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关节内注射富血小板血浆(PRP)和透明质酸(HA)联合治疗膝关节退行性关节病的疗效:一项前瞻性、随机、双盲临床试验。

Efficacy of intra-articular injection of combined platelet-rich-plasma (PRP) and hyaluronic acid (HA) in knee degenerative joint disease: a prospective, randomized, double-blind clinical trial.

机构信息

Laboratory of Applied Biomechanics, Department of Biomedical Sciences for Health, Università Degli Studi Di Milano, Via Mangiagalli 31, 20133, Milan, Italy.

U.O.C. 1° Clinica Ortopedica, ASST Gaetano Pini-CTO, Piazza Cardinal Ferrari 1, 20122, Milan, Italy.

出版信息

Arch Orthop Trauma Surg. 2024 Nov;144(11):5039-5051. doi: 10.1007/s00402-024-05603-z. Epub 2024 Oct 5.

Abstract

PURPOSE

Intra-articular injections of hyaluronic acid (HA) and platelet-rich plasma (PRP) represent promising options in the conservative treatment of early stages of knee osteoarthritis (OA). Although the combined use of these two compounds seems to have a synergistic effect in pre-clinical studies, few clinical trials compared the association of PRP and HA with PRP and HA alone. The aim of study is to evaluate the efficacy of combined intra-articular injections of PRP and HA in the treatment of mild to moderate knee OA, compared to PRP and HA alone.

METHODS

One hundred and seventy-four patients were prospectively enrolled and randomized to undergo three intra-articular injections of either HA or PRP or the combination of PRP and HA with a two-week interval period. Patients were evaluated before treatment and after 3, 6, and 12 months using Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee subjective score, Visual Analogue Scale and TEGNER Activity Scores.

RESULTS

All the treatments proved to be effective in reducing pain and improving joint function. The analysis of covariance did not show statistically significant differences among the three groups for any of the investigated outcome parameters after 6 and 12 months (WOMAC: p = 0.45 and p = 0.64, respectively). No significant differences were found in terms of adverse events (p = 0.49) and painkiller use (p = 0.28 and p = 0.56, respectively) among the three groups.

CONCLUSION

This multicenter, prospective, randomized, double-blind controlled trial revealed that intra-articular injections of PRP + HA, PRP, or HA represent a safe and viable treatment with comparable efficacy in terms of pain relief and functional outcomes in mild to moderate knee OA.

摘要

目的

关节内注射透明质酸(HA)和富含血小板的血浆(PRP)是治疗早期膝骨关节炎(OA)的有前途的选择。尽管在临床前研究中,这两种化合物的联合使用似乎具有协同作用,但很少有临床试验比较 PRP 和 HA 与 PRP 和 HA 单独联合的效果。本研究旨在评估与 PRP 和 HA 单独治疗相比,联合关节内注射 PRP 和 HA 治疗轻度至中度膝骨关节炎的疗效。

方法

174 例患者前瞻性入组并随机分为 3 组,分别接受 HA 或 PRP 或 PRP 和 HA 的联合关节内注射,间隔 2 周。患者在治疗前和治疗后 3、6 和 12 个月分别采用西部安大略省和麦克马斯特大学骨关节炎(WOMAC)评分、膝关节损伤和骨关节炎结果评分、国际膝关节文献委员会主观评分、视觉模拟评分和 Tegner 活动评分进行评估。

结果

所有治疗均能有效减轻疼痛,改善关节功能。协方差分析显示,在治疗后 6 和 12 个月时,三组患者的所有研究参数均无统计学差异(WOMAC:p=0.45 和 p=0.64)。三组之间在不良事件(p=0.49)和止痛药使用(p=0.28 和 p=0.56)方面均无显著差异。

结论

这项多中心、前瞻性、随机、双盲对照试验表明,关节内注射 PRP+HA、PRP 或 HA 是一种安全可行的治疗方法,在缓解疼痛和改善轻度至中度膝骨关节炎的功能结果方面具有相似的疗效。

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