133例注射用磷酸肌酸钠儿童药品不良反应分析

目的探讨注射用磷酸肌酸钠儿童药品不良反应发生的规律、特点及影响因素,为临床安全用药提供参考。方法对2009年1月1日至2019年9月30日山东省药品不良反应监测数据库中133例涉及注射用磷酸肌酸钠的儿童不良反应的年龄、原患疾病、发生时间、累及系统-器官及临床表现等进行分析。结果注射用磷酸肌酸钠儿童药品不良反应主要导致皮肤及其附件损害、全身性损害,多发生在用药1 d内,低钙血症的不良反应均发生于新生儿患者,多为早产儿。结论临床应关注注射用磷酸肌酸钠儿童药品不良反应,药品生产企业需加强对儿童用药的研究,进一步完善说明书,保障用药安全。

Analysis of 133 Cases of Adverse Drug Reaction Induced by Creatine Phosphate Sodium for Injection in Children

Objective To probe into the status,characterstics and influencing factors of ADR cases induced by creatine phosphate sodium for injection in children,so as to provide reference for clinic safe use of drugs.Methods We analyzed 133 ADR cases induced by creatine phosphate sodium for injection in children which were collected by Shandong adverse drug reaction monitoring database from January 1st 2009 to September 30st 2019.The patient’s age,original diseases,ADR occurrence time,adverse drug reactions involved system and the manifestation etc were analyzed.Results The ADR induced by creatine phosphate sodium for injection in children mainly involved in skin and local lesions and systemic lesions,ADR occurred most frenquently within 1day of medication,hypocalcemia easy occurred in newborns patient,most patients were prematures.Conclusion Clinic should pay attention to the ADR induced by creatine phosphate sodium for injection in children.Drug manufacturers should strengthen research on children's medication and improve the drug package inserts so as to ensure the drug use safety.