两种抗甲状腺药物引起的粒细胞减少症和抗中性粒细胞胞浆抗体相关性血管炎的比较:利用世界卫生组织国际数据库进行的药物警戒研究。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY Fundamental & Clinical Pharmacology Pub Date : 2024-02-11 DOI:10.1111/fcp.12991
Ji Yun Han, Jun Myong Lee, Se Yong Jung, Min Seo Kim, Seung Won Lee, Andreas Kronbichler, Kalthoum Tizaoui, Ai Koyanagi, Eun Young Kim, Kyungchul Song, Hyun Wook Chae, Dong Keon Yon, Jae Il Shin, Lee Smith
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引用次数: 0

摘要

背景:甲巯咪唑(MMI)和丙基硫氧嘧啶(PTU)是甲状腺毒症患者的常用药物。粒细胞减少症和抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)与高发病率和高死亡率相关,需要适当的干预措施。在本研究中,我们利用真实世界的大型药物警戒数据库比较了与 MMI 和 PTU 相关的药物不良反应:我们从 VigiBase 中检索了 1967 年至 2021 年 6 月 2 日期间所有与 MMI 和 PTU 相关的个人病例安全报告。我们进行了比例失调分析(病例/非病例分析),以分析抗甲状腺药物(病例)和整个数据库(非病例)之间报告的药物不良反应(ADR)的差异。我们进一步分析了粒细胞减少症和 AAV 病例的信息:在服用 MMI 后报告的 11 632 例 ADR 中,1633 例出现粒细胞减少,41 例出现 AAV。在摄入 PTU 后报告的 5055 例 ADR 中,459 例出现粒细胞减少,110 例出现 AAV。粒细胞减少发生在摄入 PTU 后的中位数为 28 天后,而摄入 MMI 后的中位数为 33 天。超过 95% 的粒细胞减少病例被归类为严重病例,但其中大多数病例(65.1% 的 PTU 和 70.4% 的 MMI)在采取去挑战行动(主要是停药)后均已痊愈。AAV 发生在摄入 PTU 后的中位数 668 天后,MMI 的中位数为 1162 天后:这是一项药物流行病学研究,调查了 MMI 和 PTU 引起的粒细胞减少症和 AAV。通过这项研究,我们可以为在现实环境中安全处方抗甲状腺药物提供更具体的见解。
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Comparison of agranulocytosis and anti-neutrophil cytoplasmic antibody-associated vasculitis caused by two antithyroid drugs: A pharmacovigilance study using the WHO international database

Background

Methimazole (MMI) and propylthiouracil (PTU) are commonly used for patients with thyrotoxicosis. Agranulocytosis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is associated with high morbidity and mortality, requiring appropriate interventions. In this study, we compared adverse drug effects associated with MMI and PTU using a real-world large pharmacovigilance database.

Methods

We searched all Individual Case Safety Reports reported to be associated with MMI and PTU, from VigiBase between 1967 and June 2, 2021. We conducted disproportionality analysis (case/non-case analysis) to analyze the difference in reported adverse drug reactions (ADRs) between antithyroid drugs (case) and the entire database (non-cases). We further analyzed information for the cases of agranulocytosis and AAV.

Results

Among 11 632 cases of ADRs reported after MMI intake, agranulocytosis occurred in 1633 cases and AAV occurred in 41 cases. For 5055 cases of ADRs reported after PTU intake, agranulocytosis occurred in 459 cases and AAV occurred in 110 cases. Agranulocytosis occurred after a median of 28 days after PTU intake and 33 days after MMI intake. More than 95% of the agranulocytosis cases were classified as serious, but most of them (65.1% for PTU and 70.4% for MMI) were reported to have recovered after dechallenge actions; mostly drug withdrawal. AAV occurred after a median of 668 days after PTU intake, and 1162 days after MMI intake.

Conclusions

This is a pharmacoepidemiological study investigating agranulocytosis and AAV caused by MMI and PTU. Through this research, we could provide more specific insights into a safe prescription of antithyroid drugs in a real-world setting.

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来源期刊
CiteScore
5.30
自引率
6.90%
发文量
111
审稿时长
6-12 weeks
期刊介绍: Fundamental & Clinical Pharmacology publishes reports describing important and novel developments in fundamental as well as clinical research relevant to drug therapy. Original articles, short communications and reviews are published on all aspects of experimental and clinical pharmacology including: Antimicrobial, Antiviral Agents Autonomic Pharmacology Cardiovascular Pharmacology Cellular Pharmacology Clinical Trials Endocrinopharmacology Gene Therapy Inflammation, Immunopharmacology Lipids, Atherosclerosis Liver and G-I Tract Pharmacology Metabolism, Pharmacokinetics Neuropharmacology Neuropsychopharmacology Oncopharmacology Pediatric Pharmacology Development Pharmacoeconomics Pharmacoepidemiology Pharmacogenetics, Pharmacogenomics Pharmacovigilance Pulmonary Pharmacology Receptors, Signal Transduction Renal Pharmacology Thrombosis and Hemostasis Toxicopharmacology Clinical research, including clinical studies and clinical trials, may cover disciplines such as pharmacokinetics, pharmacodynamics, pharmacovigilance, pharmacoepidemiology, pharmacogenomics and pharmacoeconomics. Basic research articles from fields such as physiology and molecular biology which contribute to an understanding of drug therapy are also welcomed.
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