基于FAERS数据库的布比卡因脂质体药品不良反应信号挖掘与分析  

Signal mining and analysis of adverse drug reactions of bupivacaine liposome based on FAERS database

作　　者：李桂凤[1] 朱增燕[1] 尚翔[2] 李芳 诸俊[1] LI Guifeng;ZHU Zengyan;SHANG Xiang;LI Fang;ZHU Jun(Department of Pharmacy,Children′s Hospital of Soochow University,Jiangsu Province,Suzhou 215001,China;不详)

机构地区：[1]苏州大学附属儿童医院药剂科,江苏省苏州市215001 [2]江苏省苏州市广济医院药学部,215137

出　　处：《临床合理用药》2025年第5期1-5,共5页Chinese Journal of Clinical Rational Drug Use

基　　金：中国红十字基金会项目(CRCF-YXFN-202302016)。

摘　　要：目的基于美国FDA不良事件报告系统(FAERS)数据库,挖掘与分析布比卡因脂质体药品不良反应(ADR)信号,为儿童临床安全用药提供依据。方法检索FAERS数据库2011年10月1日—2023年6月30日布比卡因脂质体相关ADR报告,采用报告比值比法和比例报告比值比法进行数据挖掘和分析,根据《国际医学用语词典》ADR术语集中的系统器官分类(SOC)和首选术语(PT)对ADR报告进行描述和分类。结果共检索到以布比卡因脂质体为首要怀疑药物的ADR报告1672份,涉及男性患者271例(16.21%),女性患者533例(31.88%),性别不详868例(51.91%);年龄以缺失1170例(69.98%)为主,<18岁20例(1.20%)占比最小;主要上报地区为北美洲1621例(96.95%)。共挖掘分析得到141个PT,排除与药物无关的信号后还有75个PT,其中20个PT未在布比卡因脂质体注射液的说明书中提及,ADR信号排名前5位的PT是麻醉剂心脏并发症、股神经麻痹、局麻药全身毒性反应、手术后肠梗阻、膈神经性瘫痪。共涉及SOC 15种,前3位的SOC为各类损伤、中毒及操作并发症、各类神经系统疾病、全身性疾病及给药部位各种反应。结论布比卡因脂质体导致的ADR常见的有疼痛、感觉减退、尿潴留、低血压、感染等,临床使用该药期间可重点关注患者的给药部位和神经系统的各种反应,保障临床用药安全。Objective To explore and analyze the signals of ADR of bupivacaine liposome,and to provide evidence for clinically safe use of drug in children,based on the FAERS database.Methods The FAERS database was searched for bupivacaine liposome-associated ADR reports from October 1,2011,to June 30,2023,and data were mined and analyzed by using the report odds ratio method and proportional reporting odds ratio method.ADR reports were described and classified according to the system organ classification and preferred terminology in Medical Dictionary for Regulatory Activities.Results A total of 1672 ADR reports with bupivacaine liposome as the primary suspect drug were detected,involving 271 male patients(16.21%),533 female patients(31.88%)and 868 unknown patients(51.91%).There were 1170 cases(69.98%)of missed age and 20 cases(1.20%)were less than 18 years old.The main reporting region was North America 1621 cases(96.95%).A total of 141 PTs were obtained through mining and analysis,and 75 PTs were obtained after excluding signals unrelated to drugs,20 PTs were not mentioned in the instructions of bupivacaine liposome injection.The top 5 PTs were anesthetic cardiac complications,femoral nerve palsy,systemic toxic reactions of local anesthetics,postoperative intestinal obstruction and phrenic paralysis.A total of 15 kinds of SOCs were involved,and the top 3 SOCs were various injuries,poisonings and operational complications,various neurological diseases,systemic diseases and various reactions at the administration site.Conclusion The common ADR caused by bupivacaine liposome includes pain,hypoesthesia,urinary retention,hypotension,infection,etc.During clinical use of this drug,attention can be paid to various reactions of the patient′s administration site and nervous system,to ensure clinical drug safety.

关 键 词：布比卡因脂质体 药品不良反应 FAERS数据库 信号挖掘 安全性 儿童 

分 类 号：R97[医药卫生—药品]