拟量表（VAS）上的疼痛强度。次要结局包括患者总体评分、研究者总体评分和药物评估。如果 VAS 上的疼痛减轻超过 20mm，且患者从基线至少改善 20%，则确定临床改善。通过酶联免疫吸附试验测定尿型胶原交联 C 端肽（CTXII）和血清高敏 C 反应蛋白（hsCRP）水平。通过意向治疗进行统计分析。
结果
聚合胶原安全且耐受良好。与安慰剂相比，患者在 6 个月时在 Lequesne 指数（13.1+/-0.5 比 7.1+/-0.7 比 9.6+/-0.8；P=0.027）、WOMAC（9.0+/-0.5 比 4.0+/-0.6 比 5.80+/-0.8；P=0.032）、患者 VAS（60.0+/-2.6 比 20.6+/-2.4 比 36.1+/-4.5；P=0.003）、医生 VAS（49.8+/-1.9 比 16.8+/-2.9 比 29.8+/-2.9；P=0.002）、患者总体评分（1.08+/-0.1 比 2.7+/-0.1 比 1.9+/-0.2；P=0.028）和镇痛药物使用（30.1+/-9.4 比 11.0+/-3.4 比 17.9+/-4.9；P=0.001）方面均有统计学显著改善。这种改善在随访期间持续存在。安慰剂组 CTXII 水平增加了三倍。两组间 hsCRP 和不良反应发生率无差异。
结论
聚合胶原治疗膝骨关节炎安全有效。
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