对矫形生物制剂用于非骨胳连接手术治疗的最新数据进行系统性的范围界定审查。

IF 2.3 3区 医学 Q2 ORTHOPEDICS
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引用次数: 0

摘要

导言:最近的研究表明,人们越来越关注骨科领域越来越多使用的生物制剂的成本效益和缺乏支持数据的问题。我们的目的是对最近(过去五年)发表的有关使用骨科生物制剂治疗骨折不愈合的文章进行一次系统性的范围界定综述,并总结现有的最新数据:本综述的纳入标准为2016年至2022年期间发表的英文文章,重点关注骨生物制品用于非骨连接手术治疗的情况。在2023年3月使用Pubmed/MEDLINE和Embase进行了检索。有关脊柱融合或基因治疗的研究被排除在外。此外,还排除了综述、五例或五例以下的病例报告、会议记录、初步报告、儿科或非人体研究:结果:检索发现了 1807 篇文章,经 PRISMA 核对表和排除后,符合条件的有 15 篇。证据不一,只有一项二级 RCT。最近的数据表明,骨形态形成蛋白(BMP-2)产品对化脓性和无菌性胫骨非关节炎有效。然而,关于BMP-7、富血小板血浆(PRP)、干细胞或脱矿骨基质(DBM)的证据并不确凿:讨论:就骨缺损、生物学、机械稳定性、手术技术和宿主因素而言,每种非骨关节畸形的情况都不尽相同,这也是文献中有关骨生物制剂疗效的报道相互矛盾的原因。我们可能永远也不会看到一项1级、高能级和可靠的研究来确定此类产品的疗效、安全性和成本效益:证据等级:IV。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A systematic scoping review of the latest data on orthobiologics in the surgical treatment of non-union

Introduction

Recent studies have shown a growing concern regarding the cost-effectiveness and the lack of supporting data for the biologic agents that are being increasingly used in the orthopedic field. Our aim was to conduct a systematic scoping review of recent publications (last five years) on the use of orthobiologics to treat fracture non-union and summarize the latest available data.

Patients and methods

The inclusion criteria for this review were articles published in English, from 2016 to 2022, and focusing on the use of orthobiologics for the surgical treatment of non-union. Searches were conducted in March 2023 using Pubmed/MEDLINE and Embase. Studies on spinal fusion or gene therapy were excluded. Reviews, case reports with five cases or less, conference proceedings, preliminary reports, pediatric or non-human studies were excluded as well.

Results

The search found 1807 articles, 15 were eligible after PRISMA checklist and exclusions. The evidence was heterogenous and there was only one level II RCT. Recent data suggests that bone morphogenic protein (BMP-2) products could be effective for septic and aseptic tibial non-unions. However, the evidence was not conclusive regarding BMP-7, plasma rich platelets (PRP), stem cells or demineralized bone matrix (DBM).

Discussion

Every non-union case is different in terms of bone defect, biology, mechanical stability, surgical technique and host factors, which contributes to the conflicting reports on the efficacy of orthobiologics in the literature. We might never see a level 1, high powered and robust study defining the efficacy, safety profile and cost-effectiveness of such products.

Level of evidence

IV.

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来源期刊
CiteScore
5.10
自引率
26.10%
发文量
329
审稿时长
12.5 weeks
期刊介绍: Orthopaedics & Traumatology: Surgery & Research (OTSR) publishes original scientific work in English related to all domains of orthopaedics. Original articles, Reviews, Technical notes and Concise follow-up of a former OTSR study are published in English in electronic form only and indexed in the main international databases.
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