887例静脉滴注抗菌药物不良反应报告分析

doi:10.19803/j.1672-8629.20241044

摘要/Abstract

摘要： 目的分析静脉滴注抗菌药物致药品不良反应（ADR）发生规律及临床特点,为临床安全用药提供参考。方法收集2016年1月1日至2024年12月31日本院上报至国家药品不良反应监测中心的静脉滴注抗菌药物ADR报告,对患者性别、年龄和原患疾病,ADR涉及药物类型、发生时间、累及系统-器官与临床表现、转归及关联性评价、新的和严重ADR进行分析。结果 887例ADR报告中,新的一般ADR 257例,新的严重ADR 32例,严重ADR 57例;男性占52.31%,女性占47.69%,≥60岁患者占比最高（40.47%）;共涉及抗菌药物15类40种,引发ADR病例数排序居前3位的药物种类分别是头孢菌素类（28.97%）、喹诺酮类（25.59%）和β-内酰胺酶抑制剂复方制剂（20.52%）,涉及前3位的药品是头孢曲松（17.59%）、哌拉西林他唑巴坦（15.67%）和左氧氟沙星（14.54%）;ADR多发生在用药30 min内（42.05%）,主要累及系统-器官为皮肤及其附件（62.31%）、神经系统（9.20%）和消化系统（9.02%）;大部分ADR经相应处理后痊愈或好转。结论静脉滴注抗菌药物临床表现形式多样,需高度关注严重ADR,包括过敏性休克、过敏样反应、癫痫发作、血小板减少、凝血障碍、肝功能异常等。新的ADR难以预测,临床应进一步加强ADR监测,尤其是特殊人群和高风险药物的用药监测,从而减少ADR的发生,保障用药安全。

关键词: 抗菌药物, 头孢菌素, 喹诺酮, β-内酰胺酶, 静脉滴注, 皮肤及其附件, 神经系统, 消化系统, 药品不良反应

Abstract: Objective To analyze the patterns and clinical characteristics of adverse drug reactions (ADR) induced by intravenous drip of antibacterial drugs so as to provide references for safe clinical medications. Methods Reports of ADR induced by antibacterials for intravenous drip submitted by our hospital to the National Adverse Drug Reaction Monitoring Center in 2016-2024 were collected and analyzed in terms of patients' gender and age, primary diseases, types of drugs involved in ADR, time of onset, systems and organs involved, clinical manifestations, outcomes and distribution of ADR. Results Among the 887 cases of ADR, 257 were new and mild ADR, 32 were new and severe ones, and 57 were severe ones. Among the patients involved in these ADR, 52.31% were male and 47.69% were female. The percentage of patients ages 60 and older was the highest (40.47%). Totally 40 types of antibiotics of 15 classes were involved, and the top three categories were cephalosporins (28.97%), quinolones (25.59%) and β-lactamase inhibitor combinations (20.52%) respectively. The top three drugs were ceftriaxone (17.59%), piperacillin-tazobactam (15.67%) and levofloxacin (14.54%). ADR mostly occurred within 30 minutes of administration (42.05%), and involved the skin and its accessories (62.31%), the nervous system (9.20%) and digestive system (9.02%). Most of these ADR were cured or improved after symptomatic treatment. Conclusion The clinical manifestations of adverse reactions caused by antibacterial drugs for intravenous drip are diverse, and what deserves more attention is severe ADR, including anaphylactic shock, allergy-like reactions, epileptic seizures, thrombocytopenia, coagulation disorders and abnormal liver function. New ADR are difficult to predict. Clinicians should devote more effort to monitoring of ADR, especially those among special populations and due to high-risk drugs so as to reduce the incidence of ADR and ensure safe medications.

Key words: Antibacterial Drugs, Cephalosporins, Quinolones, β-Lactamase, Intravenous Drip, Skin and Its Accessories, Nervous System, Digestive System, Adverse Drug Reaction

中图分类号:

R978
R994.11

蔡杰, 韩陈媛, 江君微. 887例静脉滴注抗菌药物不良反应报告分析[J]. 中国药物警戒, 2025, 22(9): 1018-1023.

CAI Jie, HAN Chenyuan, JIANG Junwei. 887 Reports of Adverse Drug Reactions Induced by Intravenous Drip of Antibacterial Drugs[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1018-1023.

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