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Agranulocitosis secundaria a clozapina: un estudio descriptivo en pacientes chilenos

机译:氯氮平继发的粒细胞缺乏症:智利患者的一项描述性研究

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Introduction: Agranulocytosis is one of the most serious adverse effects of clozapine. The Latin American literature is currently scarce on the subject. Objective: To describe the occurrence ofagranulocytosis or leukopenia secondary to clozapine and its associated factors in a sample ofChilean patients between the years 2011-2016. Materials and Methods: An observational,retrospective type of study was designed base on virtual information from the NationalPharmacovigilance Registry and definition of alarm levels according to the Technical Standardof clozapine, later performing statistical analysis. Results: total n 60 patients, 8 patients withsome alarm event; Alarm 1:5; Alarm II: 1; Alarm III: 2. Alarms were distributed between week1 and week 242. The incidence was higher between weeks 0 and 12 (1.26%). Until week 18,53%of alarms I and 100% of alarms III occurred, alarm II occurred in month 10. Discussion: Whencomparing patients with and without alarm, significant differences were found in the basalcount of leukocytes and neutrophils, with no differences in age and sex. Patients who presentedalarms and/or lower baseline leukocyte or neutrophil counts could eventually benefit from alonger weekly follow-up. Conclusion: This study constitutes the first step towards exploring theadverse effects profile of clozapine in Chilean patients.
机译:引言:粒细胞缺乏症是氯氮平最严重的不良反应之一。拉丁美洲文学目前在这个问题上很少。目的:描述2011-2016年间智利患者样本中氯氮平继发的粒细胞缺乏症或白细胞减少症的发生及其相关因素。材料和方法:基于国家药物警戒注册中心的虚拟信息并根据氯氮平技术标准定义警报级别,设计了观察性,回顾性研究类型,随后进行统计分析。结果:共60例患者,其中8例有一定程度的警报事件。警报1:5;警报II:1;警报III:2.警报分布在第1周和第242周之间。发生率在第0周和第12周之间较高(1.26%)。直到第18,53%的I警报和100%的III警报发生,第II个月的警报发生在第10个月。讨论:比较有无警报的患者,白细胞和中性粒细胞的基础计数有显着差异,年龄无差异和性别。出现警报和/或基线白细胞或中性粒细胞计数降低的患者最终可从每周的随访中受益。结论:本研究是探索氯氮平对智利患者不良反应的第一步。

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