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年度骨科会议上推广的生物疗法的临床证据:系统评价。

The Clinical Evidence Behind Biologic Therapies Promoted at Annual Orthopaedic Meetings: A Systematic Review.

机构信息

Rothman Institute, Philadelphia, Pennsylvania, U.S.A.

Rothman Institute, Philadelphia, Pennsylvania, U.S.A..

出版信息

Arthroscopy. 2019 Jan;35(1):251-259. doi: 10.1016/j.arthro.2018.05.037. Epub 2018 Nov 16.

DOI:10.1016/j.arthro.2018.05.037
PMID:30455088
Abstract

PURPOSE

The purpose of this study is to systematically evaluate the available clinical data for biologic therapies promoted for articular cartilage defects and osteoarthritis of the knee at the 2016 American Orthopaedic Society for Sports Medicine Meeting (AOSSM) and the 2017 Arthroscopy Association of North America meeting (AANA).

METHODS

Our sample included all exhibitors at the 2016 AOSSM meeting and 2017 AANA meeting. All biologic products marketed at each conference were identified by reviewing exhibition booths and company websites. A systematic review of the clinical data on each product was then completed using PubMed, EMBASE, and the product's own webpage. All clinical peer-reviewed studies with level I-IV evidence were included in the study. Basic science or preclinical studies were excluded.

RESULTS

There were 16 products promoted for biologic therapy for articular cartilage defects or osteoarthritis of the knee at the AOSSM meeting and 11 products promoted at the AANA meeting. A total of 280 articles detailed clinical findings for the articular cartilage products displayed at AOSSM and AANA. Of the 280, there were 36 level I evidence studies, 37 level II evidence studies, 18 level III evidence studies, and 189 level IV evidence studies. Of these articles, 91% were for 4 products. Of all biologic products promoted at the 2 meetings, 65% did not have any peer-reviewed clinical data supporting their use.

CONCLUSION

Overall, many biologic therapies promoted at leading arthroscopy and sports medicine conferences did not have clinical evidence evaluating their use in the peer-reviewed literature. Although scientific advancement requires new technology, orthopaedic surgeons should be cautious about using biologic therapies in their practice with no proven efficacy. There are likely promising new interventions that, with additional scientific research, will be proven efficacious for our patients.

CLINICAL RELEVANCE

This article gives orthopaedic surgeons a detailed example of some of the biologic treatments being offered on the market for the treatment of knee articular cartilage disease. When patients request these treatments, physicians must be able to explain the data supporting their use.

摘要

目的

本研究旨在系统评估 2016 年美国运动医学学会(AOSSM)年会和 2017 年北美关节镜协会(AANA)会议上推广的用于治疗关节软骨缺损和膝关节骨关节炎的生物治疗的现有临床数据。

方法

我们的样本包括 2016 年 AOSSM 会议和 2017 年 AANA 会议的所有参展商。通过审查展览摊位和公司网站,确定了在每次会议上销售的所有生物制品。然后使用 PubMed、EMBASE 和产品自身网页对每种产品的临床数据进行系统回顾。本研究纳入了所有具有 I-IV 级证据的临床同行评议研究,排除了基础科学或临床前研究。

结果

在 AOSSM 会议上有 16 种产品被推广用于治疗关节软骨缺损或膝关节骨关节炎,在 AANA 会议上有 11 种产品被推广。共有 280 篇文章详细介绍了在 AOSSM 和 AANA 展示的关节软骨产品的临床发现。在这 280 篇文章中,有 36 篇为 I 级证据研究,37 篇为 II 级证据研究,18 篇为 III 级证据研究,189 篇为 IV 级证据研究。这些文章中有 91%是针对 4 种产品的。在这两次会议上推广的所有生物制品中,有 65%没有任何经过同行评议的临床数据支持其使用。

结论

总体而言,许多在领先的关节镜和运动医学会议上推广的生物治疗方法在同行评议文献中没有临床证据支持其使用。尽管科学进步需要新技术,但骨科医生在没有经过证实的疗效的情况下,应谨慎使用生物治疗。可能有一些有前途的新干预措施,随着进一步的科学研究,将被证明对我们的患者有效。

临床相关性

本文为骨科医生详细介绍了一些市场上提供的用于治疗膝关节关节软骨疾病的生物治疗方法。当患者要求使用这些治疗方法时,医生必须能够解释支持其使用的数据。

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