Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
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DOI：
10.7150/ijms.10453
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发表时间：
2015
影响因子：
3.6
通讯作者：
Okuno Y
中科院分区：
文献类型：
--
作者：
Kimura G;Kadoyama K;Brown JB;Nakamura T;Miki I;Nisiguchi K;Sakaeda T;Okuno Y
目的：回顾1997-2011年提交给美国食品和药物管理局(FDA)不良事件报告系统(FAERS)的报告，以评估儿童服用抗精神病药物引起的严重不良事件。方法：对FAERS数据进行前处理，剔除重复记录，调整药品名称，对0~12岁儿童的氟哌啶醇、奥氮平、奎硫平、氯氮平、齐拉西酮、利培酮、阿立哌唑等药物使用情况进行分析。通过定量数据挖掘算法检测数据中表示与药物相关的不良事件的信号。应用于本研究的算法包括经验贝叶斯几何平均值、报告赔率比、比例报告比和贝叶斯信任传播神经网络的信息分量。抗精神病药恶性综合征(NMS)、QT延长、白细胞减少和自杀企图作为严重不良事件被重点关注。结果：在NMS方面，氟哌啶醇和阿立哌唑的信号积分高于其他抗精神病药物。仅在齐拉西酮和利培酮中检测到QT延长不良事件的显著信号。关于白细胞减少症，与氯氮平的关系值得注意。在自杀未遂的情况下，检测到氟哌啶醇、奥氮平、奎硫平、利培酮和阿立哌唑的信号。结论：研究表明，不同的第一代和第二代抗精神病药物与相关的可能导致致命后果的严重不良事件之间的相关性存在一定程度的多样性。我们建议继续进行研究，以便收集大量的相关信息，并将现有数据和新报告的数据放在多个医学观点的背景下，以提高护理水平。
Objective: The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children. Methods: Following pre-processing of FAERS data by elimination of duplicated records as well as adjustments to standardize drug names, reports involving haloperidol, olanzapine, quetiapine, clozapine, ziprasidone, risperidone, and aripiprazole were analyzed in children (age 0-12). Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms. The algorithms applied to this study include the empirical Bayes geometric mean, the reporting odds ratio, the proportional reporting ratio, and the information component of a Bayesian confidence propagation neural network. Neuroleptic malignant syndrome (NMS), QT prolongation, leukopenia, and suicide attempt were focused on as serious adverse events. Results: In regard to NMS, the signal scores for haloperidol and aripiprazole were greater than for other antipsychotics. Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone. With respect to leukopenia, the association with clozapine was noteworthy. In the case of suicide attempt, signals for haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole were detected. Conclusions: It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes. We recommend that research be continued in order to gather a large variety and quantity of related information, and that both available and newly reported data be placed in the context of multiple medical viewpoints in order to lead to improved levels of care.
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影响因子：
4.1
作者：
Gentile, Salvatore
通讯作者：
Gentile, Salvatore
DOI：
10.1016/j.pedhc.2011.10.009
发表时间：
2012-03
期刊：
Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners
影响因子：
--
作者：
Harrison JN;Cluxton-Keller F;Gross D
通讯作者：
Gross D
影响因子：
168.9
作者：
Tiihonen, Jari;Lonnqvist, Jouko;Haukka, Jari
通讯作者：
Haukka, Jari
影响因子：
168.9
作者：
Leucht, Stefan;Corves, Caroline;Davis, John M.
通讯作者：
Davis, John M.
影响因子：
4.2
作者：
Almenoff, J;Tonning, JM;LaCroix, K
通讯作者：
LaCroix, K