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富血小板血浆疗法治疗膝关节骨关节炎:来自日本真实世界临床数据的见解

Platelet-rich plasma therapy for knee osteoarthritis: Insights from real-world clinical data in Japan.

作者信息

Saita Yoshitomo, Kobayashi Yohei, Uchino Sayuri, Nishio Hirofumi, Wakayama Takanori, Fukusato Shin, Momoi Yasumasa, Nakajima Ryosuke, Yamamoto Nanako, Hada Shinnosuke, Kaneko Haruka, Ishijima Muneaki

机构信息

Department of Orthopaedics, Juntendo University, Faculty of Medicine, 3-1-3 Hongo, Bunkyo, Tokyo 113-8431, Japan.

Department of Regenerative Medicine for Locomotive Organ, Juntendo University, Faculty of Medicine, 3-1-3 Hongo, Bunkyo, Tokyo 113-8431, Japan.

出版信息

Regen Ther. 2025 Apr 17;29:427-434. doi: 10.1016/j.reth.2025.04.002. eCollection 2025 Jun.

Abstract

INTRODUCTION

Knee osteoarthritis (KOA) is highly prevalent, and platelet-rich plasma (PRP) therapy has emerged as a novel treatment option. Although PRP is promising, its effectiveness remains controversial. In Japan, PRP therapy is administered as a self-funded treatment in specialized clinics. The National Regenerative Medicine Database (NRMD) was established to support the evaluation of regenerative therapies. This study aimed to analyze patient characteristics and treatment outcomes of PRP therapy for KOA in our hospital registered in NRMD database and to identify factors that influence therapeutic effectiveness.

METHODS

This retrospective observational study analyzed PRP treatment data for KOA in our hospital from January 2020 to May 2024 which was registered in the NRMD. Leukocyte-poor PRP (LP-PRP) was prepared using the MyCells kit, and patients received three injections at 3- to 5-week intervals. The eligibility criteria included chronic knee pain unresponsive to conservative treatment for KOA. Visual Analog Scale (VAS) for knee pain were collected at baseline and 3 and 6 months post-treatment. Statistical analyses included paired t-tests, logistic regression, and one-way analysis of variance (ANOVA).

RESULTS

A total of 2068 patients (2815 knees) were included. The average age was 65.2 years, and there were more female than male patients. PRP therapy significantly improved the VAS scores from 53.5 at baseline to 35.8 at 6 months (P < 0.05). Patients with Kellgren-Lawrence (KL) grade 4 showed less improvement than those with KL grades 2 and 3. Blood neutrophil levels positively correlated with pain severity. VAS improvement negatively correlated with age and body mass index (BMI). No major adverse events were reported during the study period.

CONCLUSION

PRP therapy for KOA, as observed in the clinical setting in Japan, is a safe treatment option with significant pain reduction, particularly in patients with less severe deformity of KOA. However, its effectiveness decreases in severe deformity cases. These real-world clinical data provide valuable insights for refining the patient selection criteria and advancing KOA treatment strategies.

摘要

引言

膝关节骨关节炎(KOA)非常普遍,富血小板血浆(PRP)疗法已成为一种新的治疗选择。尽管PRP很有前景,但其有效性仍存在争议。在日本,PRP疗法在专科医院作为自费治疗。国家再生医学数据库(NRMD)的建立是为了支持对再生疗法的评估。本研究旨在分析我院在NRMD数据库中注册的KOA患者接受PRP治疗的特征和治疗结果,并确定影响治疗效果的因素。

方法

这项回顾性观察研究分析了我院2020年1月至2024年5月在NRMD注册的KOA患者的PRP治疗数据。使用MyCells试剂盒制备少白细胞PRP(LP-PRP),患者每隔3至5周接受三次注射。纳入标准包括对KOA保守治疗无反应的慢性膝关节疼痛。在基线以及治疗后3个月和6个月收集膝关节疼痛视觉模拟量表(VAS)评分。统计分析包括配对t检验、逻辑回归和单因素方差分析(ANOVA)。

结果

共纳入2068例患者(2815个膝关节)。平均年龄为65.2岁,女性患者多于男性患者。PRP疗法显著改善了VAS评分,从基线时的53.5分提高到6个月时的35.8分(P<0.05)。Kellgren-Lawrence(KL)4级患者的改善程度低于KL 2级和3级患者。血液中性粒细胞水平与疼痛严重程度呈正相关。VAS改善程度与年龄和体重指数(BMI)呈负相关。研究期间未报告重大不良事件。

结论

在日本的临床环境中观察到,PRP疗法治疗KOA是一种安全的治疗选择,可显著减轻疼痛,尤其是在KOA畸形较轻的患者中。然而,在严重畸形病例中其有效性会降低。这些真实世界的临床数据为完善患者选择标准和推进KOA治疗策略提供了有价值的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a44/12144911/91c383a457d8/gr1.jpg

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