某三甲综合医院346例抗肿瘤药物致不良反应报告分析

Analysis of 346 adverse drug reactions reports associated with antineoplastic drugs in a tertiary class A hospital

目的:分析抗肿瘤药物相关的药品不良反应(adverse drug reaction,ADR)发生的特点及规律,为临床安全使用抗肿瘤药物提供参考。方法:对我院2013–2018年抗肿瘤药物致ADR报告进行回顾性分析,共计346例,对患者性别、年龄、给药途径、引起ADR的药品种类分布、ADR累及系统/器官和临床表现、给药途径与发生时间、ADR分级与转归情况、关联性评价、报告主体等进行分析。结果:346例ADR报告中,女性患者占61.27%,男性患者占38.73%;年龄以45~59岁组占比最高(43.64%);药物种类占比最高的依次为抗代谢类(21.21%)、铂类(20.98%)和植物来源类(20.51%);累及系统/器官最常见的为血液系统(36.86%)、消化系统(16.80%);引发ADR最多的给药途径为静脉给药(85.08%);发生时间主要为用药后2 h(37.06%);严重ADR为64例(18.50%),新的ADR为6例(1.73%)。结论:抗肿瘤药物致ADR较多且严重,应加强监测高危品种、长期用药、严重ADR、新的ADR;药师应从多方面发挥作用,注重对特殊人群的药学监护,促进抗肿瘤药物在临床合理用药。

Objective:To investigate the characteristics and regularity of adverse drug reaction(ADR)induced by antineoplastic drugs,and provide references for the safe drug use.Methods:346 ADR reports induced by antineoplastic drugs from 2013 to 2018 in our hospital were retrospectively collected and analyzed in terms of gender,age,route of administration,drug type,system/organ involved in ADR,manifestation,onset time,ADR grade,prognosis,relevant evaluation,reporter and so on.Results:Among 346 ADR reports,female patients were accounted for 61.27%and male patients were accounted for 38.73%.The elderly patients aged from 45–59 years were accounted for the highest proportion(43.64%).The highest proportion of drug types associated with ADR was anti-metabolism drugs(21.21%),platinum drugs(20.98%)and plant-derived drugs(20.51%).Frequent systems/organs involved in ADR were blood system(36.86%),digestive system(16.80%).Intravenous administration was the main route of administration causing ADR(85.08%).37.06%of ADR occurred within 2 hours after administration.64 cases were severe ADR(18.50%)and 6 cases were the new ADR(1.73%).Conclusion:ADRs induced by antineoplastic drugs were more and severe.Monitoring of high-risk drugs,long-term medication,severe ADRs and new ADRs should be strengthened.Pharmacists should play an important role in many ways,pay more attentions to the special ill patients,and promote efficient and safe use of antineoplastic drugs.