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膝关节骨关节炎微片段脂肪组织治疗以患者为中心的结局:一项为期十二个月的观察性意向性治疗研究。

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months.

作者信息

Heidari Nima, Noorani Ali, Slevin Mark, Cullen Angela, Stark Laura, Olgiati Stefano, Zerbi Alberto, Wilson Adrian

机构信息

The Regenerative Clinic, 18-22 Queen Anne Street, London, UK.

Department of Life Sciences, Manchester Metropolitan University, UK.

出版信息

Stem Cells Int. 2020 Aug 4;2020:8881405. doi: 10.1155/2020/8881405. eCollection 2020.

Abstract

INTRODUCTION

Microfragmented adipose tissue (MFAT) has been shown to benefit osteoarthritic patients by reducing pain and supporting tissue regeneration through a mesenchymal stem cell (MSC)-related paracrine mechanism. This observational study of 110 knees assessed patient-centered outcomes of pain, functionality, and quality of life, analyzing their variation at twelve months following one ultrasound-guided intra-articular injection of autologous MFAT for the treatment of knee osteoarthritis (KOA).

METHOD

Inclusion criteria were as follows: VAS >50, and the presence of KOA as diagnosed on X-ray and MRI. Exclusion criteria included the following: recent injury (<3 months) of the symptomatic knee, intra-articular steroid injections performed within the last three months, and hyaluronic acid injections prior to this treatment. Changes in VAS, OKS, and EQ-5D were scored at baseline and twelve months following a single intra-articular injection of autologous MFAT. Score variation was analyzed utilizing a nonparametric paired samples Wilcoxon test. The statistical analysis is reproducible with Open Access statistical software R (version 4.0.0 or higher). The study was carried out with full patient consent, in a private practice setting.

RESULTS

Median VAS (pain) improved from 70 (IQR 20) to 30 (IQR 58) ( < 0.001); median OKS (function) improved from 25 (IQR 11) to 33.5 (IQR 16) ( < 0.001); and median EQ-5D (quality of life) improved from 0.62 (IQR 0.41) to 0.69 (IQR 0.28) ( < 0.001). No adverse events were reported during the intraoperative, recovery, or postoperative periods.

CONCLUSIONS

For patients with all grades of knee osteoarthritis who were treated with intra-articular injections of MFAT, statistically significant improvements in pain, function, and quality of life were reported. Although further research is warranted, the results are encouraging and suggest a positive role for intra-articular injection of MFAT as a treatment for knee osteoarthritis.

摘要

引言

微片段化脂肪组织(MFAT)已被证明可通过间充质干细胞(MSC)相关的旁分泌机制减轻疼痛并支持组织再生,从而使骨关节炎患者受益。这项对110个膝关节的观察性研究评估了以患者为中心的疼痛、功能和生活质量结果,分析了在一次超声引导下关节内注射自体MFAT治疗膝关节骨关节炎(KOA)后12个月时这些结果的变化。

方法

纳入标准如下:视觉模拟评分(VAS)>50,且经X射线和磁共振成像(MRI)诊断为KOA。排除标准包括:有症状膝关节近期受伤(<3个月)、在过去三个月内进行过关节内类固醇注射以及在本次治疗前进行过透明质酸注射。在单次关节内注射自体MFAT后的基线和12个月时对VAS、牛津膝关节评分(OKS)和欧洲五维度健康量表(EQ-5D)的变化进行评分。利用非参数配对样本威尔科克森检验分析评分变化。使用开放获取统计软件R(版本4.0.0或更高版本)可重现统计分析。该研究在患者完全同意的情况下,于私人诊所环境中进行。

结果

VAS(疼痛)中位数从70(四分位间距20)改善至30(四分位间距58)(<0.001);OKS(功能)中位数从25(四分位间距11)改善至33.5(四分位间距16)(<0.001);EQ-5D(生活质量)中位数从0.62(四分位间距0.41)改善至0.69(四分位间距0.28)(<0.001)。术中、恢复或术后期间均未报告不良事件。

结论

对于接受关节内注射MFAT治疗的所有等级膝关节骨关节炎患者,疼痛、功能和生活质量在统计学上有显著改善。尽管需要进一步研究,但结果令人鼓舞,表明关节内注射MFAT作为膝关节骨关节炎的一种治疗方法具有积极作用。

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