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生脉散加味治疗2型糖尿病急性肾损伤患者的临床疗效及对其肾保护的作用机制

Clinical Efficacy of Modified Shengmai Powder in the Treatment of Type 2 Diabetes Mellitus Patients with Acute Kidney Injury and Its Renal Protective Mechanism
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摘要 目的 探讨生脉散加味治疗2型糖尿病(Type 2 diabetes mellitus,T2DM)急性肾损伤(Acute kidney injury,AKI)的临床疗效及对其肾功能保护的作用机制研究。方法 选取2021年3月—2023年3月期间贵州中医药大学第二附属医院收治的T2DM合并AKI患者110例,按随机数字表法分为对照组和观察组,每组各55例。对照组给予西医治疗,观察组在对照组基础上联合生脉散加味治疗。治疗4周后,观察比较两组患者临床分级疗效,治疗前后中医证候评分、糖代谢指标[空腹血糖(Fasting blood glucose,FPG)、餐后2 h血糖(2-hour postprandial blood glucose,2 h PG)、糖化血红蛋白(Glycosylated hemoglobin,HbA1c)]、肾功能指标[血清肌酐(Serum creatinine,Scr)、尿素氮(Urea nitrogen,BUN)、内生肌酐清除率(Creatinine clearance rate,Ccr)、尿白蛋白排泄率(Urinary albumin excretion rate,UAER)、尿微量白蛋白(Micro-albumin,mALB)]、肾损伤标志物[血清胱抑素C(Cystatin C,CysC)和尿中性粒细胞明胶酶相关载脂蛋白(Neutrophil gelatinase associated apolipoprotein,NGAL)、肾损伤分子-1(Kidney injury molecule-1,KIM-1)]及炎症因子[超敏C反应蛋白(Hypersensitive C-reactive protein,hs-CRP)、肿瘤坏死因子-α(Tumor necrosis factor-α,TNF-α)、白介素-1β(Interleukin-1β,IL-1β)、白介素-6(Interleukin-6,IL-6)和白介素-18(Interleukin-18,IL-18)]变化。结果 治疗1周、4周后两组患者中医证候评分均较治疗前降低,差异有统计学意义(P<0.05);且观察组中医证候评分明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者FPG、2 h PG和HbA1c水平均较治疗前降低,差异有统计学意义(P<0.05);但两组间比较,差异无统计学意义(P>0.05)。治疗后两组患者肾功能BUN、Scr、UAER和mALB指标均较治疗前降低,Ccr指标均较治疗前升高,差异有统计学意义(P<0.05);且观察组肾功能指标BUN、Scr、UAER和mALB指标均明显低于对照组,Ccr指标明显高于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清CysC和尿KIM-1、NGAL水平均较治疗前降低,差异有统计学意义(P<0.05);且观察组血清CysC和尿KIM-1、NGAL水平均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清炎症因子hs-CRP、TNF-α、IL-1β、IL-6和IL-18水平均较治疗前降低,差异有统计学意义(P<0.05);且观察组血清炎症因子hs-CRP、TNF-α、IL-1β、IL-6和IL-18水平均明显低于对照组,差异有统计学意义(P<0.05)。治疗后观察组临床总有效率90.91%(50/55)明显高于对照组80.00%(44/55),差异有统计学意义(P<0.05)。两组患者均无死亡病例。治疗期间,两组患者不良反应率比较,差异无统计学意义(P>0.05)。结论 生脉散加味治疗T2DM合并AKI能够改善临床症状、提高临床疗效并保护肾功能,其机制或与下调肾损伤因子及炎症因子有关。 Objective To observe the clinical efficacy of Modified Shengmai Powder in the treatment of type 2 diabetes mellitus(T2DM)patients with acute kidney injury(AKI),and to explore its protective mechanism on renal function.Methods A total of 110 T2DM patients with AKI admitted to the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from March 2021 to March 2023 were divided into a control group(treated with Western medicine,n=55)and an observation group(treated with Western medicine and modified Shengmai Powder,n=55)by random number table.After 4 weeks of treatment,clinical efficacy and traditional Chinese medicine(TCM)syndrome scores were compared between the two groups.Glucose metabolism indexes[fasting blood glucose(FBG),2-h postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA1c)],renal function indexes[serum creatinine(Scr),blood urea nitrogen(BUN),endogenous creatinine clearance rate(Ccr),urinary albumin excretion rate(UAER),and urinary microalbumin(mALB)],kidney injury markers[serum cystatin C(CysC),urine neutrophil gelatinase-associated lipocalin(NGAL),kidney injury molecule-1(KIM-1)],and inflammatory factors[high-sensitivity C-reactive protein(hs-CRP),tumor necrosis factor-alpha(TNF-α),interleukin-1β(IL-1β),interleukin-6(IL-6),and interleukin-18(IL-18)]before and after treatment were also detected and compared.Results After 1 week and 4 weeks of treatment,the TCM syndrome scores of patients in both groups decreased(P<0.05),with the observation group showing a more significant reduction than the control group(P<0.05).Blood glucose(FBG,2hPG)and HbA1c were reduced in both groups after treatment(P<0.05),but there was no difference between the two groups(P>0.05).Levels of BUN,Scr,UAER,and mALB in both groups decreased while level of Ccr increased compared with those before treatment(P<0.05),with the observation group showing lower or higher levels than the control group(P<0.05).Serum CysC,urine KIM-1,and NGAL in both groups were down-regulated compared with those before treatment(P<0.05),and the observation group had lower levels than the control group(P<0.05).Serum inflammatory factors(hs-CRP,TNF-α,IL-1β,IL-6,and IL-18)were reduced after treatment in both groups,with the observation group showing lower levels compared with the control group(P<0.05).The total effective rate in the observation group was 90.91%(50/55),higher than the 80.00%(44/55)in the control group(P<0.05).No death was found in both groups,and there was no difference in the occurrence of adverse reactions between the two groups during treatment(P>0.05).Conclusion Modified Shengmai Powder can improve clinical symptoms,enhance clinical efficacy,and protect renal function in T2DM patients with AKI.Its mechanism may be related to the down-regulation of kidney injury and inflammatory factors.
作者 宋丹 陈莉 杨娟 杨传经 SONG Dan;CHEN Li;YANG Juan;YANG Chuan-jing(Department of Preventive Health Care,The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang Guizhou 550002;Department of Endocrinology,The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang Guizhou 550002)
出处 《世界中西医结合杂志》 2024年第4期730-736,共7页 World Journal of Integrated Traditional and Western Medicine
基金 贵州省中医药、民族医药科学技术研究专项课题项目(QZYY-2019-041)。
关键词 2型糖尿病 急性肾损伤 生脉散 肾功能 炎症 Type 2 diabetes mellitus Acute kidney injury Shengmai Powder Renal function Inflammation
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