Theiler R, Brühlmann P
Rheumatology Clinic and Institute for Physical Medicine and Rehabilitation, Tremli City Hospital, Zurich, Switzerland.
Curr Med Res Opin. 2005 Nov;21(11):1727-33. doi: 10.1185/030079905X65547.
Viscosupplementation with intra-articular hyaluronic acid (HA) is an alternative to the treatment of symptomatic knee osteoarthritis (OA) with pain relieving drugs. Sinovial, is a sterile, non-pyrogenic 0.8% solution of highly purified sodium hyaluronate for intra-articular application. The aim of the present study was to investigate the safety and tolerability profile of this preparation in patients with symptomatic knee OA over 24 weeks.
This was a single group, open-label study, including outpatients of both sexes, aged between 18 and 85 years, with symptomatic knee OA. All patients underwent weekly intra-articular injections of HA for 5 consecutive weeks and were followed-up for 19 additional weeks. The safety and tolerability profile (primary endpoint) was assessed by adverse event (AE) reporting. The secondary endpoint was efficacy evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) score vs. baseline. Patient and physician satisfaction were also recorded.
Intra-articular HA was generally well tolerated. The most frequent AE was pain at the injection site (5.8% of the injections); no serious treatment-related AE was reported. The WOMAC score was significantly reduced within the first 2 weeks of treatment (from 4.02 +/- 1.90 to 3.55 +/- 2.04, p = 0.0011), further decreased by the end of the injection series (week 6: 2.59 +/- 1.90; p < 0.0001) and maintained during the follow-up (week 24: 2.44 +/- 1.88; p < 0.0001). The WOMAC subscores were also significantly reduced from week 4 for 'pain' and from week 6 for 'stiffness' and 'physical function'.
In the present study, intra-articular HA was well tolerated and safe in patients with symptomatic knee OA. Based on the sustained improvements in WOMAC score and subscores, a carry-over effect lasting for at least 19 weeks after the last injection may be proposed. These results further confirm the evidence of efficacy and safety of intra-articular HA in the management of knee OA.
关节腔内注射透明质酸（HA）进行粘弹性补充是一种用止痛药物治疗症状性膝关节骨关节炎（OA）的替代方法。施沛特是一种无菌、无热原的0.8%高纯度透明质酸钠溶液，用于关节腔内注射。本研究的目的是调查该制剂在症状性膝关节OA患者中超过24周的安全性和耐受性。
这是一项单组、开放标签研究，纳入年龄在18至85岁之间、患有症状性膝关节OA的门诊患者，男女不限。所有患者连续5周每周接受一次关节腔内HA注射，并额外随访19周。通过不良事件（AE）报告评估安全性和耐受性（主要终点）。次要终点是通过西安大略和麦克马斯特大学（WOMAC）评分相对于基线的变化来评估疗效。还记录了患者和医生的满意度。
关节腔内注射HA总体耐受性良好。最常见的AE是注射部位疼痛（占注射次数的5.8%）；未报告严重的治疗相关AE。WOMAC评分在治疗的前2周内显著降低（从4.02±1.90降至3.55±2.04，p = 0.0011），在注射系列结束时进一步降低（第6周：2.59±1.90；p < 0.0001），并在随访期间维持（第24周：2.44±1.88；p < 0.0001）。WOMAC子评分在第4周时“疼痛”子评分、第6周时“僵硬”和“身体功能”子评分也显著降低。
在本研究中，关节腔内注射HA在症状性膝关节OA患者中耐受性良好且安全。基于WOMAC评分和子评分的持续改善，可能存在最后一次注射后至少持续19周的延续效应。这些结果进一步证实了关节腔内注射HA在膝关节OA治疗中疗效和安全性的证据。
