2020 年第 9 期 第 15 卷

2015—2019年北京地区醒脑静注射液临床应用不良反应分析

Analysis of adverse drug reaction in clinical application induced by Xingnaojing injection in Beijing from 2015 to 2019

作者：张琳1赵杰2魏娟娟1石秀锦1林阳1

英文作者：Zhang Lin1 Zhao Jie2 Wei Juanjuan1 Shi Xiujin1 Lin Yang1

单位：1首都医科大学附属北京安贞医院药事部100029；2北京市药品不良反应监测中心100035

英文单位：1Department of Pharmacy Beijing Anzhen Hospital Capital Medical University Beijing 100029 China; 2Beijing Center for ADR Momitoring Beijing 100035 China

关键词：药品不良反应；醒脑静注射液；用药分析

英文关键词：Adversedrugreaction;Xingnaojinginjection;Utilizationanalysis

• 摘要：

• 目的 探讨醒脑静注射液相关药品不良反应（ADR）的临床特点和原因。方法 收集北京市ADR监测中心数据库2015—2019年发生醒脑静注射液相关ADR 249例患者的临床资料，回顾性分析患者的报告年度、性别、年龄、药物及食物过敏史、原患疾病构成、发生时间、累及系统/器官和临床表现、ADR严重程度和转归，对疾病的影响以及醒脑静注射液的用法用量和合并用药情况。结果 249例患者中男86例，女163例；高发年龄为50~79岁，共163例（65.5%）。2017年报告的数量最多，为86例（34.5%)；16例（6.4%）患者既往存在药物及食物过敏史;原患疾病以脑血管病最多，为125例（50.2%）；160例（64.3%）ADR发生在用药的第1天内。249例患者共发生404例次ADR，累及皮肤及其附件79例次，主要临床表现为皮疹56例次，累及中枢及外周神经系统66例次，主要临床表现为头晕头痛51例次；严重ADR 9例，一般ADR 240例（96.4%）；痊愈94例，好转145例，未好转3例，死亡1例，不详6例。ADR使原患疾病病程延长5例，病情加重1例，死亡1例，其余242例影响不明显；36例（14.5%）患者单次给药剂量为30~40 ml，2例用药疗程＞14 d;合并用药86例（34.5%）。结论 醒脑静注射液相关ADR患者以女性较多见、中老年人高发，原患疾病多为脑血管病，多发生在用药第1天内，常累及皮肤及其附件和中枢及外周神经系统，临床超说明书用药情况包括单次给药剂量增加、用药疗程延长和儿童用药，临床应加强醒脑静注射液合理用药监管，加强对其相关ADR的识别及救治能力。

• Objective To investigate the clinical characteristics and causes of adverse drug reactions (ADR) induced by Xingnaojing injection. Methods From 2015 to 2019, clinical data of 249 patients with ADR related to Xingnaojing injection were collected from the database of Beijing Center for ADR Monitoring.The clinical data including the reporting year, gender, age, history of drug and food allergy, composition of original disease, occurrence time, involved system/organ and clinical manifestations, severity and prognosis of ADRs and its influence on the original disease, usage and dosage of Xingnaojing injection and combined medications were analyzed retrospectively. Results Among 249 patients, 86 were male and 163 were female; the high incidence age of ADR was 50-79 years［163 cases (65.5%)］. In 2017, the number of reports was the largest ［86 cases (34.5%)］; 16 cases (6.4%) had a history of drug and food allergy; the most common primary disease was cerebrovascular disease (125 cases, 50.2%); 160 cases (64.3%) occurred within the first day. A total of 404 ADR occurred in 249 patients, systems and organs affected by ADR were mainly observed to be skin and appendages disorders(79 cases), the clinical manifestations were rash (56 cases), central and peripheral nervous system in 66 cases, dizziness and headache (51 cases). There were 9 cases of severe ADR and 240 cases (96.4%) of general ADR; 94 cases were cured, 145 cases were improved, 3 cases were not improved, 1 case died and 6 cases were unknown; ADR prolonged the course of disease in 5 cases, aggravated in 1 case, died in 1 case, and the other 242 cases had no obvious effect; 36 patients (14.5%) received a single dose of 30-40 ml, 2 patients were treated for more than 14 d, and 86 patients (34.5%) were combined with medication. Conclusions Xingnaojing injection-related ADR are more common in female, with high incidence in middle-aged and elderly people. The primary disease is cerebrovascular disease and often occurs within the first day of medication. It often affects the skin and its appendages, central and peripheral nervous system. There are clinical off-label drug use, including single-dose increase, prolonged medication course and children′s medication. The clinical supervision of the rational use of Xingnaojing injection should be strengthened, and the ability to identify and treat related ADR should be strengthened.