消渴肾病方治疗气阴两虚瘀血阻络型糖尿病肾病的临床研究

发布时间：2018-06-04 22:01

本文选题：Ⅲ期糖尿病肾病 + 消渴肾病方　；参考：《山西中医学院》2016年硕士论文

【摘要】：目的:本研究通过对高继宁教授经验方“消渴肾病方”治疗早期(Ⅲ期)糖尿病肾病(气阴两虚,瘀血阻络型)随机对照的临床研究,为消渴肾病方治疗糖尿病肾病有效性及安全性提供循证医学证据。同时以氧化应激及肾脏纤维化为切入点,探讨消渴肾病方多途径、多靶点治疗糖尿病肾病的微观作用机理,为中医药治疗糖尿病肾病提供新的思路和启发。方法:将66例Ⅲ期糖尿病肾病患者按就诊顺序编号,运用随机数字表法随机分为治疗组和对照组,各33例。两组患者均给予西医糖尿病常规治疗,包括健康教育、饮食、运动、药物控制血糖、血压、血脂等,治疗组在此基础上口服消渴肾病方治疗。在治疗前、治疗第12周、第24周时观察相关疗效性及安全性指标。观察指标包括:患者症状、体征、中医症候积分及相关理化检查指标如尿常规、尿NAG酶、24小时尿蛋白、血糖、糖化血红蛋白、血清肌酐、尿素氮、胱抑素水平以评估临床疗效;检测丙二醛(MDA)的含量和超氧化物歧化酶(SOD)的活性水平,以反映氧化应激水平;测定尿转化生长因子-β1(TGF-β1)水平和IV型胶原水平,评估肾纤维化程度,从而对自拟消渴肾病方的临床疗效做出客观评价,同时检测不良反应并及时记录。结果:(1)总有效率:治疗第12周,治疗组有效率为83.33%,对照组有效率为59.38%,差异具有统计学意义(P0.05);治疗第24周,治疗组有效率为93.33%对照组有效率为62.50%,差异具有统计学意义(P0.05)。(2)中医证候积分:治疗第12周,与对照比较,治疗组患者症候明显改善差异具有统计学意义(P0.05);治疗第24周,与对照组比较,治疗组患者症候改善尤为明显,(差异具有统计学意义P0.01);且第24周治疗效果优于第12周。(3)血糖及糖化血红蛋白:治疗前、治疗第12周、治疗第24周,两组患者空腹血糖(FPG)组间比较,差异无统计学意义(P0.05);而餐后2小时血糖及糖化血红蛋白在治疗第12周、第24周差异有统计学意义(P0.05),消渴肾病方组疗效优于对照组,24周末效果尤其明显。(4)蛋白尿及肾保护作用:与对照组比较,治疗第12周、治疗第24周,治疗组尿蛋白排泄水平、尿NAG酶及胱抑素C都明显减低,差异有统计学意义(P0.01),其中尿NAG酶及胱抑素C在24周末效果优于12周末效果(P0.01)。而尿素氮及血清肌酐水平治疗前后变化无统计学差异(P0.05)。(5)抗氧化应激及抗纤维化:治疗前、治疗第12周、治疗第24周,两组患者血清MDA含量和SOD活性组间比较,治疗后MDA含量明显降低,差异有统计学意义(P0.01),SOD活性明显升高,差异有统计学意义(P0.01),且24周末效果优于12周末(P0.01)。治疗前、治疗第12周、治疗第24周,两组患者尿TGF-β1含量和Ⅳ型胶原水平组间比较,治疗组TGF-β1和Ⅳ型胶原水平明显降低,差异有统计学意义(P0.01),且24周末效果优于12周末(P0.01)。结论:1)由上述结果得出,与西医常规治疗相比,加用消渴肾病方可显著改善早期糖尿病肾病患者餐后血糖及糖化血红蛋白水平,能够有效地降低尿白蛋白排泄率,降低尿NAG酶及血清胱抑素水平,提示有一定的肾保护作用,具有一定的推广应用价值。2)消渴肾病方可通过调节MDA和SOD水平,对抗机体氧化应激反应水平,从而减轻肾脏损害,发挥对糖尿病肾病的防治作用。本方可减少尿中TGF-β1和Ⅳ型胶原水平,证明消渴肾病方具有抗肾脏纤维化,延缓DN进展的作用。
[Abstract]:Objective: to provide evidence based evidence-based medical evidence for the efficacy and safety of diabetes nephropathy in the treatment of early (stage III) diabetic nephropathy (Qi Yin deficiency and blood stasis blocking type) by Professor Gao Jining's empirical prescription "Xiaoke nephrosis recipe", and the evidence of the efficacy and safety of diabetes nephropathy in the treatment of diabetic nephropathy. In order to provide new ideas and inspiration for the treatment of diabetic nephropathy by traditional Chinese medicine, 66 patients with stage III diabetic nephropathy were randomly divided into treatment group and control group by random digital table, which were given in 33 cases. All patients were given two groups. The routine treatment of diabetes in western medicine, including health education, diet, exercise, medicine control blood sugar, blood pressure, blood lipid, etc., the treatment group was treated with oral thirst nephritic syndrome on this basis. Before treatment, the treatment was twelfth weeks, and the related safety indexes were observed at twenty-fourth weeks. The observation index included symptoms, signs, TCM syndrome scores and related principles. The examination indexes such as urine routine, urine NAG enzyme, 24 hour urine protein, blood sugar, glycated hemoglobin, serum creatinine, urea nitrogen and cystatin were used to evaluate the clinical efficacy; the content of MDA and the activity level of superoxide dismutase (SOD) were detected to reflect the level of oxygen stress; the level of urine transforming growth factor beta 1 (TGF- beta 1) and IV type were measured. Collagen level, evaluate the degree of renal fibrosis, so as to make an objective evaluation of the clinical efficacy of self-made thirst nephritic syndrome, and detect the adverse reaction and record it in time. Results: (1) the total effective rate: Twelfth weeks of treatment, the effective rate of the treatment group was 83.33%, the control group was 59.38%, the difference was statistically significant (P0.05); the treatment group was treated for twenty-fourth weeks. The treatment group had a treatment group. The efficiency of the 93.33% control group was 62.50%, the difference was statistically significant (P0.05). (2) TCM syndrome score: Twelfth weeks of treatment, compared with the control, the symptoms of patients in the treatment group were significantly improved (P0.05), and the treatment group was more obvious than the control group for twenty-fourth weeks, and the difference was statistically significant. The treatment effect of twenty-fourth weeks was better than that of twelfth weeks. (3) blood sugar and glycated hemoglobin: before treatment, Twelfth weeks of treatment and twenty-fourth weeks of treatment, the difference between the two groups of patients with fasting blood glucose (FPG) was not statistically significant (P0.05), while 2 hours after meal and glycated hemoglobin were statistically significant (P0.05) in the twenty-fourth week treatment (P0.05). The effect of thirst nephritic group was better than that of the control group, and the effect of 24 weekend was especially obvious. (4) proteinuria and renal protective effect: compared with the control group, the urinary protein excretion level, urinary NAG enzyme and cystatin C were significantly reduced in the treatment group for Twelfth weeks, and the difference was statistically significant (P0.01), in which the effect of urinary NAG and cystatin C was better than 12 at the end of the 24 week. There was no significant difference in the weekend effect (P0.01). There was no statistical difference (P0.05) before and after treatment of urea nitrogen and serum creatinine level. (5) antioxidant stress and anti fibrosis: before treatment, Twelfth weeks of treatment and twenty-fourth weeks of treatment, the serum MDA content and SOD activity group were compared between the two groups. The content of MDA decreased significantly after treatment, the difference was statistically significant (P0.01), SOD activity was clear. The difference was statistically significant (P0.01), and the effect of the 24 weekend was better than the 12 weekend (P0.01). Before treatment, Twelfth weeks and twenty-fourth weeks of treatment, the levels of TGF- beta 1 and type IV collagen in the two groups were compared, the levels of TGF- beta 1 and type IV collagen in the treatment group were significantly lower, the difference was statistically significant (P0.01), and the effect of 24 weekend was better than 12 weekend (P0 .01) conclusion: conclusion: 1) from the above results, compared with the conventional treatment of Western medicine, the addition of Xiaoke nephropathy can significantly improve the postprandial blood glucose and glycosylated hemoglobin levels in patients with early diabetic nephropathy, effectively reduce the urinary albumin excretion rate, reduce the urinary NAG enzyme and serum Cystin levels, suggesting certain renal protective effects. To promote the application value.2) Xiaoke nephropathy can be used to regulate the level of MDA and SOD to combat the level of oxidative stress reaction in the body, thus alleviating renal damage and playing a role in the prevention and treatment of diabetic nephropathy. This prescription can reduce the level of TGF- beta 1 and type IV collagen in urine, and prove that Xiaoke nephropathy has the effect of anti renal fibrosis and retarding the progress of DN.
【学位授予单位】：山西中医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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