关节内注射透明质酸钠（海乐健）治疗膝骨关节炎。一项针对亚洲人群的随机、对照、双盲、多中心试验。
Intra-articular injections of sodium hyaluronate (Hyalgan®) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population.
机构信息
Department of Orthopaedic, National Taiwan University and University Hospital, 7 Chung Shan South Road, Taipei, Taiwan.
出版信息
BMC Musculoskelet Disord. 2011 Oct 6;12:221. doi: 10.1186/1471-2474-12-221.
BACKGROUND
The efficacy and tolerability of 500-730 kDa sodium hyaluronate (Hyalgan®) for treatment of osteoarthritis (OA) pain has been established in clinical trials, but few data are available in the Asian population. We conducted a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and tolerability of this preparation in a Taiwanese population.
METHODS
Two hundred patients with mild to moderate OA of the knee were randomized to receive five weekly intra-articular injections of sodium hyaluronate or placebo. The primary efficacy outcome was the change from baseline to Week 25 in patients' evaluation of pain using a 100-mm visual analog scale (VAS) during the 50-foot walking test. Additional outcomes included Western Ontario and McMaster Universities (WOMAC) scores, time on the 50-foot walking test, patient's and investigator's subjective assessment of effectiveness, acetaminophen consumption, and the amounts of synovial fluid.
RESULTS
The Hyalgan® treatment group showed a significantly greater improvement from baseline to Week 25 in VAS pain on the 50-foot walking test than the placebo group (p = 0.0020). The Hyalgan® group revealed significant improvements from baseline to week 25 in WOMAC pain and function score than the placebo group (p = 0.005 and 0.0038, respectively) Other outcomes, such as time on the 50-foot walking test and subjective assessment of effectiveness, did not show any significant difference between groups. Both groups were safe and well tolerated.
CONCLUSIONS
The present study suggests that five weekly intra-articular injections of sodium hyaluronate are well tolerated, can provide sustained relief of pain, and can improve function in Asian patients with osteoarthritis of the knee.
TRIAL REGISTRATION
Therapeutic study, Level I-1a (randomized controlled trial with a significant difference).
背景
在临床试验中已证实 500-730 kDa 透明质酸钠（Hyalgan®）治疗骨关节炎（OA）疼痛的疗效和耐受性，但亚洲人群的数据有限。我们进行了一项随机、双盲、多中心、安慰剂对照研究，以评估该制剂在台湾人群中的疗效和耐受性。
方法
200 例膝关节轻度至中度 OA 患者随机接受每周 5 次关节内注射透明质酸钠或安慰剂。主要疗效终点为 50 英尺步行试验中患者疼痛评估的变化，使用 100mm 视觉模拟量表（VAS）在基线至 25 周。其他结局包括 Western Ontario 和 McMaster 大学（WOMAC）评分、50 英尺步行试验时间、患者和研究者对有效性的主观评估、对乙酰氨基酚的消耗以及滑液量。
结果
与安慰剂组相比，Hyalgan®治疗组在 50 英尺步行试验 VAS 疼痛方面从基线到第 25 周的改善具有显著统计学意义（p=0.0020）。与安慰剂组相比，Hyalgan®组在 WOMAC 疼痛和功能评分方面从基线到第 25 周的改善具有显著统计学意义（p=0.005 和 0.0038），其他结局，如 50 英尺步行试验时间和有效性的主观评估，两组之间无显著差异。两组均安全且耐受良好。
结论
本研究表明，每周 5 次关节内注射透明质酸钠在亚洲膝关节骨关节炎患者中耐受性良好，可提供持续的疼痛缓解，并改善功能。
试验注册
治疗性研究，一级 1a 类（具有显著差异的随机对照试验）。
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