摘要
Abstract
Objectives:To explore the adverse events(AEs)of triptorelin in the treatment of central precocious puberty(CPP)to promote rational and safe medication practices in clinical settings.
Methods:AE reports related to triptorelin treatment for CPP were collected from the Adverse Event Reporting System database of the U.S.Food and Drug Administration(FAERS)from its inception until the third quarter of 2024.The reports were classified and statistically analyzed using the System Organ Classes(SOC)and Preferred Terms(PT)from the Medical Dictionary for Regulatory Activities(MedDRA27.1).Data mining and analysis were conducted using the reporting odds ratio(ROR)method and the UK Medicines & Healthcare Products Regulatory Agency(MHRA)method.
Results:A total of 500 AE reports related to triptorelin treatment for CPP were collected,involving 168 patients.There were 22 positive AE signals,of which 7 were new findings(brain neoplasm,appendicitis,gait inability,growth retardation,hyperhidrosis,asthenia,suicidal ideation).Among AE reports,61.90％were severe cases and 21.43％required hospitalization.In addition,AEs such as abdominal pain,acne,visual impairment,epistaxis,vomiting,nausea,constipation,hypertension,and increased blood prolactin in previous studies were not detected positive signals in this study.
Conclusions:AE reports of triptorelin treatment for CPP in children were generally rare,but some AE reports were severe.Attention should be paid to newly discovered AEs,and the causes of non-positive AEs should be identified.关键词
曲普瑞林/中枢性性早熟/药品不良事件/FAERS数据库/报告比值比法/综合标准法Key words
Triptorelin/Central precocious puberty/Adverse events/FAERS database/Reporting odds ratio method/MHRA method分类
医药卫生
