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儿童、青少年及成人抗精神病药物治疗期间的体重增加:全球药物警戒数据库Vigibase中的不成比例性分析

Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase.

作者信息

Kaguelidou Florentia, Valtuille Zaba, Durrieu Geneviève, Delorme Richard, Peyre Hugo, Treluyer Jean-Marc, Montastruc François, Chouchana Laurent

机构信息

Department of Pediatric Pharmacology, APHP.Nord, Robert Debre Hospital, Paris Cité University, Paris, France.

Clinical Investigations Center, Inserm CIC1426, Hôpital Robert Debré, 48 boulevard Sérurier, 75019, Paris, France.

出版信息

Drug Saf. 2023 Jan;46(1):77-85. doi: 10.1007/s40264-022-01252-6. Epub 2022 Dec 2.

Abstract

INTRODUCTION

While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in children and adolescents.

OBJECTIVE

The aim of this study was to assess antipsychotic-induced weight-gain reporting in children and adolescents as compared to adults, and according to the type of antipsychotic.

METHODS

The study is an observational, case-non-case study using individual case safety reports from the WHO global pharmacovigilance database VigiBase from 1 January 2000 to 2 June 2021. Disproportionality in antipsychotic-related weight-gain reporting in children and adolescents compared to adults was evaluated based on reporting odds ratios (RORs) with corresponding 95% confidence intervals (CIs) through multivariate logistic regression modeling. Analysis was adjusted for sex, region of reporting, year of notification, reporter qualification, concomitant use of antidepressants, and use of more than one antipsychotic.

RESULTS

Among 282,224 antipsychotic-related spontaneous reports included in this analysis, we identified 16,881 (6.0%) weight-gain cases. Disproportionality in weight-gain reporting was found in children (adjusted ROR (aROR) 3.6; 95% CI 3.3-3.8) and in adolescents (aROR 2.3; 95% CI 2.2-2.4) compared to adults. Use of risperidone was associated with the highest increase in weight-gain reporting in children (aROR 4.9; 95% CI 3.9-6.1) and adolescents (aROR 3.6; 95% CI 3.1-4.1).

CONCLUSIONS

Compared to adults, weight-gain reporting with antipsychotics was disproportionally higher in the pediatric population, especially in children under 12 years of age. Considering the impact of weight gain on global morbidity and mortality, physicians should closely monitor weight gain in young patients, especially children on risperidone.

摘要

引言

虽然抗精神病药物引起的体重增加在成年人中已有广泛描述,但在儿童和青少年中尚未得到更好的特征描述。

目的

本研究的目的是评估与成年人相比,儿童和青少年中抗精神病药物引起体重增加的报告情况,并根据抗精神病药物的类型进行评估。

方法

该研究是一项观察性病例对照研究,使用了世界卫生组织全球药物警戒数据库VigiBase中2000年1月1日至2021年6月2日的个体病例安全报告。通过多变量逻辑回归模型,基于报告比值比(ROR)及相应的95%置信区间(CI),评估儿童和青少年与成年人相比抗精神病药物相关体重增加报告的不成比例情况。分析对性别、报告地区、通知年份、报告者资质、抗抑郁药的联合使用以及多种抗精神病药物的使用进行了调整。

结果

在本分析纳入的282,224份抗精神病药物相关自发报告中,我们识别出16,881例(6.0%)体重增加病例。与成年人相比,儿童(调整后的ROR(aROR)3.6;95%CI 3.3 - 3.8)和青少年(aROR 2.3;95%CI 2.2 - 2.4)体重增加报告存在不成比例情况。使用利培酮与儿童(aROR 4.9;95%CI 3.9 - 6.1)和青少年(aROR 3.6;95%CI 3.1 - 4.1)体重增加报告的最高增加相关。

结论

与成年人相比,儿科人群中抗精神病药物导致体重增加的报告比例过高,尤其是12岁以下儿童。考虑到体重增加对全球发病率和死亡率的影响,医生应密切监测年轻患者,尤其是使用利培酮的儿童的体重增加情况。

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