157例硫酸镁注射剂不良反应/事件报告分析  

Analysis of 157 Reports of ADR/ADE Induced by Magnesium Sulfate 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》2013年第12期737-739,743,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的通过分析硫酸镁注射剂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2010年1月至2013年6月期间我省药品不良反应监测中心数据库中收集到的157例硫酸镁注射剂不良反应报告进行统计和分析。结果用药患者以20～39岁女性患者居多（69．43％）；在30rain内发生的不良反应占68．79％；ADR／ADE主要累及胃肠系统（36．36％），全身性损害（25．17％）。主要临床表现为恶心，呕吐、潮红、头晕、心悸等。结论我省数据库中硫酸镁注射剂的不良反应大多为已知的不良反应，建议加强对硫酸镁注射剂不良反应的监测，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 reacfion（ADR） induced by magne- sium sulfate injection to provide references for clinical rational use of the drugs. Methods 157 cases of ADR/ADE related to the magnesium sulfate injection from January 2010 to June 2013 in Henan province were analyzed using retrospective study method. Results Most of the patients taking the drug were female whose age was 20~39（69.43%）. The cases occurred within 30 minutes accounted for 68.79~,6 of the total. The main ADREADE damages were systemic damage（36.36%） and gastrointestinal system damage（25.17%）. The ADR manifestations mainly covered nausea, vomiting, flushing, dizziness and palpitation, etc. Conclusiorl The ADREADE induced by magnesium sulfate injection had been recorded in Henan ADR monitoring database. It is suggested that we should strengthen the ADR monitoting of magnesium sulfate injection, and improve the drug instruction, in order to reduce the incidence of severe ADR/ADE.

关 键 词：硫酸镁注射剂 不良反应 事件 分析 

分 类 号：R916.62[医药卫生—药学]