30例醒脑静注射液不良反应/事件文献分析  

Literature Analysis of 30 Adverse Drug Reaction/Event Cases Induced by Xingnaojing Injection

作　　者：邹箴蕾[1] 杨乐[1] 郭晓昕[1] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2014年第11期683-686,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨醒脑静注射液不良反应/事件的发生原因与规律,为临床安全用药提供参考。方法对30例国内文献报道的醒脑静注射液不良反应/事件进行统计和分析。结果中老年患者占56.67%;43.33%的病例用于治疗非说明书适应证的病症;13.33%的病例超剂量用药;70.00%的患者在用药开始后的30 min内发生不良反应/事件;不良反应/事件可发生首次用药和连续用药过程中;33.33%的病例有合并用药情况;不良反应/事件累及6个系统-器官,以过敏反应和过敏性休克为主的全身性损害占60.00%。结论临床医务人员应注意询问患者的过敏史,应严格遵照说明书规定的适应证和用法用量使用醒脑静注射液,谨慎联合用药,用药过程中加强不良反应监测;药品生产企业应加强醒脑静注射液的质量控制研究与安全性研究,以及修改完善说明书的安全性内容。Objective To analyze the causes and characteristics of the adverse drug reaction/event （ADR/ADE） cases induced by Xingnaojing injection provide references for clinical rational drug use. Methods 30 ADR/ADE cases induced by Xingnaojing injection were analyzed retrospectively. Results The middle-aged and the old patients ac counted for 56.67%. The use of Xingnaojing injection in 43.33% cases is beyond the indications of the drug instruc tions. The dosage of Xingnaojing injection in 13.33% cases is more than the dosage of the drug instructions. 70.00% of ADR/ADE occurred within 30 minutes after administration. The ADR/ADE can occur in the first time medication or continuous administration process. 33.33% of the patients had combined medication. The ADR/ADE involved six systems-organs. Systemic damage in which allergic reactions and anaphylactic shock is majority accounted for 60.00%. Conclusion Clinicians should pay attention to allergies of patients. The instruction should be adhered to. The combined medication should be cautious. The monitoring of adverse drug reactions should been strengthened. The drug manufacturing enterprise should strengthen the quality control and drug safety research, and improve the drug instructions of Xingnaojing injection.

关 键 词：醒脑静注射液 不良反应/事件 文献分析 

分 类 号：R965[医药卫生—药理学]