1012例生脉注射液不良反应/事件分析

1012 cases of adverse reactions/event of shengmai injections

目的分析生脉注射液的安全性,探讨不良反应发生的一般规律及特点,为临床合理用药提供参考。方法采用回顾性研究方法,对国家中心提供的1028例生脉注射液不良反应/事件报告表进行统计和分析。结果生脉注射液引起的不良反应未见性别差异,ADR/ADE在各年龄组段均有分布,所致不良反应主要为:发热伴全身性损害388例(38.34%),皮肤及附件损害202例(19.96%),心血管系统一般损害113例(11.17%),胃肠系统损害70例(6.92%),不良反应主要表现为速发型,应警惕过敏性休克。结论应加强对生脉注射液不良反应的监测,不盲目扩大适应证,加强质量标准的研究,注重优化生产工艺,确保用药安全、有效。

Aim To analyse the safety of Shengmai injections,to discuss the general rules and characteristics of adverse reactions and to provide a reference for clinical medication.Methods By retrospective study,1 028 cases of adverse reaction/event reports provided by the National Center were statistically analyzed.Results The adverse reactions of Shengmai Injections had no gender differences,ADR/ADE distributing in all age groups.Main adverse events included 388 cases of fever and systemic damages（38.34%）,202 cases of skin and appendages damages（19.96%）,113 cases of cardiovascular system damages（11.17%）,70 cases of gastrointestinal system damages（6.92%）,and anaphylactic shock should be alerted to.Conclusion It is very necessary to strengthen the monitoring of adverse reactions and the research to the quality standard,to ensure drug safety and effectiveness.