Environmental Research Center, ICS MAUGERI SPA SB, Institute of Pavia, IRCCS, Pavia, Italy.
Occupational Medicine Unit, Department of Public Health, Experimental Forensic Medicine - University of Pavia, via Boezio 24, Pavia, Italy.
Ann Work Expo Health. 2017 Oct 1;61(8):994-1002. doi: 10.1093/annweh/wxx065.
Antineoplastic drugs (ADs) will continue to represent a potential risk for personnel involved in the handling of these compounds and great concerns have been raised by the presence of ADs in many surveyed workplaces. Eight hospitals were investigated by means of wipe sampling for surface residue determination. Each wipe sample was tested for five ADs considered suitable exposure markers. Cyclophosphamide (CP), gemcitabine (GEM), 5-fluorouracil (5-FU), platinum-containing drugs (Pt), and epi-doxorubicin (EPI) contamination levels were measured in 85 per cent of the studied pharmacies and 93 per cent of outpatient care units (OpCUs). This study showed that 83 out of 349 samples were positive in Pharmacies, this proportion being statistically significant (χ2 = 42.9, p < 0.001). The positive samples provided evidence of at least one substance with levels greater than the limit of detection (LOD). The two most frequently detected substances were Pt (42%) and CP (30%). These accounted for 72 per cent of the whole dataset, followed by 5-FU and GEM. Based on the 90th percentile of wipe sampling data distribution, we suggest hygienic guidance values (HGVs) of 3.6, 1.0, 0.9, and 0.5 ng cm-2 for CP, 5-FU, GEM and Pt, respectively, as the best target levels of the surface contamination load in Italian pharmacies. The approach of proposing guidance values at the 90th percentile of results obtained from workplaces with good hygiene practice was found to be a simple and practical way of controlling occupational exposure. HGVs were challenged in this study as technical threshold limits to benchmark AD residual surface contamination at workplaces.
抗肿瘤药物（AD）将继续对处理这些化合物的人员构成潜在风险，并且在许多调查工作场所中存在 AD 引起了极大的关注。对八家医院进行了擦拭采样，以确定表面残留量。每个擦拭样本均用于测试五种被认为是合适暴露标志物的 AD。在 85%的研究药房和 93%的门诊护理单位（OpCU）中测量了环磷酰胺（CP）、吉西他滨（GEM）、5-氟尿嘧啶（5-FU）、含铂药物（Pt）和表阿霉素（EPI）的污染水平。本研究表明，在药房中，349 个样本中有 83 个呈阳性，这一比例具有统计学意义（χ2=42.9，p<0.001）。阳性样本证明至少有一种物质的含量超过了检测限（LOD）。检测到的两种最常见的物质是 Pt（42%）和 CP（30%）。这两种物质占整个数据集的 72%，其次是 5-FU 和 GEM。基于擦拭采样数据分布的第 90 个百分位数，我们建议意大利药房的 CP、5-FU、GEM 和 Pt 的卫生指导值（HGV）分别为 3.6、1.0、0.9 和 0.5 ng cm-2。建议在具有良好卫生实践的工作场所中从结果获得的第 90 个百分位数提出指导值的方法被认为是控制职业暴露的简单实用方法。在这项研究中，HGV 被作为技术阈值限制，用于基准工作场所 AD 残留表面污染。
