Tang Xin, Zhou Zong-Ke, Liu Gang, Shen Bin, Kang Peng-De, Li Jian, Li Qi, Pei Fu-Xing
Department of Orthopaedic Surgery, West China Hospital of Sichuan University, No. 37, Guoxue Alley, Chengdu, 610041, People's Republic of China.
Clin Rheumatol. 2015 Jan;34(1):151-6. doi: 10.1007/s10067-014-2519-0. Epub 2014 Feb 13.
The aim of this study was to prospectively evaluate the long-term efficacy and tolerability of hyaluronic acid (HA) for the treatment of knee pain due to Kashin-Beck disease (KBD). A total of 113 patients with KBD-based knee pain were treated with a 3-week course of HA. Clinical assessments were performed for each patient at 0 (baseline), 1, 2, 4, 8, 12, 24, and 52 weeks. The primary efficacy measure was the visual analog scale (VAS) pain score. The secondary efficacy measures included the WOMAC A (pain), B (stiffness), and C (function) scores; the total WOMAC score; and the global assessments by patients and physicians. Tolerability was evaluated based on adverse events (AEs) and physician reporting. The VAS was significantly reduced within the first 4 weeks of treatment, and the reduction was maintained over 52 weeks (p < 0.001 at each endpoint). These data were supported by the secondary variables WOMAC A (all p < 0.001), WOMAC B (p = 0.002, 0.003, and 0.019, respectively), WOMAC C (all p < 0.001), total WOMAC (all p < 0.001), and the global assessments by patients and physicians at weeks 12, 24, and 52. No serious AEs were reported, and the overall incidence of AEs was 10.6 %. This study suggests that the intra-articular injection of HA is effective and well tolerated for the treatment of knee pain due to KBD as HA therapy resulted in an improvement of symptoms for at least 52 weeks. Additional randomized double-blind studies are needed to confirm our findings.
本研究旨在前瞻性评估透明质酸（HA）治疗大骨节病（KBD）所致膝关节疼痛的长期疗效和耐受性。共有113例基于KBD的膝关节疼痛患者接受了为期3周的HA治疗。在0（基线）、1、2、4、8、12、24和52周时对每位患者进行临床评估。主要疗效指标是视觉模拟量表（VAS）疼痛评分。次要疗效指标包括WOMAC A（疼痛）、B（僵硬）和C（功能）评分；WOMAC总分；以及患者和医生的整体评估。根据不良事件（AE）和医生报告评估耐受性。VAS在治疗的前4周内显著降低，且在52周内持续降低（每个终点p<0.001）。这些数据得到了次要变量WOMAC A（所有p<0.001）、WOMAC B（分别为p = 0.002、0.003和0.019）、WOMAC C（所有p<0.001）、WOMAC总分（所有p<0.001）以及患者和医生在12、24和52周时的整体评估的支持。未报告严重AE，AE的总体发生率为10.6%。本研究表明，关节腔内注射HA治疗KBD所致膝关节疼痛有效且耐受性良好，因为HA治疗可使症状改善至少52周。需要更多的随机双盲研究来证实我们的发现。
