Department of orthopaedics, North Tees and Hartlepool NHS Trust, Hardwick road, Stockton on Tees, TS18 9PE, UK.
North Tees and Hartlepool NHS Trust.
Foot (Edinb). 2021 Dec;49:101738. doi: 10.1016/j.foot.2020.101738. Epub 2020 Sep 9.
The aim of this study was to evaluate the efficacy and safety of a single, peri-tendinous injection of hyaluronic acid for mid-portion, non-insertional Achilles tendinopathy.
A prospective, open labelled, single center, pilot study was conducted. All patients enrolled received a single peri-tendinous injection of Ostenil Tendon™ (40 mg/2 ml 2% HA with 0.5% mannitol). Outcome measures were Visual Analogue Scale (VAS) pain score and Manchester-Oxford Foot Questionnaire (MOxFQ) scores at 2 weeks and at final follow at 12 weeks. Any major and minor adverse effects were recorded. To assess change in VAS and MOxFQ scores, t test and Wilcoxon signed rank test were employed.
Seventeen patients were enrolled in this study with a mean follow-up of 12 weeks. Mean pre-injection VAS score was 9.38 cm (9-9.8), which significantly reduced post-injection to a mean score of 4.09 cm (2-8) at week-2 stage, and further improved to 3.01 cm (2-3.9) at the final follow-up (p < 0.0001). MOxFQ score showed a significant improvement from pre-injection value of 67.77 (63.03-72.55) to 31.18 (13-60) at week-2 stage, and further improved to 24.20 (15.73-32.67) at the final follow-up (p < 0.0001). The mean improvement from pre-injection to the final follow up was 43.57 (34.25-52.90). No adverse effects for injections were recorded.
This small series suggests an encouraging response of a single injection of HA as an effective and safe option for non-insertional Achilles tendinopathy.
本研究旨在评估单次关节周围注射透明质酸治疗中段非插入性跟腱病的疗效和安全性。
进行了一项前瞻性、开放标签、单中心、试点研究。所有入组患者均接受单次关节周围注射 Ostenil TendonTM（含 0.5%甘露醇的 2%透明质酸 40mg/2ml）。在 2 周和 12 周的最终随访时，采用视觉模拟评分（VAS）疼痛评分和曼彻斯特-牛津足部问卷（MOxFQ）评分评估疗效。记录任何主要和次要不良事件。采用 t 检验和 Wilcoxon 符号秩检验评估 VAS 和 MOxFQ 评分的变化。
本研究共纳入 17 例患者，平均随访 12 周。平均注射前 VAS 评分为 9.38cm（9-9.8），注射后第 2 周降至 4.09cm（2-8），最终随访时进一步改善至 3.01cm（2-3.9）（p<0.0001）。MOxFQ 评分从注射前的 67.77（63.03-72.55）显著改善至第 2 周的 31.18（13-60），最终随访时进一步改善至 24.20（15.73-32.67）（p<0.0001）。从注射前到最终随访的平均改善值为 43.57（34.25-52.90）。未记录到注射相关不良事件。
这项小系列研究表明，单次注射透明质酸是一种有效且安全的非插入性跟腱病治疗选择，结果令人鼓舞。
