摘要
目的分析注射用磷酸肌酸钠新的和严重的药品不良反应(ADR)相关因素,为临床安全用药提供参考。方法检索2008年1月1日至2018年12月31日山东省上报国家药品不良反应监测系统的ADR报告,筛选出注射用磷酸肌酸钠新的和严重的ADR病例报告,并对其性别、年龄及用药原因、过敏史情况,给药方式、合并用药、ADR转归等进行统计分析。结果104例注射用磷酸肌酸钠新的和严重的ADR报告中,新的一般报告71例(68.27%),严重报告33例(31.73%)。男61例,女43例,男女性别比为1.42∶1。以61~70岁及≤10岁居多,占57.69%。既往有ADR事件5例。多数ADR发生在用药1 d内,累及系统主要为胃肠系统损害、全身性损害、皮肤及其附件损害、中枢及外周神经系统损害、呼吸系统损害等,主要表现为恶心、呕吐、寒战、高热、皮疹、瘙痒、头晕、胸闷等。结论注射用磷酸肌酸钠药品说明书警示力度不足,临床应重视其ADR的预防,规范临床应用,加强用药过程中的监测,从而保障用药安全有效。
Objective To analyze the factors related to new and serious adverse drug reactions(ADRs)induced by creatine phosphate sodium for injection,and provide reference for clinical medication safety.Methods As was reported by Shandong Province to the national ADR monitoring system between January 2008 and December 2018,104 cases of new and serious ADRs of creatine phosphate sodium for injection were retrieved for analysis.The information about these cases of ADRs,such as patients'age and gender,preexisting diseases,allergy,methods of administration,combined therapy,t he onset time and results of ADRs,was analyzed statistically.Results Of the 104 reports about new and serious ADRs of creatine phosphate sodium for injection,71 cases(68.27%)were new ADRs,and 33 cases(31.73%)were severe ones.There were 61 males and 43 females involved,and the ratio of males to females was 1.42∶1.Most of them were aged 61-70 years or less than 10 years old,accounting for 57.69%of the total.There had been 5 cases of adverse drug reactions/incidents before.Most of these ADRs occurred within one day of treatment.The systems involved were mainly gastrointestinal damage,systemic damage,damage to the skin and its attachments,damage to central and peripheral nervous systems,and damage to the respiratory system.The main manifestations included nausea,vomiting,chills,high fever,rash,itching,dizziness,and chest tightness.Conclusion The drug instructions for creatine phosphate sodium for injection are not specific enough.The prevention of ADRs and standard clinical application should become a priority,and drug use has to be monitored to ensure safe and effective drug use.
作者
孙春晓
田月洁
谢彦军
许莉莉
常虹
霍艳飞
吴世福
SUN Chunxiao;TIAN Yuejie;XIE Yanjun;XU Lili;CHANG Hong;HUO Yanfei;WU Shifu(Shandong Provincial Center for ADR Monitoring,Jinan Shandong 250014,China)
出处
《中国药物警戒》
2021年第2期145-149,159,共6页
Chinese Journal of Pharmacovigilance
关键词
注射用磷酸肌酸钠
药品不良反应
安全用药
creatine phosphate sodium for injection
adverse drug reactions
medication safety
