医疗器械中增塑剂的应用和安全性研究进展

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (2): 100-103.

医疗器械中增塑剂的应用和安全性研究进展

林铌^{1, 2}, 靳洪涛^{1, 2}, 王爱平^{1, 2*, *}

1中国医学科学院药物研究所新药安全评价研究中心,北京100050;
2药物安全评价关键技术北京市工程实验室,北京100176

收稿日期:2013-09-03 修回日期:2016-02-03 出版日期:2014-02-08 发布日期:2016-02-03
通讯作者: 王爱平,男,研究员,博士生导师,药物安全性评价。E-mailwangaiping@imm.ac.cn
作者简介:林铌,女,博士,药物安全性评价。
基金资助:
基金项目：“重大新药创制”资助课题,课题号：2013ZX09302302; 2012ZX09301002-001-009

Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices

LIN Ni^{1, 2}, JIN Hong-tao^{1, 2}, WANG Ai-ping^{1, 2, *}

1New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing 100050, China；
2Beijing Engineering Laboratory on Key Technology of Drug Safety Evaluation, Beijing 100176, China

Received:2013-09-03 Revised:2016-02-03 Online:2014-02-08 Published:2016-02-03

摘要/Abstract

摘要： 目的了解并总结医疗器械中增塑剂应用现状及其安全性研究的最新进展。方法列举常用医疗器械中增塑剂的种类,简要说明塑料医用器械在临床上的应用,搜集并整理已有的增塑剂毒性的研究资料,以归纳医疗器械中最常用的增塑剂对人体的潜在风险,最后对增塑剂安全性评价策略进行总结。结果塑料医疗器械临床应用广泛,其中加入的增塑剂,如DEHP存在潜在风险并会产生以生殖毒性和肝毒性为主的不良反应。对塑料医疗器械的风险评估主要对医疗器械中增塑剂的释放量和摄入量这两个方面进行评价。结论医疗增塑剂的应用和安全性研究的讨论对医用增塑剂的风险评估及今后发展新型增塑剂具有指导意义。

关键词: 医疗器械, 增塑剂, 临床应用, 安全性评价

Abstract: ObjectiveTo understand the clinical use and the progress in safety evaluation of plasticizers in medical devices. MethodsThe author sorted several species of plasticizers, and briefly summarized the clinical use of plastical medical devices, then collected the latest data and results of the study on toxicity of plasticizers so as to prove that the plasticizer released from medical devices was potentially harmful to human health and summarized the strategy of safety evaluation of plasticizers. ResultsPlastical medical devices are widely used in clinic, and the addition of plasticizers such as DEHP, carries protential risk and has adverse reactions mainly as reproductive toxicity and hepatotoxicity. The risk assessment of plastical medical devices should be based on the release and intake amount of plasticizers. ConclusionThe discussion on use and safety evaluation of medical plasticizers may provide guidance for the risk assessment and the development of new plasticizers.

Key words: medical devices, plasticizer, clinical use, safety evaluation

中图分类号:

R955

林铌, 靳洪涛, 王爱平. 医疗器械中增塑剂的应用和安全性研究进展[J]. 中国药物警戒, 2014, 11(2): 100-103.

LIN Ni, JIN Hong-tao, WANG Ai-ping. Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices[J]. Chinese Journal of Pharmacovigilance, 2014, 11(2): 100-103.

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