卡格列净治疗2型糖尿病合并心血管高风险患者的安全性及其对相关指标的影响  

Effects of Safety and Other Related Indexes of Canagliflozin in the Treatment of Type 2 Diabetes Complicated with High Risk of Cardiovascular Disease

作　　者：翟鑫[1] 罗德钦 管频[1] 江帆[1] 冯光球[1] 陈娟[1] 曾敏[1] 钟春荣[1] 吴从印 ZHAI Xin;LUO Deqin;GUAN Pin;JIANG Fan;FENG Guangqiu;CHEN Juan;ZENG Min;ZHONG Chunrong;WU Congyin(Health Care Zone 4,Hainan Provincial People’s Hospital/Hainan Hospital Affiliated to Hainan Medical College,Haikou 570311,China;Dept.of Endocrinology and Metabolism,Haikou People’s Hospital/Haikou Hospital Affiliated to Xiangya Medical College,Central South University,Haikou 570208,China)

机构地区：[1]海南省人民医院/海南医学院附属海南医院保健中心四区,海口570311 [2]海口市人民医院/中南大学湘雅医学院附属海口医院内分泌代谢科,海口570208

出　　处：《中国药房》2020年第16期2005-2009,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81760054);海南省基础与应用基础研究计划(No.2019RC367)。

摘　　要：目的:观察卡格列净治疗2型糖尿病合并心血管高风险患者的安全性及其对相关指标的影响。方法:选择2018年12月-2019年4月海南省人民医院和海口市人民医院收治的2型糖尿病合并心血管高风险患者306例,按随机数字表法分为观察组(153例)和对照组(153例)。对照组患者给予胰岛素、二甲双胍、磺酰脲类等常规降糖药物治疗;观察组患者在对照组治疗的基础上给予卡格列净片100 mg,每日1次,口服。两组患者的疗程均为1年。观察两组患者治疗前后糖化血红蛋白(HbA1c)水平和体质量指数(BMI)、舒张压(SBP)、收缩压(DBP)和肾小球滤过率估计值(eGFR)并记录用药后安全性(心血管原因死亡、心肌梗死、缺血性卒中、心力衰竭住院、全因死亡等)和治疗期间严重不良反应/事件(低血糖、糖尿病酮症酸中毒、骨折、急性肾损伤等等)的发生情况。结果:对照组共有5例患者未完成随访,其中3例退出研究、2例失访;观察组共有4例患者未完成随访,其中1例退出研究、3例失访。治疗前,两组患者HbA1c水平和BMI、SBP、DBP、eGFR比较,差异均无统计学意义(P>0.05)。治疗后,两组患者HbA1c水平和观察组患者BMI、SBP均显著低于同组治疗前,且观察组显著低于对照组(P<0.05);两组患者治疗后eGFR均显著高于同组治疗前,且观察组显著高于对照组(P<0.05)。观察组患者心血管原因死亡发生率、全因死亡率均显著低于对照组(P<0.05);两组患者其他安全性指标及严重不良反应/事件发生率比较,差异均无统计学意义(P>0.05)。结论:卡格列净可显著降低2型糖尿病合并心血管高风险患者的心血管原因死亡及全因死亡的发生风险,改善其血糖、血压,且不会增加严重不良反应/事件的发生。OBJECTIVE:To observe the safety and other related indexes of canagliflozin in the treatment of type 2 diabetes complicated with high risk of cardiovascular disease.METHODS:Totally 306 patients,admitted to Hainan Provincial People’s Hospital and Haikou People’s Hospital,with type 2 diabetes complicated with high risk of cardiovascular disease were selected from Dec.2018 to Apr.2019.They were divided into observation group(153 cases)and control group(153 cases)according to random number table.The control group was treated with insulin,metformin or sulfonylureas conventional hypoglycemic therapy,and the observation group was treated with Canagliflozin tablets 100 mg,once a day,po,on the basis of control group.The course of treatment was 1 year in both groups.The levels of HbA1c,BMI,SBP,DBP and e GFR before and after treatment were observed in 2 groups,and the incidence of safety(including death from cardiovascular causes,myocardial infarction,ischemic stroke,hospitalization for heart failure and death from any cause etc.)after treatment and serious ADR/ADE(including hypoglycemia,diabetic ketoacidosis,fracture,acute kidney injury etc.)during the treatment were recorded.RESULTS:A total of 5 patients in the control group were not followed up,in which 3 quited and 2 were lost;and 4 patients in the observation group were not followed up,in which 1 quited and 3 were lost.Before treatment,there were no statistical significance in the levels of HbA1c,BMI,SBP,DBP and eGFR between 2 groups(P>0.05).After treatment,HbA1c levels of 2 groups,BMI and SBP of observation group were all significantly lower than those before treatment with the same group;HbA1c level and SBP of observation group were significantly lower than those of control group(P<0.05).eGFR levels of 2 groups after treatment were significantly higher than before treatment with the same group,while the observation group was significantly higher than that of contrl group.The incidence of death from cardiovascular causes and death from any cause in observation grou

关 键 词：2型糖尿病 卡格列净 心血管 高风险 安全性 

分 类 号：R587.1[医药卫生—内分泌]