Schierl Rudolf, Böhlandt Antje, Nowak Dennis
Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-University Munich, Ziemssenstrasse 1, D-80336 Muenchen, Germany.
Ann Occup Hyg. 2009 Oct;53(7):703-11. doi: 10.1093/annhyg/mep050. Epub 2009 Jul 20.
Antineoplastic drugs are widely used in anticancer therapy due to their cytotoxic activity but many of them are classified as carcinogenic, mutagenic, or teratogenic to humans. In order to evaluate personal exposure, surface monitoring has been successfully applied for several years. In this study, we present a statistical description of our data set from 102 German pharmacies and propose 'threshold guidance values (TGVs)' to facilitate interpretation of monitoring results.
Our database included 1008 results for platinum (PT) and 1237 for 5-fluorouracil (FU) collected in 102 pharmacies in Germany. Wipe sampling on site was performed with one validated procedure. PT concentrations were measured by voltammetry and FU by gas chromatography/mass spectrometry. Data were stratified into 10 locations and statistically evaluated.
Contamination was detected on all surfaces in the pharmacies with high levels on storage shelves and floors. The median values for the different locations ranged from 0.20 to 1.70 pg cm(-2) (mean: 0.57 pg cm(-2)) for PT and from 2.50 to 10.00 pg cm(-2) (mean: 5.34 pg cm(-2)) for FU. The mean 75th percentiles were 3.92 pg cm(-2) (PT) and 28.90 pg cm(-2) (FU). The TGV 1 value was set at the median value and results below demonstrate good working practices. Contaminations above the TGV 2, which was assigned at the 75th percentile, show a clear need for optimizing the handling procedures.
The introduction of TGVs helps to reduce occupational exposure and allows pharmacy personnel to benchmark their own contamination levels. This provides a basis for improvement in occupational safety precautions and for regular contamination controls.
抗肿瘤药物因其细胞毒性活性而广泛应用于抗癌治疗，但其中许多药物对人类具有致癌、致突变或致畸性。为了评估个人暴露情况，表面监测已成功应用多年。在本研究中，我们对来自102家德国药店的数据集进行了统计描述，并提出了“阈值指导值（TGVs）”以方便对监测结果进行解读。
我们的数据库包含在德国102家药店收集的1008份铂（PT）检测结果和1237份5-氟尿嘧啶（FU）检测结果。采用一种经过验证的程序在现场进行擦拭采样。PT浓度通过伏安法测量，FU通过气相色谱/质谱法测量。数据按10个地点分层并进行统计评估。
在药店的所有表面均检测到污染，储存货架和地面上的污染水平较高。不同地点的PT中位数浓度范围为0.20至1.70 pg/cm²（平均值：0.57 pg/cm²），FU为2.50至10.00 pg/cm²（平均值：5.34 pg/cm²）。平均第75百分位数分别为3.92 pg/cm²（PT）和28.90 pg/cm²（FU）。TGV 1值设定为中位数，低于该值的结果表明操作规范良好。高于TGV 2（设定为第75百分位数）的污染表明明显需要优化操作程序。
引入TGVs有助于减少职业暴露，并使药店工作人员能够将自己的污染水平作为基准。这为改进职业安全预防措施和定期进行污染控制提供了依据。
