Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (1): 64-67.
DOI: 10.19803/j.1672-8629.2021.01.12

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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 Shifu1,*, WANG Chunting2,*   

  1. 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

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

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