中国药物警戒 ›› 2025, Vol. 22 ›› Issue (1): 99-103.
DOI: 10.19803/j.1672-8629.20240337

• 安全与合理用药 • 上一篇    下一篇

808例抗精神病药品不良反应报告分析

戴彪1,2,3,4, 曹银1,2,3,4, 孙艳红1,2,3,4, 张元元1,2,3,4, 夏清荣1,2,3,4,*   

  1. 1安徽医科大学附属心理医院药剂科,安徽 合肥 230022;
    2合肥市第四人民医院药剂科,安徽 合肥 230022;
    3安徽省精神卫生中心精神药理研究室,安徽 合肥 230022;
    4安徽省精神心理疾病临床医学研究中心,安徽 合肥 230022
  • 收稿日期:2024-05-21 出版日期:2025-01-15 发布日期:2025-01-22
  • 通讯作者: *夏清荣,男,硕士,主任药师,医院药学。Email: 1356835730@qq.com
  • 作者简介:戴彪,男,在读硕士,副主任药师,临床药学。
  • 基金资助:
    安徽省临床重点专科资助（皖卫医秘〔2022〕105号）; 合肥市第七周期临床重点（培育）专科资助（皖卫医秘〔2023〕72号）

808 Cases of Adverse Drug Reaction Caused by Antipsychotic Drugs

DAI Biao1,2,3,4, CAO Yin1,2,3,4, SUN Yanhong1,2,3,4, ZHANG Yuanyuan1,2,3,4, XIA Qingrong1,2,3,4,*   

  1. 1Department of Pharmacy, Affiliated Psychological Hospital of Anhui Medical University, Hefei Anhui 230022, China;
    2Department of Pharmacy, Hefei Fourth People's Hospital, Hefei Anhui 230022, China;
    3Department of Mental Pharmacology, Anhui Mental Health Center, Hefei Anhui 230022, China;
    4Clinical Medical Research Center of Mental and Psychological Diseases in Anhui Province, Hefei Anhui 230022, China
  • Received:2024-05-21 Online:2025-01-15 Published:2025-01-22

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摘要： 目的 分析抗精神病药物所致不良反应（ADR）的发生特点、规律及影响因素,为规范临床合理用药提供参考。方法 收集2022年1月1日至2023年12月31日安徽精神卫生中心医院上报至国家药品不良反应监测系统的抗精神病药物所致ADR报告808例,应用帕累托图对患者年龄、药物种类分布、发生时间以及累及系统-器官等数据进行统计分析。结果 808例抗精神病药物所致ADR中,男女比例为1.3∶1;20~29岁、30~39岁、10~19岁3个年龄段报告比例最大,分别为27.97%、22.40%、17.20%;ADR报告共涉及15种抗精神病药物,上报频次排名前5位的药物依次为利培酮（20.42%）、奥氮平（20.17%）、喹硫平（13.49%）、阿立哌唑（13.24%）及氯氮平（13.24%）;引起ADR的给药途径主要为口服给药（95.79%）;ADR在2~10 d内发生最多（37.62%）;ADR累及的系统-器官以神经系统损害例数最多（46.78%）;一般ADR 728例（90.10%）,严重ADR 80例（9.90%）,多数不良反应经对症处理预后良好。结论 经由帕累托图分析,抗精神病药物引起的ADR应综合考虑患者的年龄、发生时间和药物种类等因素,及时发现药物风险信号,采取有效的干预措施,确保患者用药安全。

关键词: 抗精神病药物, 利培酮, 奥氮平, 喹硫平, 阿立哌唑, 氯氮平, 帕累托图, 药品不良反应

Abstract: Objective To analyze the characteristics, patterns, and influencing factors of adverse drug reactions (ADR) caused by antipsychotic drugs, and to provide data for clinical rational drug use. Methods A total of 808 reports about ADR caused by antipsychotic drugs reported by Anhui Mental Health Center Hospital to the National Adverse Drug Reaction Monitoring System between 2022 to and 2023 were collected. The Pareto chart was used to analyze the age of the patients, distribution of types of drugs, time of occurrence, and the major organs/systems involved. Results Among the 808 cases of ADR caused by antipsychotic drugs, the ratio of males to females was 1.3:1, and the incidence was high in groups ages 20-29, 30-39, and 10-19, accounting for 27.97%, 22.40%, and 17.20%, respectively. The reports of ADR involved a total of 15 antipsychotic drugs, with the top 5 drugs as risperidone (20.42%), olanzapine (20.17%), quetiapine (13.49%), aripiprazole (13.24%), and clozapine (13.24%). The main route of administration that caused ADR was oral administration (95.79%). ADR occurred most frequently within 2 to 10 days (37.62%). Neurological damage (46.78%) was the dominating ADR among the organs/systems affected. Among the 808 reports of ADR, there were 728 cases (90.10%) of mild ADR and 80 cases (9.90%) of severe ADR. Most adverse reactions had a good prognosis after symptomatic treatment. Conclusion According to Pareto chart analysis, the age of patients, onset time, and drug types should be considered in case of ADR caused by antipsychotic drugs. It is critical to promptly detect risk signals of drug use and take effective intervention measures to ensure patients' safety.

Key words: Antipsychotic Drugs, Risperidone, Olanzapine, Quetiapine, Aripiprazole, Clozapine, Pareto Chart, Adverse Drug Reaction

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