拉莫三嗪致55例不良反应分析  

Analysis of 55 Cases of Adverse Drug Reactions Induced by Lamotrigine

作　　者：白荷荷[1] 聂晓静[1] 王金萍[1] 夏丽 郑南波[1] Bai Hehe;Nie Xiaojing;Wang Jingpin;Xia Li;Zheng Nanbo(Department of Pharmacy,Xi’an Central Hospital,Xi’an 710003, China)

机构地区：[1]西安市中心医院药剂科

出　　处：《中国药师》2019年第8期1480-1483,共4页China Pharmacist

摘　　要：目的:探讨拉莫三嗪致不良反应(ADR)的临床表现、危险因素、发生机制及临床转归,为临床安全用药提供参考。方法:收集2016年1月~2018年11月在我院进行拉莫三嗪血药浓度监测的476例门急诊及住院患者资料,对患者的基本信息、用药情况、血药浓度和ADR发生及转归情况进行统计分析。结果:经关联性评价确定为ADR共55例,男32例,ADR发生率12.44%(55/442);女23例,ADR发生率11.11%(23/207);儿童20例,ADR发生率17.39%(20/115);以神经系统损害(58.82%)、消化系统损害(19.12%)和皮肤及其附件损害(13.24%)较为多见。已知ADR 45例,罕见ADR 8例(包括严重ADR 2例:1例无菌性脑膜炎、1例急性肝损伤),新的ADR 2例。拉莫三嗪血药浓度高于参考浓度范围的患者ADR发生率较高,为80.00%。经停药、调整给药剂量及对症支持治疗后,除2例共济失调、1例体质量增加未好转,其余均痊愈。结论:拉莫三嗪所致ADR存在个体差异,儿童患者比例较高,血药浓度监测和基因检测有利于癫痫患者个体化精准治疗。Objective: To explore the clinical manifestations,risk factors,mechanism and clinical outcome of lamotrigine induced adverse drug reactions (ADRs) to provide reference for clinical safe drug use.Methods: All the clinical data were collected from 476 patients monitored lamotrigine serum concentration from Jan.2016 to Nov.2018 in Xi’an Central Hospital.The general information medication,medication situation,serum concentration of lamotrigine,and occurrence and outcome of ADRs were statistically analyzed by Excel.Results: A total of 55 cases of ADRs were determined by correlation evaluation including 32 males with the incidence of ADRs of 12.44%(55 /442),23 female with the incidence of ADRs of 11.11%(23 /207),and 20 children with the incidence of ADRs of 17.39%(20 /115).Neurological damage (58.82%),digestive system damage (19.12%) and skin and its accessories damage (13.24%) were the most common.There were 45 cases of common ADRs,8 cases of rare ADRs (including 2 cases of severe ADRs: one case of aseptic meningitis and one case of acute liver injury),and 2 cases of new ADRs.The incidence of lamotrigine induced ADRs was 80.00% in patients with serum concentration of lamotrigine higher than the reference concentration.Except for 2 cases of ataxia and one case of body mass gain,all the patients were recovered after the drug withdrawal,dosage adjustment and symptomatic support treatment.Conclusion: Lamotrigine induced ADRs has individual differences,and the incidence of ADRs in children is relatively high.Serum concentration monitoring of lamotrigine and genetic testing are conducive to individualized and accurate treatment of epilepsy patients.

关 键 词：药品不良反应 拉莫三嗪 血药浓度 无菌性脑膜炎 急性肝损伤 

分 类 号：R971.6[医药卫生—药品]