102例垂体后叶注射液不良反应/事件报告分析  

Analysis of 102 Reports of ADR/ADE Induced by Posterior Pituitary Injection

作　　者：李文武[1] 

机构地区：[1]河南省食品药品评价中心,河南郑州450004

出　　处：《中国药物警戒》2015年第4期232-234,244,共4页Chinese Journal of Pharmacovigilance

基　　金：河南省科技厅软科学资助项目(142102310075)

摘　　要：目的：通过分析垂体后叶注射液不良反应发生的一般规律和特点，为临床合理用药提供参考。方法采用回顾性研究方法，对2004年1月～2014年6月期间河南省药品不良反应监测中心数据库中收集到的102例垂体后叶注射液不良反应报告进行统计和分析；对国内3个厂家的药品说明书进行统计分析。结果 ADR/ADE 主要累及胃肠系统损害（66.10%）和中枢神经系统损害（8.48%）等，严重不良反应表现为意识丧失和低钠血症等；说明书中未见有低钠血症的风险提示。结论重视垂体后叶素致低血钠的风险，完善国内企业说明书，减少严重不良反应的发生。Objective To study the general pattern and characteristics of adverse drug reaction（ADR） induced by posterior pituitary injection to provide references for clinical rational use of the drugs. Methods 102 cases of ADR/ADE related to the posterior pituitary injection from January 2004 to June 2014 in Henan province were analyzed using retrospective study method.The drug instructions of three domestic pharmaceutical enterprises were compared. Results The main ADR/ADE damages involved gastrointestinal system（60.10%） and central nervous system （8.48%）, the severe ADRs manifestations mainly covered unconsciousness, hyponatremia etc. There was no warning of hyponatremia in the drug instructions. Conclusion It should be concerned about hyponatremia induced by hypophysin, perfect the drug instruction, in order to reduce the incidence of severe ADR/ADE.

关 键 词：垂体后叶注射液 不良反应/事件 分析 

分 类 号：R973.1[医药卫生—药品] R994.11[医药卫生—药学]