山东省46619例药品不良反应报告分析

Analysis of 46619 cases of adverse drug reaction

目的:对46619例药品不良反应进行分析,发掘警戒信号,为安全用药提供参考。方法:采用回顾性研究方法,对山东省2006年收集的药品不良反应及报告质量进行综合分析。结果:监测数据反映了全省药品不良反应发生情况,静脉注射用药引起不良反应数量最多;抗微生物药物和中药引起的不良反应数量和严重程度均居前两位;病例报告的填写尚不完善,质量有待提高;阿奇霉素注射剂和双黄连注射剂警戒信号明显。结论:应进一步加强对抗微生物药物和中药的安全性监测,重视阿奇霉素注射剂和双黄连注射剂的再评价。

Objective： To analyze 46 619 cases of adverse drug reaction and find phamareovigilance signal. Methods： To anlyze 46 619 ADR reports of shandong province in 2006 with retrospective case study. Results： The data reflect the occurrence of adverse reactions in shandong province. Intravenous injection is the main pathway, The cases induced by antibiotics and traditional chinese medicine display higher quantity and more serious.The quality of the reports needs to be improved.The phamarcovigilance signal of azithromycin injection and shuanghuanglian injection is obvious. Conclusion： Safety monitoring of antibiotics and traditional chinese medicines should be further strengthened. Attention should be paid to the revaluation of azithromycin injection and shuanghuan-glian injection.