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环磷酰胺、异环磷酰胺和甲氨蝶呤的环境污染:对加拿大51个中心的研究

Environmental Contamination with Cyclophosphamide, Ifosfamide, and Methotrexate: A Study of 51 Canadian Centres.

作者信息

Janes Alexia, Tanguay Cynthia, Caron Nicolas J, Bussières Jean-François

机构信息

is a Research Assistant in the Pharmacy Practice Research Unit and the Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec. She is also a DPharm candidate with the Faculté des sciences pharmaceutiques et biologiques de Lille, Lille, France.

BSc, MSc, is a Research Assistant in the Pharmacy Practice Research Unit and the Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec.

出版信息

Can J Hosp Pharm. 2015 Jul-Aug;68(4):279-89. doi: 10.4212/cjhp.v68i4.1467.

Abstract

BACKGROUND

Occupational exposure to hazardous drugs may lead to adverse reproductive effects. There is no safe exposure limit for health care professionals.

OBJECTIVES

To monitor levels of cyclophosphamide, ifosfamide, and methotrexate contamination in oncology pharmacy and patient care areas in Canadian health care institutions.

METHODS

The study was conducted in 2014. Hospitals with at least 50 acute care beds were invited to participate. At each participating centre, 12 standardized sites (6 in pharmacy areas and 6 in patient care areas) were sampled. The samples were analyzed for the presence of cyclophosphamide, ifosfamide, and methotrexate by ultra-performance liquid chromatography tandem mass spectrometry technology. The limits of detection were 0.36 pg/cm(2) for cyclophosphamide, 0.95 pg/cm(2) for ifosfamide, and 0.97 pg/cm(2) for methotrexate. Descriptive statistical analyses were performed to determine the median, 75th percentile, and maximum levels.

RESULTS

Fifty-one hospitals participated in this descriptive study, and a total of 584 samples were quantified. Overall, 294 (50%) of the samples were positive for cyclophosphamide, 125 (21%) for ifosfamide, and 54 (9%) for methotrexate. The most frequently contaminated sampling sites in pharmacy areas were the front grille inside the hood and the floor in front of the hood and, in patient care areas, the armrest and outpatient clinic counter. The 75th percentiles for surface concentration were 10.8 pg/cm(2) for cyclophosphamide, 1.59 pg/cm(2) for ifosfamide, and below the limit of detection for methotrexate.

CONCLUSIONS

Relative to 3 other multicentre studies conducted in Quebec over the past few years, the proportion of positive samples remained constant. Nonetheless, the 75th percentile surface concentration of antineoplastic drugs has been decreasing and seems to have reached a plateau. Local (country-specific or region-specific) and attainable goals for surface contamination with hazardous drugs should be set annually, so long as no health-based limit is known.

摘要

背景

职业接触危险药物可能导致不良生殖影响。医疗保健专业人员没有安全接触限值。

目的

监测加拿大医疗机构肿瘤药房和患者护理区域中环磷酰胺、异环磷酰胺和甲氨蝶呤的污染水平。

方法

该研究于2014年进行。邀请了至少有50张急性护理床位的医院参与。在每个参与中心,对12个标准化地点(药房区域6个,患者护理区域6个)进行采样。通过超高效液相色谱串联质谱技术分析样品中环磷酰胺、异环磷酰胺和甲氨蝶呤的存在情况。环磷酰胺的检测限为0.36 pg/cm²,异环磷酰胺为0.95 pg/cm²,甲氨蝶呤为0.97 pg/cm²。进行描述性统计分析以确定中位数、第75百分位数和最高水平。

结果

51家医院参与了这项描述性研究,共对584个样品进行了定量分析。总体而言,294个(50%)样品中环磷酰胺呈阳性,125个(21%)异环磷酰胺呈阳性,54个(9%)甲氨蝶呤呈阳性。药房区域污染最频繁的采样点是通风橱内的前格栅和通风橱前的地面,在患者护理区域是扶手和门诊柜台。表面浓度的第75百分位数,环磷酰胺为10.8 pg/cm²,异环磷酰胺为1.59 pg/cm²,甲氨蝶呤低于检测限。

结论

相对于过去几年在魁北克进行的其他3项多中心研究,阳性样品的比例保持不变。尽管如此,抗肿瘤药物表面浓度的第75百分位数一直在下降,似乎已达到平稳状态。在尚无基于健康的限值的情况下,应每年设定危险药物表面污染的本地(特定国家或特定地区)可实现目标。

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