目的 分析咸陽市第一人民醫(yī)院2016年1月—2020年12月中藥注射劑有關的藥品不良反應（ADR）/藥品不良事件（ADE）發(fā)生的規(guī)律及特點，完善并推進國家藥物警戒工作。方法 采用Excel對2016年1月—2020年12月年咸陽市第一人民醫(yī)院上報的289例中藥注射液劑所致ADR/ADE的患者性別、年齡、藥品種類、累及系統(tǒng)/器官、主要臨床表現(xiàn)、發(fā)生時間、關聯(lián)性評價等信息進行歸納統(tǒng)計。結果 289例ADR/ADE中，老年患者（年齡≥65歲）及兒童（年齡≤14歲）發(fā)生比例較高，發(fā)生ADR/ADE的藥品種類主要為活血類和補益類藥物，主要表現(xiàn)為皮膚及其附件損害，發(fā)生時間集中在用藥2 h內；嚴重ADR/ADE上報3例，給予對癥處理后患者均明顯好轉；引發(fā)ADE的不合理用藥共計67例，其中以適應癥不適宜占比最高。結論 應建立醫(yī)療機構內的藥物警戒制度，明確上報范圍和職責，加強中藥注射劑ADR/ADE的監(jiān)測力度，提高用藥安全性，促進合理用藥。

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.

R969.3

咸陽市重點研發(fā)計劃科技專項項目（2020新冠肺炎04）