429例中成药不良反应报告回顾性分析

Retrospective Analysis of 429 ADR Reports Induced by Chinese Patent Medicine

目的了解中成药发生新的/严重的药品不良反应(ADR)情况,为临床安全合理用药提供参考。方法基于2015年1月~2019年12月我院不良反应药品信息上报系统,提取中成药不良反应报告进行统计和分析。结果429例中成药ADR,男性略高于女性(1:0.7),ADR的多发年龄段主要为>50岁和<10岁(337例,78.55%);发生ADR的剂型主要集中在注射制剂(304例,70.86%);累及的系统/器官主要为消化系统和皮肤及其附件(159例,37.06%)。结论临床应重点监测特殊人群的ADR,尤其中药注射剂的用药初期,应加强中成药ADR上报,鼓励生产厂家修订中成药说明书。

Objective To understand the new and serious adverse drug reactions(ADRs)of Chinese patent medicine and to provide reference for clinical rational drug use.Methods The ADR reports of Chinese patent medicine from the ADR information reporting system of our hospital from 2015 to 2019 were extracted for statistics and analysis.Results In 429 cases with ADRs induced by Chinese patent medicine,the ADR incidence in males was slightly higher than that in females(1:0.7);the ADR incidence was the highest in>50 years old and<10 years old age groups(337 cases,78.55%);the injection preparation was the dosage form that with the highest ADR incidence(304 cases,70.86%);and the mainly affected systems/organs were the digestive system and the skin and its accessories(159 cases,37.06%).Conclusion Clinical ADR monitoring should focus on specific population,edspecially the patients that were at the early stage of medication.The reporting of ADRs of Chinese patent medicine should be strengthened and the revision of drug instructions should also be encouraged.