Analysis of Adverse Reaction Reports and Risk Signal Mining of Ritodrine Hydrochloride in Shenzhen
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.
Shenzhenritodrine hydrochlorideadverse drug reactionsignal miningpregnancy periodthreatened abortion
国家科技期刊平台
NSTL
万方数据
维普
