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创伤与骨科领域的抗菌涂层植入物——临床综述与风险效益分析

Antimicrobial coated implants in trauma and orthopaedics-A clinical review and risk-benefit analysis.

作者信息

Alt Volker

机构信息

Department of Trauma, Hand and Reconstructive Surgery, University Hospital Giessen-Marburg, Campus Giessen, Rudolf-Buchheim-Str. 7, Germany.

出版信息

Injury. 2017 Mar;48(3):599-607. doi: 10.1016/j.injury.2016.12.011. Epub 2016 Dec 21.

Abstract

Implant-associated infections remain a major issue in orthopaedics and antimicrobial functionalization of the implant surface by antibiotics or other anti-infective agents have gained interest. The goal of this article is to identify antimicrobial coatings, for which clinical data are available and to review their clinical need, safety profile, and their efficacy to reduce infection rates. PubMed database of the National Library of Medicine was searched for clinical studies on antimicrobial coated implants for internal fracture fixation devices and endoprostheses for bone surgery, for which study design, level of evidence, biocompatibility, development of resistance, and effectiveness to reduce infection rates were analyzed. Four different coating technologies were identified: gentamicin poly(d, l-lactide) coating for tibia nails, one high (MUTARS) and one low amount silver (Agluna) technology for tumor endoprostheses, and one povidone-iodine coating for titanium implants. There was a total of 9 published studies with 435 patients, of which 7 studies were case series (level IV evidence) and 2 studies were case control studies (level III evidence). All technologies were reported with good systemic and local biocompatibility, except the development of local argyria with blue to bluish grey skin discoloration after the use of silver MUTARS megaendoprostheses. For the local use of gentamicin, there is contradictory data on the risk of emergence of gentamicin-resistance strains, a risk that does not seem to exist for silver and iodine based technologies. Regarding reduction of infection rates, one case control study showed a significant reduction of infection rates by Agluna silver coated tumor endoprostheses. Based on socio-economic data, there is a strong need for improvement of infection prevention and treatment strategies, including implant coatings, in fracture care, primary and revision arthroplasty, and bone tumor surgery. The reviewed gentamicin, silver Agluna, and povidone-iodine technologies have shown a good risk benefit ratio for patients. Further data from randomized control trials are desirable, although this will remain challenging in the context of infection prevention due to the required large sample size of such studies.

摘要

植入物相关感染仍是骨科领域的一个主要问题,通过抗生素或其他抗感染剂对植入物表面进行抗菌功能化已引起关注。本文的目的是确定有临床数据可用的抗菌涂层,并综述其临床需求、安全性概况以及降低感染率的疗效。检索了美国国立医学图书馆的PubMed数据库,查找关于用于骨折内固定装置和骨外科假体的抗菌涂层植入物的临床研究,并分析了这些研究的设计、证据水平、生物相容性、耐药性发展以及降低感染率的有效性。确定了四种不同的涂层技术:用于胫骨钉的庆大霉素聚(d,l-丙交酯)涂层、用于肿瘤假体的一种高银量(MUTARS)和一种低银量(Agluna)技术,以及用于钛植入物的聚维酮碘涂层。共有9项发表的研究涉及435名患者,其中7项研究为病例系列(IV级证据),2项研究为病例对照研究(III级证据)。除了使用MUTARS大型银质肿瘤假体后出现局部银质沉着症伴皮肤蓝至蓝灰色变色外,所有技术均报告具有良好的全身和局部生物相容性。对于庆大霉素的局部使用,关于庆大霉素耐药菌株出现风险的数据存在矛盾,而基于银和碘的技术似乎不存在这种风险。关于降低感染率,一项病例对照研究表明,Agluna银涂层肿瘤假体可显著降低感染率。基于社会经济数据,在骨折护理、初次和翻修关节成形术以及骨肿瘤手术中,迫切需要改进包括植入物涂层在内的感染预防和治疗策略。所综述的庆大霉素、Agluna银和聚维酮碘技术对患者显示出良好的风险效益比。尽管由于此类研究所需的大样本量,在感染预防背景下进行随机对照试验仍具有挑战性,但仍需要进一步的随机对照试验数据。

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