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目的:分析儿童发生万古霉素不良反应(ADR)的一般特点及规律,为合理用药提供参考。方法:用Pareto最优分析,对2009-2015年湖南省儿童医院上报国家药品不良反应监测系统的38例万古霉素ADR报告进行整理,从患儿年龄、性别、用药后ADR发生时间、合并用药、ADR累及器官/系统及临床表现等方面进行统计分析。结果:发生万古霉素ADR的患儿中,男性高于女性(73.7%vs 26.3%);患儿年龄集中在1个月~2岁(79.0%);ADR发生时间主要在用药60 min以内(50.0%)和用药7 d后(21.1%);有27例(71.1%)使用3种及以上药物联合治疗;ADR主要临床表现为过敏反应(64.6%),主要累及皮肤及其附件。结论:临床医师、药师应了解儿童万古霉素ADR的特点和规律,加强其应用监测,以减少ADR的发生。
Objective: To analyze the general characteristics and regularities of ADR in children, and to provide a reference for rational drug use. Methods: According to Pareto optimal analysis, 38 cases of vancomycin ADR reported by National Children’s Adverse Drug Reaction Monitoring System from 2009 to 2015 in Hunan Children’s Hospital were sorted out. According to the age, sex, ADR occurrence time, , ADR involving organ / system and clinical manifestations and other aspects of statistical analysis. Results: The prevalence of vancomycin ADR was higher in males than in females (73.7% vs 26.3%); children aged 1 month to 2 years (79.0%); ADR occurred mainly within 60 minutes 50.0%) and 7 days after treatment (21.1%). 27 (71.1%) patients were treated with 3 or more drugs. The main clinical manifestations of ADR were anaphylaxis (64.6%), mainly involving the skin and its appendages. Conclusion: Clinicians and pharmacists should understand the characteristics and rules of vancomycin ADR in children and strengthen their application monitoring to reduce the occurrence of ADR.