Sun Shu-Fen, Chou Yi-Jiun, Hsu Chien-Wei, Hwang Chiao-Wen, Hsu Pei-Te, Wang Jue-Long, Hsu Ya-Wen, Chou Mei-Chia
Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan. sfsun.tw@@yahoo.com.tw
Osteoarthritis Cartilage. 2006 Sep;14(9):867-74. doi: 10.1016/j.joca.2006.03.003. Epub 2006 Apr 24.
To investigate the efficacy, safety and the duration of treatment effectiveness of intra-articular hyaluronic acid (Artz, Japan) in patients with ankle osteoarthritis (OA).
As a prospective clinical trial, 93 patients with unilateral ankle pain for at least 6 months and radiographically classified as Kellgren-Lawrence grade I or II ankle OA were included. After five weekly intra-articular Artz injections, the Ankle Osteoarthritis Scale (AOS), the American Orthopaedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, ankle sagittal range of motion (ROM), patients' global satisfaction, local adverse events and consumption of rescue analgesics were analyzed.
Seventy-five patients completed the study. Significant improvement in AOS and AOFAS ankle/hindfoot scores was noted at 1 week, 1 month, 3 months and 6 months post the fifth injection (P < 0.001 compared with baseline). The mean reduction of AOS score was 1.9, 2.6, 2.5 and 2.6 at each following visit (P < 0.001). The mean AOFAS ankle/hindfoot score improved from 64 points at baseline to 75, 78, 78, and 78 points at 1 week, 1 month, 3 months and 6 months, respectively, post the fifth injection (P < 0.001). Ankle sagittal ROM did not improve significantly (P > 0.05). The majority of patients reported satisfaction at 1 week (100%), 1 month (100%), 3 months (90.7%) and 6 months (86.7%) follow-up. Local adverse events occurred in 6.7% of patients. Acetaminophen consumption dropped significantly following treatment (P < 0.001).
Five weekly intra-articular injections of Artz provide pain relief and functional improvements in patients with Kellgren-Lawrence grades I and II ankle OA. The clinical effect was rapid at 1 week and may last for 6 months or more.
探讨关节腔内注射透明质酸（日本的Artz）治疗踝关节骨关节炎（OA）患者的疗效、安全性及治疗效果持续时间。
作为一项前瞻性临床试验，纳入93例单侧踝关节疼痛至少6个月且经影像学检查分类为Kellgren-Lawrence I级或II级踝关节OA的患者。在每周1次关节腔内注射Artz共5次后，分析踝关节骨关节炎量表（AOS）、美国矫形足踝协会（AOFAS）踝/后足评分、踝关节矢状面活动度（ROM）、患者总体满意度、局部不良事件及急救镇痛药的使用情况。
75例患者完成了研究。在第5次注射后的1周、1个月、3个月和6个月时，AOS和AOFAS踝/后足评分有显著改善（与基线相比，P < 0.001）。随后每次随访时AOS评分的平均降低值分别为1.9、2.6、2.5和2.6（P < 0.001）。第5次注射后，AOFAS踝/后足评分从基线时的64分分别改善至1周、1个月、3个月和6个月时的75分、78分、78分和78分（P < 0.001）。踝关节矢状面ROM无显著改善（P > 0.05）。大多数患者在随访1周（100%）、1个月（100%）、3个月（90.7%）和6个月（86.7%）时表示满意。6.7%的患者发生局部不良事件。治疗后对乙酰氨基酚的使用量显著下降（P < 0.001）。
每周1次关节腔内注射Artz共5次可缓解Kellgren-Lawrence I级和II级踝关节OA患者的疼痛并改善功能。临床效果在1周时迅速出现，且可能持续6个月或更长时间。
