Afdeling Orthopedie, St. Maartenskliniek, Hengstdal 3, P.O. Box 9011, 6500 GM Nijmegen, The Netherlands.
Foot Ankle Surg. 2010 Dec;16(4):159-63. doi: 10.1016/j.fas.2009.10.003. Epub 2009 Nov 8.
To determine the efficacy, safety and dose dependency of intra-articular Orthovisc(®) hyaluronic acid injections in the ankle.
A prospective single blinded study in patients with symptomatic ankle-osteoarthritis. Patients were randomly allocated to 1, 2, 3 ml, or 3 weekly injections of 1 ml (3 × 1 ml). Primary outcome was 'pain during walking' at 15 weeks measured on a 100mm VAS.
Twenty-six patients (ITT) participated. The 3 × 1 ml dose group showed statistically significant decreases at week 7 for 'pain during walking' and 'pain at rest' (p=0.046). At week 15 decreases were significant for 'pain at rest' (p=0.046). There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle.
Orthovisc(®) viscosupplementation in the ankle joint is effective and well tolerated. The 3 × 1 ml dose regimen shows the best results.
确定关节内 Orthovisc（®）透明质酸注射治疗踝关节骨关节炎的疗效、安全性和剂量依赖性。
对有症状的踝关节骨关节炎患者进行前瞻性、单盲研究。患者随机分配至 1ml、2ml、3ml 或每周 1ml（3×1ml）3 次注射组。主要终点是 15 周时的 100mm VAS 测量的“行走时疼痛”。
26 例患者（意向治疗人群）参与了研究。3×1ml 剂量组在第 7 周时“行走时疼痛”和“休息时疼痛”显著降低（p=0.046）。第 15 周时“休息时疼痛”也显著降低（p=0.046）。单次剂量组的 VAS 评分均无显著降低。7 例患者出现注射踝关节暂时性局部肿胀和疼痛增加。
Orthovisc（®）关节内透明质酸补充治疗踝关节骨关节炎有效且耐受良好。3×1ml 剂量方案效果最佳。
