三才粉剂治疗初诊2型糖尿病（阴虚热盛型）的有效性及安全性观察

发布时间：2018-07-22 17:26

【摘要】：目的：观察三才粉剂治疗初诊2型糖尿病(阴虚热盛型)患者的有效性及安全性(与二甲双胍单药对照)。方法：采用随机、平行对照、多中心的研究方法,选取经过统一规范的饮食控制及运动疗法2周后仍符合纳入标准的80例患者随机均分为试验组及对照组。试验组予三才粉剂冲服,对照组予盐酸二甲双胍片口服,在相同的基础治疗下干预12周。干预期间观察并比较两组患者治疗前后空腹血糖(FPG)、餐后2小时血糖(2hPG)、糖化血红蛋白(HbAlc),体重(wt)、体重指数(BMI)、腰围,空腹胰岛素(FINS)、HOMA胰岛素抵抗指数(HOMA-IR)、胰岛素敏感指数(ISI)、HOMA胰岛B细胞功能指数(HOMA-β),总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C),并检测三大常规、肝肾功、心电图等安全性指标,记录不良反应发生率及其严重程度,对三才粉剂的有效性和安全性作出评价。结果：1.两组FPG、2hPG、HbA1c治疗后均显著降低(P0.01)；治疗后组间差异无统计学意义(P0.05)。2.治疗后两组体重、BMI、腰围均有下降趋势,但差异无统计学意义(P0.05)。3.两组Ln(HOMA-β)治疗前后比较差异有统计学意义(P0.05),治疗后组间差异无统计学意义(P0.05)；治疗后两组Ln(ISI)均升高,但试验组差异有统计学意义(P0.05),对照组差异无统计学意义(P0.05)；两组Ln(HOMA-IR)、FINS治疗前后比较差异无统计学意义(P0.05)。4.试验组TC治疗前后比较差异有统计学意义(P0.05),对照组差异无统计学意义(P0.05)；两组TG、HDL-C、LDL-C治疗前后比较差异均无统计学意义(P0.05)。5.两组治疗前后中医证候均有显著改善(P0.01),但试验组明显优于对照组(P0.01)。6.此次研究过程中,安全性指标未见明显异常,不良反应发生率低。结论：三才粉剂能显著降低患者的血糖和糖化血红蛋白,其降糖效果与二甲双胍相当。三才粉剂能明显改善患者的临床症状,且能增加胰岛素敏感性、改善胰岛β细胞功能、降低总胆固醇,无明显不良反应,是控制血糖和调节血脂的有效中药粉剂。
[Abstract]:Objective: to observe the efficacy and safety of Sancai powder in the treatment of newly diagnosed type 2 diabetes mellitus. Methods: a randomized, parallel controlled, multicenter study was used to select 80 patients who met the inclusion criteria after 2 weeks of standardized diet control and exercise therapy, and were randomly divided into two groups: the experimental group and the control group. The experimental group was given Sancai powder and the control group was given metformin hydrochloride orally for 12 weeks under the same basic treatment. Fasting blood glucose (FPG), postprandial blood glucose (2hPG), glycosylated hemoglobin (HbAlc), body mass index (wt), waist circumference were observed and compared before and after treatment. Fasting insulin (fins) HOMA insulin resistance index (HOMA-IR), insulin sensitivity index (ISI), HOMA- 尾, total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and liver and kidney function were measured. Safety indexes such as electrocardiogram (ECG), adverse reaction rate and severity were recorded, and the efficacy and safety of Sancai powder were evaluated. The result is 1: 1. After treatment, the two groups of FPGN 2hPGN HbA1c significantly decreased (P0.01), there was no significant difference between the two groups after treatment (P0.05). 2. After treatment, the weight and waist circumference of the two groups decreased, but the difference was not statistically significant (P0.05). 3. The difference of Ln (HOMA- 尾) between the two groups before and after treatment was statistically significant (P0.05), but there was no significant difference between the two groups after treatment (P0.05), the Ln (ISI) of the two groups increased after treatment, but the difference was statistically significant in the experimental group (P0.05), but there was no significant difference in the control group (P0.05). There was no significant difference between the two groups in Ln (HOMA-IR) and fins before and after treatment (P0.05). 4. There was significant difference in TC before and after treatment in the trial group (P0.05), but there was no significant difference in the control group (P0.05); there was no significant difference between the two groups before and after the treatment of HDL-Con LDL-C (P0.05). Before and after treatment, the TCM syndromes of the two groups were significantly improved (P0.01), but the experimental group was obviously superior to the control group (P0.01) .6. In the course of this study, the safety indexes were not abnormal and the incidence of adverse reactions was low. Conclusion: Sancai powder can significantly reduce blood glucose and glycosylated hemoglobin, and its effect is equivalent to metformin. Sancai powder can obviously improve the clinical symptoms of the patients, increase insulin sensitivity, improve the function of islet 尾 cells, reduce total cholesterol, and have no obvious adverse reactions. It is an effective Chinese medicine powder for controlling blood sugar and regulating blood lipid.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R587.1

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