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建立使用自体组织修复生物制剂组合治疗膝关节骨关节炎的具有临床意义的变化指标。

Establishing metrics of clinically meaningful change for treating knee osteoarthritis with a combination of autologous orthobiologics.

作者信息

Centeno Christopher J, Ghattas James R, Dodson Ehren, Steinmetz Neven J, Murphy Matthew B, Berger Dustin R

机构信息

Centeno-Schultz Clinic, Broomfield, CO, USA.

Regenexx, Research and Development, Broomfield, CO, USA.

出版信息

Sci Rep. 2025 Feb 28;15(1):7244. doi: 10.1038/s41598-025-91972-3.

DOI:10.1038/s41598-025-91972-3
PMID:40021765
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11871318/
Abstract

Autologous bone marrow concentrate (BMC), platelet-rich plasma (PRP), and platelet lysate (PL) have emerged as promising orthobiologic treatment options for knee osteoarthritis (OA). The present observational study reports minimal clinically important difference (MCID) and substantial clinical benefit (SCB) values for several patient-reported outcome measures (PROMs) used to monitor changes in joint pain and function following percutaneous treatment of knee OA with a combination of BMC and platelet products (n = 295 knees). Distribution-based approaches were used to determine 12-month MCID values for the International Knee Documentation Committee (IKDC) subjective, Lower Extremity Functional Scale (LEFS), Numeric Pain Scale (NPS), and modified Single Assessment Numeric Evaluation (SANE) scores. Alternatively, a within-cohort, anchor-based approach, leveraging the modified SANE as a global transition question, was used to determine MCID values of 12.2, 8.4, and - 1.8, and SCB values of 29.5, 22.5, and - 3.0 for IKDC, LEFS, and NPS, respectively. Approximately 87% of treated knees reported change scores that met or exceeded an MCID value while 59% reported change scores that met or exceeded an SBC value for one or more PROMs. In reporting MCID and SCB values for PROMs following the treatment of knee OA with a combination of BMC and platelet products, we sought to provide a foundation for assessing the clinical efficacy of orthobiologic interventions in this developing field.

摘要

自体骨髓浓缩物(BMC)、富血小板血浆(PRP)和血小板裂解物(PL)已成为治疗膝关节骨关节炎(OA)的有前景的骨科生物治疗选择。本观察性研究报告了几种患者报告结局指标(PROMs)的最小临床重要差异(MCID)和显著临床获益(SCB)值,这些指标用于监测经皮联合使用BMC和血小板产品治疗膝关节OA后关节疼痛和功能的变化(n = 295膝)。基于分布的方法用于确定国际膝关节文献委员会(IKDC)主观评分、下肢功能量表(LEFS)、数字疼痛量表(NPS)和改良单评估数字评价(SANE)评分的12个月MCID值。另外,采用队列内基于锚定的方法,以改良SANE作为整体转变问题,分别确定IKDC、LEFS和NPS的MCID值为12.2、8.4和 -1.8,SCB值为29.5、22.5和 -3.0。大约87%接受治疗的膝关节报告的变化分数达到或超过MCID值,而59%报告的变化分数达到或超过一个或多个PROMs的SBC值。在报告联合使用BMC和血小板产品治疗膝关节OA后PROMs的MCID和SCB值时,我们旨在为评估这一发展中领域的骨科生物干预措施的临床疗效提供基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/6c3e9c03905c/41598_2025_91972_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/7fff684f824c/41598_2025_91972_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/1d6ee3f9cb00/41598_2025_91972_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/19476058fdf0/41598_2025_91972_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/b55f6b0c382c/41598_2025_91972_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/6c3e9c03905c/41598_2025_91972_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/7fff684f824c/41598_2025_91972_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/1d6ee3f9cb00/41598_2025_91972_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/19476058fdf0/41598_2025_91972_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/b55f6b0c382c/41598_2025_91972_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6dd/11871318/6c3e9c03905c/41598_2025_91972_Fig5_HTML.jpg

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