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全球与药物不良反应相关的住院和死亡事件:具有国家覆盖范围的研究的系统评价。

Hospitalizations and deaths related to adverse drug events worldwide: Systematic review of studies with national coverage.

机构信息

Postgraduate Program On Health Sciences, School of Medicine, Universidade Federal de Goiás - UFG, Goiânia, Goiás, Brazil.

Hospital of Clinics, Universidade Federal de Goiás - UFG/EBSERH, Goiânia, Goiás, Brazil.

出版信息

Eur J Clin Pharmacol. 2022 Mar;78(3):435-466. doi: 10.1007/s00228-021-03238-2. Epub 2021 Oct 30.

Abstract

PURPOSE

Adverse drug events are related to negative outcomes in healthcare, including hospitalization, increased duration of hospital stay and death. The aim of this study was to conduct a systematic review to evaluate hospitalizations and deaths related to adverse drug events worldwide, reported in studies with national coverage.

METHODS

The protocol was registered in PROSPERO (CRD42020157008). We performed a systematic search on Medline, Embase, CINAHL, LILACS, and the Cochrane Library (until March 2020) using pre-specified terms. We included published studies that reported data on hospitalizations and/or deaths related to adverse drug events from a national perspective and the use of secondary data as a source of information. Two reviewers independently extracted and synthesized data. The quality of the studies was assessed using an adapted version of the Joanna Briggs Institute critical appraisal checklist for prevalence studies. Narrative summaries of findings were undertaken.

RESULTS

Among 59,336 citations, 62 studies were included for data extraction and synthesis. Among these studies, 41 studies included the outcome of hospitalization, 16 included the death outcome, and five included both outcomes. Administrative databases regarding discharges and registries of vital statistics were the most common sources of information. The relative frequency of hospitalizations ranged from 0.03% to 7.3%, and from 9.7 to 383.0/100,000 population, whereas mortality rate ranged from 0.1 to 7.88/100,000 population.

CONCLUSION

Our study highlights information about adverse drug events using large administrative databases in a national scenario and provides an overview of databases and methods implemented to detect adverse drug events.

摘要

目的

药物不良反应与医疗保健中的不良结局有关,包括住院、住院时间延长和死亡。本研究旨在进行系统评价,评估全球范围内与药物不良反应相关的住院和死亡情况,这些研究报告了具有国家覆盖范围的研究数据。

方法

该方案已在 PROSPERO(CRD42020157008)中注册。我们使用预先指定的术语在 Medline、Embase、CINAHL、LILACS 和 Cochrane 图书馆(截至 2020 年 3 月)进行了系统搜索。我们纳入了从国家角度报告与药物不良反应相关的住院和/或死亡数据以及使用二级数据作为信息来源的已发表研究。两名审查员独立提取和综合数据。使用 Joanna Briggs 研究所针对流行性病学研究的评估清单的改编版本评估研究的质量。对研究结果进行了叙述性总结。

结果

在 59,336 条引文中,有 62 项研究被纳入进行数据提取和综合。这些研究中,有 41 项研究包括住院结果,16 项研究包括死亡结果,5 项研究同时包括这两个结果。关于出院的行政数据库和生命统计登记册是最常见的信息来源。住院的相对频率范围为 0.03%至 7.3%,每 100,000 人口的死亡率为 9.7 至 383.0/100,000,而死亡率范围为 0.1 至 7.88/100,000 人口。

结论

我们的研究使用国家范围内的大型行政数据库强调了药物不良反应信息,并提供了有关用于检测药物不良反应的数据库和方法的概述。

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