我院2004~2006年严重药品不良反应报告分析

目的:了解我院严重药品不良反应(ADR)发生的情况和特点,以促进合理用药。方法:对我院2004年6月~2006年12月收集到的25例严重ADR报告,按ADR因果关系判断标准进行分析、评价。结果:涉及药品21种,引起ADR例/次最多的是抗感染药,共12种,其次为中药制剂;所涉及的系统以皮肤及其附件和神经系统最为常见;发现3例新的、严重的为药品说明书或文献未见报道的ADR。结论:严重ADR的发生与多种因素有关,应增强合理用药意识,以减少和避免严重ADR的发生,保证药物治疗安全、有效。

Analysis of Serious ADR Cases in Our Hospital from 2004 to 2006

OBJECTIVE： To investigate the situation and characteristics of serious adverse drug reactions （ADR） occurred in our hospital in order to promote rational clinical drug use. METHODS： 25 severe ADR cases collected in our hospital from Jun. 2004 to Dec. 2006 were analyzed statistically and evaluated based on the ADR causality judgment criteria. RESULTS： The 25 severe ADR were associated with 21 kinds of drugs, with anti -infectives （12 kinds） making up the highest proportion, followed by traditional Chinese medicine preparations. The main systems involved in he ADR were skin and its appendages and nervous system. 3 new and severe ADR cases were found to have no report in package inserts or literature. CONCLUSION： Severe ADR may be induced by many factors, therefore, it is necessary to strengthen the awareness of rational drug use to guard against severe ADR and ensure safe and effective medication.