超说明书用药对高龄患者药品不良反应的影响

Influence of Off-Label Uses to Adverse Drug Reactions in Aged Patients

关键词:  超说明书用药  高龄患者  药品不良反应

Key words:  off label uses  aged patients  ADR

摘要:

目的 探讨超说明书用药对高龄患者药品不良反应(adverse drug reactions，ADR)的影响。方法 回顾性研究宁波市第二医院电子病历中为期6个月的≥80岁高龄患者的用药及ADR。结果 共有108例患者纳入研究，给予医嘱1 084条(平均每例患者10.04条)，其中超说明书用药122条(占总医嘱数的11.25%)，有18例患者发生了19例次ADR(16.7%)，患者至少有1种超说明书用药的(n=65)发生1次ADR(n=17例)，要比按说明书用药患者频繁(n=43对1例)。说明书内用药的962条医嘱中发生ADR的是7条(0.73%)，而超说明书的122条医嘱中为12条(9.8%)。结论 高龄患者中使用至少1种超说明书用药引起的ADR显著高于按说明书用药。

Abstract:

OBJECTIVE To discuss the influence of off-label uses to ADR(adverse drug reactions) in aged patients. METHODS Retrospective examine the drugs and ADRs of aged patients who were greater than or equal to the age of 80 in elcectronic medical records in six months. RESULTS A total of 108 patients were included in the study and 1 084 drug prescriptions were given to them(median 10.04 prescriptions per patient). In 122 cases(11.25% of all prescriptions) drugs were used in an off-label manner. A total of 19 ADR were observed in 18 patients(16.7%). Patients receiving at least one off-label use during hospitalization(n=65) experienced an ADR significantly more frequently(n=17 patients) than patients receiving only licensed drugs(n=43 vs 1 patient). ADRs were associated with 7(0.73%) of the 962 licensed drug prescriptions and with 12(9.8%) of the 122 off-label use prescriptions. CONCLUSION This study demonstrates that the incidence of ADR caused by off-label use is more frequently than patients receiving only licensed drugs in aged patients.