Laboratoire de Biochimie et de Pharmaco-toxicologie, Centre Hospitalier Lyon-Sud - HCL, Pierre Bénite, France.
Ansell Healthcare Europe NV, Brussels, Belgium.
J Oncol Pharm Pract. 2021 Sep;27(6):1395-1408. doi: 10.1177/1078155220950423. Epub 2020 Aug 26.
Exposure to anticancer drugs is one of the known risks for people working in specialist oncology units. Wearing gloves is a vital form of personal protection. The aim of this study was to assess, in close to real use dynamic conditions, the permeability of 15 surgical and examination gloves made from different materials when exposed to 27 anticancer drugs included in the list from international Guides and Recommendations.
Gloves were tested by using controlled dynamic conditions replicating flexion and extension movements that mimic typical clinical applications. Tests were performed at 37°C or at 43°C for 30 min and anticancer drugs were tested at the highest concentration used in clinical practice. To determine the permeation rate, the quantification of anticancer drugs was performed with selective and sensitive analytical methods such as inductively coupled plasma-mass spectroscopy and liquid chromatography-mass spectrometry.
All the gloves met the EN 16523-1 European standard (1000 ng/(min.cm)). The penetration rate of busulfan, carmustine and thiotepa exceeded the ASTM D-6978-05 American standard (10 ng/(min.cm)) with several surgical and/or examination gloves. This standard was met in all of cases when double gloving was used. Breakage of several nitrile gloves was observed in relation with the excipient used by drugs suppliers.
Permeation is a complex multifactorial phenomenon. However, we have suggested that the thickness of the glove and three physicochemical parameters (molecular weight, topological polar surface area and hydrogen bond donor) of the drug were the main parameters affecting permeation.
接触抗癌药物是在肿瘤专科工作的人员已知的风险之一。戴手套是个人防护的重要形式。本研究旨在评估在接近实际使用的动态条件下，当暴露于国际指南和建议中列出的 27 种抗癌药物时，15 种不同材料制成的手术和检查手套的渗透性。
使用控制的动态条件测试手套，模拟典型的临床应用中的弯曲和伸展运动。测试在 37°C 或 43°C 下进行 30 分钟，抗癌药物以临床实践中使用的最高浓度进行测试。为了确定渗透速率，使用选择性和灵敏的分析方法，如电感耦合等离子体质谱法和液相色谱-质谱法，对抗癌药物进行定量。
所有手套均符合欧洲标准 EN 16523-1（1000ng/（min.cm））。几种手术和/或检查手套中，布硫磷、卡莫司汀和噻替哌的渗透速率超过了美国标准 ASTM D-6978-05（10ng/（min.cm））。当使用双层手套时，所有情况下均符合该标准。与药物供应商使用的赋形剂有关，几种丁腈手套出现了破裂。
渗透是一个复杂的多因素现象。然而，我们提出手套的厚度和药物的三个物理化学参数（分子量、拓扑极性表面积和氢键供体）是影响渗透的主要参数。
