1388例严重药品不良反应报告分析

Analysis of 1388 Cases of Serious Adverse Drug Reaction

目的对1388例严重药品不良反应病例进行分析,挖掘警戒信号,为临床安全用药提供参考。方法采用回顾性研究方法,对山东省2006年收集的1388例严重药品不良反应报告表进行综合分析。结果本组资料中,引起严重药品不良反应(数量及严重程度)前两位的为抗微生物药及中药制剂,其中阿奇霉素注射剂和双黄连注射剂经综合评价,确定为重点监测品种;在给药途径与严重药品不良反应的分析中发现,静脉注射给药引起严重不良反应的情况较多。结论应进一步加强对抗微生物药和中药制剂的安全性监测,重视阿奇霉素注射剂和双黄连注射剂的再评价。

Objective To analyze 1 388 cases of serious adverse drug reaction and find phamarcovigilance signals.Methods 1 388 reports collected by Shandong Center for ADR Monitoring in 2006 were analyzed using retrospective study method.Results The antibiotics and Traditional Chinese Medicine（TCM） injection caused the higher proportion of serious adverse drug reaction with serious degree.The azithromycin injection and Shuanghuanglian injection were determined as the intensive detection varities.Injection is the main way for administration.Conclusion Safety monitoring for antibiotics and TCM injection should be further strengthened.Attention should be paid to the reevaluation of azithromycin injection and Shuanghuanglian injection.