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异种移植生物补片在胸腹壁外科和普通外科中的应用:技术评估及临床有效性与安全性数据综述

Xenograft biologic mesh in parietal and general surgery: Technical assessment and review of clinical effectiveness and safety data.

作者信息

Sainfort A, Denis Hallouard I, Hartmann D, Aulagner G, Francois Y, Tiffet O, Barabino G, Nuiry O, Armoiry X

机构信息

Pharmacie, hospices civils de Lyon, 69500 Bron, France.

Pharmacie des dispositifs médicaux, centre hospitalo-universitaire de Saint-Étienne, 42055 Saint-Étienne, France.

出版信息

J Visc Surg. 2016 Dec;153(6):403-417. doi: 10.1016/j.jviscsurg.2016.08.002. Epub 2016 Sep 8.

DOI:10.1016/j.jviscsurg.2016.08.002
PMID:27618702
Abstract

STUDY AIM

To describe the main technical characteristics of biologic prostheses used for parietal reinforcement and to present the state of the art on their risk/benefit ratio.

METHODS

We conducted a technical analysis of manufacturer specifications of the biologic prostheses that are currently available in France accompanied by a literature review by selecting meta-analyses and systematic reviews, randomized controlled trials and publications of health technology rating agencies.

RESULTS

Biological implants for parietal reinforcement are mainly intended for use in a contaminated environment where the use of synthetic prostheses is contra-indicated. We identified fourteen systematic reviews and meta-analyses and one randomized controlled trial. Six ongoing clinical trials were identified as well as two clinical trials that had been interrupted. In the current state of knowledge, there are no high-level evidence data on the therapeutic contribution of biologic prostheses that allow prioritization of the various biologic prostheses according to their characteristics or their different manufacturing processes.

CONCLUSION

Pending the results of current randomized controlled trials to validate the indications and an eventual specific reimbursement, indications for the use of biologic parietal reinforcement prostheses seems to be limited to rare clinical situations and only after collegial discussion.

摘要

研究目的

描述用于腹壁加固的生物假体的主要技术特征,并介绍其风险/效益比的现状。

方法

我们对法国目前可用的生物假体的制造商规格进行了技术分析,并通过选择荟萃分析和系统评价、随机对照试验以及卫生技术评估机构的出版物进行文献综述。

结果

用于腹壁加固的生物植入物主要用于污染环境,在这种环境中禁忌使用合成假体。我们确定了十四项系统评价和荟萃分析以及一项随机对照试验。确定了六项正在进行的临床试验以及两项已中断的临床试验。就目前的知识水平而言,没有关于生物假体治疗作用的高级证据数据,无法根据其特性或不同制造工艺对各种生物假体进行优先排序。

结论

在当前随机对照试验结果验证适应症并最终实现特定报销之前,生物腹壁加固假体的使用适应症似乎仅限于罕见的临床情况,并且仅在经过合议讨论后使用。

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