Gupta Ashim, Viswanath Arun, Kumar G Hari
Regenerative Medicine, Future Biologics, Lawrenceville, USA.
Orthopedics, SP Fort Hospital, Thiruvananthapuram, IND.
Cureus. 2024 Sep 18;16(9):e69662. doi: 10.7759/cureus.69662. eCollection 2024 Sep.
Introduction The knee, the most frequently affected joint in osteoarthritis (OA), impacts the life quality of millions of individuals globally, resulting in a considerable healthcare burden. Conservative treatments are preferred, turning to surgical intervention when necessary. Nonetheless, these conventional modalities have drawbacks. Recently, the use of regenerative medicine therapies, including autologous peripheral blood-derived orthobiologics (APBOs), such as leukocyte-poor platelet-rich plasma (LP-PRP), has evolved and demonstrated the ability to manage knee OA. The primary objective of this investigation was to evaluate the efficacy of LP-PRP via widely used patient-reported outcome measures (PROMs) in grade I or II (on the Kellgren-Lawrence scale) knee OA patients. The secondary objective was to characterize the formulated LP-PRP and determine the efficiency of the leukodepletion filter used for leukocyte removal and platelet recovery. Methods This investigation was a retrospective analysis of data collected from patients treated at a single center over a period of 15 months. Data from 40 patients included in this study were intra-articularly injected with 3mL of formulated LP-PRP under ultrasound guidance. PROMs questionnaires, including Kujala and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, were used and responses were documented at baseline and up to 12 months follow-up. The characterization of the formulated LP-PRP and the efficiency of the leukodepletion filter in removing leukocytes and recovering platelets were assessed via complete blood count (CBC) analysis. Results The intra-articular administration of LP-PRP resulted in statistically significant improvements in Kujala and WOMAC scores in patients with Grade I or II OA of the knee at all follow-up time points (four to 12 months) compared to the respective baseline scores. The subgroup analysis showed significant improvements in Kujala and WOMAC scores in both male and female grade I or II knee OA patients with or without comorbidities, including diabetes and/or hypertension. The characterization of formulated PRP showed platelet concentration to be at least 6x compared to the baseline whole blood levels, the absolute platelet count to be at least 5 billion, and total leukocytes, lymphocytes, neutrophils, and RBCs were depleted by over 88%, 82%, 98%, and 98%, respectively. In addition, the utilization of the PuriBlood leukocyte reduction filter (Puriblood Medical Co. Ltd., Baoshan Township, Taiwan) led to the depletion of approximately 93% of leukocytes and the recovery of about 83% of platelets. Conclusions Administration of LP-PRP resulted in significant improvements in pain and function of patients suffering from grade I or II OA of the knee. In addition, the leukodepletion filter used to formulate LP-PRP, successfully resulted in the depletion of leukocytes while recovering the platelets. More sufficiently powered, multi-center, prospective, non-randomized, and randomized controlled trials with long-term follow-up are needed to further establish the effectiveness of this formulation in knee OA patients.
引言 膝关节是骨关节炎(OA)中最常受累的关节,影响着全球数百万人的生活质量,造成了相当大的医疗负担。保守治疗是首选,必要时才采用手术干预。然而,这些传统方法存在缺点。最近,包括自体外周血来源的生物制剂(APBOs),如少白细胞富血小板血浆(LP-PRP)在内的再生医学疗法不断发展,并已证明有能力治疗膝关节OA。本研究的主要目的是通过广泛使用的患者报告结局指标(PROMs)来评估LP-PRP对I级或II级(根据Kellgren-Lawrence分级)膝关节OA患者的疗效。次要目的是对配制的LP-PRP进行特性分析,并确定用于白细胞去除和血小板回收的白细胞滤除器的效率。
方法 本研究是对一个中心在15个月内治疗的患者收集的数据进行的回顾性分析。本研究纳入的40例患者的数据是在超声引导下关节内注射3mL配制的LP-PRP。使用了PROMs问卷,包括库贾拉评分以及西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分,并在基线和长达12个月的随访中记录了患者的回答。通过全血细胞计数(CBC)分析评估配制的LP-PRP的特性以及白细胞滤除器在去除白细胞和回收血小板方面的效率。
结果 与各自的基线评分相比,在所有随访时间点(4至12个月),关节内注射LP-PRP使I级或II级膝关节OA患者的库贾拉评分和WOMAC评分有统计学意义的显著改善。亚组分析显示,无论有无合并症(包括糖尿病和/或高血压),I级或II级膝关节OA的男性和女性患者的库贾拉评分和WOMAC评分均有显著改善。配制的PRP特性分析显示,血小板浓度至少是基线全血水平的6倍,绝对血小板计数至少为50亿,总白细胞、淋巴细胞、中性粒细胞和红细胞分别减少了88%以上、82%、98%和98%以上。此外,使用PuriBlood白细胞减少滤器(台湾宝山镇Puriblood Medical Co. Ltd.)可使约93%的白细胞减少,约83%的血小板回收。
结论 注射LP-PRP可使I级或II级膝关节OA患者的疼痛和功能有显著改善。此外,用于配制LP-PRP的白细胞滤除器成功减少了白细胞,同时回收了血小板。需要开展更有充分统计学效力的多中心、前瞻性、非随机和随机对照试验,并进行长期随访,以进一步确定该制剂对膝关节OA患者的有效性。