利培酮药物不良反应/事件277例临床特点分析

Clinical Characteristics and Analysis of 277 Cases of Adverse Drug Reactions Events of Risperidone

目的:分析精神疾病患者服用利培酮所致药物不良反应/事件(ADR/ADE)的发生特点和规律,为临床合理用药提供参考。方法:对2019年1月至2021年12月江西省精神病院上报国家药品不良反应监测中心的277例利培酮的ADR/ADE报告表进行回顾性统计分析。结果:277例利培酮ADR/ADE的患者中男性(131例,占47.29%),女性(146例,占52.71%),发生率最高年龄段是18~30岁(32.85%);原患疾病中精神分裂症占比最高(225例,81.23%);不存在超适应证使用情况,但有2例超过说明书每日用量16 mg;累及系统-器官排前三的依次是神经系统(130例,占46.43%)、内分泌系统与代谢(52例,18.57%)、消化系统(50例,占17.86%);临床表现前三分别是锥体外系反应、肝功能异常、催乳素增高;纳入的ADR/ADE报告表共277例,一般的(195例,占70.40%),严重的(82例,占29.60%),大部分病例转归情况都良好。结论:精神疾病患者利培酮不良反应在年龄分布上以18~50岁所占比例最高;临床表现前三分别是锥体外系反应、肝功能异常、催乳素增高;预后较好。

Objective:To analyze the characteristics,regularity and medication of adverse drug reactions/events(ADR/ADE)caused by risperidone,so as to provide reference for clinical rational drug use.Methods:The ADR/ADE report forms of 277 cases of risperidone reported by JiangXi Mental Health Center to the national adverse reaction monitoring center from January 2019 to December 2021 were retrospectively analyzed.Results:Among the 277 patients with risperidone ADR/ADE,131 cases were male(47.29%)and 146 cases were female(52.71%).The highest incidence was 18-30 years old(32.85%).Schizophrenia accounted for the highest proportion of primary diseases(225 cases,81.23%).There was no use beyond indications,but 2 cases exceeded the daily dosage of 16mg in the manual.The top three involving system organs were the nervous system(130 cases,accounting for 46.43%),endocrine system and metabolism(52 cases,18.57%),digestive system(50 cases,accounting for 17.86%).The first three clinical manifestations were extrapyramidal reaction,abnormal liver function and increased prolactin.A total of 277 cases were included in the ADR/ADE report form,including general cases(195 cases,accounting for 70.40%)and serious cases(82 cases,accounting for 29.60%).The prognosis of most cases was good.Conclusion:In the age distribution of risperidone in mental patients,the highest proportion was from 18 to 50 years;the top three clinical manifestations are extrapyramidal reaction,abnormal liver function and increased prolactin;the prognosis is good.