Mandl Lisa A, Hotchkiss Robert N, Adler Ronald S, Lyman Stephen, Daluiski Aaron, Wolfe Scott W, Katz Jeffrey N
Hospital for Special Surgery, New York, NY 10021, USA.
Curr Med Res Opin. 2009 Sep;25(9):2103-8. doi: 10.1185/03007990903084016.
Carpometacarpal osteoarthritis (CMC OA) is highly prevalent in older adults, and is often unresponsive to medical treatment. Intra-articular Hylan G-F 20 has been shown to improve pain and function in patients with knee OA; however, its effectiveness in CMC OA is less clear.
32 patients with CMC OA were injected with Hylan G-F 20, once weekly for three consecutive weeks. Patients were assessed 4, 12, 20 and 26 weeks after the first injection. A last-value carried forward analysis was performed.
Average age was 64 years, (range 46-79), 69% were female and 97% Caucasian. Fifty-three percent had at least one previous corticosteroid injection in the affected CMC joint. At 26 weeks, mean visual analogue scale (VAS) for pain had improved significantly (15.2 mm; p-value = 0.006). Disabilities of the arm, shoulder and hand questionnaire (DASH) scores also improved significantly (12.6; p-value < 0.001). A DASH change of 10-14 is considered clinically meaningful. Neither key strength nor opposition grip strength improved. VAS scores for pain at 26 weeks showed good correlation with patient satisfaction (Spearman r = 0.52, p-value < 0.01). Adverse events potentially related to the injections included three episodes of post-injection pain and swelling, and one case of crystal proven pseudogout.
Intra-articular Hylan G-F 20 injections reduced pain and improved function in patients with CMC OA at 26 weeks in this small open label study. Limitations of this study include its small, open label design. Larger randomized controlled trials are needed to confirm these results, and to determine predictors of response to treatment.
This study was approved by the Institutional Review Board at the Hospital for Special Surgery, New York, NY, USA and registered at (www.ClinicalTrials.Gov)# NCT00198029.
掌指关节骨关节炎（CMC OA）在老年人中非常普遍，且通常对药物治疗无反应。关节内注射透明质酸钠凝胶（Hylan G-F 20）已被证明可改善膝骨关节炎患者的疼痛和功能；然而，其在 CMC OA 中的有效性尚不清楚。
32 例 CMC OA 患者接受 Hylan G-F 20 注射，每周一次，连续三周。在首次注射后 4、12、20 和 26 周对患者进行评估。进行末次观察值结转分析。
平均年龄为 64 岁（范围 46 - 79 岁），69%为女性，97%为白种人。53%的患者在受影响的 CMC 关节至少接受过一次皮质类固醇注射。在 26 周时，疼痛的平均视觉模拟量表（VAS）评分显著改善（15.2 mm；p 值 = 0.006）。手臂、肩部和手部功能障碍问卷（DASH）评分也显著改善（12.6；p 值 < 0.001）。DASH 评分变化 10 - 14 被认为具有临床意义。关键力量和对掌握力均未改善。26 周时的疼痛 VAS 评分与患者满意度显示出良好的相关性（Spearman r = 0.52，p 值 < 0.01）。与注射潜在相关的不良事件包括 3 次注射后疼痛和肿胀发作，以及 1 例经晶体证实的假痛风病例。
在这项小型开放标签研究中，关节内注射 Hylan G-F 20 在 26 周时减轻了 CMC OA 患者的疼痛并改善了功能。本研究的局限性包括其小型开放标签设计。需要更大规模的随机对照试验来证实这些结果，并确定治疗反应的预测因素。
本研究获得美国纽约特种外科医院机构审查委员会的批准，并在（www.ClinicalTrials.Gov）# NCT00198029 注册。
