2016—2020年咸阳市第一人民医院中药注射剂的药物警戒分析

Pharmacovigilance analysis of traditional Chinese medicine injection in the First People’s Hospital of Xianyang from 2016 to 2020

目的分析咸阳市第一人民医院2016年1月—2020年12月中药注射剂有关的药品不良反应(ADR)/药品不良事件(ADE)发生的规律及特点,完善并推进国家药物警戒工作。方法采用Excel对2016年1月—2020年12月年咸阳市第一人民医院上报的289例中药注射液剂所致ADR/ADE的患者性别、年龄、药品种类、累及系统/器官、主要临床表现、发生时间、关联性评价等信息进行归纳统计。结果 289例ADR/ADE中,老年患者(年龄≥65岁)及儿童(年龄≤14岁)发生比例较高,发生ADR/ADE的药品种类主要为活血类和补益类药物,主要表现为皮肤及其附件损害,发生时间集中在用药2 h内;严重ADR/ADE上报3例,给予对症处理后患者均明显好转;引发ADE的不合理用药共计67例,其中以适应症不适宜占比最高。结论应建立医疗机构内的药物警戒制度,明确上报范围和职责,加强中药注射剂ADR/ADE的监测力度,提高用药安全性,促进合理用药。

Objective To analyze the regularity and characteristics of ADR/ADE related to traditional Chinese medicine injection in the First People’s Hospital of Xianyang from January 2016 to December 2020, and improve and promote national pharmacovigilance work. Methods Using Excel, 289 cases of ADR/ADE caused by traditional Chinese medicine injection reported by The First People’s Hospital of Xianyang from January 2016 to December 2020 were summarized and statistically analyzed, including gender, age, drug type, involved system/organ, main clinical manifestations, occurrence time, correlation evaluation and other information. Results Among 289 cases of ADR/ADE, elderly patients(age ≥ 65 years old) and children(age ≤ 14 years old) had a high proportion of ADR/ADE. The main types of ADR/ADE occurred were blood activating drugs and supplement drugs, mainly manifested as skin and accessory damage, and the occurrence time was concentrated within 2 hours of administration. 3 Cases of severe ADR/ADE were reported, and all patients improved significantly after symptomatic treatment. A total of 67 cases of irrational drug use caused ADE, among which unsuitable indications accounted for the highest proportion. Conclusion It is necessary to establish a pharmacovigilance system in medical institutions, clarify the reporting scope and responsibilities, and strengthen the ADR/ADE of traditional Chinese medicine injection.