《移植器官质量与安全指南（第6版）》解读——生物安全性预警

沈国杰; 屠振华

doi:10.3969/j.issn.1674-7445.2020.01.016

《移植器官质量与安全指南（第6版）》解读——生物安全性预警

doi: 10.3969/j.issn.1674-7445.2020.01.016

沈国杰,
屠振华^,

310003 杭州，浙江大学医学院附属第一医院外科监护室（沈国杰），人体器官捐献与移植协调办公室（屠振华），肝胆胰外科肝移植中心（屠振华）

基金项目:

中国人体器官捐献专项研究课题 CODRF201702

深圳市三名工程 SZSM201412006

详细信息

作者简介:
沈国杰，男，1991年生，硕士，住院医师，研究方向为器官捐献与重症医学，Email：shenguojie0303@163.com

通讯作者:
屠振华，男，1980年生，博士，副主任医师，研究方向为器官移植与器官捐献，Email：richardtu@163.com

中图分类号: R617, O213.1
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- 被引次数: 0
出版历程
- 收稿日期: 2019-09-23
- 网络出版日期: 2021-01-19
- 刊出日期: 2020-01-15

Interpretation of Guide to the Quality and Safety of Organs for Transplantation (6th edition): biosafety early warning

Shen Guojie,
Tu Zhenhua^,

Surgical Intensive Care Unit, the First Affiliated Hospital of College of Medicine of Zhejiang University, Hangzhou 310003, China

More Information

Corresponding author: Tu Zhenhua, Email: richardtu@163.com

摘要

摘要: 随着器官捐献和移植事业的蓬勃发展，完善管理体系，确保移植器官的质量和安全也越来越重要。欧盟的《移植器官质量与安全指南(第6版)》在生物安全性预警方面提出了严重不良反应和严重不良事件的定义，以及管理和报告的流程，鼓励器官移植相关医务人员尽早发现不良反应和不良事件，并进行调查、评估和反馈。同时对移植风险警戒和监控进行了系统地阐述，值得临床学习和实践。
- 器官移植 /
- 生物安全性预警 /
- 警戒和监控 /
- 不良反应 /
- 不良事件 /
- 预警沟通 /
- 预警协调 /
- 移植器官质量安全
Abstract: With the rapid development of organ donation and transplantation, it becomes increasingly important to improve the management system and ensure the quality and safety of organs for transplantation. Guide to the Quality and Safety of Organs for Transplantation (6th Edition) by European Committee provides the definitions of severe adverse reactions and severe adverse events in the perspective of biosafety early warning, delivers management and reporting processes, and encourages medical staff involved in organ transplantation to identify the adverse reactions and adverse events as soon as possible, and to carry out investigation, assessment and feedback. At the same time, it also systematically illustrates the warning and monitoring of organ transplantation risk, which is worthy of application in clinical study and practice.
- Organ transplantation /
- Biosafety early warning /
- Warning and monitoring /
- Adverse reaction /
- Adverse event /
- Early warning communication /
- Early warning coordination /
- Quality and safety of organs for transplantation

HTML全文

图 1 SARE的报告流程

Figure 1. Reporting process of SARE

下载: 全尺寸图片幻灯片

表 1 不良反应严重性程度量表

Table 1. Severity scale of adverse reaction

严重程度	注释
非严重	无需住院治疗或无长期不良后果的轻微损伤
严重	引起住院或住院时间延长，和(或)持续或严重的残疾 (1)为防止永久性损伤行手术治疗或其他医疗干预 (2)传播严重疾病或病程延长
危及生命	活体捐献者或器官受者需重大干预如血管活性药物、机械通气、进入重症监护，避免死亡或传播危及生命的疾病
死亡	活体捐献者或受者死亡

下载: 导出CSV

表 2 描述归因性调查的可能结果的量表

Table 2. The scale describing the possible outcomes of attribution survey

分级	组织和细胞预警归因调查结果^①	传染病和恶性肿瘤传播的标准^②
不可评估	归因性评估数据不足	归因性评估数据不足
排除	排除合理性怀疑，将不良反应归因于其他原因的确凿证据有明确的证据将不良反应归因于其他原因，而不是捐献过程或移植器官	疑似传播并满足以下条件中的至少1个：(1)明确证据表明其他原因; (2)进行适当的诊断检测未能在同一捐献者的任何移植受者中记录相同病原体的感染; (3)实验室证据表明受者在移植前感染了相同的病原体或已患有肿瘤
可能	将不良反应归因于移植过程或移植器官或其他原因的证据不明确	疑似传播：(1)单个受者体内发现病原体或肿瘤的实验室证据; (2)数据表明有传播，但不足以证实
很有可能	证据明显支持将不良反应归因于供器官	满足以下两个条件：(1)疑似传播; (2)受者体内病原体或肿瘤的实验室证据满足以下两个条件中的至少1个：(1)其他受者体内有相同病原体或肿瘤的实验室证据; (2)捐献者体内有相同病原体或肿瘤的实验室证据; (3)如有移植前实验室证据，这些证据必须表明移植前相关受者病原体是阴性的
确定	对不良反应归因于移植过程或移植器官，证据是无可置疑的	满足以下所有条件：(1)疑似传播; (2)受者体内发现病原体或肿瘤的试验室证据; (3)其他受者体内有相同病原体或肿瘤的实验室证据(如有其它受者); (4)捐献者体内有相同病原体或肿瘤的实验室证据; (5)如有移植前实验室证据，这些证据必须表明移植前相关受者病原体是阴性的
注：①改编自EUSTITE-SoHO V & S^[8]。 ②改编自美国疾病传播咨询委员会发布的血液预警量表^[24]。

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