中国药业2024，Vol.33Issue(8)：5-8,4.DOI:10.3969/j.issn.1006-4931.2024.08.002
深圳市盐酸利托君不良反应报告分析和风险信号挖掘
Analysis of Adverse Reaction Reports and Risk Signal Mining of Ritodrine Hydrochloride in Shenzhen
摘要
Abstract
Objective To provide a reference for the clinical safe use of ritodrine hydrochloride.Methods The adverse drug reaction(ADR)monitoring data in Shenzhen reported to the National Center for Adverse Drug Reaction Monitoring from January 1,2017 to December 31,2021 were collected from the Guangdong Province Pharmacovigilance and Risk Control System.A total of 775 pieces of data were obtained,involving 698 patients and 1 389 case times of ADRs,of which 51 cases(147 case times)of ADR were related to ritodrine hydrochloride.Based on the World Health Organization Adverse Reaction Terminology(2015 Edition),the systems/organs involved in ADRs were recorded.The ADR signals of ritodrine hydrochloride were mined by the reporting odds ratio(ROR),proportional reporting ratio(PRR)and Medicines and Healthcare Products Regulatory Agency(MHRA)methods.Results A total of 147 case times of ritodrine hydrochloride-related ADRs involved 12 systems/organs and 54 clinical manifestations,with the systemic diseases(36 case times,24.49%)and chest tightness(20 case times,13.61%)being the most common.The case times and patients with ADRs occurring at the 32nd week of pregnancy was the most.The detection of nine ADR signals(chest tightness,cardiopalmus,palpitation,tachycardia,short breath,arrhythmia,local tremble,hypokalemia,local numbness)were statistically significant(P<0.05),among which,chest tightness,short breath and local tremble were the new ADRs.Conclusion The ADRs of ritodrine hydrochloride are mostly related to the activation of the renin-angiotensin-aldosterone system and the physiological changes of the human body during pregnancy.When using this drug in the clinic,we need to strictly control the dosage and timing(gestational week),strengthen monitoring,pay attention to the medication of women with advanced maternal age(≥35 years)to decrease the occurrence of severe ADRs.关键词
深圳市/盐酸利托君/药品不良反应/信号挖掘/妊娠期/先兆流产Key words
Shenzhen/ritodrine hydrochloride/adverse drug reaction/signal mining/pregnancy period/threatened abortion分类
医药卫生引用本文复制引用
肖霄,唐碧雨,吴建茹,魏芬芳,李丽敏,吴文宇..深圳市盐酸利托君不良反应报告分析和风险信号挖掘[J].中国药业,2024,33(8):5-8,4.基金项目
广东省自然科学基金[2023A1515011495] （）
广东省药品监督管理局科技创新项目[2021ZDB01,2021JDB01,2021TDB06,2022TDB16]. （）
