45例丹参川芎嗪注射液不良事件分析

Analysis of 45 adverse events cases of Danshen Chuanxiongqin Injection

目的:通过对丹参川芎嗪注射液不良事件(ADE)的分析,探讨该药品对人体的安全性作用,为临床医生合理用药提供依据。方法:通过对2012年1月到2019年6月在成都中医药大学附属医院住院人群中收集丹参川芎嗪注射液致不良事件病例,应用文献计量学方法进行分析。结果:共收集到45例丹参川芎嗪注射液致不良事件病例。46岁以上人群为高发人群(占80%);不同原发疾病中以有呼吸系统疾病的患者发生ADE的几率高,其次是消化和泌尿系统;丹参川芎嗪注射液致不良事件涉及人体多系统损害,以皮肤及附件损害占比最高,其他依次为全身性损害、用药部位损害等。患者经积极治疗。对症处理后会痊愈或好转。结论:应重视不同患者个体差异规范用法用量并加强用药全程监护。

Objective:Adverse events (ADE) of Danshen Chuanxiongqin injection was analyzed to evaluate the safety and provide the evidence for rational application in clinic.Method:Adverse events of Danshen Chuanxiongqin injection were collected from hospitalized patients in the Affiliated hospital of Chengdu University of Traditional Chinese Medicine from January,2012 to June,2019 and analyzed by bibliometrics.Result:A total of 45 cases of adverse events of Danshen Chuanxiongqin injection were collected.The patient over 46 years old was high incidence group (80%).Among different primary diseases,patients with respiratory diseases had a high incidence of ADE,followed by digestive and urinary disease.Adverse events of Danshen Chuanxiongqin injection involved multi-system damage of human body,with skin and accessory damage accounting for the highest proportion,followed by systemic damage and drug site damage etc.The patients recovered or felt better after treatment.Conclusion:we should pay more attention to individual differences of patients and standardize the usage and dosage.The medication monitoring should be strengthened during the all period of treatment.