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针对膝关节骨关节炎的特定骨髓浓缩物治疗方案的剂量反应分析。

A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis.

作者信息

Centeno Christopher J, Al-Sayegh Hasan, Bashir Jamil, Goodyear Shaun, Freeman Michael D

机构信息

Centeno-Schultz Clinic, 403 Summit Blvd Suite 201, Broomfield, CO, 80021, USA.

Forensic Research and Analysis, Portland, OR, USA.

出版信息

BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z.

Abstract

BACKGROUND

Prior studies describing the treatment of symptomatic knee osteoarthritis with injections of bone marrow concentrate have provided encouraging results. The relationship between the cellular dose contained within the bone marrow concentrate and efficacy of the treatment, however, is unclear. In the present study we describe clinical outcomes for symptomatic knee osteoarthritis in relation to higher and lower cell concentrations contained within a bone marrow concentrate treatment protocol.

METHODS

Data from an ongoing patient registry was culled to identify 373 patients that received bone marrow concentrate injections for the treatment of 424 osteoarthritic knee joints. The clinical scales for these patients were assessed at baseline and then tracked post-procedure at 1, 3, 6 and 12 months, and annually thereafter. Tracked outcomes included the numeric pain scale; a lower extremity functional questionnaire; an International Knee Documentation Committee scale; and a subjective improvement rating scale. Using pain and functional outcome measures, a receiver operating characteristic analysis was used to define an optimal clinical outcome threshold at which bone marrow nucleated cell count could be divided into either a lower or higher cell count group within a treatment protocol.

RESULTS

The lower and higher cell count groups were defined using a threshold of 4 × 10(8) cells. There were 224 and 185 knee joints treated in the lower (≤4 × 10(8)) and higher (>4 × 10(8)) cell count groups respectively. Most joints were diagnosed with early stage knee osteoarthritis. Both the lower and higher cell count groups demonstrated significant positive results with the treatment for all of the pain and functional metrics. The higher cell count group reported lower post treatment numeric pain scale values, in comparison with the lower cell count group (1.6 vs. 3.2; P < 0.001). No significant differences were detected for the other metrics, however.

CONCLUSIONS

Improved function and reduced pain was observed in patients treated with a bone marrow concentrate protocol regardless of cellular dose; however, patients receiving a higher concentration of cells reported a better pain outcome in comparison with the lower dose group. These preliminary findings suggest that cell dose may be an important factor governing clinical outcomes in autologous bone marrow concentrate treatment of knee osteoarthritis. Further studies using a larger patient population may help elucidate these findings.

摘要

背景

先前关于注射骨髓浓缩物治疗有症状膝关节骨关节炎的研究取得了令人鼓舞的结果。然而,骨髓浓缩物中所含细胞剂量与治疗效果之间的关系尚不清楚。在本研究中,我们描述了在骨髓浓缩物治疗方案中,较高和较低细胞浓度与有症状膝关节骨关节炎临床结果之间的关系。

方法

从一个正在进行的患者登记处筛选数据,以确定373例接受骨髓浓缩物注射治疗424个骨关节炎膝关节的患者。在基线时评估这些患者的临床量表,然后在术后1、3、6和12个月以及此后每年进行跟踪。跟踪的结果包括数字疼痛量表;下肢功能问卷;国际膝关节文献委员会量表;以及主观改善评定量表。使用疼痛和功能结果测量,通过受试者工作特征分析来定义一个最佳临床结果阈值,在该阈值下,骨髓有核细胞计数可在治疗方案中分为较低或较高细胞计数组。

结果

较低和较高细胞计数组是使用4×10⁸个细胞的阈值定义的。较低(≤4×10⁸)和较高(>4×10⁸)细胞计数组分别治疗了224个和185个膝关节。大多数关节被诊断为早期膝关节骨关节炎。较低和较高细胞计数组在所有疼痛和功能指标的治疗中均显示出显著的阳性结果。与较低细胞计数组相比,较高细胞计数组报告的治疗后数字疼痛量表值更低(1.6对3.2;P<0.001)。然而,其他指标未检测到显著差异。

结论

无论细胞剂量如何,接受骨髓浓缩物治疗方案的患者功能均有改善且疼痛减轻;然而,与低剂量组相比,接受较高细胞浓度的患者疼痛结果更好。这些初步发现表明,细胞剂量可能是自体骨髓浓缩物治疗膝关节骨关节炎临床结果的一个重要决定因素。使用更大患者群体的进一步研究可能有助于阐明这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ba6/4575428/dccfcc0a76ec/12891_2015_714_Fig1_HTML.jpg

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