133例注射用磷酸肌酸钠儿童药品不良反应分析

doi:10.19803/j.1672-8629.2021.01.12

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (1): 64-67.
DOI: 10.19803/j.1672-8629.2021.01.12

133例注射用磷酸肌酸钠儿童药品不良反应分析

许莉莉¹, 田月洁¹, 谢彦军¹, 孙春晓¹, 常虹¹, 霍艳飞¹, 吴世福^1,*, 王春婷^2,*

¹山东省药品不良反应监测中心,山东济南 250014;
²国家药品监督管理局药品评价中心,北京 100022

收稿日期:2019-11-03 修回日期:2021-01-18 出版日期:2021-01-15 发布日期:2021-01-18
通讯作者: ^*吴世福,男,硕士,主任药师,药品不良反应监测与评价。E-mail:wushifu01@shandong.cn
作者简介:许莉莉,女,硕士,主管药师,药品不良反应监测与评价。

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

XU Lili¹, TIAN Yuejie¹, XIE Yanjun¹, SUN Chunxiao¹, CHANG Hong¹, HUO Yanfei¹, WU Shifu^1,*, WANG Chunting^2,*

¹Shandong Provincial Center for ADR Monitoring,Jinan Shandong 250014,China;
²Center for Drug Reevaluation,NMPA,Beijng 100022,China

Received:2019-11-03 Revised:2021-01-18 Online:2021-01-15 Published:2021-01-18

摘要/Abstract

摘要： 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。

关键词: 注射用磷酸肌酸钠, 儿童, 药品不良反应, 低钙血症

Abstract: 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.

Key words: creatine phosphate sodium for injection, children, adverse-drug reaction, hypocalcemia

中图分类号:

R994.11

许莉莉, 田月洁, 谢彦军, 孙春晓, 常虹, 霍艳飞, 吴世福, 王春婷. 133例注射用磷酸肌酸钠儿童药品不良反应分析[J]. 中国药物警戒, 2021, 18(1): 64-67.

XU Lili, TIAN Yuejie, XIE Yanjun, SUN Chunxiao, CHANG Hong, HUO Yanfei, WU Shifu, WANG Chunting. Analysis of 133 Cases of Adverse Drug Reaction Induced by Creatine Phosphate Sodium for Injection in Children[J]. Chinese Journal of Pharmacovigilance, 2021, 18(1): 64-67.

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133例注射用磷酸肌酸钠儿童药品不良反应分析

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

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