中国新药杂志

新型冠状病毒肺炎疫情下血液制品安全性探讨

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田伯凯 ¹^,² , 张华 ²

中国新药杂志 | 新药述评与论坛 2021,30(19): 1794-1800

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中国新药杂志 |新药述评与论坛 2021 , 30 (19) : 1794 -1800

新型冠状病毒肺炎疫情下血液制品安全性探讨

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田伯凯¹^,², 张华²

作者信息

¹北京大学　工学院工业工程与管理系，北京　100871

²北京大学　药物信息与工程研究中心，北京　100871

通讯作者:

张华，女，高级工程师，研究方向：药品监管法规与政策研究。E-mail：hzhang@lflegend.com。

作者简介:

田伯凯，男，硕士研究生，研究方向：监管科学与质量管理。E-mail：1801214088@pku.edu.cn。

Discussion on the safety of blood products during the COVID-19 pandemic

Bo-kai TIAN¹^,², Hua ZHANG²

Affiliations

¹Peking University Department of Industrial Engineering and Management, College of Engineering, Beijing 100871, China

²Peking University Center for Pharmaceutical Information and Engineering Research, Beijing 100871, China

出版时间: 2021-10-15

文章导航

摘要

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本文旨在分析新型冠状病毒肺炎（COVID-19）疫情下血液制品在安全性上存在的风险，研究世界卫生组织、美国FDA以及血浆蛋白治疗制剂协会在COVID-19疫情下保证血液制品安全性的应急对策，为我国血液制品监管在突发公共卫生事件时的应对措施提出改进的建议。运用文献资料法、比较研究法和描述性研究法，分析COVID-19疫情下我国血液制品监管在应对突发公共卫生事件时存在的问题。我国在应对突发疫情或传染性公共卫生突发事件时，政府监管部门应当与血液制品生产企业、行业协会、专业咨询团队加强沟通合作，及时提供科学性的行业指南，并充分发挥行业协会作用，保证我国已上市血液制品的安全性。

关键词

新型冠状病毒肺炎 / 血液制品 / 安全性 / 供血浆者 / 病毒检测 / 病毒去除/灭活

Abstract

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To analyze the safety risks of blood products during the COVID-19 pandemic, and to study the emergency countermeasures of the World Health Organization (WHO), the US FDA (FDA) and the Plasma Protein Therapeutics Association (PPTA) to ensure the safety of blood products during the COVID-19 pandemic, in order to suggest improvements for blood product regulation in China in response to public health emergencies. This article uses literature review, comparative research and descriptive research methods to analyze the existing problems of blood product regulation in response to public health emergencies during the COVID-19 pandemic. When responding to sudden epidemic situations or infectious public health emergencies, Chinese government regulatory agencies should strengthen communication and cooperation with blood product manufacturers, industry associations, and professional consulting teams, providing timely scientific industry guidelines to give a full play as the role of industry associations so as to ensure the safety of blood products on the market.

Key words

COVID-19 / blood products / safety / plasma donor / virus detection / virus removal/inactivation

引用本文

田伯凯, 张华. 新型冠状病毒肺炎疫情下血液制品安全性探讨. 中国新药杂志, 2021 , 30 (19) : 1794 -1800 .

Bo-kai TIAN, Hua ZHANG. Discussion on the safety of blood products during the COVID-19 pandemic[J]. Chinese Journal of New Drugs, 2021 , 30 (19) : 1794 -1800 .

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2021年第30卷第19期

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首发时间：2026-10-30
出版时间：2021-10-15

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录用日期：2020-11-16

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作者信息

¹北京大学　工学院工业工程与管理系，北京　100871

²北京大学　药物信息与工程研究中心，北京　100871

通讯作者:

张华，女，高级工程师，研究方向：药品监管法规与政策研究。E-mail：hzhang@lflegend.com。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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