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基于捷克和斯洛伐克医院和药房的长期监测结果,提出抗肿瘤药物表面污染的指导值建议。

Proposals of guidance values for surface contamination by antineoplastic drugs based on long term monitoring in Czech and Slovak hospitals and pharmacies.

机构信息

RECETOX, Faculty of Science, Masaryk University, Brno, Czechia.

Masaryk Memorial Cancer Institute, Brno, Czechia.

出版信息

Front Public Health. 2023 Sep 14;11:1235496. doi: 10.3389/fpubh.2023.1235496. eCollection 2023.

DOI:10.3389/fpubh.2023.1235496
PMID:37780438
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10537921/
Abstract

INTRODUCTION

The exposures to hazardous antineoplastic drugs (AD) represent serious risks for health care personnel but the exposure limits are not commonly established because of the no-threshold effects (genotoxic action, carcinogenicity) of many ADs. In this study, we discussed and derived practically applicable technical guidance values (TGV) suitable for management of AD risks.

METHODS

The long-term monitoring of surface contamination by eight ADs was performed in pharmacies and hospitals in the Czech Republic and Slovak Republic in 2008-2021; in total 2,223 unique samples were collected repeatedly in 48 facilities. AD contamination was studied by LC-MS/MS for cyclophosphamide, ifosfamide, methotrexate, irinotecan, paclitaxel, 5-fluorouracil and gemcitabine and by ICP-MS for total Pt as a marker of platinum-based ADs.

RESULTS

The study highlighted importance of exposure biomarkers like 5-fluorouracil and especially carcinogenic and persistent cyclophosphamide, which should be by default included in monitoring along with other ADs. Highly contaminated spots like interiors of laminar biological safety cabinets represent a specific issue, where monitoring of contamination does not bring much added value, and prevention of staff and separated cleaning procedures should be priority. Rooms and surfaces in health care facilities that should be virtually free of ADs (e.g., offices, kitchenettes, daily rooms) were contaminated with lower frequency and concentrations but any contamination in these areas should be carefully examined.

DISCUSSION AND CONCLUSIONS

For all other working places, i.e., majority of areas in pharmacies and hospitals, where ADs are being prepared, packaged, stored, transported, or administered to patients, the study proposes a generic TGV of 100 pg/cm. The analysis of long-term monitoring data of multiple ADs showed that the exceedance of one TGV can serve as an indicator and trigger for improvement of working practices contributing thus to minimizing of unintended exposures and creating a safe work environment.

摘要

简介

接触有害抗肿瘤药物(AD)会对医护人员的健康造成严重威胁,但由于许多 AD 具有无阈值效应(遗传毒性作用、致癌性),因此通常无法确定接触限值。在这项研究中,我们讨论并得出了适用于 AD 风险管理的实用技术指导值(TGV)。

方法

2008 年至 2021 年,在捷克共和国和斯洛伐克共和国的药房和医院中,对 8 种 AD 的表面污染进行了长期监测;总共在 48 个设施中重复收集了 2223 个独特的样本。通过 LC-MS/MS 研究了环磷酰胺、异环磷酰胺、甲氨蝶呤、伊立替康、紫杉醇、5-氟尿嘧啶和吉西他滨的 AD 污染,通过 ICP-MS 研究了总铂作为铂类 AD 标志物的污染。

结果

该研究强调了暴露生物标志物(如 5-氟尿嘧啶)的重要性,特别是致癌和持久的环磷酰胺,应默认将其与其他 AD 一起纳入监测。像层流生物安全柜内部这样高度污染的地方是一个特殊问题,在这些地方,污染监测并没有带来太多附加值,而员工和单独的清洁程序的预防应该是优先事项。医疗保健设施中几乎不含 AD 的房间和表面(例如,办公室、小厨房、日常房间)的污染频率和浓度较低,但应仔细检查这些区域的任何污染。

讨论和结论

对于所有其他工作场所,即在药房和医院中准备、包装、储存、运输或向患者施用 AD 的大部分区域,该研究提出了 100pg/cm 的通用 TGV。对多种 AD 长期监测数据的分析表明,超过一个 TGV 可以作为改进工作实践的指标和触发因素,从而有助于最大限度地减少意外接触并创造安全的工作环境。

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