668例新生儿药品不良反应报告分析

目的:了解新生儿药品不良反应发生的特点及规律,为药物的合理、安全使用及减少不良反应的发生提供依据和参考。方法:采用回顾性分析的方法,对2015—2018年收集的668份新生儿药品不良反应报告,按照患儿的性别、年龄、发生时间、给药途径、剂型、累及系统-器官、关联性评价及转归等情况进行统计分析。结果:668例新生儿药品不良反应中,男女比例为1.03∶1,平均年龄为6.5±0.11d;新生儿患者ADR发生时间最多的在用药后1~7 d内(248例,占37.13%);单给药途径以静脉滴注为主(43.41%),共涉及药物类别12种,其中引起ADR排名前三位的药物类别分别是抗菌药物(56.89%)、中成药(13.17%)、呼吸系统类药物(7.63%);668例ADR共累及多个系统,最常见的临床表现是皮肤及其附件损害共373例次(55.84%),其次为胃肠系统损害194例(29.04%),心血管系统损害36例次(5.39%)。结论:应对新生儿用药风险多加防范,采取多种措施促进新生儿合理、安全用药,尽量减少和避免新生儿不良反应的发生。

Analysis of Adverse Drug Reactions in 668 Neonates

Objective:To investigate the characteristics and discipline of neonatal adverse drug reaction,providing evidences for rational drug using,and reducing the ADR occurrence in children.Methods:With the retrospective method,a total of 668 ADR reports were collected dating from 2015 to 2018.The data of age,occurrences time of ADR,routes of administration,dosage forms,affected systems and organs,relevance evaluations and prognoses were analyzed statistically.Results:Among 668 ADR reports,the gender ratio of male to female was 1.03∶1,the average age of the patients was 6.5±0.11 days.The most occurred time was immediately to 7 days after medication(248 cases,37.13%).Intravenous administration was the main route(33.41%).There were 12 kinds of drug categories related to ADR.The ranking of the top 3 categories related with ADRs were anti-infection drugs(56.89%),traditional Chinese medicine(13.17%),respiratory system drugs(7.63%).Multiple systems and organs(668 frequencies)were affected,the most common was skin and accessory systems damage(373 frequencies,55.84%),followed by digestive system damage(194 frequencies,29.04%),the third was cardiovascular system damage(36 frequencies,5.39%).Conclusion:We should strengthen the risk prevention system on neonatal drug using,take various measures to promote rational and safe drug using on neonates,do our better to reduce the ADR occurrence.