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Abstract：
Background: Although aripiprazole and risperidone are used widespread in pediatrics, there are still limited pieces of evidence on their actual safety profile. By using the EudraVigilance database, we carried out an analysis to perform a comprehensive overview of reported adverse events among children and adolescents treated with aripiprazole and risperidone. Methods: Descriptive analysis was performed of all individual case safety reports (ISCRs) submitted to EudraVigilance associated with aripiprazole and risperidone and related to the pediatric population from 2016 to 2018. Results: A total of 855 and 2,242 ISCRs for aripiprazole and risperidone, respectively, were recorded for a total of 11,042 suspected adverse drug reactions (2,993 for aripiprazole and 8,049 for risperidone). Most ISCRs were related to male patients (65.0 and 86.3% for aripiprazole and risperidone, respectively) and were serious (81.0 and 94.1% for aripiprazole and risperidone, respectively). Schizophrenia spectrum and other psychotic disorders, such as disruptive, impulse-control, and conduct disorders, and autism spectrum disorder were the top three clinical indications for aripiprazole (19.0, 16.1, and 11.6%, respectively). For risperidone, attention-deficit/hyperactivity disorder (25.4%), disruptive, impulse-control, and conduct disorders (17.1%), and bipolar and related disorders (14.2%) were more commonly reported as clinical indications. Data also showed a high proportion of use for clinical conditions not authorized in children. Psychiatric disorders were the main related adverse events for aripiprazole (20.2%), and among these, suicidal behavior was one of the most reported (14.9%). Reproductive system and breast disorders were the main related adverse events for risperidone (19.8%), and gynecomastia was the most reported event; metabolism and nutrition disorders, mainly reported as weight gain disorders, were more reported in children (3-11 years) than in adolescents (12-17 years). Conclusions: Our results demonstrate that spontaneously reported adverse events associated with aripiprazole and risperidone reflect what is already known in terms of safety profile, although with about 90% of them being serious. This analysis stresses the need for further studies and effective training and information activities to better define the actual benefit/risk ratio of these drugs in pediatric patients.
摘要：
背景：尽管阿立哌唑和利培酮在儿科中广泛使用，关于其实际安全性的证据仍然有限。通过使用EudraVigilance数据库，我们进行了一项分析,对阿立哌唑和利培酮治疗的儿童和青少年中报告的不良事件进行了全面概述.方法：对2016年至2018年提交给EudraVigilance的所有与阿立哌唑和利培酮相关的病例安全性报告（ISCR）进行描述性分析，并与儿科人群相关。结果：阿立哌唑和利培酮共855和2,242个ISCR，分别,共记录了11,042例可疑药物不良反应(阿立哌唑2,993例,利培酮8,049例).大多数ISCR与男性患者有关（阿立哌唑和利培酮分别为65.0％和86.3％，分别）和严重（阿立哌唑和利培酮分别为81.0%和94.1%，分别)。精神分裂症和其他精神病，比如破坏性的，脉冲控制，和行为障碍，孤独症谱系障碍是阿立哌唑的前三个临床适应症（19.0％，16.1％和11.6％，分别)。对于利培酮,注意力缺陷/多动障碍(25.4%)，破坏性的,脉冲控制，和品行障碍(17.1%)，双相和相关疾病(14.2%)更常被报道为临床适应症。数据还显示，儿童未授权的临床病症的使用比例很高。精神病是阿立哌唑的主要相关不良事件（20.2%），其中，自杀行为是报告最多的(14.9%)。生殖系统和乳腺疾病是利培酮的主要相关不良事件（19.8%），男性乳房发育症是报告最多的事件；代谢和营养紊乱，主要报告为体重增加障碍，儿童（3-11岁）比青少年（12-17岁）报告的更多。结论：我们的结果表明，自发报告的与阿立哌唑和利培酮相关的不良事件反映了已知的安全性。尽管其中约90％是认真的。该分析强调需要进一步研究以及有效的培训和信息活动，以更好地定义这些药物在儿科患者中的实际获益/风险比。
