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透明质酸与富血小板血浆:一项比较临床结果及对膝关节骨关节炎关节内生物学影响的前瞻性、双盲随机对照试验

Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis.

作者信息

Cole Brian J, Karas Vasili, Hussey Kristen, Pilz Kyle, Fortier Lisa A

机构信息

Department of Orthopedics, Rush University Medical Center, Chicago, Illinois, USA.

Department of Surgery, Rush Oak Park Hospital, Oak Park, Illinois, USA.

出版信息

Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.

DOI:10.1177/0363546516665809
PMID:28146403
Abstract

BACKGROUND

The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials when compared with hyaluronic acid (HA), an accepted nonsurgical treatment for symptomatic OA. Biological analysis of PRP has demonstrated an anti-inflammatory effect on the intra-articular environment.

PURPOSE

To compare the clinical and biological effects of an intra-articular injection of PRP with those of an intra-articular injection of HA in patients with mild to moderate knee OA.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

A total of 111 patients with symptomatic unilateral knee OA received a series of either leukocyte-poor PRP or HA injections under ultrasound guidance. Clinical data were collected before treatment and at 4 time points across a 1-year period. Synovial fluid was also collected for analysis of proinflammatory and anti-inflammatory markers before treatment and at 12 and 24 weeks after treatment. Several measures were used to assess results: (1) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; (2) International Knee Documentation Committee (IKDC) subjective knee evaluation, visual analog scale (VAS) for pain, and Lysholm knee score; and (3) difference in intra-articular biochemical marker concentrations.

RESULTS

There were 49 patients randomized to treatment with PRP and 50 randomized to treatment with HA. No difference was seen between the groups in the primary outcome measure (WOMAC pain score). In the secondary outcome measure, linear contrasts identified a significantly higher IKDC score in the PRP group compared with the HA group at 24 weeks (mean ± standard error [SE], 65.5 ± 3.6 vs 55.8 ± 3.8, respectively; P = .013) and at final follow-up (52 weeks) (57.6 ± 3.37 vs 46.6 ± 3.76, respectively; P = .003). Linear contrasts also identified a statistically lower VAS score in the PRP group versus the HA group at 24 weeks (mean ± SE, 34.6 ± 3.24 vs 48.6 ± 3.7, respectively; P = .0096) and 52 weeks (44 ± 4.6 vs 57.3 ± 3.8, respectively; P = .0039). An examination of fixed effects showed that patients with mild OA and a lower body mass index had a statistically significant improvement in outcomes. In the biochemical analysis, differences between groups approached significance for interleukin-1β (mean ± SE, 0.14 ± 0.05 pg/mL [PRP] vs 0.34 ± 0.16 pg/mL [HA]; P = .06) and tumor necrosis factor α (0.08 ± 0.01 pg/mL [PRP] vs 0.2 ± 0.18 pg/mL [HA]; P = .068) at 12-week follow-up.

CONCLUSION

We found no difference between HA and PRP at any time point in the primary outcome measure: the patient-reported WOMAC pain score. Significant improvements were seen in other patient-reported outcome measures, with results favoring PRP over HA. Preceding a significant difference in subjective outcomes favoring PRP, there was a trend toward a decrease in 2 proinflammatory cytokines, which suggest that the anti-inflammatory properties of PRP may contribute to an improvement of symptoms. Registration: ClinicalTrials.gov (Identifier: NCT02588872).

摘要

背景

与透明质酸(HA)相比,富含血小板血浆(PRP)用于治疗骨关节炎(OA)在随机对照试验中显示出混合的临床结果,HA是一种已被认可的用于有症状OA的非手术治疗方法。PRP的生物学分析已证明其对关节内环境具有抗炎作用。

目的

比较关节内注射PRP与关节内注射HA对轻至中度膝OA患者的临床和生物学影响。

研究设计

随机对照试验;证据等级,1级。

方法

总共111例有症状的单侧膝OA患者在超声引导下接受了一系列贫白细胞PRP或HA注射。在治疗前和1年期间的4个时间点收集临床数据。还在治疗前以及治疗后12周和24周收集滑液,以分析促炎和抗炎标志物。使用了几种测量方法来评估结果:(1)西安大略和麦克马斯特大学骨关节炎指数(WOMAC)疼痛子量表;(2)国际膝关节文献委员会(IKDC)主观膝关节评估、疼痛视觉模拟量表(VAS)和Lysholm膝关节评分;(3)关节内生化标志物浓度的差异。

结果

49例患者被随机分配接受PRP治疗,50例被随机分配接受HA治疗。在主要结局指标(WOMAC疼痛评分)上,两组之间未见差异。在次要结局指标中,线性对比显示,PRP组在24周时的IKDC评分显著高于HA组(分别为均值±标准误[SE],65.5±3.6对55.8±3.8;P = 0.013)以及在最终随访(52周)时(分别为57.6±3.37对46.6±3.76;P = 0.003)。线性对比还显示,PRP组在24周时的VAS评分在统计学上低于HA组(分别为均值±SE,34.6±3.24对48.6±3.7;P = 0.0096)以及52周时(分别为44±4.6对57.3±3.8;P = 0.0039)。固定效应分析表明,轻度OA和较低体重指数的患者在结局方面有统计学上的显著改善。在生化分析中,两组之间在12周随访时白细胞介素-1β(均值±SE,0.14±0.05 pg/mL[PRP]对0.34±0.16 pg/mL[HA];P = 0.06)和肿瘤坏死因子α(0.08±0.01 pg/mL[PRP]对0.2±0.18 pg/mL[HA];P = 0.068)方面的差异接近显著。

结论

我们发现在主要结局指标即患者报告的WOMAC疼痛评分上,HA和PRP在任何时间点均无差异。在其他患者报告的结局指标上有显著改善,结果显示PRP优于HA。在主观结局方面有利于PRP的显著差异出现之前,两种促炎细胞因子有下降趋势,这表明PRP的抗炎特性可能有助于症状改善。注册信息:ClinicalTrials.gov(标识符:NCT02588872)。

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