背景:虽然罕见,鉴于缺少指南,对金属植入物的过敏反应代表了诊断挑战。
目的:就金属过敏反应的特征以及各种诊断工具在可疑金属植入物过敏中的应用达成欧洲专家共识。
方法:采用名义分组技术(NGT)制定共识声明。最初,在安全服务器上创建了一个在线文献数据库,以提供全面的信息。针对金属植入物过敏的潜在方面制定了23项声明,重点是诊断,并分为五个领域。为了达成共识,由12名专家组成的小组最初确实完善和重新制定了那些模棱两可或措辞不明确的陈述。通过面对面(9/12)或虚拟参与(3/12),进行了匿名在线投票。
结果:在20/23声明中达成共识(≥80%的协议)。专家组一致认为,在持续的无法解释的症状的情况下,尽管植入物过敏很少,但仍应考虑。是的,然而,建议留出足够的时间来解决与植入物愈合和整合相关的症状。获得问卷辅助的标准化病史和患者结果的标准化评分也被所有专家认为是重要的步骤。关于具有额外的后期阅读的贴片测试的效用/性能存在广泛的共识。人们认识到,淋巴细胞转化试验(LTT)有许多局限性,通常被推荐。在进行整形外科植入之前,不建议对无植入物组件潜在过敏史的患者进行过敏筛查.
结论:使用专家共识程序,创建了有关可疑金属植入物过敏的过敏诊断的声明。确定了未达成共识的领域,强调专家围绕诸如假定过敏的术前测试等主题的不确定性,种植体周围过敏和体外测试的组织学相关性,这强调了进一步研究的必要性。
BACKGROUND: Although rare, allergic reactions to metal implants represent a diagnostic challenge in view of missing
guidelines.
OBJECTIVE: To develop an European expert
consensus on characteristics of metal allergy reactions and the utility of various diagnostic tools in suspected metal implant allergy.
METHODS: A nominal group technique (NGT) was applied to develop
consensus statements. Initially an online literature database was created on a secure server to enable a comprehensive information. Twenty-three statements were formulated on potential aspects of metal implant allergy with a focus on diagnostics and grouped into five domains. For the consensus development, the panel of 12 experts initially did refine and reformulate those statements that were ambiguous or had unclear wording. By face-to-face (9/12) or virtual participation (3/12), an anonymous online voting was performed.
RESULTS: Consensus (≥80% of agreement) was reached in 20/23 statements. The panel agreed that implant allergy despite being rare should be considered in case of persistent unexplained symptoms. It was, however, recommended to allow adequate time for resolution of symptoms associated with healing and integration of an implant. Obtaining questionnaire-aided standardized medical history and standardized scoring of patient outcomes was also considered an important step by all experts There was broad consensus regarding the utility/performance of patch testing with additional late reading. It was recognized that the lymphocyte transformation test (LTT) has to many limitations to be generally recommended. Prior to orthopaedic implant, allergy screening of patients without a history of potential allergy to implant components was not recommended.
CONCLUSIONS: Using an expert
consensus process, statements concerning allergy diagnostics in suspected metal implant allergy were created. Areas of nonconsensus were identified, stressing uncertainty among the experts around topics such as preoperative testing in assumed allergy, histological correlate of periimplant allergy and in vitro testing, which underscores the need for further research.