钠-葡萄糖共转运蛋白2抑制剂与生殖器感染不良事件:基于真实世界的上市后监测数据分析  

Genital infections following the use of different sodium-glucose cotransporter-2 inhibitors:a real-world analysis of post-marketing surveillance data

作　　者：商永光 张镭[2] 郭冬杰[2] 邵宏[1] SHANG Yong-guang;ZHANG Lei;GUO Dong-jie;SHAO Hong(Department of Pharmacy Administra-tion and Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Baeijing 10191,China;Department of Phar macy,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]北京大学医学部药学院药事管理与临床药学系,北京100191 [2]中日友好医院药学部,北京100029

出　　处：《中国医院药学杂志》2020年第16期1739-1743,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:挖掘及评价不同钠-葡萄糖共转运蛋白2抑制剂(Sodium-Glucose Cotransporter-2 Inhibitors,SGLT-2i)与生殖器感染不良事件的关联性及特点。方法:基于2004年第一季度至2019年第二季度美国药监局不良事件报告系统主数据库数据,运用比例失衡测量法及贝叶斯分析法对不同SGLT-2i与生殖器感染不良事件的相关性进行数据挖掘与评价,同时比较不良事件的发生时间及预后。结果:经评价为SGLT-2i导致生殖器感染报告例数254份;7种SGLT-2i中恩格列净/盐酸二甲双胍与生殖器感染不良事件关联性最强(ROR=16.34,95%CI=12.73~20.97;PRR=16.15,χ^2=889.11;EBGM=16.03,95%CI的,=12.49);SGLT-2i与盐酸二甲双胍组成的复方制剂相比于SGLT-2i具有更高的生殖器感染风险;不良事件致残或致死率坎格列净27.4%(20/73)vs.达格列净11.9%(5/42)vs.恩格列净12.8%(16/125)具有显著差异(P=0.007)。结论:本研究通过对FAERS数据的挖掘和分析,为不同SGLT-2i相关生殖器感染的风险及特点提供精准数据支持,同时本研究可对该不良事件进行持续监测,对相关药物风险进行识别与比较。OBJECTIVE To test the correlation between the use of sodium glucose cotransporter-2 inhibitors(SGLT-2 i)and Genital infections(GIs) occurrences by assessing the publicly available United States Food and Drug Administration Adverse Event Reporting System(FAERS).METHODS Disproportionality analysis and Bayesian analysis were used to mine suspected GIs data for SGLT-2 i use from the first quarter in 2004 to the second quarter in 2019 of the FAERS,and the time to onset and fatality rates of myocarditis following different ICI regimens were also compared. RESULTS A total of 254 reports of GIs adverse events were identified with SGLT-2 i.Among 7 SGLT-2 is,empagliflozin/metformin hydrochloride had the highest association with GIs based on the highest reporting odds ratio(ROR=16.34,95% two-sided CI=12.73-20.97),proportional reporting ratio(PRR=16.15,χ^2=889.11)and empirical Bayes geometric mean(EBGM=16.03,95% one-sided CI=12.49).The combination of canagliflozin,dapagliflozin,empagliflozin plus metformin hydrochloride had higher GIs risk than single preparation;The ratio of death or disability of different SGLT-2 i associated GIs was significant different(P=0.007):Canagliflozin(27.4%,20/73)vs.dapagliflozin(11.9%,5/42)vs.Empagliflozin(12.8%,16/125).CONCLUSION This study provides accurate data support for the risk and characteristics of genital infections associated with different SGLT-2 i through the mining and analysis of FAERS data,and this study can continuously monitor this adverse event and identify and compare the associated drug risks.

关 键 词：钠-葡萄糖共转运蛋白2抑制剂 生殖器感染 不良反应 美国不良事件报告系统 数据挖掘 

分 类 号：R969[医药卫生—药理学]