山西省儿童医院严重药品不良反应/事件报告分析
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篇名: 山西省儿童医院严重药品不良反应/事件报告分析
TITLE:
摘要: 目的:了解儿童发生严重药品不良反应/事件(SADR/SADE)的基本信息及特点。方法:对山西省儿童医院2012-2013年收集的SADR/SADE报告按人群、药品类别、临床表现、住院费用、转归等方面进行统计、分析,并与2008-2009年上报的SADR/SADE报告进行比较。结果:2012-2013年收集的123例SADR/SADE报告中男性(51.22%)多于女性(48.78%);导致SADR/SADE的药品类别以抗感染药居多(占30.40%),其次是解热镇痛抗炎药(占19.20%);SADR/SADE的主要临床表现以皮肤及其附件损害为主(占35.88%),其次为神经系统损害(占34.35%)。两个时间段发生SADR/SADE的类型均为误服药物、不合理用药及SADR,差异无统计学意义(P>0.05);涉及主要药品(前14位)所占比例的差异亦无统计学意义(P>0.05)。结论:临床应继续加强儿童SADR/SADE的监测与防范,积极采取有效措施,保障儿童用药安全。
ABSTRACT: OBJECTIVE: To understand the basic information and characteristics of severe ADR/ADE (SADR/SADE) in children. METHODS: The SADR/SADE collected from Shanxi Children’s Hospital during 2010-2013 were analyzed statistically in respects of the population, drug category, clinical manifestation,hospitalization expenses,outcomes, etc., and then were compared with which reported on 2008-2009. RESULTS: Of 123 SADR/SADE cases during 2012-2013, male (51.22%) was more than female (48.78%); main type of SADR/SADE-inducing drugs was anti-infective drugs (30.40%), followed by antipyretic analgesic and anti-inflammatory drugs(19.20%);main clinical manifestations were lesion of skin and its appendants (35.88%), followed by neurological symptoms damage(34.35%). The types of SADR/SADE in two periods were drug misuse, irrational drug use and severe SADR, without statistical significance (P>0.05). There was no statistically significant difference in the proportion of main involved drugs (P>0.05). CONCLUSIONS: SADR/SADE monitoring and prevention in children should be strengthened continuously, and effective measures also should be adopted so as to guarantee the safety of drug use.
期刊: 2016年第27卷第2期
作者: 赵瑞玲,张冠东,张丽锋,王晓玲
AUTHORS: ZHAO Ruiling,ZHANG Guandong,ZHANG Lifeng,WANG Xiaoling
关键字: 儿童用药;严重不良反应;严重不良事件;报告;分析
KEYWORDS: Pediatric drug use; SADR; SADE; Report; Analysis
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