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卡格列净联合依那普利治疗糖尿病肾病患者的临床研究

Clinical trial of canagliflozin combined with enalapril in the treatment of diabetic nephropathy
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摘要 目的观察卡格列净与依那普利联合应用于糖尿病肾病(DN)中的效果。方法将DN患者随机分成对照组和试验组。2组患者均接受重组人胰岛素注射液的基础治疗,对照组口服依那普利片10 mg(qd);试验组在对照组治疗的基础上,口服卡格列净片100 mg(qd)。2组患者均治疗8周。比较2组患者的肾功能、血糖指标、血清血管内皮生长因子(VEGF)、转化生长因子-β(TGF-β)、同型半胱氨酸(HCY)水平、临床疗效及药物不良反应发生率。结果对照组和试验组分别纳入71例和73例。治疗后,试验组和对照组的β2微球蛋白(β2-MG)分别为(0.21±0.03)和(0.28±0.04)mg·L^(-1);血尿素氮(BUN)分别为(4.23±0.42)和(5.58±0.65)mmol·L^(-1);血肌酸酐(SCr)分别为(89.32±8.29)和(101.25±10.18)μmol·L^(-1);24 h微量白蛋白(mAlb)分别为(49.38±5.06)和(58.21±6.43)mg;糖化血红蛋白(HbA1c)分别为(6.10±0.11)%和(6.45±0.16)%;餐后2 h血糖分别为(6.05±0.78)和(7.68±1.82)mmol·L^(-1);空腹血糖(FBG)分别为(5.02±0.32)和(5.67±0.65)mmol·L^(-1);VEGF分别为(350.18±20.04)和(389.04±24.16)pg·mL^(-1);TGF-β分别为(148.32±16.57)和(168.24±20.02)pg·mL^(-1);HCY分别为(13.12±2.38)和(19.35±3.21)μmol·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组总有效率分别为83.56%(61例/73例)和67.61%(48例/71例),在统计学上差异有统计学意义(P<0.05)。试验组和对照组的药物不良反应总发生率分别为6.85%和4.23%,在统计学上差异无统计学意义(P>0.05)。结论卡格列净联合依那普利用于治疗糖尿病肾病效果确切,可改善患者肾功能,调节血糖代谢,下调血清VEGF、TGF-β、HCY水平,且安全性可靠。 Objective To observe the effect of canagliflozin combined with enalapril on diabetic nephropathy(DN).Methods DN patients were randomly divided into control group and treatment group.All patients in 2 groups received basic treatment of recombinant human insulin injection,and the control group was orally administered enalapril tablet 10 mg(qd).The treatment group was given orally canagliflozin tablet 100 mg(qd)on the basis of the control group.Both groups were treated for 8 weeks.Renal function,blood glucose index,serum vascular endothelial growth factor(VEGF),transforming growth factor-β(TGF-β),homocysteine(HCY)levels,clinical efficacy and incidence of adverse drug reactions were compared between 2 groups.Results There were 71 cases were included in the control group and 73 cases in the treatment group.After treatment,β2 microglobulin(β2-MG)in treatment group and control group were(0.21±0.03)and(0.28±0.04)mg·L^(-1);blood urea nitrogen(BUN)were(4.23±0.42)and(5.58±0.65)mmol·L^(-1);serum creatinine(SCr)were(89.32±8.29)and(101.25±10.18)μmol·L^(-1);24 h microalbumin(mAlb)were(49.38±5.06)and(58.21±6.43)mg;glycosylated hemoglobin(HbA1c)were(6.10±0.11)%and(6.45±0.16)%;2 h postprandial blood glucose levels were(6.05±0.78)and(7.68±1.82)mmol·L^(-1);fasting blood glucose(FBG)were(5.02±0.32)and(5.67±0.65)mmol·L^(-1);VEGF levels were(350.18±20.04)and(389.04±24.16)pg·mL^(-1);TGF-βwere(148.32±16.57)and(168.24±20.02)pg·mL^(-1);HCY were(13.12±2.38)and(19.35±3.21)μmol·L^(-1),the differences were statistically significant(allP<0.05).After treatment,the total effective rate of treatment group and control group were 83.56%(61 cases/73 cases)and 67.61%(48 cases/71 cases),the difference was statistically significant(P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 6.85%and4.23%,with no significant difference(P>0.05).Conclusion Canagliflozin combined with enalapril is effective in the treatment of diabetic nephropathy,which can improve renal function,regulate blood glucose metabolism,and down-regulate serum VEGF,TGF-βand HCY levels,and is safe and reliable.
作者 邹俊杰 郭嘉惠 殷汉 王漾漾 张金龙 李玲 ZOU Jun-jie;GUO Jia-hui;YIN Han;WANG Yang-yang;ZHANG Jin-long;LI Ling(Department of Pharmacy,Zhongda Hospital Affiliated to Southeast University,Nanjing 210003,Jiangsu Province,China;Department of Endocrinology,Zhongda Hospital Affiliated to Southeast University,Nanjing 210003,Jiangsu Province,China)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2024年第9期1248-1251,共4页 The Chinese Journal of Clinical Pharmacology
基金 江苏省自然科学基金资助项目(BK20201350)。
关键词 卡格列净 依那普利 糖尿病肾病 临床疗效 安全性 canagliflozin enalapril diabetic nephropathy clinical effect safety
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