Orthopaedic Surgery, Whangārei Hospital, Whangārei, New Zealand.
Orthopaedic Surgery, St Vincent's Hospital Melbourne, Melbourne, Australia.
Bone Joint J. 2024 Sep 1;106-B(9):907-915. doi: 10.1302/0301-620X.106B9.BJJ-2024-0258.R1.
Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient's blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA.
A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months).
A total of 40 patients were analyzed (21 nSTRIDE; 19 saline) in the study. No significant difference was found between nSTRIDE and saline groups for WOMAC total score at 12 months (mean difference -10.4 (95% CI -24.4 to 3.6; p = 0.141). There were no significant differences in WOMAC or KOOS scores across all timepoints. VAS scores favoured the saline group for both rest and worst pain scales at 12 months post-injection (mean difference (worst) 12 months 21.5 (95% CI 6.2 to 36.8; p = 0.008); mean difference (rest) 12 months 17.8 (95% CI 2.2 to 33.4; p = 0.026)). There were no adverse events recorded in either study group.
Our study demonstrates no significant differences between nSTRIDE and saline groups in KOOS and WOMAC scores over time. Notably, APS injection resulted in significantly worse pain symptoms at 12 months compared to saline injection.
膝骨关节炎（OA）的特征是涉及多种细胞因子途径的慢性炎症过程，导致关节软骨退化。使用药物或自体抗炎因子的关节内治疗为非手术治疗提供了潜在的选择。自体蛋白溶液（APS）是一种使用患者血液产生细胞和抗炎细胞因子浓缩物的产品。本研究评估了与生理盐水相比，特定 APS 关节内注射（nSTRIDE）对中度膝 OA 患者报告的结果测量指标的影响。
进行了一项平行、双盲、安慰剂对照的随机对照试验，其中单侧中度膝 OA（Kellgren-Lawrence 分级 2 或 3）的患者接受 nSTRIDE 或生理盐水（安慰剂）注射到其症状性膝关节。主要结局是干预后 12 个月时 Western Ontario 和 McMaster 大学骨关节炎指数（WOMAC）总分的差异。次要结局包括 WOMAC 分量表评分、膝关节损伤和骨关节炎结果评分（KOOS）以及所有随访时间点（3、6 和 12 个月）的视觉模拟量表（VAS）评分。
研究中共分析了 40 名患者（nSTRIDE 21 名；生理盐水 19 名）。在 12 个月时，nSTRIDE 组和生理盐水组的 WOMAC 总分无显著差异（平均差异-10.4（95%CI-24.4 至 3.6；p=0.141）。在所有时间点，WOMAC 或 KOOS 评分均无显著差异。VAS 评分在注射后 12 个月时，盐水组在休息和最痛量表上均更优（最差疼痛平均差异（12 个月）21.5（95%CI6.2 至 36.8；p=0.008）；休息时平均差异（12 个月）17.8（95%CI2.2 至 33.4；p=0.026））。在两个研究组中均未记录到不良事件。
我们的研究表明，在 KOOS 和 WOMAC 评分方面，nSTRIDE 组与生理盐水组在不同时间点均无显著差异。值得注意的是，与生理盐水注射相比，APS 注射在 12 个月时导致疼痛症状明显恶化。
