基于FAERS的阿片类药物便秘不良事件数据挖掘  

Data Mining of Opioids-Induced Constipation Adverse Events Based on FAERS

作　　者：周磊 朱炜炜[1] 李里[1] 杜晓艳 吴斌[1] ZHOU Lei;ZHU Weiwei;LI Li;DU Xiaoyan;WU Bin(West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西医院,四川成都610041

出　　处：《中国药业》2024年第20期115-119,共5页China Pharmaceuticals

基　　金：国家重点研发计划课题[2020YFC2008302]。

摘　　要：目的促进阿片类药物的临床合理使用。方法提取美国食品和药物管理局不良事件报告系统(FAERS)2004年至2022年阿片类药物(11个)的药品不良事件(ADE)报告,采用报告比值比法(ROR)和信息组件(IC)法进行数据分析。结果共纳入400986例以阿片类药物为首要怀疑药物的报告,其中便秘事件6045例。2004年至2022年,阿片类药物ADE报告及便秘事件报告数量均呈上升趋势;阿片类药物引起的便秘以北美洲患者(71.65%)及非健康专家(57.44%)报告为主。报告数量排名前5的阿片类药物分别为羟考酮(2394例)、芬太尼(895例)、丁丙诺啡(846例)、吗啡(791例)、曲马多(596例),累计占比超90%;共8个药品生成信号,其中羟考酮[ROR=1.54,95%CI(1.48,1.61)]、芬太尼[ROR=1.33,95%CI(1.24,1.42)]、丁丙诺啡[ROR=1.32,95CI%(1.23,1.41)]、吗啡[ROR=2.27,95%CI(2.11,2.44)]、曲马多[ROR=2.03,95%CI(1.87,2.20)]与便秘存在明显关联;随着患者年龄增大,ADE信号强度增加。便秘病例阿片类药物以口服(羟考酮、吗啡、曲马多)和经(透)皮给药(芬太尼、丁丙诺啡)为主。结论阿片类药物的使用与便秘存在相关性,临床应加强监测长期使用该类药物老年患者的相关胃肠道功能,保障患者的用药安全,同时进一步提高药学服务质量。Objective To promote the rational clinical use of opioids.Methods The drug adverse event(ADE)reports of 11 opioids in the FDA Adverse Event Reporting System(FAERS)from 2004 to 2022 were extracted,and the reporting odds ratio(ROR)and information component(IC)methods were use for data analysis.Results A total of 400986 cases of reports with opioids as the primary suspected drug were included,including 6045 cases of constipation events.The quantity of opioids-induced ADE reports and opioids-induced constipation(OIC)events showed an upward trend from 2004 to 2022.The cases of OIC were mainly from the North America(71.65%),and 57.44%were reported by non-health experts.The top five opioids with more reports were oxycodone(2394 cases),fentanyl(895 cases),buprenorphine(846 cases),morphine(791 cases)and tramadol(596 cases),accounting for over 90%cumulatively.Eight drugs generated signals,among which oxycodone[ROR=1.54,95%CI(1.48,1.61)],fentanyl[ROR=1.33,95%CI(1.24,1.42)],buprenorphine[ROR=1.32,95%CI(1.23,1.41)],morphine[ROR=2.27,95%CI(2.11,2.44)]and tramadol[ROR=2.03,95%CI(1.87,2.20)]were significantly associated with constipation;and the ADE signal intensity increased with age.Oral(oxycodone,morphine,tramadol)and transdermal(fentanyl,buprenorphine)were the main routes of administration in constipation cases.Conclusion There is a correlation between the use of opioids and constipation.We should strengthen monitoring of the gastrointestinal function of elderly patients using opioids for a long time to ensure their medication safety,and improve the quality of pharmaceutical care.

关 键 词：阿片类药物 便秘 美国食品和药物管理局不良事件报告系统 数据挖掘 

分 类 号：R969.3[医药卫生—药理学] R971[医药卫生—药学]