中国药物警戒 ›› 2020, Vol. 17 ›› Issue (9): 617-621.
DOI: 10.19803/j.1672-8629.2020.09.15

• 安全与合理用药 • 上一篇    下一篇

某院140例严重药品不良反应/事件报告分析

游翠玉1, 许晓丽1, 李莎1, 薛思宇2, 陈思颖1, 王茂义1,*   

  1. 1西安交通大学第一附属医院药学部,陕西 西安 710061;
    2陕西省韩城市人民医院药剂科,陕西 韩城 715400
  • 收稿日期:2020-08-17 修回日期:2020-08-17 出版日期:2020-09-15 发布日期:2020-08-17
  • 通讯作者: *王茂义,男,主任药师,临床药学。E-mail:1127827480@qq.com
  • 作者简介:游翠玉,女,硕士,主管药师,药剂学。

140 Cases of Severe Adverse Drug Reactions/Events in a Hospital

YOU Cuiyu1, XU Xiaoli1, LI Sha1, XUE Siyu2, CHEN Siying1, WANG Maoyi1,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Medical College, Xi'an Jiaotong University, Xi'an Shaanxi 710061, China;
    2Hancheng People's Hospital of Shaanxi Province, Hancheng Shaanxi 715400, China
  • Received:2020-08-17 Revised:2020-08-17 Online:2020-09-15 Published:2020-08-17

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摘要： 目的 统计某院严重药品不良反应/事件(ADR/AE)报告,评价其发生原因及特点,为临床合理、安全、有效用药提供一定的参考。方法 收集统计西安交通大学第一附属医院2016年1月至2019年6月间140例严重ADR/AE报告,分别对患者年龄、性别、药品种类、累及系统-器官及不良反应表现、给药途径等进行统计和分析。结果 在140例严重ADR/AE报告中,男女比例约为1.17:1,其中50岁以上患者(68.57%)最多。涉及药品以抗肿瘤药物(42.86%)和抗感染药物(24.29%)为主,报告中居前15种有13种抗肿瘤药物和2种抗感染药物,其中报告最多的是伏立康唑。严重ADR/AE的临床表现以血液系统损害最为常见。用药途径以静脉滴注构成比最高,占比59.28%。结论 临床应对中老年患者用药、抗肿瘤药物和抗菌药物加以重点关注,加强用药后的监测工作以及临床药师的用药指导,以减少或避免ADR/AE的发生,保障患者的用药安全。

关键词: 严重药品不良反应/事件, 报告分析, 用药安全

Abstract: Objective To investigate the causes and characteristics of serious adverse drug reaction (ADR)/adverse event (AE) that occurred in the First Affiliated Hospital of Xi'an Jiaotong University along with literature research so as to provide reference for clinical rational, safe and effective drug use. Methods The clinical data on 140 cases of serious ADR/AE was collected between January 2016 and June 2019 in the hospital. The patients' age, gender, types of drugs, systems-organs involved, adverse manifestations and routes of administration were statistically analyzed. Results The ratio of male patients to female ones was 1.17:1 and the incidence of ADR/AE was the highest among patients over 50 years old (68.57%). The drugs involved were mainly anti-tumor (42.86%) and anti-infective (24.29%) drugs. There were 13 anti-tumor drugs and 2 antimicrobial drugs among the top 15 drugs, and voriconazole was responsible for more ADR cases than any of the other drugs. The main clinical manifestation was blood system damage. The incidence of ADR related to intravenous infusion was the highest, accounting for 59.28%. Conclusion Clinicians should be more cautious with the medication for middle-aged and elderly patients and with the usage of anti-tumor and antimicrobial drugs. Post-medication monitoring and guidance of clinical pharmacists should be put in place in order to reduce or prevent the occurrence of ADR/ AE and ensure the safety of patients' medication.

Key words: severe adverse drug reactions/events, report analysis, drug safety

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