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富血小板血浆注射的临床疗效及其与生长因子在治疗轻中度膝骨关节炎中的关系:与透明质酸相比的随机双盲对照临床试验。

Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid.

机构信息

Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea.

Department of Orthopedic Surgery, Seoul Medical Center, Seoul, Republic of Korea.

出版信息

Am J Sports Med. 2021 Feb;49(2):487-496. doi: 10.1177/0363546520986867.

Abstract

BACKGROUND

Although platelet-rich plasma (PRP) has potential as a regenerative treatment for knee osteoarthritis, its efficacy varies. Compositional differences among types of PRP could affect clinical outcomes, but the biological characterization of PRP is lacking.

PURPOSE

To assess the efficacy of intra-articular PRP injection in knee osteoarthritis as compared with hyaluronic acid (HA) injection and to determine whether the clinical efficacy of PRP is associated with its biological characteristics.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

A total of 110 patients with symptomatic knee osteoarthritis received a single injection of leukocyte-rich PRP (1 commercial kit) or HA. Clinical data were assessed at baseline and at 6 weeks and 3 and 6 months after injection. The primary endpoint was an improvement in the International Knee Documentation Committee (IKDC) subjective score at 6 months, and the secondary endpoints were improvements in scores based on the Patient Global Assessment, the visual analog scale (VAS) for pain, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Samsung Medical Center patellofemoral score. Cell counts and concentrations of growth factors and cytokines in the injected PRP were assessed to determine their association with clinical outcomes.

RESULTS

PRP showed significantly improvement in IKDC subjective scores at 6 months (11.5 in the PRP group vs 6.3 in the HA group; = .029). There were no significant differences between groups in other clinical outcomes. The Patient Global Assessment score at 6 months was better in the PRP group ( = .035). The proportion of patients who scored above the minimal clinically important difference (MCID) for VAS at 6 months was significantly higher in the PRP group ( = .044). Within the PRP group, the concentrations of platelet-derived growth factors were high in patients with a score above the MCID for VAS at 6 months. The incidence of adverse events did not differ between the groups ( > .05).

CONCLUSION

PRP had better clinical efficacy than HA. High concentrations of growth factors were observed in patients who scored above the MCID for clinical outcomes in the PRP group. These findings indicate that concentration of growth factors needs to be taken into consideration for future investigations of PRP in knee osteoarthritis.

REGISTRATION

NCT02211521 (ClinicalTrials.gov identifier).

摘要

背景

虽然富含血小板的血浆(PRP)作为膝关节骨关节炎的再生治疗具有潜力,但它的疗效因人而异。PRP 类型之间的组成差异可能会影响临床结果,但 PRP 的生物学特征尚不清楚。

目的

评估关节内 PRP 注射治疗膝关节骨关节炎的疗效与透明质酸(HA)注射的疗效,并确定 PRP 的临床疗效是否与其生物学特性相关。

研究设计

随机对照试验;证据水平,1 级。

方法

共 110 例有症状的膝关节骨关节炎患者接受了白细胞丰富的 PRP(1 种商业试剂盒)或 HA 的单次注射。在注射后 6 周、3 个月和 6 个月时评估临床数据。主要终点是 6 个月时国际膝关节文献委员会(IKDC)主观评分的改善,次要终点是患者总体评估、视觉模拟评分(VAS)疼痛、西安大略和麦克马斯特大学骨关节炎指数以及三星医疗中心髌股评分的改善。评估注射 PRP 中的细胞计数和生长因子及细胞因子浓度,以确定它们与临床结果的关系。

结果

PRP 在 6 个月时 IKDC 主观评分显著改善(PRP 组 11.5 分,HA 组 6.3 分; =.029)。两组在其他临床结果方面无显著差异。PRP 组 6 个月时患者总体评估评分更好( =.035)。PRP 组 6 个月时 VAS 评分高于最小临床重要差异(MCID)的患者比例显著更高( =.044)。在 PRP 组中,6 个月时 VAS 评分高于 MCID 的患者血小板衍生生长因子浓度较高。两组的不良事件发生率无差异( >.05)。

结论

PRP 的临床疗效优于 HA。在 PRP 组中,临床结果高于 MCID 的患者观察到较高浓度的生长因子。这些发现表明,在未来对膝关节骨关节炎的 PRP 研究中需要考虑生长因子的浓度。

注册

NCT02211521(ClinicalTrials.gov 标识符)。

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