Rivera Fabrizio, Bertignone Luca, Grandi Giancarlo, Camisassa Roberto, Comaschi Guido, Trentini Diego, Zanone Marco, Teppex Giuseppe, Vasario Gabriele, Fortina Giorgio
Department of Orthopedic Trauma, SS Annunziata Hospital, Savigliano, CN, Italy.
, Via Servais 200 A 16, Turin, Italy.
J Orthop Traumatol. 2016 Mar;17(1):27-33. doi: 10.1007/s10195-015-0388-1. Epub 2015 Nov 14.
Intra-articular injection of hyaluronic acid is a well-established therapy for the treatment of knee osteoarthritis. The aim of the study was to assess the effectiveness and safety of the use of Arthrum HCS(®) (40 mg hyaluronic acid and 40 mg chondroitin sulfate in 2 mL).
This was an open, multicenter, prospective study. Men or women over 40 years of age with documented knee osteoarthritis and WOMAC subscore A (severity of pain) ≥25 were enrolled. They received three weekly intra-articular injections of sodium hyaluronate 2 % and chondroitin sulfate 2 % in combination. WOMAC subscore A was assessed at 1, 3 and 6 months after the last injection.
One hundred and twelve patients were included (women, 66 %). The mean (SD) WOMAC subscore A decreased from 52.1 (15.2) at inclusion to 20.5 (19.7) at month 6 (P < 0.0001). The mean subscore was already significantly decreased 1 month after the last injection at 25.7 (P < 0.0001). Pain relief and consumption of analgesic drugs, both assessed with visual analogic scale (VAS), consistently decreased. The investigators were satisfied/very satisfied as regards the therapeutic effectiveness of sodium hyaluronate-chondroitin sulfate in reducing pain (77 %), improving mobility (78 %) and reducing the consumption of analgesics (74 %). Only one adverse effect was reported by one patient (knee tumefaction).
These results suggest that intra-articular injections of Arthrum HCS(®) (sodium hyaluronate plus chondroitin sulfate) in patients with knee osteoarthritis are efficient and safe. These results should be confirmed in a randomized controlled study.
IV.
关节腔内注射透明质酸是治疗膝关节骨关节炎的一种成熟疗法。本研究的目的是评估使用 Arthrum HCS(®)(2毫升中含40毫克透明质酸和40毫克硫酸软骨素)的有效性和安全性。
这是一项开放性、多中心、前瞻性研究。纳入年龄在40岁以上、有膝关节骨关节炎记录且WOMAC子评分A(疼痛严重程度)≥25的男性或女性。他们接受每周一次、共三次的关节腔内注射2%透明质酸钠和2%硫酸软骨素的联合治疗。在最后一次注射后1、3和6个月评估WOMAC子评分A。
纳入112例患者(女性占66%)。WOMAC子评分A的平均值(标准差)从纳入时的52.1(15.2)降至第6个月时的20.5(19.7)(P<0.0001)。最后一次注射后1个月时平均评分已显著降低至25.7(P<0.0001)。通过视觉模拟量表(VAS)评估的疼痛缓解情况和镇痛药使用量均持续下降。研究者对透明质酸钠 - 硫酸软骨素在减轻疼痛(77%)、改善活动能力(78%)和减少镇痛药使用量(74%)方面的治疗效果感到满意/非常满意。仅1例患者报告了1例不良反应(膝关节肿胀)。
这些结果表明,膝关节骨关节炎患者关节腔内注射Arthrum HCS(®)(透明质酸钠加硫酸软骨素)有效且安全。这些结果应在随机对照研究中得到证实。
IV级