Objective To understand the current status of off-label drug use, and investigate the correlation between adverse drug events ( ADE ) and off-label drug use. Methods ADE and off-label drug use in a hospital from January 2014 to December 2016 were statistically analyzed, and the correlation between ADE and off-label drug use was analyzed. Results In 330 patients with ADE, 497 cases of organ or systemic injuries were found, among which skin and accessory injuries were the most, accounting for 57. 95％. In 415 cases of off-label medication orders, a total of 450 types of directions were found, among which the frequencies of off-single dose and over dosage were the highest, accounting for 33. 78％ and 34. 22％, respectively. There was a correlation between off-label drug use and the duration of ADE and involved organ or system ( P < 0. 05 ) . Conclusion There is a correlation between off-label drug use and the occurrence of ADE, and the corresponding government departments should strengthen supervision.%目的 了解超药品说明书用药现状,探讨药品不良反应事件(ADE)与其相关性.方法 统计某院2014年1月至2016年12月的ADE及超药品说明书用药情况,并分析两者的相关性.结果 330例ADE患者共发生器官/系统损害497例次,其中以皮肤及其附件受损害最多,占57.95％;415例超药品说明书用药医嘱中,发现450项超说明书用药类型,其中以超单次剂量和超给药频次最多见,分别占33.78％和34.22％.超药品说明书用药与ADE发生时间及受累器官/系统具有相关性(P<0.05).结论 超药品说明书用药与ADE的发生具有相关性,相应政府部门需加大监管力度.
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