基于FAERS数据库对复发缓解型多发性硬化症一线治疗口服药物不良事件的挖掘与分析  

Mining and analyzing adverse events of relapsing remitting multiple sclerosis first-line treatment oral drug based on FAERS data

作　　者：方琼彤 吴新荣 张美容[1] 利程 陈奕伸[1] 罗文基[1] FANG Qiong-tong;WU Xin-rong;ZHANG Mei-rong;LI Cheng;CHEN Yi-shen;LUO Wen-ji(Department of Pharmacy,The Fifth Affiliated Hospital of Sun Yat-sen University,Guangdong Zhuhai 519000,China;Department of Pharmacy,General Hospital of Southern Theatre Command of PLA,Guangdong Guangzhou 510010,China)

机构地区：[1]中山大学附属第五医院药学部,广东珠海519000 [2]中国人民解放军南部战区总医院药学部,广东广州510010

出　　处：《中国医院药学杂志》2022年第22期2366-2372,共7页Chinese Journal of Hospital Pharmacy

基　　金：2022年珠海市社会发展领域科技计划项目(编号:2220004000230)。

摘　　要：目的:对复发缓解型多发性硬化症(relapsing remitting multiple sclerosis, RRMS)一线治疗口服药物芬戈莫德、特立氟胺、富马酸二甲酯和西尼莫德的不良事件(adverse events, AE)报告进行分析,挖掘不良反应(adverse drug reaction, ADR)风险信号,对比其差异性,为临床合理用药提供参考。方法:采用比值失衡法对报告系统收录的4种RRMS一线治疗药物的AE报告进行信号挖掘。结果:检索到芬戈莫德AE报告55 634份,特立氟胺21 533份,富马酸二甲酯74 501份,西尼莫德4 018份,女性多于男性;主要上报国家是美国;发生严重AE的结局占10.78%~16.25%。4种目标药物均累及神经系统疾病,包括多发性硬化症复发、头痛和步态障碍等。另外,芬戈莫德出现脂溢性角化病、皮肤血管瘤和淋巴细胞计数减少等风险信号;特立氟胺出现膀胱疾病、肌肉无力和腹泻等信号、富马酸二甲酯需关注胃病、核磁共振成像异常和淋巴细胞计数减少等信号;西尼莫德出现黄斑水肿、心率下降和淋巴细胞计数减少等信号。结论:ADR风险信号与累及系统基本与说明书一致,证明研究的可靠性。RRMS一线治疗口服药物的风险信号有所差异,可为临床用药提供参考。OBJECTIVE To analyze the adverse events(AE)reports of the first-line treatment of oral drugs fengomod, terifluoramine, dimethyl fumarate and sinimod for relapsing remitting multiple sclerosis(RRMS),explore the risk signals of adverse reaction(ADR),compare their differences, and provide reference for clinical rational drug use.METHODS The ratio imbalance method was used to mine the adverse event reports of RRMS first-line therapies in the FDA,s adverse event reporting system.RESULTS A total AE reports of fingolimod, teriflunomide, dimethyl fumarateand siponimod 55 634,21 533,74 501 and 4 018,respectively.The main reporting country was the United States;severe AE occurred in 10.78% to 16.25% of patients.All targeted drugs were involved in neurological disorders, including recurrent multiple sclerosis, headache and gait disorders.In addition, fingolimod showed risk signals such as seborrheic keratosis, cutaneous hemangioma and reduced lymphocyte count;teriflunomide showed signs of bladder disease, muscle weakness and diarrhea, and dimethyl fumarate should be concerned about signs of stomach disease, abnormal MRI and reduced lymphocyte count.Siponimod showed signs of macular edema, decreased heart rate, and decreased lymphocyte count.CONCLUSION The ADR signal and the involved system were consistent with the instructions, proving the study’s reliability of the study.There were some differences in the RRMS first-line treatment oral drug signals in the FAERS database, which could provide a reference for clinical medication.

关 键 词：复发缓解型多发性硬性化症 芬戈莫德 特立氟胺 富马酸二甲酯 西尼莫德 不良反应信号 数据挖掘 

分 类 号：R979.1[医药卫生—药品]