多中心PIVAS集中调配人员抗肿瘤药物职业暴露评估

目的:评估我国静脉药物调配中心(PIVAS)调配人员抗肿瘤药物职业暴露状况。方法:以环磷酰胺(CP)与阿糖胞苷(CAR)为标志物,纳入我国十家医院的PIVAS,对其进行环境监测与生物效应监测。结果:(1)环境监测,十家PIVAS工作环境中环磷酰胺(CP)与阿糖胞苷(CAR)存在不同程度的污染,且不局限于药物调配区域;随着PIVAS运行年限的增长,抗肿瘤药物污染向普通控制区扩散的趋势;现有防护装备下,十家医院PIVAS工作人员的手套与口罩内侧存在不同程度的抗肿瘤药物残留。(2)生物学监测,PIVAS职业接触抗肿瘤药物人员的尿液浓缩致突变率较控制组要高(P<0.05),淋巴细胞总凋亡率也有增高的趋势(P=0.195),然而,这些指标的改变是否意味着遗传毒性反应的发生还需进一步探讨。结论:本课题初步探讨我国PIVAS抗肿瘤药物调配人员的职业暴露情况,旨在为政府部门以及行业内制定统一的抗肿瘤药物调配指南与职业防护规范提供依据。

A multicenter investigation of occupational exposure risks in workers to antineoplastic drugs in pharmacy intravenous admixture services

OBJECTIVE To evaluate occupational exposure risks in workers at pharmacy intravenous admixture services (PIVAS). METHODS Ten PIVAS from Chinese hospitals were selected, and work environment and biological effects were monitored with cyclophosphamide (CP) and cytarabine (CAR) as markers. RESULTS For environmental monitoring, different levels of contamination existed in ten PIVAS besides of antineoplastic drug (AD) admixture area. With increase of PIVAS running years, AD pollution tended to spread to general controlled area. Under current protective measures, detectable residues still existed in inner surfaces of masks and gloves. For biological effect monitoring, mutagenic activity of exposed group was significantly higher than control group (P<0.05). It was also noteworthy that rate of total lymphocyte apoptosis increased slightly in exposed group compared to control group (P=0.195). However, whether those changes could lead to genotoxic responses still needed further investigations. CONCLUSION This article preliminarily investigates occupational exposure risks of workers handling ADs at PIVAS in China. We aim to provide some references for government department or intra-industry to establish unified guidelines and occupational protection specifications for safe handling of antineoplastic drugs.