药物性肝损伤与 FDA 不良事件报告系统（FAERS）中典型生成型抗精神病药物相关。

Drug-induced liver injury associated with atypical generation antipsychotics from the FDA Adverse Event Reporting System (FAERS).

机构信息

Suzhou Guangji Hospital, Affiliated Guangji Hospital of Soochow University, Suzhou, Jiangsu Province, 215008, China.

Department of Orthopedics, The Second Affiliated Hospital of Soochow University, Suzhou, China.

出版信息

BMC Pharmacol Toxicol. 2024 Aug 30;25(1):59. doi: 10.1186/s40360-024-00782-2.

DOI:10.1186/s40360-024-00782-2

PMID:39215339

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11363531/

Abstract

BACKGROUND

Recent studies have shown that liver enzyme abnormalities were not only seen with typical antipsychotics (APs) but also with atypical antipsychotics (AAPs). During the last 20 years, the hepatotoxicity of various antipsychotics received much attention. However, systematic evaluations of hepatotoxicity associated with APs are limited.

METHODS

All drug related hepatic disorders cases were retrieved from the FDA Adverse Event Reporting System (FAERS) database using standardized MedDRA queries (SMQ) from the first quarter of 2017 to the first quarter of 2022. Patient characteristics and prognosis were assessed. In this study, a case/non-case approach was used to calculate reporting odds ratio (RORs) and 95% confidence intervals (CIs). We calculated the drug-induced liver injury (DILI) RORs for each AAPs.

RESULTS

A total of 408 DILI cases were attributed to AAPs during the study period. 18.6% of these were designated as serious adverse event (SAE), which include death (19.74%), hospitalization (68.42%), disability (2.63%), and life-threatening (9.21%) outcomes. The RORs values in descending order were: quetiapine (ROR = 0.782), clozapine (ROR = 0.665), aripiprazole (ROR = 0.507), amisulpride (ROR = 0.308), paliperidone (ROR = 0.212), risperidone (ROR = 0.198), ziprasidone (0.131).

CONCLUSION

The result found in our study was that all AAPs didn't have a significant correlation with increased hepatotoxicity. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of DILI.

摘要

背景

最近的研究表明，肝酶异常不仅见于典型抗精神病药（APs），也见于非典型抗精神病药（AAPs）。在过去的 20 年中，各种抗精神病药的肝毒性受到了广泛关注。然而，系统评估与 APs 相关的肝毒性的研究有限。

方法

使用标准化 MedDRA 查询（SMQ）从 2017 年第一季度到 2022 年第一季度，从 FDA 不良事件报告系统（FAERS）数据库中检索所有与药物相关的肝障碍病例。评估患者特征和预后。在本研究中，采用病例/非病例方法计算报告比值比（ROR）和 95%置信区间（CI）。我们计算了每种 AAP 的药物性肝损伤（DILI）ROR。

结果

在研究期间，共有 408 例 DILI 病例归因于 AAPs。其中 18.6%为严重不良事件（SAE），包括死亡（19.74%）、住院（68.42%）、残疾（2.63%）和危及生命（9.21%）。按降序排列的 ROR 值分别为：喹硫平（ROR=0.782）、氯氮平（ROR=0.665）、阿立哌唑（ROR=0.507）、氨磺必利（ROR=0.308）、帕利哌酮（ROR=0.212）、利培酮（ROR=0.198）、齐拉西酮（0.131）。