白茯苓丸中药煎剂对糖尿病前期患者的临床疗效观察

发布时间：2018-04-17 08:37

本文选题：糖尿病前期 + 血糖调节异常　；参考：《山西医科大学》2017年硕士论文

【摘要】：目的:1.研究白茯苓丸的降糖作用,用白茯苓丸中药煎剂对糖尿病前期患者进行临床干预,分析干预前后的血糖变化水平;2.实验组和对照组降血糖效果的对比研究,观察干预后的两组患者血糖下降水平和效果评价;3.白茯苓丸对血脂的干预效果研究;4.观察白茯苓丸对中医证候的改善情况。方法:以符合糖尿病前期的诊断标准、相关中医证候符合气阴两虚(如不耐劳力、食后脘腹胀满,偶有心烦、手足心热、腿软难以久立,大便粘滞)的患者及排除标准作为筛选的工具,选取山西医科大学第一附属医院在2016年5月到2016年12月于中医科门诊就诊的患者,符合上述标准的46例患者。对入选患者进行随机分为试验组和对照组,试验组给予白茯苓丸中药煎剂,每日1剂,早晚分服200ml;对照组用天麦消渴片进行干预,一次2片,一天两次,疗程都设置为6周。采集两组受试者试验前的血液样本、试验中每7天采集两组受试者的血液样本,并记录两组受试者的中医证候变化。所采集的血液样本即刻送我院化验科化验,记录受试者空腹血糖、75g无水葡萄糖摄入后2小时血糖、糖化血红蛋白、血清甘油三酯、血清胆固醇,高密度脂蛋白、低密度脂蛋白的变化。疗效评价参考《中药新药临床研究指导原则》对得到的指标进行评价,分为显效、有效、无效。实验过程中得到的计量资料以均数±标准差(x±s)表示,分析采用独立样本t检验,P0.05,认为差异有统计学意义;得到的计数资料用卡方(χ2)检验,P0.05,认为差异有统计学意义。结果:1.一般资料分析干预前评价两组的性别无差异,年龄、BMI指数、空腹血糖(FPG)、餐后2小时血糖(P2BG)、糖化血红蛋白(Hb A1c)、血清甘油三酯(TG)、血清胆固醇(TC)、高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)经检验,P0.05,差异无统计学意义。2.血糖相关指标分析2.1分别对比试验组干预前后FBG、P2BG、Hb A1c,P0.05,差异有统计学意义。对照组干预前后的血糖相关指标FBG、P2BG、Hb A1c,P0.05,差异有统计学意义;2.2两组受试者干预后血糖相关指标FBG、P2BG、Hb A1c对比,P0.05,差异无统计学差异;对比白茯苓丸干预后血糖指标FBG、P2BG、Hb A1c的均数均小于天麦消渴片干预后的血糖指标的均数,说明白茯苓丸复方汤药制剂的降糖效果要优于对照组天麦消渴片的降糖效果。3.血脂相关指标分析3.1试验组干预前后,对比其LDL-C、TC均数±标准差,P0.05,差异有统计学意义,TG、HDL-C的对比分析,P0.05,差异没有统计学意义;对照组干预前后血脂相关指标分析,P0.05,差异无统计学意义。3.2两组的调脂效果对比,在调节LDL-C方面,P0.05,差异有统计学意义;白茯苓丸干预后的低密度脂蛋白的均数小于对照组,说明白茯苓丸复方汤药制剂在降低低密度脂蛋白的效果上优于天麦消渴片。4.有效率对比分析试验组显效者20例,有效者0例,无效者3例;对照组显效16例,0例有效,7例无效,整个试验过程中无不良反应发生。对比两组显效率,P0.05,差异无统计学意义。5.中医证候改善率对比分析对改善中医证候的效果进行对比研究,试验组的改善率高于对照组,P0.05,差异有统计学意义。结论:1.白茯苓丸汤有降糖的效果,且降糖力度和天麦消渴片相当;2.白茯苓丸汤和天麦消渴片两种药物均可以降低血糖水平,但在显效率方面二者未显示出统计学差异;3.白茯苓丸中药煎剂可以降低LDL-C、TC的浓度,且降低LDL-C的力度优于天麦消渴片;4.白茯苓丸汤对中医证候的改善效果优于天麦消渴片。
[Abstract]:Objective: To study the hypoglycemic effect of 1. white Poria pill, clinical intervention on patients with pre diabetes with white Poria pill of Chinese medicine decoction, the change of blood glucose level before and after the intervention analysis; comparative study of the 2. experimental group and control group hypoglycemic effect, evaluation of two groups of patients to observe the blood glucose level and decreased after the intervention effect of intervention; 3. white Poria the effect of pill on blood lipid; improvement of 4. white Poria Pill on the observation of TCM syndrome. Methods: according to diagnostic criteria of pre diabetes, TCM syndromes associated with Yin deficiency (such as resistance to labor, after eating flatulence, occasionally upset, hot feeling, difficult to long leg soft, sticky stool) the patients and exclusion criteria as a screening tool, the First Affiliated Hospital of Shanxi Medical University from May 2016 to December 2016 in the outpatient department of traditional Chinese medicine patients, 46 patients were in conformity with the standards of the patients. Were randomly divided into experimental group and control group, the experimental group was given the white Poria pill of Chinese medicine decoction, 1 dose daily, sooner or later the service 200ml; the control group with tianmaixiaoke tablet intervention, a 2 tablets, two times a day. The course is set to 6 weeks. Collecting two groups of subjects before the blood test sample test in every 7 days to collect two subjects blood samples, and record the changes of TCM syndrome of the two groups of subjects. Blood samples were collected immediately sent to the testing laboratory of our hospital, and records the subjects' fasting blood glucose, 75g glucose intake after 2 hours blood glucose, glycosylated hemoglobin, serum serum cholesterol, triglyceride, high density lipoprotein, low density lipoprotein changes. The curative effect evaluation of reference "Chinese medicine clinical research guiding principles > on of the evaluation indicators, divided into markedly effective, effective and ineffective. The measurement data in the experiment with the mean and standard deviation (x + s) said the analysis The independent sample t test, P0.05, that the difference was statistically significant; count data obtained by chi square test, P0.05 (x 2), considered statistically significant. Results: 1. general data before intervention evaluation of two groups of gender differences, age, BMI index, fasting blood glucose (FPG), after the meal 2 hours blood glucose (P2BG), glycosylated hemoglobin (Hb A1c), serum triglyceride (TG), serum cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C) by P0.05 test, there was no significant difference in.2. blood glucose related index analysis before and after the 2.1 comparative experiments were FBG group intervention P2BG, Hb, A1c, P0.05, the difference was statistically significant. The control indexes of blood glucose before and after the intervention group FBG, P2BG, Hb, A1c, P0.05, FBG, the difference was statistically significant; the relevant indicators of blood glucose of 2.2 subjects in the two groups after the intervention of P2BG, Hb P0.05, A1c comparison, the difference was not statistically different compared to white Poria; dry pill The prognosis of the glycemic index of FBG, P2BG, Hb, A1c were less than the average number of days of wheat were dry Xiaoke tablets glycemic index prognosis, that the hypoglycemic effect of Fuling pill compound decoction preparation is superior to the control group of tianmaixiaoke tablet.3. hypoglycemic effect of serum lipids of 3.1 experimental groups before and after intervention, compared with the LDL-C. TC standard deviation, P0.05, a statistically significant difference of TG, HDL-C analysis, P0.05, the difference was not statistically significant; the control group before and after the intervention of lipid related indicators analysis, P0.05, no statistical significance differences in lipid regulating effects of.3.2 two groups of P0.05, in the regulation of LDL-C, and the difference was statistically significant dry white Poria pill; low density lipoprotein prognosis were less than the control group, said that Fuling pill compound decoction preparation superior in low density lipoprotein on the effect of tianmaixiaoke tablet.4. efficiency analysis of 20 cases of test group, have 0 cases with effect, 3 cases; 16 cases of the control group, 0 cases were effective, 7 cases ineffective, no adverse reactions occurred during the whole experiment. Comparing the two groups of significant efficiency, P0.05, there was no significant difference in.5. syndrome improvement rate comparison and Analysis on the comparative study of the improvement of TCM syndrome effect. The improvement of the experimental group was significantly higher than the control group, P0.05, the difference was statistically significant. Conclusion: 1. white Poria pill decoction has a hypoglycemic effect, and hypoglycemic strength and tianmaixiaoke tablets; 2. white Poria pill and tianmaixiaoke tablets of two kinds of drugs can reduce blood glucose levels, but not in significant efficiency two showed significant difference; 3. white Poria pill decoction can reduce LDL-C, TC concentration, and reduce the strength of the LDL-C is better than that of tianmaixiaoke tablets; 4. white Poria pill Decoction on syndrome of traditional Chinese medicine better than tianmaixiaoke tablets.

【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

【参考文献】