MoRe Foundation, Antwerp, Belgium.
Antwerp University, Antwerp, Belgium.
Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):988-997. doi: 10.1007/s00167-020-06064-8. Epub 2020 May 25.
The study wanted to investigate the benefit, durability and safety of autologous protein solution (APS) injection(s) in a middle-aged female-only cohort suffering predominantly from patellofemoral osteoarthritis.
Fifty females (aged 50.4 ± 6.5) with mainly moderate-severe (86%) patellofemoral cartilage wear (PFCW) were treated with a unilateral intra-articular APS injection. The KOOS, NRS, Kujala, UCLA and EQ-5D were assessed at baseline and 1, 3, 6, and 12 months post-injection. Therapeutic response rate (TRR) was based on KOOS pain improvement > 10 points. Absolute improvement for, respectively, therapy responders and non-responders was determined. Second APS injection was administered if improvement was deemed insufficient by the patient after 3 months.
The TRR remained stable averaging to 53.7% at final follow-up with subjects improving overall from 40.3 ± 18.7 to 57.3 ± 24.8 points on KOOS pain (p = 0.0002) and from 48.4 ± 13.0 to 56.3 ± 18.1 points on Kujala (p = 0.0203) at 12 months. Significant improvement was observed for the other KOOS subscales and NRS at each follow-up. In absolute values, APS responders improved with 30.5 ± 11.4 points on KOOS pain at 12 months. In contrast, non-responders deteriorated with 5.9 ± 8.9 points relative to baseline. A second APS injection was administered in 28 subjects. Patients with definite synovitis improved more on KOOS symptoms (p = 0.017) and KOOS ADL (p = 0.037) at 12 months compared to non-synovitis subjects. Mild-moderate arthralgia (46%) and effusion (29%) were commonly observed during the first month post-injection.
This study evidenced a 54% response rate at 12 months to a single or second APS injection in a middle-aged female population with advanced patellofemoral cartilage wear. Moderate temporary flares can be expected without affecting clinical outcomes. Second APS injection has low efficacy in initially poor responding patients after 3 months. Major synovitis on baseline MRI appeared to be a beneficial prognosticator for pain relief and functional improvement after APS.
IV.
本研究旨在调查在主要患有髌股关节炎的中年女性队列中，使用自体蛋白溶液（APS）注射治疗的益处、持久性和安全性。
50 名女性（年龄 50.4±6.5 岁），主要有中重度（86%）髌股软骨磨损（PFCW），接受单侧关节内 APS 注射治疗。在注射后 1、3、6 和 12 个月时，采用 KOOS、NRS、Kujala、UCLA 和 EQ-5D 进行评估。根据 KOOS 疼痛改善>10 分，确定治疗反应率（TRR）。分别确定治疗反应者和无反应者的绝对改善。如果患者在 3 个月后认为改善不足，则进行第二次 APS 注射。
在最终随访时，TRR 保持稳定，平均为 53.7%，患者在 KOOS 疼痛方面总体从 40.3±18.7 分改善至 57.3±24.8 分（p=0.0002），在 Kujala 方面从 48.4±13.0 分改善至 56.3±18.1 分（p=0.0203）。在每个随访时，其他 KOOS 子量表和 NRS 均观察到显著改善。在绝对值上，APS 反应者在 12 个月时 KOOS 疼痛改善了 30.5±11.4 分。相比之下，无反应者相对于基线恶化了 5.9±8.9 分。28 名患者接受了第二次 APS 注射。与非滑膜炎患者相比，有明确滑膜炎的患者在 12 个月时在 KOOS 症状（p=0.017）和 KOOS ADL（p=0.037）方面改善更多。注射后第一个月，常见轻度至中度关节痛（46%）和关节积液（29%）。
在髌股软骨磨损严重的中年女性人群中，单次或第二次 APS 注射 12 个月后的反应率为 54%。预计会出现中等程度的暂时恶化，但不会影响临床结果。在 3 个月后对初始反应不佳的患者进行第二次 APS 注射效果较低。基线 MRI 上出现主要滑膜炎似乎是 APS 治疗后缓解疼痛和改善功能的有益预后因素。
IV。
