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膝关节重度骨关节炎患者的粘弹性补充治疗:一项随机双盲临床试验的六个月随访

Viscosupplementation in patients with severe osteoarthritis of the knee: six month follow-up of a randomized, double-blind clinical trial.

作者信息

Campos André Luiz Siqueira, E Albuquerque Rodrigo Satamini Pires, da Silva Edmilson Barbosa, Fayad Sami Gobbi, Acerbi Lucas Delunardo, de Almeida Felipe Nunes, Ooka Nelson Hiroyuki Myiabe, Franco José Sergio, Gameiro Vinícius Schott

机构信息

Orthopedics Department, Hospital Federal dos Servidores do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.

, Rua Comendador Queiroz, 68/501, Icaraí, Niterói, RJ, 24230-220, Brazil.

出版信息

Int Orthop. 2017 Nov;41(11):2273-2280. doi: 10.1007/s00264-017-3625-9. Epub 2017 Aug 30.

DOI:10.1007/s00264-017-3625-9
PMID:28856435
Abstract

PURPOSE

To analyze the early outcomes of viscosupplementation in patients with severe knee osteoarthritis.

METHOD

A randomized, double-blind clinical trial of 143 knees divided into three groups: Group 1 - intra-articular injection of triamcinolone; Group 2 - hylan GF20; and Group 3 - triamcinolone + hylan GF20. Outcomes were evaluated using Lysholm and KSS scores before treatment and after one, three and six months.

RESULTS

Within-group comparisons revealed improvements in Lysholm scores in all groups in the one month evaluation relative to pre-treatment levels (p < 0.01). This improvement was maintained in the third month after treatment (p > 0.05). Scores at six months were significantly lower than those observed in the previous follow-up assessments (p < 0.05), but still higher than pre-treatment levels (p < 0.05). KSS scores also improved after one month relative to pre-treatment levels (p < 0.01). This improvement was still present at three and six months after treatment in the corticosteroid group (p > 0.05). Patients treated with hylan GF20 showed lower scores in the last evaluation relative to month one (p < 0.05). No significant differences were observed between the treatment groups (p > 0.05).

CONCLUSIONS

Viscosupplementation increased functional scores in patients with severe osteoarthritis of the knee, especially within three months of injection. However, it was not superior to the use of triamcinolone.

摘要

目的

分析重度膝关节骨关节炎患者玻璃酸钠补充疗法的早期疗效。

方法

一项随机、双盲临床试验,143个膝关节被分为三组:第1组——关节腔内注射曲安奈德;第2组——透明质酸钠凝胶(hylan GF20);第3组——曲安奈德+透明质酸钠凝胶(hylan GF20)。在治疗前以及治疗后1个月、3个月和6个月使用Lysholm评分和膝关节协会(KSS)评分对疗效进行评估。

结果

组内比较显示,在1个月评估时,所有组的Lysholm评分相对于治疗前水平均有所改善(p < 0.01)。这种改善在治疗后第3个月得以维持(p > 0.05)。6个月时的评分显著低于之前的随访评估时的评分(p < 0.05),但仍高于治疗前水平(p < 0.05)。KSS评分在1个月后相对于治疗前水平也有所改善(p < 0.01)。在皮质类固醇组中,治疗后3个月和6个月时这种改善仍然存在(p > 0.05)。接受透明质酸钠凝胶(hylan GF20)治疗的患者在最后一次评估时的评分相对于第1个月时较低(p < 0.05)。各治疗组之间未观察到显著差异(p > 0.05)。

结论

玻璃酸钠补充疗法提高了重度膝关节骨关节炎患者的功能评分,尤其是在注射后的3个月内。然而,它并不优于曲安奈德的使用。

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