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评估糖尿病治疗医疗器械中的异冰片丙烯酸酯含量。

Evaluation of Isobornyl Acrylate Content in Medical Devices for Diabetes Treatment.

机构信息

Dermatology and Allergology, Feldafing, Germany.

Department of Dermatology and Allergology, Ludwig-Maximilian University, Munich, Germany.

出版信息

Diabetes Technol Ther. 2019 Oct;21(10):533-537. doi: 10.1089/dia.2019.0163. Epub 2019 Jul 9.

Abstract

Along with increased usage of continuous glucose monitors, flash glucose monitors, and patch pumps by patients with diabetes, the frequency of skin reactions has also increased. Skin irritation and itching can be annoying to users. However, more serious contact allergies to one or more components of the adhesives or plastic material of the housing of the devices can become lifelong. Redness and itchiness are so strong that patients can no longer use a particular system. In August 2017, a major culprit allergen, isobornyl acrylate (IBOA), was identified for these more serious reactions. Our objective was to evaluate IBOA content in different medical products. The plastic material used for the housing of the Freestyle Libre ( = 3), Dexcom G6 ( = 3), and Enlite ( = 4) was analyzed for IBOA content by gas chromatography-mass spectrometry. Adhesives of the different systems were also analyzed. IBOA was found in the housings of Freestyle Libre and Enlite sensor, but not in the Dexcom G6. Patients with an IBOA allergy should consider switching to a medical product without IBOA. Furthermore, removal of IBOA from devices that contact the skin is encouraged.

摘要

随着糖尿病患者对连续血糖监测仪、瞬感血糖监测仪和贴片泵的使用增加,皮肤反应的频率也有所增加。皮肤刺激和瘙痒会让使用者感到烦恼。然而,更严重的接触过敏反应可能会对设备的粘合剂或外壳塑料材料的一个或多个成分产生终身影响。皮肤会出现强烈的红肿和瘙痒,以至于患者无法再使用特定的系统。2017 年 8 月,一种主要的致敏原异丁烯酸异冰片酯(IBOA)被确定为这些更严重反应的罪魁祸首。我们的目的是评估不同医疗产品中的 IBOA 含量。通过气相色谱-质谱法分析了用于 Freestyle Libre( = 3)、Dexcom G6( = 3)和 Enlite( = 4)外壳的塑料材料中的 IBOA 含量。还分析了不同系统的粘合剂。IBOA 存在于 Freestyle Libre 和 Enlite 传感器的外壳中,但不存在于 Dexcom G6 中。对 IBOA 过敏的患者应考虑改用不含 IBOA 的医疗产品。此外,还应鼓励从接触皮肤的设备中去除 IBOA。

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