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盐酸哌甲酯致儿童治疗相关不良事件国内外文献分析

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目的 分析盐酸哌甲醋(methylphenidate,MPH)导致的儿童治疗相关不良事件(treatment emergent adverse events,TEAE)的特点,提出防范MPH安全事件的建议.方法 检索中国知网、维普、万方、PubMed、Web of Science、EMbase等数据库中MPH致儿童TEAE的个案报告,对患者的性别、年龄、用药剂量、合并用药情况、TEAE出现时间及临床表现等进行统计分析.结果 收集个案报告39篇,涉及患者50例,其中治疗组47例,非治疗组3例.治疗组中男女比为3.7∶1,6~15岁患者比例最高,共40例(80%),MPH致儿童TEAE多发生在给药后1~30 d内(32例,64%),主要累及精神系统(12例,21.43%)和神经系统(11例,19.64%).非治疗组中2例患者为超剂量使用,TEAE均发生在1 h内,主要累及神经系统.50例患者中49例好转,1例不详.结论 在使用MPH时,应对其可能发生的安全问题加以防范,从而提高合理用药水平.
Literature Analysis of Treatment Emergent Adverse Events Induced by Methylphenidate in Children
OBJECTIVE To analyze the characteristics of methylphenidate(MPH)related treatment emergent adverse events(TEAE)in children,so as to provide recommendations for prevention of MPH safety events.METHODS Case reports of MPH-in-duced TEAE in children were retrieved from CNKI,VIP,Wan Fang,PubMed,Web of Science,EMbase and other databases,and the gender,age,dosage,drug combination,time of adverse reactions and clinical manifestations of the patients were statistically analyzed.RESULTS A total of 39 case reports were collected,involving 50 cases,including 47 cases in the treatment group and 3 cases in the non-treatment group.In the treatment group,the ratio of male to female was 3.7∶1,with 40 cases(80%)in patients aged 6-15 years.Most TEAEs occurred within 1-30 d after drug administration(32 cases,64%),and the TEAEs mainly involved mental sys-tem(12 cases,21.43%)and nervous system(11 cases,19.64%).In the non-treatment group,2 patients were overdosed,and ad-verse reactions occurred within 1 h,mainly involving mental system and nervous system.Among the 50 cases,49 cases were improved after drug withdrawal and/or symptomatic treatment,and 1 case had unknown prognosis.CONCLUSION It is necessary to prevent the possible safety problems in the use of MPH,so as to improve the level of rational drug use.

methylphenidatetreatment emergent adverse eventliterature analysissecurity

李巧玲、刘林慧、刘茂昌、彭静

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华中科技大学同济医学院附属武汉儿童医院药学部,武汉 430016

盐酸哌甲酯 治疗相关不良事件 文献分析 安全性

武汉市卫生健康科研基金武汉市卫生健康科研基金

WZ21A07WZ22Q07

2024

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
年,卷(期):2024.59(7)
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