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富血小板血浆用于肩袖修复的系统评价:我们是否遵循了骨科生物制品研究的最低信息要求?

Systematic Review of Platelet-Rich Plasma for Rotator Cuff Repair: Are We Adhering to the Minimum Information for Studies Evaluating Biologics in Orthopaedics?

作者信息

DeClercq Madeleine G, Fiorentino Alyson M, Lengel Haylie A, Ruzbarsky Joseph J, Robinson Sara K, Oberlohr Verena T, Whitney Kaitlyn E, Millett Peter J, Huard Johnny

机构信息

Center for Regenerative Sports Medicine, Steadman Philippon Research Institute, Vail, Colorado, USA.

The Steadman Clinic, Vail, Colorado, USA.

出版信息

Orthop J Sports Med. 2021 Dec 7;9(12):23259671211041971. doi: 10.1177/23259671211041971. eCollection 2021 Dec.

Abstract

BACKGROUND

The therapeutic efficacy of orthobiologic therapies for rotator cuff repair is difficult to evaluate owing to reporting inconsistences. In response, the Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO) guidelines were developed to ensure standard reporting on orthobiologic therapies.

PURPOSE

To systematically review clinical studies evaluating platelet-rich plasma (PRP) for full-thickness rotator cuff repair and adherence to MIBO guidelines.

STUDY DESIGN

Scoping review; Level of evidence, 4.

METHODS

A search was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines using PubMed, EMBASE, and the Cochrane Library databases. Inclusion criteria were clinical studies reporting on rotator cuff tears (≥1 cm) surgically repaired with PRP. Patient demographics, biologic intervention, and adherence to the MIBO guidelines were systematically reviewed.

RESULTS

A total of 19 studies (1005 patients) were included in this review. Across all studies, 58.5% of the MIBO checklist items for PRP were reported. Out of 47 checklist items, 19 were reported in over 85% of studies, whereas 22 were reported in less than half of studies. Details of whole-blood processing and characteristics, as well as PRP processing and characteristics, were reported inconsistently, and no study provided adequate information to enable the precise replication of preparation protocols for PRP.

CONCLUSION

This systematic review highlights the current reporting deficiencies within the scientific literature of important variables for evaluating PRP for full-thickness rotator cuff repair. There was widespread variability among published studies that evaluate PRP for this application and, more specifically, studies were limited by inconsistent universal reporting of whole-blood and PRP processing and postprocessing characteristics. To improve our understanding of biologic efficacy and to promote repeatability, stricter adherence to the MIBO guidelines is necessary. We propose that the checklist limitations be addressed and that modification of the MIBO guidelines be considered to improve the reporting of individual components within certain categories.

摘要

背景

由于报告不一致,难以评估骨科生物治疗对肩袖修复的疗效。为此,制定了《骨科生物制剂评估研究的最低信息标准》(MIBO)指南,以确保对骨科生物治疗进行标准化报告。

目的

系统评价评估富血小板血浆(PRP)用于全层肩袖修复及遵循MIBO指南情况的临床研究。

研究设计

范围综述;证据等级,4级。

方法

根据PRISMA(系统评价和Meta分析的首选报告项目)指南,使用PubMed、EMBASE和Cochrane图书馆数据库进行检索。纳入标准为报告PRP手术修复肩袖撕裂(≥1 cm)的临床研究。对患者人口统计学、生物干预措施以及遵循MIBO指南的情况进行系统评价。

结果

本综述共纳入19项研究(1005例患者)。在所有研究中,PRP的MIBO清单项目报告率为58.5%。在47项清单项目中,19项在超过85%的研究中被报告,而22项在不到一半的研究中被报告。全血处理和特征以及PRP处理和特征的细节报告不一致,且没有研究提供足够信息以精确复制PRP制备方案。

结论

本系统评价突出了当前科学文献中在评估PRP用于全层肩袖修复的重要变量报告方面的不足。在评估PRP用于该应用的已发表研究中存在广泛差异,更具体地说,研究受到全血和PRP处理及处理后特征的普遍报告不一致的限制。为了增进我们对生物疗效的理解并促进可重复性,有必要更严格地遵循MIBO指南。我们建议解决清单的局限性,并考虑修改MIBO指南以改善某些类别中各个组成部分的报告。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1094/8655472/1d4e9cbff9fc/10.1177_23259671211041971-fig1.jpg

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