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一项旨在确定骨科植入物致敏潜力的观察性研究。

An observational study to determine the sensitizing potential of orthopedic implants.

机构信息

Department of Dermatology, Venereology and Leprology Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Department of Orthopedic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Indian J Dermatol Venereol Leprol. 2021 Nov-Dec;87(6):826-830. doi: 10.4103/ijdvl.IJDVL_789_18.

DOI:10.4103/ijdvl.IJDVL_789_18
PMID:32134002
Abstract

INTRODUCTION

Patients who receive orthopedic implants have been shown to develop sensitivity to its components and there are concerns that this sensitivity might lead to contact dermatitis or implant-related problems like loosening and/or failure. The objective of the study was to determine the sensitizing potential of orthopedic implants.

METHODS

Fifty-four patients undergoing knee, hip, or shoulder replacement surgeries between July 2014 and July 2015 were recruited. Patch tests were performed before the implant surgery with 10 allergens likely to be implicated in metal hypersensitivity. Postimplant patch test was performed 6 months after surgery. A majority of the patch tests were applied on the arms.

RESULTS

Four positive reactions were recorded in the preimplant patch tests - three positive reactions to nickel and one to chromium. Thirty patients made themselves available for the follow-up patch test. The incidence of new contact sensitivity to components of implants was 13.8% (4/29) at 6 months. One patient who had undergone knee replacement developed eczematous lesions around the knee joint after surgery. This patient tested negative to patch test at both the times.

LIMITATIONS

Short follow-up duration and performing patch tests on the arms, a site known to elicit less positive patch test response compared to the back in sensitized individuals, are limitations of the study.

CONCLUSION

There is an increase in the sensitivity to implanted components after 6 months of joint replacement surgery. The incidence of new sensitivity to a component of the implant was 13.8% (4/29). In this context, nickel is a good sensitizer and could sensitize 50% of patients who received a nickel-containing implant.

摘要

简介

接受骨科植入物的患者已被证实对其组件敏感,人们担心这种敏感性可能导致接触性皮炎或与植入物相关的问题,如松动和/或失效。本研究的目的是确定骨科植入物的致敏潜力。

方法

2014 年 7 月至 2015 年 7 月期间,招募了 54 名接受膝关节、髋关节或肩关节置换手术的患者。在植入手术前用 10 种可能与金属过敏有关的过敏原进行斑贴试验。术后 6 个月进行植入后斑贴试验。大多数斑贴试验应用于手臂。

结果

在植入前斑贴试验中记录了 4 个阳性反应-3 个对镍的阳性反应和 1 个对铬的阳性反应。30 名患者可进行随访斑贴试验。在 6 个月时,植入物成分的新接触敏感性发生率为 13.8%(4/29)。1 名接受膝关节置换术的患者在手术后膝关节周围出现湿疹样病变。该患者在两次斑贴试验中均呈阴性。

局限性

本研究的局限性在于随访时间短,以及在手臂上进行斑贴试验,与致敏个体背部相比,手臂是一个引起阳性斑贴试验反应较少的部位。

结论

关节置换术后 6 个月,对植入物成分的敏感性增加。对植入物成分的新敏感性发生率为 13.8%(4/29)。在这种情况下,镍是一种很好的致敏剂,可使 50%接受含镍植入物的患者致敏。

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