世界卫生组织药物警戒数据库中的氯氮平相关性心肌炎:关注来自不同国家的报告

IF 5.2 3区 医学 Q1 PSYCHIATRY Revista de psiquiatria y salud mental Pub Date : 2022-10-01 DOI:10.1016/j.rpsm.2021.07.004
Carlos De las Cuevas , Emilio J. Sanz , Can-Jun Ruan , Jose de Leon
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引用次数: 31

摘要

氯氮平相关性心肌炎的发病率因国家而异。VigiBase是世界卫生组织的全球数据库,该数据库拥有来自145个国家药品机构的2500万份自发报告的药物不良反应(ADR)报告。方法:2021年1月15日,VigiBase自成立以来的搜索重点是氯氮平患者的心肌炎。使用标准的VigiBase对歧化率的对数测量(称为信息成分(IC))研究了3572个单独的报告。IC衡量的是预期比率和报告比率之间的不相称性。剔除重复后,在logistic回归模型中对3274例不同的心肌炎患者进行了研究。结果第一例病例发表于1980年,但自1993年以来,VigiBase氯氮平心肌炎IC显著;而且,目前它的药效非常强(IC = 6.0, IC005-IC995 = 5.9-6.1),与其他抗精神病药物有统计学差异。3274例不同类型心肌炎患者中,不严重者占43.4%,严重但不致命者占51.8%,致命者占4.8%。超过一半(1621/3274)的报告来自澳大利亚,其中69.2%不严重,27.7%严重但不致命,3.1%致命。亚洲国家只有41例。结论在药物警戒研究中,混杂因素可以解释统计学相关性,但这些结果的强度和稳健性与心肌炎与早期氯氮平治疗明确相关的假设是一致的(84%[1309/1560]和5%[82/1560]在第一个月和第二个月)。来自澳大利亚的心肌炎报告在很大程度上被夸大了。亚洲国家可能少报心肌炎给他们的药品机构。
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Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries

Introduction

The incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies.

Methods

On January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients. The 3572 individual reports were studied using the standard VigiBase logarithmic measure of disproportionality called information component (IC). The IC measures the disproportionality between the expected and the reported rates. After duplicates were eliminated there were 3274 different patients with myocarditis studied in logistic regression models.

Results

The first case was published in 1980 but since 1993 the VigiBase clozapine-myocarditis IC has been significant; moreover, currently it is very strong (IC = 6.0, IC005–IC995 = 5.9–6.1) and statistically significantly different from other antipsychotics. Of the 3274 different patients with myocarditis, 43.4% were non-serious cases, 51.8% were serious but non-fatal, and 4.8% were fatal. More than half (1621/3274) of the reports came from Australia, of which 69.2% were non-serious, 27.7% serious but non-fatal, and 3.1% fatal. Asian countries contributed only 41 cases.

Conclusions

In pharmacovigilance studies, confounding factors may explain statistical associations, but the strength and robustness of these results are compatible with the hypothesis that myocarditis is definitively associated with early clozapine treatment (84% [1309/1560] and 5% [82/1560] in the first and second months). Myocarditis reports from Australia are over-represented to a major degree. Asian countries may be underreporting myocarditis to their drug agencies.

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3.30%
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期刊介绍: The Spanish Journal of Psychiatry and Mental Health (SJPMH), incorporated into ISSN 1888-9891, is the official scientific publication of the Spanish Society of Psychiatry and Mental Health. The journal focuses on studying mental illnesses, their pathological processes, and their psychosocial consequences, and aims to disseminate scientific advances in all areas related to mental health and illness. SJPMH accepts unpublished works on psychiatry and mental health, including their medical and social implications. The journal provides space for research in the biological, clinical, and psychosocial fields. Manuscripts undergo peer-review by external reviewers before being accepted for publication. SJPMH is indexed in Index Medicus/Medline, IBECS, Social Sciences Citation Index Journal Citation Reports/Social Sciences Edition, and Current Contents/Social and Behavioral Sciences.
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