Orthopaedic Clinic, 2nd Medical School, Charles University, Prague, Czech Republic.
Int Orthop. 2011 Mar;35(3):341-8. doi: 10.1007/s00264-010-1010-z. Epub 2010 Apr 19.
This was a 13-week, multicentre, randomised, parallel, double-blind study. One hundred men and women volunteers aged ≥ 40 years with knee osteoarthritis (KOA) were randomised to once daily enzymatic hydrolysed collagen (EHC) 10 g or glucosamine sulphate (GS) 1.5 g for 90 consecutive days. Follow-up took place after two weeks and after one, two and three months. Primary [visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC Index)] and secondary outcomes variables, assessed at weeks two, four, eight and 12, were KOA pain intensity measured by quadruple visual analogue scales in the target knee, the WOMAC total score index, patient's and investigator's global assessments of disease activity, joint assessment, use of rescue medication (ibuprofen 400 mg tablets) and assessment of Quality of Life index (SF-36 Questionnaire). Safety and tolerability were also evaluated. Clear improvement was observed in both joint pain and symptoms in patients with KOA treated with EHC (Colatech®) and significant differences were observed. Mean reductions from baseline for EHC 10 g daily and GS 1.5 g, respectively, were KOA pain intensity reduction in the target knee for Colatech® (p < 0.05): WOMAC index decrease ≤ 15 points at the last visit (day 90) for Colatech® in 16 patients (34.04%) (p < 0.05) and for glucosamine in six patients (13.04%); total score index for painful joints: Colatech® 1.6 (p < 0.05) and glucosamine 1.8; total score index for swollen joints: Colatech® 0.5 (p < 0.05) and glucosamine 0.7; patient's global assessment of efficacy as the sum of improvement good + ideal: 80.8% for Colatech® and 46.6% for glucosamine (p < 0.05). EHC (Colatech®) showed superior improvement over GS in the SF-36 Questionnaire in the Physical Health Index (42.0 for Colatech and 40.0 for glucosamine). The incidence of adverse events was similar in both groups. Both EHC and GS were well tolerated.
这是一项为期 13 周、多中心、随机、平行、双盲研究。100 名年龄≥40 岁的膝骨关节炎（KOA）男性和女性志愿者被随机分为每日一次酶解胶原蛋白（EHC）10g 或硫酸氨基葡萄糖（GS）1.5g，连续 90 天。在两周后、一个月、两个月和三个月后进行随访。主要[视觉模拟量表（VAS）、安大略西部和麦克马斯特大学（WOMAC 指数）]和次要结局变量在第 2、4、8 和 12 周进行评估，包括目标膝关节 KOA 疼痛强度的四重视觉模拟量表测量、WOMAC 总评分指数、患者和研究者对疾病活动的整体评估、关节评估、救援药物（布洛芬 400mg 片剂）的使用和生活质量指数（SF-36 问卷）评估。还评估了安全性和耐受性。用 EHC（Colatech®）治疗的 KOA 患者的关节疼痛和症状均明显改善，且具有显著差异。每日 10g EHC 和 1.5g GS 的平均基线降低分别为 Colatech®目标膝关节 KOA 疼痛强度的降低（p<0.05）：在最后一次就诊（第 90 天）时 WOMAC 指数的降低≤15 分的患者为 Colatech®的 16 例（34.04%）（p<0.05）和 GS 的 6 例（13.04%）；疼痛关节的总评分指数：Colatech®1.6（p<0.05）和 GS 1.8；肿胀关节的总评分指数：Colatech®0.5（p<0.05）和 GS 0.7；患者对疗效的整体评估，即改善良好+理想的总和：Colatech®为 80.8%，GS 为 46.6%（p<0.05）。在 SF-36 问卷的身体健康指数中，EHC（Colatech®）在 GS 上的改善明显优于 GS（Colatech 为 42.0，GS 为 40.0）。两组的不良反应发生率相似。EHC 和 GS 均具有良好的耐受性。
