利用不成比例分析，通过美国食品药品监督管理局不良事件报告系统和日本药品不良事件报告数据库的数据评估瑞氏综合征概况。

Assessment of Reye's syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis.

作者信息

Matsumoto Kiyoka, Hasegawa Shiori, Nakao Satoshi, Shimada Kazuyo, Mukai Ririka, Tanaka Mizuki, Satake Riko, Yoshida Yu, Goto Fumiya, Inoue Misaki, Ikesue Hiroaki, Iguchi Kazuhiro, Hashida Tohru, Nakamura Mitsuhiro

机构信息

Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.

Department of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan.

出版信息

SAGE Open Med. 2020 Nov 20;8:2050312120974176. doi: 10.1177/2050312120974176. eCollection 2020.

DOI:10.1177/2050312120974176

PMID:33282307

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7686594/

Abstract

OBJECTIVES

Reye's syndrome is a rare and potentially fatal illness that is defined as encephalopathy accompanied by liver failure. The aim of this study was to assess Reye's syndrome profiles by analyzing data from the spontaneous reporting system database.

METHODS

We analyzed reports of Reye's syndrome using the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases. The reporting odds ratio and proportional reporting rate were used to detect the pharmacovigilance signal.

RESULTS

The US Food and Drug Administration Adverse Event Reporting System contains 12,201,620 reports from January 2004 to June 2020, of which 186 are on Reye's syndrome. The Japanese Adverse Drug Event Report contains 646,779 reports from April 2004 to September 2020, of which 30 are on Reye's syndrome. In the US Food and Drug Administration Adverse Event Reporting System database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, acetaminophen, and valproate sodium were 404.6 (302.6-541.0, n = 80), 15.1 (6.7-34.1, n = 6), 26.2 (16.1-42.6, n = 18), 10.7 (5.5-20.9, n = 9), and 47.1 (26.2-84.6, n = 12), respectively. In the Japanese Adverse Drug Event Report database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, loxoprofen, acetaminophen, and valproate sodium were 14.1 (5.4-36.8, n = 5), 51.7 (22.2-120.5, n = 7), 135.0 (40.8-446.2, n = 3), 17.6 (6.7-46.0, n = 5), 24.0 (9.2-62.6, n = 5), and 13.8 (3.3-57.9, n = 2), respectively. The reported number of female patients aged 30-39 years was the highest in the Japanese Adverse Drug Event Report.

CONCLUSION

Although the frequency of the occurrence of Reye's syndrome is low, the possible risk of the disease occurring in adult females should be considered.

摘要

目的

瑞氏综合征是一种罕见且可能致命的疾病，定义为伴有肝功能衰竭的脑病。本研究的目的是通过分析自发报告系统数据库中的数据来评估瑞氏综合征的概况。

方法

我们使用美国食品药品监督管理局不良事件报告系统和日本药品不良事件报告数据库分析瑞氏综合征的报告。报告比值比和比例报告率用于检测药物警戒信号。

结果

美国食品药品监督管理局不良事件报告系统包含2004年1月至2020年6月的12,201,620份报告，其中186份是关于瑞氏综合征的。日本药品不良事件报告包含2004年4月至2020年9月的646,779份报告，其中30份是关于瑞氏综合征的。在美国食品药品监督管理局不良事件报告系统数据库中，阿司匹林、双氯芬酸、布洛芬、对乙酰氨基酚和丙戊酸钠的报告比值比（95%置信区间，病例数）分别为404.6（302.6 - 541.0，n = 80）、15.1（6.7 - 34.1，n = 6）、26.2（16.1 - 42.6，n = 18）、10.7（5.5 - 20.9，n = 9）和47.1（26.2 - 84.6，n = 12）。在日本药品不良事件报告数据库中，阿司匹林、双氯芬酸、布洛芬、洛索洛芬、对乙酰氨基酚和丙戊酸钠的报告比值比（95%置信区间，病例数）分别为14.1（5.4 - 36.8，n = 5）、51.7（22.2 - 120.5，n = 7）、135.0（40.8 - 446.2，n = 3）、17.6（6.7 - 46.0，n = 5）、24.0（9.2 - 62.6，n = 5）和13.8（3.3 - 57.9，n = 2）。在日本药品不良事件报告中，报告的30 - 39岁女性患者数量最多。