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器官和组织生物监测的价值：一项横断面分析。

The value of organ and tissue biovigilance: a cross-sectional analysis.

作者信息

Navarro Aurora, Len Oscar, Muñiz-Diaz Eduardo, Vives Corrons Joan-Lluis, Dominguez-Gil Beatriz, Vilarrodona Anna, Tort Jaume

机构信息

Oganització Catalana de Trasplantaments (OCATT), Barcelona, Spain.

Associate teacher, University of Barcelona, Barcelona, Spain.

出版信息

Front Transplant. 2024 Feb 20;3:1307946. doi: 10.3389/frtra.2024.1307946. eCollection 2024.

DOI:10.3389/frtra.2024.1307946
PMID:38993767
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11235277/
Abstract

INTRODUCTION

Biovigilance (BV) systems aim to improve the quality and safety of tissues and organs for transplantation. This study describes the Catalan BV system and analyzes its utility.

METHODS

It is a retrospective analysis of notifications on serious adverse events (SAEs) and reactions (SARs) since the implementation of the BV system (2008 for tissues and 2016 for organs) until 2020. Variables are presented to describe the most common critical steps of the pathway and complications associated with the quality and safety of tissues and organs.

RESULTS

A total of 154 and 125 notifications were reported to the Tissue and the Organ BV systems, respectively. Most SAEs were related to unexpected donor diseases and implemented actions were assured on those deemed preventable. Regarding SARs, donor-transmitted infections and malignancies (only organs) were the most common, followed by graft failure (tissues) and process-related (organs). The incidence of SAEs and SARs related to tissue was 3.44‰ and 0.22‰, respectively. The corresponding figures for organs were 31.48‰ and 8.8‰, respectively.

DISCUSSION

The analysis of the notifications to the Catalan BV systems has provided useful information about existing risks associated with the quality and safety of tissues and organs, and enabled the implementation of actions targeted to diminish risks and mitigate damage.

摘要

引言

生物监测（BV）系统旨在提高移植用组织和器官的质量与安全性。本研究描述了加泰罗尼亚生物监测系统并分析了其效用。

方法

这是一项回顾性分析，涵盖了自生物监测系统实施以来（组织为2008年，器官为2016年）至2020年期间关于严重不良事件（SAE）和不良反应（SAR）的报告。呈现变量以描述该流程最常见的关键步骤以及与组织和器官质量与安全相关的并发症。

结果

组织生物监测系统和器官生物监测系统分别收到了154份和125份报告。大多数严重不良事件与意外的供体疾病有关，并且对那些被认为可预防的事件采取了保障措施。关于不良反应，供体传播的感染和恶性肿瘤（仅器官）最为常见，其次是移植物失败（组织）和与流程相关的（器官）。与组织相关的严重不良事件和不良反应的发生率分别为3.44‰和0.22‰。器官的相应数字分别为31.48‰和8.8‰。

讨论

对加泰罗尼亚生物监测系统报告的分析提供了有关组织和器官质量与安全相关现有风险的有用信息，并促成了旨在降低风险和减轻损害的行动实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/a8da700206f8/frtra-03-1307946-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/29b1f98b3750/frtra-03-1307946-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/4e7563c35a9c/frtra-03-1307946-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/04ff7d1d4d2e/frtra-03-1307946-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/348d0e525e69/frtra-03-1307946-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/a8da700206f8/frtra-03-1307946-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/29b1f98b3750/frtra-03-1307946-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/4e7563c35a9c/frtra-03-1307946-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/04ff7d1d4d2e/frtra-03-1307946-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/348d0e525e69/frtra-03-1307946-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/976b/11235277/a8da700206f8/frtra-03-1307946-g005.jpg

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