Yoshida Jin, Tei Genshin, Mochizuki Chie, Masu Yoshie, Koda Shigeki, Kumagai Shinji
Department of Environmental Health, Osaka Prefectural Institute of Public Health, 1-3-69, Nakamichi, Higashinari-ku, Osaka 537-0025, Japan.
Ann Occup Hyg. 2009 Mar;53(2):153-60. doi: 10.1093/annhyg/men081.
The aim of the preset study was to evaluate the applicability of a closed system device to protect against occupational contamination and exposure to antineoplastic drugs in the work environment of a hospital.
We compared the contamination by and exposure to cyclophosphamide (CPA) between a conventional mixing method and a mixing method using a closed system device. Wipe samples in the preparation room, gloves samples and 24-h urine samples of pharmacists preparing antineoplastic drugs were collected. Working surfaces inside the biological safety cabinet (BSC), front side of the air grilles of the BSC, stainless steel trays, working table and floor were wiped. At first, sample collection was done on 5 days over an interval of 2 weeks using the conventional mixing method. After 2 weeks training for using the closed system device, sample collection was done 5 days over an interval of 2 weeks using the closed system device.
When pharmacists prepared antineoplastic drugs by the conventional method, CPA was detected from all wipe samples, and the mean and median concentrations of CPA were 1.0 and 0.16 ng cm(-2), respectively (range was from 0.0095 to 27 ng cm(-2)). When pharmacists prepared antineoplastic drugs with a closed system device, CPA was detected from 75% of the wipe samples at mean and median concentrations of 0.18 and 0.0013 ng cm(-2), respectively (the range was from lower than detection limit to 4.4 ng cm(-2)). Using the closed system device significantly reduced the surface contamination of CPA for all wipe sampling points in the preparation room (Mann-Whitney's U-test). The range of CPA of glove samples used in the conventional method and closed system device ranged from lower than detection limit to 3200 ng per glove-pair and from lower than detection limit to 740 ng per glove-pair, respectively. Using the closed system device significantly reduced the gloves contamination of CPA (Mann-Whitney's U-test). The range of urinary CPA of six pharmacists preparing the antineoplastic drugs with the conventional method and closed system device ranged from lower than detection limit to 170 ng day(-1) and from lower than detection limit to 15 ng day(-1), respectively. Using the closed system device significantly reduced the amount of urinary CPA in pharmacists preparing the antineoplastic drugs (Wilcoxon's signed ranks test).
We concluded that a closed system device can reduce occupational contamination and exposure to antineoplastic drugs in the hospital work environment.
本研究旨在评估一种封闭系统装置在医院工作环境中预防职业性接触抗肿瘤药物及其污染的适用性。
我们比较了传统混合方法与使用封闭系统装置的混合方法中环磷酰胺(CPA)的污染情况及接触程度。收集了配制抗肿瘤药物的药剂师在制剂室的擦拭样本、手套样本及24小时尿液样本。对生物安全柜(BSC)内部的工作表面、BSC通风口正面、不锈钢托盘、工作台和地面进行擦拭。首先,采用传统混合方法,在2周的间隔内分5天进行样本采集。在经过2周使用封闭系统装置的培训后,使用封闭系统装置在2周的间隔内分5天进行样本采集。
药剂师采用传统方法配制抗肿瘤药物时,所有擦拭样本均检测出CPA,CPA的平均浓度和中位数浓度分别为1.0和0.16 ng/cm²(范围为0.0095至27 ng/cm²)。药剂师使用封闭系统装置配制抗肿瘤药物时,75%的擦拭样本检测出CPA,平均浓度和中位数浓度分别为0.18和0.0013 ng/cm²(范围为低于检测限至4.4 ng/cm²)。使用封闭系统装置显著降低了制剂室所有擦拭采样点的CPA表面污染(曼-惠特尼U检验)。传统方法和封闭系统装置使用的手套样本中CPA的范围分别为低于检测限至每副手套3200 ng和低于检测限至每副手套740 ng。使用封闭系统装置显著降低了手套上CPA的污染(曼-惠特尼U检验)。6名采用传统方法和封闭系统装置配制抗肿瘤药物的药剂师尿液中CPA的范围分别为低于检测限至170 ng/天和低于检测限至15 ng/天。使用封闭系统装置显著降低了配制抗肿瘤药物的药剂师尿液中CPA的含量(威尔科克森符号秩检验)。
我们得出结论,封闭系统装置可减少医院工作环境中抗肿瘤药物的职业性污染及接触。