质子泵抑制剂相关不良反应在儿科人群中的表现：自发报告数据的分析。

Adverse reactions related to proton pump inhibitors in pediatric population: an analysis of spontaneous reporting data.

机构信息

Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi," University of Messina, Messina, Italy.

Sicilian Regional Pharmacovigilance Center, University Hospital of Messina, Messina, Italy.

出版信息

Expert Opin Drug Saf. 2022 Jan;21(1):127-132. doi: 10.1080/14740338.2021.1978975. Epub 2021 Sep 20.

DOI:10.1080/14740338.2021.1978975

PMID:34494498

Abstract

BACKGROUND

The use of proton pump inhibitors (PPIs) has increased in the last 10 years in children. Data regarding their safety profile are limited. The aim of this study was to analyze data from the Italian spontaneous reporting system (SRS) database to evaluate the incidence and characteristics of PPI-related adverse drug reactions (ADRs) in children.

RESEARCH DESIGN AND METHODS

This was an observational, retrospective study analyzing PPI-related ADR reports in children in the Italian SRS database between January 1, 2001, and December 31 2020. ADRs were coded according to the system organ class term level. Factors associated with ADR seriousness were investigated.

RESULTS

Seventy spontaneous reports of ADRs related to PPIs were analyzed. Esomeprazole and lansoprazole caused the highest number of ADRs equally (27% respectively), and the most frequently reported ADRs presented with gastrointestinal (24%) and/or skin manifestations (21.3%). More than a half of PPI prescriptions were off label for pediatric population. Serious ADRs were 19 (27.1%). Serious ADRs were more frequent in reports presenting PPIs combined with other drugs in comparison to reports with PPI single therapies (p = 0.03).

CONCLUSIONS

PPI-related ADRs in children are mostly not serious, and combination therapy seems to be associated with ADR seriousness.

摘要

背景

质子泵抑制剂（PPIs）在过去 10 年中在儿童中的使用有所增加。关于其安全性概况的数据有限。本研究旨在分析意大利自发报告系统（SRS）数据库中的数据，以评估儿童中与 PPI 相关的不良药物反应（ADR）的发生率和特征。

研究设计和方法

这是一项观察性、回顾性研究，分析了 2001 年 1 月 1 日至 2020 年 12 月 31 日期间意大利 SRS 数据库中与儿童 PPI 相关的 ADR 报告。ADR 根据系统器官类别术语级别进行编码。研究调查了与 ADR 严重程度相关的因素。

结果

分析了 70 份与 PPIs 相关的 ADR 自发报告。埃索美拉唑和兰索拉唑引起的 ADR 数量相同（各占 27%），报告最多的 ADR 表现为胃肠道（24%）和/或皮肤表现（21.3%）。超过一半的 PPI 处方是儿科人群的标签外用药。严重 ADR 有 19 例（27.1%）。与报告中 PPI 单一疗法相比，报告中 PPI 联合其他药物的严重 ADR 更常见（p=0.03）。