摘要
目的探讨盐酸氨溴索注射液致严重药品不良反应(ADR)的临床特点,为临床合理用药提供参考。方法收集2023~2024年云南省盐酸氨溴索注射液致严重药品不良反应的报告343例进行统计分析。结果在343例患者中,5~14岁儿童发生严重ADR的比例最高;患者原患疾病与盐酸氨溴索注射液的适应症相符;有52例患者超说明书用量使用;严重ADR发生时间以首次用药30 min内为主;主要累及全身、心脏系统,出现最多的严重ADR表现为心悸。结论临床用药期间,应严格按照说明书使用,防范ADR的发生;药品说明书警示力度不足,应加强药品上市后安全监测,保障临床用药安全。
OBJECTIVE To explore the clinical characteristics of severe adverse drug reactions(ADR)caused by ambroxol hydrochloride injection,and provide references for clinical rational drug use.METHODS A total of 343 reports of serious adverse drug reactions caused by ambroxol hydrochloride injection in Yunnan Province from 2023 to 2024 were collected for statistical analysis.RESULTS Among the 343 patients,the proportion of severe ADR in children aged 5 to 14 years old was the highest;the patient's original disease was consistent with the indica-tions of ambroxol hydrochloride injection;52 patients used the dosage beyond the instruction manual;the occurrence time of severe ADR was mainly within 30 minutes of the first medication;it mainly affected the systemic and cardiac systems,and the most severe ADR manifested as palpitations.CONCLUSION During clinical use of drugs,it should be used strictly in accordance with the instructions to prevent the occurrence of ADR;if the warning of drug instructions is insufficient,safety monitoring after the drug is launched should be strengthened to ensure the safety of clinical use.
作者
聂红科
杨淑婷
蒋晓峰
NIE Hong-ke;YANG Shu-ting;JIANG Xiao-feng(Yunnan Provincial Drug Evaluation Center,Kunming 650000,China)
出处
《海峡药学》
2025年第12期118-122,共5页
Strait Pharmaceutical Journal
关键词
盐酸氨溴索
不良反应
安全性
合理用药
分析
Ambroxol hydrochloride
Adverse drug reactions
Safety
Rational drug use
Analysis1
