中国药物评价2025，Vol.42Issue(2)：147-152,6.
盐酸雷尼替丁注射剂不良反应/事件文献分析
Literature Analysis of Ranitidine Hydrochloride Injection Related Adverse Drug Reaction/Event
摘要
Abstract
Objective:To explore the general characteristics of adverse reaction/event(ADR/ADE)caused by ranitidine hydrochloride injection,and provide reference for clinical safety medicine.Methods:Literature published from CNKI and PubMed databases until May 2024 were searched,and case reports of ADR/ADE caused by ranitidine hydrochloride injection were collected for retrospective analysis.Results:40 pieces of literature were collected and 47 patients were involved,including 27 males and 20 females,with an average age of(51.94±20.75)years.The daily dosage was recorded clearly in 41 cases,daily dose of 50-200 mg in 37 patients,and daily dosage of 400mg in 5 patients exceeded the recommended range of instructions.Anaphylaxis was the most common adverse reactions.70.21％cases occurred allergic reactions within 1 day of medication.All 47 patients were treated with intravenous medication,and statistical tests indi-cated that the risk of anaphylactic shock,cardiac arrest,laryngeal edema,dyspnea,bronchospasm and severe fatal ADR/ADE caused by intravenous push was higher than that of intravenous drip.Adverse reactions/events were analyzed with MedDRA,most of which were psy-chiatric disorders(19.05％),respiratory,thoracic and mediastinal disorders(17.14％),followed by cardiac disorders(16.19％).The main clinical manifestations were dyspnea,cardiac arrest,anaphylactic shock,irritability,lethargy,hypotension and so on.42 patients improved or recovered after drug withdrawal and/or symptomatic treatment,and 5 patients died.Conclusion:Clinicals should pay more attention to the serious fatal ADR/ADE caused by ranitidine hydrochloride injection,such as anaphylactic shock,laryngeal edema,bron-chospasm,cardiac arrest,respiratory and cardiac arrest.Standardize usage and dosage of ranitidine hydrochloride injection,strengthen drug monitoring and patient treatment,and ensure public drug safety.关键词
雷尼替丁/不良反应/不良事件/病例分析Key words
Ranitidine/Adverse event/Adverse reaction/Case analysis分类
医药卫生引用本文复制引用
陈亚飞,许莉莉,路晓,张继秋,刘孟妮,吴蕊,邱健珉,王春婷..盐酸雷尼替丁注射剂不良反应/事件文献分析[J].中国药物评价,2025,42(2):147-152,6.基金项目
药品监管科学全国重点实验室课题项目(2024SKLDRS0232) （2024SKLDRS0232）
山东省药品不良反应专业评价平台(临沂)项目(药品2024SDADR040) （临沂）
山东省药品不良反应监测中心委托课题项目(药品-2024-SDADR-021) （药品-2024-SDADR-021）
