质子泵抑制剂相关不良反应的自发报告。

Spontaneous reporting of adverse reactions related to proton pump inhibitors.

作者信息

Dipasquale Valeria, Cicala Giuseppe, Laganà Francesca, Cutroneo Paola, Trimarchi Giuseppe, Spina Edoardo, Romano Claudio

机构信息

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

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

出版信息

Dig Liver Dis. 2023 May;55(5):595-600. doi: 10.1016/j.dld.2022.10.024. Epub 2022 Nov 18.

DOI:10.1016/j.dld.2022.10.024

PMID:36404233

Abstract

BACKGROUND

Proton pump inhibitors (PPIs) are widely prescribed in all age groups, and their use is increasing. However, their safety profile has been frequently questioned.

AIMS

The aim of this study was to analyze the characteristics of PPI-related adverse drug reactions (ADRs) reported to the Italian spontaneous reporting system (SRS) database and relative to an Italian region (Sicily).

METHODS

A 20-year observational, retrospective study was conducted, evaluating PPI-related ADR reports from Sicily between January 1st, 2001, and June 30th, 2021. The factors associated with ADR seriousness were investigated.

RESULTS

A total of 148 spontaneous reports of ADRs related to PPIs were analyzed. Lansoprazole was the drug with the highest number of associated reports (30.87%). The most frequently reported ADRs were cutaneous (24.56%) and/or gastrointestinal manifestations (18.10%), the latter especially in the case of lansoprazole-related ADRs (p<0.006). The great majority of ADR reports were relative to on-label prescriptions. Serious ADRs were 39 (26.35%). Serious ADRs were more common in reports including omeprazole than in reports containing other PPIs (p<0.008) and in reports presenting PPIs combined with other drugs than in reports with PPI single therapies (p<0.001).

CONCLUSION

Most PPI-related ADRs are non-serious. Omeprazole and combination therapy seem to be associated with ADR seriousness.

摘要

背景

质子泵抑制剂（PPIs）在所有年龄组中都被广泛处方，且其使用量正在增加。然而，它们的安全性一直备受质疑。

目的

本研究的目的是分析向意大利自发报告系统（SRS）数据库报告的、与意大利一个地区（西西里岛）相关的PPI相关药物不良反应（ADRs）的特征。

方法

进行了一项为期20年的观察性回顾性研究，评估2001年1月1日至2021年6月30日期间西西里岛与PPI相关的ADR报告。调查了与ADR严重程度相关的因素。

结果

共分析了148份与PPIs相关的ADR自发报告。兰索拉唑是相关报告数量最多的药物（30.87%）。最常报告的ADR是皮肤表现（24.56%）和/或胃肠道表现（18.10%），后者在与兰索拉唑相关的ADR中尤为常见（p<0.006）。绝大多数ADR报告与标签上的处方有关。严重ADR有39份（26.35%）。严重ADR在包含奥美拉唑的报告中比在包含其他PPIs的报告中更常见（p<0.008），在PPIs与其他药物联合使用的报告中比在PPI单一疗法的报告中更常见（p<0.001）。