我院2002～2006年新的和严重的药品不良反应报告分析

Retrospective Analysis of New and Severe ADR Case Reports in Our Hospital from 2002 to 2006

目的:了解我院新的和严重的药品不良反应(ADR)发生的特点。方法:对我院2002～2006年医务人员自愿呈报的新的(包括新的一般的和新的严重的)和严重的ADR(不包括新的严重的ADR)报告进行统计分析。结果:我院5a共收到新的和严重的ADR报告586份,占报告总数的33.56%,其中新的ADR报告为349份,严重的ADR报告为237份。5a间两类报告数均呈上升趋势。引发新的或严重的ADR多为1种可疑药品;可疑药品中抗感染药所占比例最大,其次是抗肿瘤药。新的和严重的ADR涉及最多是皮肤及其附件损害,次之为循环系统。可疑药品引发新的ADR部分临床表现外源数据库已有报道,同质文献比>0,但大多数临床表现为首次报道,同质文献比为0。严重ADR主要导致患者住院或住院时间延长,次之为对生命有危险并能够导致人体永久的或显著的伤残。结论:临床应密切关注新的ADR,重视严重的ADR,以避免严重的ADR重复发生。

OBJECTIVE： To study the features of the new and severe adverse drug reactions （ADR） occurred in our hospital. METHODS： The new ADR（including new common type and new severe type） and severe ones （excluding new severe type） submitted voluntarily by the medical staff in our hospital during 2002-2006 were subjected to a retrospective analysis. RESULTS： A total of 586 new and severe ADR reports were obtained in the 5 years, accounting for 33.56% of the total ADR reports. Of the 586 reports（33.56%）, 349 were new ADR, and 237 were severe ADR, showing an uptrend for the new and severe types over the 5 years. Most of new and severe ADR were caused by one kind of suspected drugs, with anti - infective agents showing the highest percentage, followed by anti - tumor agents. The main presentation of the new and severe ADR was lesion of skin and its appendages, followed by lesion of symptoms of circulatory system. Although part of the clinical manifestations of ADR of the suspected drugs had been reported in literature with the homogeneous literature ratio being 〉0, most symptoms of ADR were reported for the first time with the homogeneous literature ratio being 0. The predominant outcome of severe ADR were hospitalization or delayed hospitalization course, followed by increased risk of death or patients＇ permanent or distinct disabling. CONCLUSION： New and severe ADR should be given close attention in the clinic to guard against severe ADR.