摘要
目的:挖掘和评价中利格列汀上市后的不良反应adverse drug reactions(ADR)信号,为临床用药提供参考。方法:对FDA不良事件报告系统(AERS)采用报告比值比(ROR)法挖掘出利格列汀的不良反应信号,统计分析纳入研究信号对应的用药信息。结果:研究纳入AERS 2011年第1季度~2018年第3季度不良事件报告共25 617 331份,首要怀疑利格列汀的报告11 240份,挖掘出利格列汀不良反应信号213个,其中皮肤和皮下组织不良反应信号35个。发生皮肤和皮下组织不良反应患者中,男女比例相似,年龄集中在40岁以上。与其他不良反应相比,皮肤和皮下组织不良反应在患者性别(P=0. 427)、年龄(P=0. 679)、剂量(P=0. 174)无统计学差异,在用药时长(P=0. 001)有统计学差异。结论:利格列汀可引起多种皮肤反应如皮疹、水疱、皮肤剥脱、史蒂文斯-约翰逊综合征等,用药时需密切观察。
Objective: To mine and evaluate the adverse drug reactions (ADR) signals induced by linagliptin in post-marketing experience and to provide references for clinical medication. Methods: ROR method was used to mine the ADR signals of linagliptin from the Adverse Event Reporting System (AERS) submitted to FDA. The medication information related to the study signal was statistically analyzed. Results: A total of 25 617 331 reports of AERS from January 2011 to September 2018 were included into the study,among which 11 240 were primarily suspected to be related tolinagliptin. Atotal of 213 ADR signals related to linagliptin were mined,among which 35 signals were regarding skin and subcutaneous tissue. Among the patients with skin and subcutaneous tissue ADRs,the ratios of male and female were almost equal,and the patients concentrated at ages of 40 years old or above. Comparing skin and subcutaneous tissue adverse reactions to others,significant difference was observed in medication duration (P = 0. 001),but not in gender (P = 0. 427),age (P = 0. 679),and dosage (P = 0. 174).Conclusion: Linagliptin might cause multiple skin reactions such as rash,blister,skin exfoliation,Stevens-Johnson syndrome and so on,thus medication of linagliptin should be carefully monitored.
作者
彭媛
周玥
冯婧
杨明
赵曜
刘福
PENG Yuan;ZHOU Yue;FENG Jing;YANG Ming;ZHAO Yao;LIU Fu(Department of Pharmacy,Affiliated Hospital of North Sichuan Medical College,Nanchong 637000,China;Department of Pharmacy,Nanchong Second People's Hospital,Nanchong 637000,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第5期595-600,共6页
Chinese Journal of New Drugs
基金
2017年川北医学院附属医院院级科研课题(58)。
关键词
利格列汀
自发呈报系统
信号挖掘
药物警戒
linagliptin
spontaneous reporting system
signals mining
pharmacovigilance
