摘要
目的探讨2型糖尿病住院患者恩格列净不良反应的发生情况。方法通过医院信息系统收集2020年5月1日至12月31日在中日友好医院住院期间使用恩格列净的所有患者的病历资料,根据药品说明书指出的主要不良反应,就应用恩格列净后尿路感染、低血糖和低血压等事件的发生情况进行回顾性分析,依据《药品不良反应报告和监测工作手册》进行药物与不良反应的因果关系评价,将评价结果为肯定、很可能和可能者判定为恩格列净不良反应。结果设定时段内应用恩格列净治疗的住院患者共718例,男性517例,女性201例;年龄(59±12)岁;恩格列净剂量均为10 mg口服、1次/d,用药时间为(7±3)d;住院时间为(8±4)d。718例患者中有17例(2.4%)发生恩格列净相关不良反应(因果关系评价结果均为可能),其中发生尿路感染(均表现为无症状细菌尿)者11例(1.5%),低血糖4例(0.6%),低血压2例(0.3%)。发生不良反应的17例患者中男性8例,女性9例,女性不良反应发生率明显高于男性[4.5%(9/201)比1.5%(8/517),χ^(2)=5.376,P=0.020];发生尿路感染的11例患者中男性4例,女性7例,女性尿路感染发生率明显高于男性[3.5%(7/201)比0.8%(4/517),χ^(2)=7.040,P=0.008]。17例患者的病历中均未记载上述不良反应与恩格列净相关,也均未作为药物不良反应上报。结论2型糖尿病住院患者恩格列净相关不良反应主要表现为尿路感染、低血糖和低血压,对女性患者尤应加强尿路感染的防范。临床医务人员对恩格列净不良反应的认识有待提高。
Objective To explore the occurrence of adverse reactions of empagliflozin in hospi-talized patients with type 2 diabetes mellitus.Methods Medical records of all patients who were treated with empagliflozin during hospitalization in China-Japan Friendship Hospital from May 1 to December 31,2020 were collected through the hospital information system.According to the main adverse reactions indi-cated in the label of empagliflozin,the occurrence of urinary tract infection,hypoglycemia,and hypotension after the application of empagliflozin was retrospectively analyzed.According to the Handbook of Adverse Drug Reaction Reporting and Monitoring in China,the causality between drugs and adverse reactions was evaluated,and those adverse events that were certainly,probably,and possibly related to empagliflozin were judged as empagliflozin-related adverse reactions.Results A total of 718 inpatients received empa-gliflozin treatment during the study period,including 517 males and 201 females,with age of(59±12)years.The doses of empagliflozin were all 10 mg orally once daily.The treatment time was(7±3)days and the length of hospital stay was(8±4)days.Among 718 patients,17(2.4%)experienced adverse reactions possibly related to empagliflozin,including 11(1.5%)with urinary tract infection(all showing asymptomatic bacteriuria),4(0.6%)with hypoglycemia,and 2(0.3%)with hypotension.There were 8 males and 9 females among the 17 patients with adverse reactions,and the incidence of adverse reactions in females was significantly higher than that in males[4.5%(9/201)vs.1.5%(8/517),χ^(2)=5.376,P=0.020].Among the 11 patients with urinary tract infection,4 were male,7 were female,and the incidence of urinary tract infec-tion in females was significantly higher than that in males[3.5%(7/201)vs.0.8%(4/517),χ^(2)=7.040,P=0.008].In the medical records of the 17 patients,the above-mentioned adverse reactions were all not documented as related to empagliflozin,and were all not reported as adverse drug reactions.Conclusions The adverse reactio
作者
高文娟
李朋梅
赵莉
Gao Wenjuan;Li Pengmei;Zhao Li(Department of Pharmacy,China‑Japan Friendship Hospital,Beijing 100029,China;Department of Pharmacy,Baoan District Shiyan People′s Hospital,Shenzhen 518108,China)
出处
《药物不良反应杂志》
CSCD
2021年第6期293-297,共5页
Adverse Drug Reactions Journal
关键词
钠‐葡萄糖转运蛋白2抑制剂
糖尿病
2型
泌尿道感染
低血糖症
低血压
恩格列净
Sodium-glucose transporter 2 inhibitors
Diabetes mellitus,type 2
Drug-related side effects and adverse reactions
Urinary tract infections
Hypoglycemia
Hypotension
Empa-gliflozin
