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达格列净联合百令胶囊治疗糖尿病肾病患者的有效性及安全性评价

Efficacy and safety of dapagliflozin combined with Bailing Capsule in treatment of patients with diabetic kidney disease
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摘要 目的评估达格列净联合百令胶囊对糖尿病肾病(diabetic kidney disease,DKD)患者治疗的有效性及安全性。方法选取青岛大学附属医院2019年1月—2023年12月收治的早期DKD患者1162例,经倾向评分匹配(PSM)均衡组间协变量后,根据治疗方法不同分为对照组(达格列净单药组)与联合组(达格列净+百令胶囊治疗组),每组417例。比较两组患者治疗12个月后的临床疗效、血糖指标水平、肾功能指标水平、安全性指标(肝功能、血常规指标)水平及不良事件发生率。结果治疗12个月后,联合组患者临床疗效显著高于对照组(Z=2.919,P<0.05);联合组患者空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)水平低于治疗前,且治疗前后的差值显著高于对照组(t=41.91~59.57,P<0.05);联合组患者血液中肌酐(Scr)、尿素氮(BUN)水平和尿液中的24 h尿蛋白含量(24hUpro)、尿蛋白排泄率(UAER)显著低于治疗前,且治疗前后的差值也显著高于对照组(t=12.51~154.90,P<0.05)。治疗12个月后,两组患者的肝功能、血常规指标水平均在正常范围内,低糖血症、尿路感染等不良事件的发生比例比较也无显著差异(P>0.05)。结论达格列净联合百令胶囊可以显著降低DKD患者血糖水平,改善肾功能的各项指标,临床疗效优于达格列净单药治疗,且安全性良好。 Objective To investigate the efficacy and safety of dapagliflozin combined with Bailing Capsule in the treatment of patients with diabetic kidney disease(DKD).Methods A total of 1162 patients with early-stage DKD who were admitted to The Affiliated Hospital of Qingdao University from January 2019 to December 2023 were enrolled,and after propensity score matching was performed to balance intergroup covariates,the patients were divided into control group(dapagliflozin monotherapy)and combination group(dapagliflozin+Bailing Capsule)according to their treatment modality,with 417 patients in each group.The two groups were compared in terms of clinical outcome,blood glucose parameters,renal function parameters,safety indicators(liver function and routine blood test results),and the incidence rate of adverse events after 12 months of treatment.Results\After 12 months of treatment,the combination group had a significantly better clinical outcome than the control group(Z=2.919,P<0.05);the combination group had reductions in the levels of fasting plasma glucose,2 hour postprandial glucose,and HbA1c after treatment,with significantly greater reductions in these indicators compared with the control group(t=41.91-59.57,P<0.05).The combination group had significant reductions in serum creatinine,blood urea nitrogen,24 hour urinary protein,and urinary albumin excretion rate after treatment,with significantly greater reductions in these indicators compared with the control group(t=12.51-154.9,P<0.05).After 12 months of treatment,liver function parameters and routine blood test results remained within normal ranges in both groups,and there were no significant differences between the two groups in the incidence rates of adverse events such as hypoglycemia and urinary tract infection(P>0.05).Conclusion Dapagliflozin combined with Bailing Capsule can significantly reduce the level of blood glucose and improve renal function parameters in patients with DKD,with a better clinical effect than dapagliflozin monotherapy and with a favorable safety profile.
作者 隋营营 周泉 韩亚斐 孙加琳 韩志武 SUI Yingying;ZHOU Quan;HAN Yafei;SUN Jialin;HAN Zhiwu(School of Basic Medicine,Qingdao University,Qingdao 266073,China)
出处 《精准医学杂志》 2025年第4期326-330,共5页 Journal of Precision Medicine
基金 山东省中医药科技重点项目(Z-2022076)。
关键词 糖尿病肾病 中西医结合疗法 钠-葡萄糖共转运蛋白2抑制剂 百令胶囊 倾向性评分 治疗结果 达格列净 Diabetic nephropathies Integrated chinese traditional and western medicine therapy Sodium-glucose transporter 2 inhibitors Bailing Capsule Propensity score Treatment outcome Dapagliflozin
作者简介 通信作者:韩志武,Email:zhiwu1218@126.com;通信作者:孙加琳,Email:sjlsyyk-412@163.com。
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