滋阴活血汤治疗阴虚血瘀型糖尿病肾病的临床研究

发布时间：2018-02-11 22:48

本文关键词： 滋阴活血汤阴虚血瘀型糖尿病肾病临床研究　出处：《云南中医学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的:观察和研究以灯盏花和生地黄为君药自拟“滋阴活血汤”配合常规治疗措施,治疗阴虚血瘀型糖尿病肾病(Ⅲ期)的临床疗效,以及本方对糖尿病肾病阴虚血瘀型患者相关实验室指标的影响,从而客观探讨“滋阴活血汤”治疗阴虚血瘀型糖尿病肾病的临床疗效。方法:1.收集符合该研究纳入标准的患者(Ⅲ期糖尿病肾病,符合中医证型阴虚血瘀型)70例,采取单盲法,按照就诊次序随机分组,试验组35例,对照组35例。2.在临床研究前,用统计学方法检测两组患者的性别、年龄、病程、主要症状、肾功能等,确定两组之间差异无统计学意义。3.治疗方法:对两组入选受试者同时行糖尿病肾病常规疗法,具体治疗措施是:⑴对受试者进行糖尿病相关知识的教育讲解,规范患者饮食习惯,嘱其进行适量运动;肥胖者,可运动减肥。⑵征求内分泌科医生意见,给予患者注射胰岛素控制血糖(血糖控制水平:7.0mmol/L≥空腹血糖≥3.9mmol/L,11.1mmol/L≥餐后2小时血糖≥3.9mmol/L)。⑶给予血管紧张素转换酶抑制剂(ACEI)及血管紧张素Ⅱ阻滞剂(ARB)降压,血压控制在90-140/60-90mm Hg。⑷纠正水、电解质及酸碱平衡的紊乱。对照组:在对受试者进行上述常规治疗的同时,密切关注患者的生命体征和病情进展情况,确保患者生命安全,同时记录患者症状、体征及相关实验室指标。试验组:在上述常规治疗方法上加用自拟的滋阴活血汤,水煎服,1剂/日,200-300ml/次,早、中、晚各1次。4.疗程及治疗:4周为一疗程,治疗并观察12周。治疗期间严格按照拟定方案对两组病人进行治疗,不得运用或配合使用其他治疗阴虚血瘀证型的药物或措施。5.在第0周及第12周分别对试验对象的安全性指标进行检测,从而对患者的服药安全性作出客观评价。结果:1.经过12周的临床试验后,比较两组的总有效率,对照组为41.94%,试验组为74.19%,p=0.0470.05,差异有统计学意义;说明试验组疗效明显优于对照组。2.在中医症候疗效方面,对照组总有效率32.26%,试验组总有效率70.97%;二者比较,p=0.0030.05,差异有统计学意义;说明滋阴活血汤在改善患者中医症候方面,疗效显著。3.将对照组与试验组试验后的尿微量白蛋白水平进行分析,结果,p=0.020,说明试验组效果优于对照组;将两组受试对象试验后的尿蛋白定量水平进行分析,结果,p=0.002,说明差异存在统计学意义,试验组效果优于对照组;以上两个结果说明滋阴活血汤在抑制糖尿病肾病患者尿蛋白流失方面效果显著。4.将对照组和试验组试验前后的血浆纤维蛋白原进行比较,对照组p=0.0910.05,差异无统计学意义;试验组p=0.0000.05,差异有统计学意义。说明滋阴活血汤能降低糖尿病肾病患者血浆纤维蛋白原。5.治疗前后对照组和试验组的安全性指标对比无统计学意义(p0.05)。结论:通过对本试验的临床观察及数据处理可知,采用滋阴活血汤联合糖尿病肾病基础疗法的试验组总有效率高于单用糖尿病肾病基础疗法的对照组,且试验后试验组的尿微量白蛋白和尿蛋白定量均明显低于对照组,整个试验过程中无患者出现不良反应,说明滋阴活血汤对糖尿病肾病(Ⅲ期)阴虚血瘀型患者安全有效,可应用于临床服务患者。
[Abstract]:Objective: To observe and study with Breviscapine and Radix Rehmanniae for routine treatment with drug by "Ziyin Huoxue Decoction" in treatment of diabetic nephropathy, yin deficiency and blood stasis type (III) clinical efficacy, and the formula on diabetic nephropathy in patients with Yin deficiency and blood stasis type related laboratory index influence, so as to explore the objective clinical effect of nourishing yin and promoting blood circulation kidney yin deficiency and Blood Stasis Decoction "in the treatment of diabetes. Methods: 1. collect meet the inclusion criteria of the study patients (stage III diabetic nephropathy with TCM syndrome of yin deficiency and blood stasis type) 70 cases, using single blind method, according to the order of treatment were randomly divided into experimental group 35 cases, control group 35 cases of.2. before clinical studies, two groups of patients with gender, age of detection using statistical methods, the course of disease, the main symptoms of kidney function, determine the difference between the two groups was not statistically significant.3. treatment method: two groups of enrolled subjects and diabetic nephropathy usually Conventional therapy, specific treatment is as follows: diabetes related knowledge on subjects of the education on standard diet, have their regular exercise; obese, can exercise to lose weight. The doctors give patients for Department of Endocrinology, injection of insulin to control blood sugar (glucose control level: 7.0mmol/L or fasting blood glucose than 3.9mmol/L, 11.1mmol/L more than 2 hour postprandial blood glucose over 3.9mmol/L). The given angiotensin-converting enzyme (ACEI) inhibitors and angiotensin II antagonist (ARB) blood pressure, blood pressure control in the 90-140/60-90mm Hg. the correct water, electrolyte and acid-base disorders. The control group in the conventional treatment on the subjects at the same time, close attention to the vital signs of the patients and the progression of the disease, ensure the safety of patients, and record the patient's symptoms, signs and laboratory indexes. The test group: in the conventional treatment method By using the self-made ziyinhuoxie soup, water decoction, 1 dose / day, 200-300ml/ time, early, late 1 times.4. treatment and treatment: 4 weeks for a course of treatment and observation of 12 weeks. During the treatment, in strict accordance with the plan of two groups of patients were treated with drug use or not use the other treatment of yin deficiency and blood stasis type or.5. and measures in zeroth weeks, 12 weeks respectively on the test object safety indexes were detected, so as to make an objective evaluation on the medication safety of patients. Results: after 1. clinical trials after 12 weeks, total efficiency of two groups, 41.94% in the control group, experimental group 74.19%, p=0.0470.05, the difference was statistically significant; the experimental group was significantly better than the control group.2. in TCM symptoms curative effect, the total efficiency of the control group 32.26%, experimental group total efficiency of 70.97%; the two, p=0.0030.05, the difference was statistically significant; indicating ziyinhuoxie soup In the improvement of TCM symptoms, the curative effect of.3. control group and the experimental group after the experiment of the urinary albumin levels were analyzed, the results show, p=0.020, the experimental group was better than the effect of the control group; the two groups of urine protein quantitative level test object was analyzed. Results show, p=0.002, the difference had statistical significance the effect of the experimental group than the control group; the above two results indicated that ziyinhuoxie soup in the inhibition of urinary protein loss has significant effect.4. the control of plasma fibrinogen before and after the original test group and test group compared to control group p=0.0910.05, the difference was not statistically significant; the test group p=0.0000.05, the difference was statistically significant. Ziyinhuoxie decoction can reduce diabetic nephropathy patients before and after plasma fibrinogen.5. therapy compared with safety indexes of the control group and the experimental group had no statistical significance (P0.05). Conclusion: through the clinical observation and experimental data processing show that the experimental group of Ziyin Huoxue Decoction Combined with diabetic nephropathy based therapy the total efficiency is higher than that of control group with single therapy of diabetic nephropathy, experimental group, urinary albumin and urinary protein and test weight were significantly lower than the control group, no adverse the reaction in the whole experimental process, description yin Huoxue Decoction on diabetic nephropathy (phase III) safety of yin deficiency and blood stasis patients effectively, and can be applied to clinical services for patients.

【学位授予单位】：云南中医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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