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关节内注射透明质酸钠-硫酸软骨素治疗膝骨关节炎的有效性:一项多中心前瞻性研究。

Effectiveness of intra-articular injections of sodium hyaluronate-chondroitin sulfate in knee osteoarthritis: a multicenter prospective study.

作者信息

Rivera Fabrizio, Bertignone Luca, Grandi Giancarlo, Camisassa Roberto, Comaschi Guido, Trentini Diego, Zanone Marco, Teppex Giuseppe, Vasario Gabriele, Fortina Giorgio

机构信息

Department of Orthopedic Trauma, SS Annunziata Hospital, Savigliano, CN, Italy.

, Via Servais 200 A 16, Turin, Italy.

出版信息

J Orthop Traumatol. 2016 Mar;17(1):27-33. doi: 10.1007/s10195-015-0388-1. Epub 2015 Nov 14.

Abstract

BACKGROUND

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).

MATERIALS AND METHODS

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.

RESULTS

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).

CONCLUSION

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.

LEVEL OF EVIDENCE

IV.

摘要

背景

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。

材料与方法

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。

结果

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)。

结论

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。

证据水平

IV级

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/4805636/72eb161fb7cb/10195_2015_388_Fig1_HTML.jpg

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