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一种安全输液装置降低护士接触抗肿瘤药物职业暴露的评估:一项对照前瞻性研究。Contamoins-1。

Evaluation of a safe infusion device on reducing occupational exposure of nurses to antineoplastic drugs: a comparative prospective study. Contamoins-1.

机构信息

Département de Pharmacie, Institut de Cancérologie Lucien Neuwirth, 108 bis avenue Albert Raimond, 42270, Saint-Priest-en-Jarez, France.

Direction de La Recherche Clinique Et de L'Innovation, Hospices Civils de Lyon, 3 quai des Célestins, Cedex 2, 69229, Lyon, France.

出版信息

Int Arch Occup Environ Health. 2021 Aug;94(6):1317-1325. doi: 10.1007/s00420-021-01679-x. Epub 2021 Mar 17.

Abstract

PURPOSE

Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement.

METHODS

A monocentric comparative before/after study was carried out in an oncology day hospital to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual infusion practices. The rate of nurses' gloves contamination was estimated. To avoid false negatives and to ensure sampling reproducibility, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate logistic regression analysis.

RESULTS

The usual practice led to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 85% in multivariate analysis (Odds ratio = 0.15; 95% confidence interval = 0.05-0.46; p < 0.001). Topotecan was identified in 100% of the samples. Only one case of cross-contamination has occurred.

CONCLUSION

Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

摘要

目的

尽管抗癌药物回路中的环境污染有所减少,但护士在化疗药物给药过程中仍有职业暴露的风险。许多医疗器械旨在确保给药安全,但没有经过科学评估来验证实际的改善效果。

方法

在肿瘤日间医院进行了一项单中心前后对照研究,以评估安全输液装置在减少与常规输液实践相比药物暴露方面的效果。估计了护士手套污染的发生率。为了避免假阴性并确保采样重现性,每个手套样本都用一滴拓扑替康进行了污染。使用多变量逻辑回归分析研究了污染与其他变量之间的关联。

结果

常规实践导致 58.3%的样本污染,而安全输液装置导致 15%的样本污染:安全输液装置在多变量分析中降低了手套污染的风险 85%(比值比=0.15;95%置信区间=0.05-0.46;p<0.001)。100%的样本中都检测到了拓扑替康。仅发生了一起交叉污染的情况。

结论

尽管目前使用中性溶剂冲洗输液器的做法,但护士的职业暴露仍然很高,而安全输液装置显著降低了这种暴露的风险。然而,手套污染只是一个替代终点。结果证实,空袋的断开会导致职业暴露。除了因袋子泄漏导致的污染外,未检测到交叉污染。安全输液装置非常有效,但并未完全消除暴露。

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