注射用七叶皂苷钠致严重不良反应的相关因素分析

Analysis of Related Factors of Severe Adverse Reactions Induced by Sodium Aescinate for Injection

目的探讨注射用七叶皂苷钠致严重不良反应发生的特点。方法采用回顾性研究方法,对注射用七叶皂苷钠的严重不良反应报告进行分析。结果注射用七叶皂苷钠严重不良反应主要表现为寒战、发热、过敏性休克、过敏样反应、呼吸困难等,严重不良反应多在30min内发生(34.31%)。结论注射用七叶皂苷钠的严重不良反应特别是过敏性休克和肾功能衰竭应引起医护人员的高度重视,企业应及时修改说明书不良反应项并增加警示语。

OBJECTIVE To explore the character- istics of the serious adverse reactions caused by Sodium Aeseinate （ SA ） for injection. METHODS By retro- spective study methods, we analyzed the reports of SA for injection serious ADR. RESULTS SA for injection can cause serious adverse reactions such as chills, fever, allergic shock, allergic reactions, difficulty breathing, etc. Serious adverse reactions occurred mostly with- in30min （ 34.31% ） . CONCLUSION Medical staff should pay attention to serious adverse reactions espe- cially allergic shock and renal failure caused by SA for injection. Drug manufacturers should promptly modify the manual adverse drug reactions and increase the warning language.