630例药品不良反应报告分析

Reports on adverse drug reaction:Analysis of 630 cases

目的由于药品上市前的临床研究病例数有限,许多不安全因素不可预测。通过收集药品上市后的不良反应报告,可了解药品不良反应(adverse drug reaction,ADR)发生的特点和一般规律,保障用药安全,避免不良反应的发生。方法对2006年1月至2008年12月的630例ADR报告进行回顾性统计分析。结果 ADR报告例数最多的是药品科577例,占91.58%;年龄分段在18～59岁的患者ADR发生率较高,占67.94%;静脉给药是导致ADR的主要因素,占66.98%;ADR发生率最高的为抗感染药物,占58.73%,其次为中药制剂,占8.81%;临床表现以皮肤及其附件损害最为常见,占39.46%。结论应高度重视ADR上报工作,加强合理用药特别是抗菌药物合理用药教育,慎用静脉注射剂,以减少或避免ADR的发生,确保患者安全用药。

Objective Due to the limited number of clinical cases for the trials of drugs before put on the market,many risk factors in the use of medicine are quite unpredictable.This study aimed to gain an insight into the characteristics and general laws of adverse drug reaction （ADR）,and promote the prevention of ADR and the safety of drug using.Methods We retrospectively analyzed the reports on 630 cases ADR from January 2006 to December 2008.Results The largest number of ADR case reports were from the department of pharmacy （91.58%）;the highest incidence of ADR was among those aged 18-59 years （67.94%）;the route of medication for most ADRs was intravenous injection （66.98%）;those that caused the most frequent occurrence of ADR were anti-infection drugs （58.73%） and Chinese medicinal formulations （8.81%）;and the commonest clinical symptoms of ADR were lesions on the skin and its annexes （39.46%）.Conclusion Great importance should be attached to ADR reports,education on the rational use of drugs,especially antibiotics,and prudent use of intravenous injection,so as to reduce or prevent the incidence of ADR and ensure the safety of medication.