基于国外药物警戒安全性自发呈报系统的氯巴占儿童不良事件数据分析

doi:10.19803/j.1672-8629.20230226

摘要/Abstract

摘要： 目的分析氯巴占在0~17岁儿童真实世界临床应用药品不良反应/事件（adverse drug reaction/event,ADR/ADE）的发生情况,为儿科临床应用氯巴占提供参考。方法收集世界卫生组织（WHO）个例安全性病例报告（VigiBase）数据库（建库至2022年11月16日）、美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库（2004年1月1日到2022年11月17日）及欧盟药品管理局药物警戒（Eudra Vigilance）数据库（建库至2022年11月13日）中0~17岁人群中氯巴占的ADR/ADE报告数据。运用描述分析和比例报告比值比（PRR）数据挖掘算法检测药物ADR/ADE信号。结果共检索到氯巴占ADR/ADE报告31 990份,其中Eudra Vigilance数据库3 885份、FAERS数据库19 066份、VigiBase数据库9 039份。3个数据库均显示氯巴占在3~11岁儿童报告占比较高（13.08%~14.54%）,氯巴占神经系统异常和精神障碍的ADR/ADE报告较多;Eudra Vigilance数据库中神经系统疾病、精神病类、胃肠系统疾病和皮肤及皮下组织类疾病在年龄大的儿童中出现的相对偏多,而呼吸系统/胸及纵隔疾病在年龄偏小的儿童中出现的相对偏多。FAERS数据挖掘显示0~2岁儿童婴儿松弛综合征ADR/ADE信号PRR值高达718.58,需引起关注;3~11岁儿童攻击性和认知障碍PRR值较高,12~17岁食欲下降和攻击性PRR值较高。结论儿科临床应用氯巴占时需关注神经系统、精神、皮肤及皮下组织和呼吸系统的ADR/ADE,氯巴占可能对新生儿有影响,年龄<2岁患儿和妊娠、哺乳期女性使用需谨慎。

关键词: 氯巴占, 儿童, 药品不良反应/事件, 神经系统异常, 精神障碍, 数据分析

Abstract: Objective To analyze the occurrence of adverse drug reactions/events (ADR/ADE) in real world clinical use of clobazam among children aged 0 to 17, and to provide data for clinical use of clobazam in pediatrics. Methods The data on reports of ADR/ADE of clobazam in the population aged 0 to 17 was retrieved from the WHO global database (VigiBase) of reported potential side effects of medicinal products (from inception to November 16, 2022), FDA Adverse Event Reporting System (FAERS) database (from January 1, 2004 to November 17, 2022) and from European Union Drug Regulating Authorities Pharmacovigilance (Eudra Vigilance) database (from inception to November 13, 2022). Descriptive analysis and proportional reporting ratio (PRR) data mining algorithms were used to detect ADR/ADE signals. Results A total of 31 990 ADR/ADE reports were retrieved for clobazam, including 3 885 from Eudra Vigilance, 19 066 from FAERS, and 9 039 from VigiBase. All the three databases showed that clobazam-related reports accounted for a relatively higher proportion (13.08% ~ 14.54%) of those relating to children aged 3 to 11, and clobazam was involved in more ADR/ADE reports related to the nervous system disorders and psychiatric disorders. In the Eudra Vigilance database, the incidence of nervous system disorders, psychiatric and gastrointestinal disorders and skin & subcutaneous tissue diseases was higher in older children, while respiratory & thoracic and mediastinal disorders were more common in younger children. FAERS data mining showed that the PRR value of ADR/ADE signals of infant relaxation syndrome among children aged 0 to 2 was as high as 718.58, which was worthy of attention. Besides, the PRR values of aggressiveness and cognitive impairment were higher in children ages 3 to 11, so were the PRR values of appetite decline and aggressiveness in children ages 12 to 17. Conclusion In clinical use of clobazam in pediatrics, attention should be paid to the ADR/ADE related to the nervous system, psychiatry, skin & subcutaneous tissue and the respiratory system. Clobazam may have an effect on newborns, so it should be used with caution in children under 2 years old, and in pregnant and lactating women.

Key words: clobazam, children, adverse drug reaction/event, nervous system disorders, psychiatric disorders, data analysis

中图分类号:

R971
R994.11

彭静, 庹亚莉, 李巧玲, 周荣, 李新林, 彭惠. 基于国外药物警戒安全性自发呈报系统的氯巴占儿童不良事件数据分析[J]. 中国药物警戒, 2023, 20(11): 1264-1268.

PENG Jing, TUO Yali, LI Qiaoling, ZHOU Rong, LI Xinlin, PENG Hui. Data analysis of adverse events of clobazam among children based on foreign pharmacovigilance safety spontaneous reporting system[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1264-1268.

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