摘要
目的基于美国食品药品管理局(FDA)不良事件报告系统(FAERS),对加巴喷丁类药物(加巴喷丁和普瑞巴林)相关不良事件进行数据挖掘,为临床安全使用加巴喷丁类药物提供参考。方法下载2004—2019年共64个季度FAERS数据,经药品提取系统(MedEx)药品名称标准化、国际医学用语词典(MedDRA)不良事件系统分类等数据清洗,提取以加巴喷丁类药物(加巴喷丁和普瑞巴林)为首要怀疑药品的不良事件报告病例,采用比例报告比值法(PRR)和报告比值比法(ROR)进行信号检测。结果共提取到以加巴喷丁类药物为首要怀疑药品的不良事件报告病例121701例(加巴喷丁27744例,普瑞巴林93957例);男女比例0.46,中位年龄59岁,报告者多为消费者(56.35%)和医师(21.67%);美国报告最多,占81.97%。主要给药途径为口服;另有超过半数的病例未报告给药途径。加巴喷丁和普瑞巴林检测出双信号(PRR法和ROR法均检出信号)的报告例数分别为16415例(占加巴喷丁报告总例数的18.32%)和79589例(占普瑞巴林报告总例数的27.33%);两者神经系统疾病、全身性疾病及给药部位反应、精神病类、损伤、中毒及手术并发症的报告例数均相对较多;加巴喷丁检测出双信号且报告例数排名前5位的首选术语(PT)依次为药物性超敏反应、嗜睡、对非适应证用药无效、产品用于未经批准的适应证、自杀念头;国内说明书尚未载明自杀念头的风险。普瑞巴林检测出双信号的PT中,撤退综合征、药物戒断综合征、故意错用产品、故意导致的产品使用问题等的报告例数排在前15位。结论该研究有效地利用PRR法和ROR法挖掘加巴喷丁类药物不良反应信号,建议临床用药时充分考虑加巴喷丁类药物可能的不良反应,合理用药,并做好用药监护。
Objective To detect and analyze safety signals of gabapentinoids(gabapentin and pregabalin)by the data mining methods based on FDA adverse event reporting system(FAERS)database,and to provide references for clinical safe use of gabapentinoids.Methods Data from FARES from 2004Q1 to 2019Q4(64 quarters)were downloaded.After drug names standardization by MedEx and adverse events classification by MedDRA etc.,the adverse event report cases were extracted using the gabapentin and pregabalin as the primary suspected drug,and the ADR signal detection was conducted using PRR and ROR methods.Results A total of 121701 cases(gabapentin 27744 cases,pregabalin 93957 cases)were gathered.Among them,the male/female ratio was 0.46,and the median age was 59 years old.Reports from“consumers”accounted for 56.35%,and from“physicians”accounted for 21.67%.Most reports were from the United States,accounting for 81.97%.The main route of administration were oral.More than half of the cases did not report the route of gabapentinoids administration.ADR signals were detected by proportional reporting ratio(PRR)method and reporting odds ratio(ROR)method,of which 16415 cases(18.32%)for gabapentin and 79589 cases(27.33%)for pregabalin.The number of reported cases of“nervous system disorders”,“general disorders and administration site conditions”,“psychiatric disorders”and“injury,poisoning and procedural complications”was relatively large for both.The top 5 preferred term(PT)for gabapentin which was detected ADR daul-signals were as follow:drug hypersensitivity,somnolence,drug ineffective for unapproved indication,product use in unapproved indication,suicidal ideation,of which“suicidal ideation”has not been included in Chinese gabapentin specification yet.The top 15 preferred term(PT)for pregabalin which was detected ADR daul-signals include withdrawal syndrome,drug withdrawal syndrome,intentional product misuse and intentional product use issue.Conclusion In this study,ROR and PRR are effectively used to extract the a
作者
龚巧燕
吴斌
罗敏
徐珽
GONG Qiaoyan;WU Bin;LUO Min;XU Ting(Department of Pharmacy,West China Hospital,Sichuan University,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2021年第11期1580-1589,共10页
Herald of Medicine
基金
2018年四川省干部保健科研课题(川干研2018-104)。
