摘要
目的分析利培酮药品不良反应(ADR)的特点和规律,提高患者用药安全性。方法回顾性分析绵阳市第三人民医院2016—2021年上报至国家药品不良反应监测中心的利培酮ADR报告260例。结果患者平均年龄(42.20±16.44)岁,以青中年为主。ADR发生时间主要在用药后1个月内,占81.15%。260例ADR报告中用药剂量1~6 mg/d,其中4~6 mg/d 189例(72.69%),给药剂量<4 mg/d未发生严重ADR,用药剂量4、5、6 mg/d严重ADR分别占2.97%、3.45%、5.08%,相关性分析显示,用药剂量与严重ADR发生率之间存在显著正相关关系(r=0.935,P<0.01)。260例ADR报告中,单一用药122例(46.92%),联合2种及以上抗精神病药物治疗138例(53.08%),联合用药患者多采用利培酮联合SGAs,125例(48.08%)。单一用药神经系统损害及代谢紊乱构成比高于联合用药,消化系统损害构成比低于联合用药(P<0.05)。椎体外系不良反应143例次(46.13%)占比最大,其中单一用药75例次(51.02%),联合用药68例次(41.72%)。结论利培酮导致的锥体外系不良反应与用药剂量存在相关性,其严重ADR的发生与每天用药剂量呈显著正相关,利培酮与其他抗精神病药物联用相对较安全,但使用该药物时仍需谨慎增加剂量和联合用药,并加强ADR监测,以确保患者用药安全。
Objective To analyze the characteristics and patterns of adverse drug reactions(ADRs)of risperidone,to improve the safety of medication for patients.Methods A total of 260 ADR reports of risperidone reported by Mianyang Third People′s hospital to the national adverse drug reaction monitoring center from 2016 to 2021 were retrospectively analyzed.Results The average age of patients was(42.20±16.44)years old,mainly young and middle-aged.ADR mainly occurred within one month after medication,accounting for 81.15%.In 260 ADR reports,the dosage range was 1~6 mg/d,of which 189 cases(72.69%)were given 4~6 mg/d.No severe ADR occurred in patients with a dose of<4 mg/d.The incidence of severe ADR was 2.97%,3.45%and 5.08%in patients with doses of 4,5 and 6 mg/d,respectively.The correlation analysis showed that there was a significant positive correlation between the dosage and the incidence of severe ADR(r=0.935,P<0.01).In 260 ADR reports,122 cases(46.92%)were treated with single medication and 138 cases(53.08%)were treated with two or more antipsychotic drugs,the combination therapy was mostly used with risperidone combined with SGAs,with 125 cases(48.08%).The proportion of neurological damage and metabolic disorders caused by single drug use was higher than that of combination drug use,while the proportion of digestive system damage was lower than that of combination drug use(P<0.05).143 cases(46.13%)of extravertebral adverse reactions accounted for the largest proportion,with 75 cases(51.02%)of single medication and 68 cases(41.72%)of combined medication.Conclusion The extrapyramidal adverse reactions caused by risperidone were correlated with the dosage.The incidence of severe ADR was significantly positively correlated with the daily dose of the drug.Risperidone is relatively safe when combined with other antipsychotics,but its dosage or combination should be increased cautiously,and ADR monitoring should be strengthened to ensure the safety of patients.
作者
曹莉莎
王继生
张芳
何淼泉
陈静
郭濠宁
CAO Lisha;WANG Jisheng;ZHANG Fang;HE Miaoquan;CHEN Jing;GUO Haoning(Department of Clinical Pharmacy,Sichuan Mental Health Center/the Third Hospital of Mianyang,Sichuan Province,Mianyang 621000,China)
出处
《临床合理用药杂志》
2023年第26期41-44,48,共5页
Chinese Journal of Clinical Rational Drug Use
关键词
利培酮
不良反应
用药安全
Risperidone
Adverse reactions
Medication safety