骨髓抽吸浓缩物与富血小板血浆治疗膝骨关节炎 2 年的疗效相当：一项前瞻性随机试验。
Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial.
机构信息
Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.
Department of Mathematics and Statistics, University of West Florida, Pensacola, Florida, USA.
出版信息
Am J Sports Med. 2022 Mar;50(3):618-629. doi: 10.1177/03635465211072554.
BACKGROUND
Autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) are being used clinically as therapeutic agents for the treatment of knee osteoarthritis.
PURPOSE/HYPOTHESIS: The purpose of this study was to compare the efficacy of BMC and PRP on pain and function in patients with knee osteoarthritis up to 24 months after injection. It was hypothesized that patients receiving BMC would have better sustained outcomes than those receiving PRP.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
A total of 90 participants aged between 18 and 80 years with symptomatic knee osteoarthritis (Kellgren-Lawrence grades 1-3) were randomized into 2 study groups: PRP and BMC. Both groups completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and subjective International Knee Documentation Committee (IKDC) questionnaire before and 1, 3, 6, 9, 12, 18, and 24 months after a single intra-articular injection of leukocyte-rich PRP or BMC. A linear mixed-effects model was performed to quantify the effects over time and the difference between the groups. This model has the random effect for time to assess the extent in which the change over time differs from one person to another.
RESULTS
An overall 84 patients completed questionnaires from baseline to 12 months; however, 17 patients (n = 9; PRP group) were lost to follow-up at 18 months and 25 (n = 13; PRP group) at 24 months. There were no statistically significant differences in IKDC ( = .909; 95% CI, -6.26 to 7.03) or WOMAC ( = .789; 95% CI, -6.26 to 4.77) scores over time between the groups. Both groups had significantly improved IKDC ( < .001; 95% CI, 0.275-0.596) and WOMAC ( = .001; 95% CI, -0.41 to -0.13) scores from baseline to 24 months after the injection. These improvements plateaued at 3 months and were sustained for 24 months after the injection, with no difference between PRP and BMC at any time point.
CONCLUSIONS
For the treatment of osteoarthritis, PRP and BMC performed similarly out to 24 months. BMC was not superior to PRP.
REGISTRATION
NCT03289416 (ClincalTrials.gov identifier).
背景
自体富血小板血浆（PRP）和骨髓抽吸浓缩物（BMC）已在临床上用作治疗膝骨关节炎的治疗剂。
目的/假设：本研究的目的是比较 BMC 和 PRP 在注射后长达 24 个月时对膝骨关节炎患者疼痛和功能的疗效。假设接受 BMC 的患者的持续结果将优于接受 PRP 的患者。
研究设计
随机对照试验；证据水平，2。
方法
共有 90 名年龄在 18 至 80 岁之间、有症状的膝骨关节炎（Kellgren-Lawrence 分级 1-3）患者被随机分为 2 个研究组：PRP 和 BMC。两组患者在单次关节内注射富含白细胞的 PRP 或 BMC 前以及 1、3、6、9、12、18 和 24 个月后均完成了西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）和主观国际膝关节文献委员会（IKDC）问卷。线性混合效应模型用于随时间量化影响和组间差异。该模型具有时间的随机效应，用于评估人与人之间随时间变化的程度。
结果
总体上，84 名患者从基线完成了 12 个月的问卷调查；然而，17 名患者（n = 9；PRP 组）在 18 个月时失访，25 名患者（n = 13；PRP 组）在 24 个月时失访。组间在 IKDC（=.909；95%CI，-6.26 至 7.03）或 WOMAC（=.789；95%CI，-6.26 至 4.77）评分方面，随时间均无统计学差异。两组患者在注射后至 24 个月时 IKDC（<.001；95%CI，0.275-0.596）和 WOMAC（=.001；95%CI，-0.41 至-0.13）评分均有显著改善。这些改善在 3 个月时达到平台期，并在注射后持续 24 个月，PRP 和 BMC 在任何时间点均无差异。
结论
对于骨关节炎的治疗，PRP 和 BMC 在 24 个月内表现相似。BMC 并不优于 PRP。
登记
NCT03289416（ClincalTrials.gov 标识符）。
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