Tang Xin, Zhou Zong-Ke, Shen Bin, Kang Peng-de, Pei Fu-Xing, Li Jian
Orthopedic Department, West China Hospital, Sichuan University, Chengdu, China.
Int J Rheum Dis. 2019 Mar;22(3):392-398. doi: 10.1111/1756-185X.13435. Epub 2018 Nov 20.
To prospectively evaluate the long-term efficacy and safety of repeated sodium hyaluronate injections for the treatment of knee pain due to Kashin-Beck disease (KBD).
A total of 85 patients with KBD-based knee pain were treated with two cycles of a 5-week course of sodium hyaluronate and received clinical assessments with a follow-up period of 24 months after the first cycle. The primary efficacy measure was the visual analogue scale (VAS) pain score. The second efficacy measure included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores; and the patients' and physicians' global assessments. Tolerability was evaluated based on adverse events (AEs).
Seventy-one patients (83.5%) completed the final study. The VAS was significantly reduced from 65.06 ± 12.21 mm (mean ± standard deviation [SD]) at baseline to 30.17 ± 11.92 mm at 6 months and was maintained for 24 months (35.79 ± 7.92 mm, P < 0.01 vs baseline). This finding was supported by the secondary variables (the WOMAC A, B and C scores; the total WOMAC scores; and the global assessments of the patients and their physicians at months 6, 12, 18 and 24). The overall incidence of AEs during the first and second cycles was 8 (9.4%) and 7 patients (8.2%), respectively. No serious AEs were reported.
Repeated once yearly cycles of intra-articular sodium hyaluronate injections may improve knee KBD symptoms during the inbetween cycle period as well as exert a significant carry-over effect for at least 1 year after the repeated cycle. Other randomized double-blind studies are needed to confirm the findings from our study.
前瞻性评估重复注射透明质酸钠治疗大骨节病（KBD）所致膝关节疼痛的长期疗效及安全性。
85例KBD所致膝关节疼痛患者接受两个疗程、为期5周的透明质酸钠治疗，并在第一个疗程后进行24个月的临床评估。主要疗效指标为视觉模拟量表（VAS）疼痛评分。次要疗效指标包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分以及患者和医生的整体评估。根据不良事件（AE）评估耐受性。
71例患者（83.5%）完成最终研究。VAS评分从基线时的65.06±12.21mm（均值±标准差[SD]）显著降至6个月时的30.17±11.92mm，并维持24个月（35.79±7.92mm，与基线相比P<0.01）。这一结果得到次要变量的支持（WOMAC A、B和C评分；WOMAC总分；以及患者和医生在第6、12、18和24个月的整体评估）。第一个和第二个疗程期间AE的总发生率分别为8例（9.4%）和7例（8.2%）。未报告严重AE。
每年重复一次关节腔内注射透明质酸钠可能在疗程间期改善膝关节KBD症状，并在重复疗程后至少1年内产生显著的持续效应。需要其他随机双盲研究来证实本研究结果。
