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首页> 外文期刊>Cadernos de Saúde Pública >Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive studyReacciones adversas a medicamentos en el sistema de farmacovigilancia de Brasil, de 2008 a 2013: estudio descriptivo
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Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive studyReacciones adversas a medicamentos en el sistema de farmacovigilancia de Brasil, de 2008 a 2013: estudio descriptivo

机译：从2008年到2013年向巴西药物理解系统报告的不良药物核心：从2008年到2013年的巴西药物检药系统中药物的描述性研究差异：描述性研究

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The study aimed to analyze suspected adverse drug reactions reported to Brazil’s pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.
机译：该研究旨在分析2008年至2013年巴西药物检测系统（Notivisa-Medicationo）报告的疑似不良药物反应。这是一个描述性研究，其数据库中的分析单元是报告和药物不良反应对。共有26,554个报告，报告率为22.8 /百万居民/年。女性患者的报告盛行（60.5％），白色/种族（58.1％）。年龄从0到112岁（中位数= 46岁）。在弱势群体（老年人和儿童）中发生近三分之一（32.5％）疑似不良药物。分析了54,288对药物不良反应对，具有严重不良药物反应的患病率（59.2％），具有临床上重要效果（83.1％）。严重不良药物反应中最常见的药物属于L组，抗肿瘤和免疫调节剂（32.1％）和J，一般抗感染剂用于全身用途（27％），而最受影响的系统组织类是条件皮肤和相关疾病（23.7％）。 Notivisa-Medicationo是对巴西销售的药物安全的警告标志和假设的重要资源。但是，每百万居民/年的报告率远低于中等和高收入国家所描述的居民。

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