Acampora Antonio, Castiglia Loredana, Miraglia Nadia, Pieri Maria, Soave Claudio, Liotti Francesco, Sannolo Nicola
Dipartimento di Medicina Pubblica e della Sicurezza Sociale,Università degli Studi di Napoli, Naples, Italy.
Ann Occup Hyg. 2005 Oct;49(7):611-8. doi: 10.1093/annhyg/mei029. Epub 2005 Jun 17.
The efficacy of preventive and organisational measures implemented in Italy to prevent the contamination of cytotoxic drug preparation rooms has been investigated, and oncologic wards of two Italian hospitals were examined. The sampling strategy was based not only on potential sources of contamination but also on responses to detailed questionnaires on workplace practices and work organisation. Wipe samples were taken from different surfaces of preparation rooms, before and after the work shift, over a span of a month. Cyclophosphamide was taken as the marker drug that reflects exposure to cytotoxic drugs, being measurable by GC/MS. In one of the two hospitals (Hospital A), a large amount of cyclophosphamide was found, both before and after shift, on the workbench (median value, 2.55 microg dm(-2), before shift), on the floor between the operator working position and the waste bin (>10 microg dm(-2), after shift), as also on door handles and storage shelves. No quantifiable levels of cytotoxic drug were detected in the second hospital investigated (Hospital B). These results could be attributed to the efficacy of cleaning procedures and working practices. In fact, both hospitals were provided with vertical-laminar airflow hoods and the (male) nurses had attended special training courses; but in Hospital A, cleaning procedures were carried out without substances used specifically for the cleaning of surfaces contaminated by cytotoxic drugs such as sodium hypochlorite. Working practices did not include Luer Lock devices. Cyclophosphamide concentrations found in both hospitals, compared with the quantities of drug handled, gave evidence of the importance of the correct handling of cytotoxic agents as a major tool in reducing contamination levels. The results reveal the insufficiency of the risk management measures which do not take into account working practices that are prevailing, and stress the necessity for periodic environmental monitoring, indispensable for evolving effective procedures to prevent antineoplastic drug exposure.
对意大利为防止细胞毒性药物配制室受到污染而实施的预防和组织措施的效果进行了调查，并对两家意大利医院的肿瘤科病房进行了检查。抽样策略不仅基于潜在的污染源，还基于对有关工作场所操作和工作组织的详细问卷的答复。在一个月的时间里，在工作班次前后从配制室的不同表面采集擦拭样本。环磷酰胺被用作反映细胞毒性药物暴露情况的标记药物，可通过气相色谱/质谱法进行测量。在两家医院中的一家（医院A），在工作台（班次前中位数为2.55微克/平方分米）、操作人员工作位置与垃圾桶之间的地板上（班次后>10微克/平方分米）以及门把手和储物架上，在班次前后均发现了大量环磷酰胺。在调查的第二家医院（医院B）未检测到可量化水平的细胞毒性药物。这些结果可归因于清洁程序和工作做法的效果。事实上，两家医院都配备了垂直层流通风柜，并且（男）护士都参加了专门的培训课程；但在医院A，清洁程序是在没有使用专门用于清洁被细胞毒性药物污染表面的物质（如次氯酸钠）的情况下进行的。工作做法中不包括鲁尔锁装置。与处理的药物数量相比，两家医院中发现的环磷酰胺浓度证明了正确处理细胞毒性药物作为降低污染水平的主要工具的重要性。结果表明，风险管理措施没有考虑到普遍存在的工作做法，存在不足，并强调了定期环境监测的必要性，这对于制定有效的预防抗肿瘤药物暴露程序是必不可少的。
