目的:利用美国药品食品监督管理局不良事件报告系统(F DA Adverse Event Reporting System，FAERS)获取依库珠单抗的不良事件(adverse drug event，ADE)信息，深入评估其安全性，为药物使用提供参考。方法:通过OpenVigil 2。1网站查询和提取FAERS数据库建库至2023年3月的原始数据，筛选出涉及依库珠单抗的ADE报告，并采用报告比值比(reporting odds ratio，ROR)和比例报告比值法(proportional reporting ratio，PRR)作为信号检测指标，设定相应的阈值条件，对ADE进行统计分析和系统分类。结果:共收集到25 840份依库珠单抗的ADE报告，发现471个有效信号，涉及27个系统器官分类(sys-tem organ classification，SOC)，主要包括全身性疾病和给药部位各种反应、各类检查、感染和侵袭性疾病等。信号强度排名前3的依次为总补体活性降低、血管外溶血和血红蛋白尿。在报告的患者中，年龄主要分布在18～59岁(11。00％)，女性患者比例较男性高(42。96％vs。31。33％)。同时，还发现了新的ADE，如眼睑下垂、胆石症、脾肿大和Budd-Chiari综合征。结论:在使用依库珠单抗时，需要关注ADE高发的女性患者，同时警惕与感染相关的ADE，及时采取预防措施。此外，研究发现了一些新的ADE，临床用药过程中应提高警惕。
Signal mining and analysis of adverse drug events of eculizumab based upon FAERS
OBJECTIVE To employ the FDA Adverse Event Reporting System(FAERS)to obtain the adverse drug event(ADE)information of ecucizumab and assess its safety for provide references for rational drug dosing.METHODS Through OpenVigil 2.1 website for extracting the raw data of FAERS database until March 2023,ADE reports of ecucizumab were selected.Reporting odds ratio(ROR)and proportional reporting ratio(PRR)were utilized as signal detection parameters for set-ting the corresponding threshold conditions for statistical analysis and systematic classification of ADEs.RESULTS A total of 25840 ADE reports of eculizumab were collected with 471 valid signals.And 27 system organ classes(SOCs)included systemic diseases and administration site reactions,various examinations,infections and invasive diseases.Top three signal intensities were lower total complement activity,extravascular hemolysis and hemoglobinuria.Among the reported patients,age distribution was primarily between 18 and 59 years(11.00％)with a higher proportion of females(42.96％vs.31.33％)than males.Moreover,several novel ADEs were identified,such as eyelid ptosis,cholelithiasis,splenomegaly and Budd-Chiari syndrome.CONCLUSION During dosing of eculizumab,greater attention should be paid to females with a high incidence of ADEs.Physi-cians stay on a high vigilance for infection-associated ADEs and some new occurrences.
eculizumabFAERS databasesignal miningdisproportionality analysisadverse drug event
NETL
NSTL
万方数据
