114例鸦胆子油乳注射液不良反应/事件分析

Analysis of 114 Adverse Drug Reactions/Events Induced by Brucea Jananica Oil Injection

目的探讨鸦胆子油乳注射液不良反应发生的规律及特点,为临床合理用药提供参考。方法采用回顾性研究方法,对国家药品不良反应监测数据库中的114例鸦胆子油乳注射液不良反应/事件报告表进行统计和分析。结果鸦胆子油乳注射液所致不良反应主要为变态反应,其中发热伴全身性损害52例(45.61%)、胃肠系统损害29例(占25.44%),中枢及外周神经系统损害11例(9.65%)。结论应加强对鸦胆子油乳注射液不良反应的监测。生产厂家药品说明书中记载的不良反应过于简单,应及时更新,以促进药品的合理应用。

Objective To explore the general rule and the characteristics of adverse drug reaction（ADR） induced by Brucea jananica oil injection and to provide some references for clinical medicine and rational use of drug. Methods 114 ADR reports were collected by Center for drug reevaluation and analyzed using retrospective study method. Results The main ADR of by Brucea jananica oil injection respectively were allergic reactions, then fever with system damage 52 cases（45.61%）, digestive system damage 29 cases（25.44%）, central and peripheral nerve system damage 11 cases（9.65%）. Conclusion It is important to attach importance to the ADR caused by Brucea jananica oil injection. The prescription information of production is too simple.It must update in order to promote application reasonably.