【摘要】：目的：觀察三才粉劑治療初診2型糖尿病(陰虛熱盛型)患者的有效性及安全性(與二甲雙胍單藥對(duì)照)。方法：采用隨機(jī)、平行對(duì)照、多中心的研究方法,選取經(jīng)過統(tǒng)一規(guī)范的飲食控制及運(yùn)動(dòng)療法2周后仍符合納入標(biāo)準(zhǔn)的80例患者隨機(jī)均分為試驗(yàn)組及對(duì)照組。試驗(yàn)組予三才粉劑沖服,對(duì)照組予鹽酸二甲雙胍片口服,在相同的基礎(chǔ)治療下干預(yù)12周。干預(yù)期間觀察并比較兩組患者治療前后空腹血糖(FPG)、餐后2小時(shí)血糖(2hPG)、糖化血紅蛋白(HbAlc),體重(wt)、體重指數(shù)(BMI)、腰圍,空腹胰島素(FINS)、HOMA胰島素抵抗指數(shù)(HOMA-IR)、胰島素敏感指數(shù)(ISI)、HOMA胰島B細(xì)胞功能指數(shù)(HOMA-β),總膽固醇(TC)、甘油三酯(TG)、高密度脂蛋白膽固醇(HDL-C)、低密度脂蛋白膽固醇(LDL-C),并檢測(cè)三大常規(guī)、肝腎功、心電圖等安全性指標(biāo),記錄不良反應(yīng)發(fā)生率及其嚴(yán)重程度,對(duì)三才粉劑的有效性和安全性作出評(píng)價(jià)。結(jié)果：1.兩組FPG、2hPG、HbA1c治療后均顯著降低(P0.01)；治療后組間差異無統(tǒng)計(jì)學(xué)意義(P0.05)。2.治療后兩組體重、BMI、腰圍均有下降趨勢(shì),但差異無統(tǒng)計(jì)學(xué)意義(P0.05)。3.兩組Ln(HOMA-β)治療前后比較差異有統(tǒng)計(jì)學(xué)意義(P0.05),治療后組間差異無統(tǒng)計(jì)學(xué)意義(P0.05)；治療后兩組Ln(ISI)均升高,但試驗(yàn)組差異有統(tǒng)計(jì)學(xué)意義(P0.05),對(duì)照組差異無統(tǒng)計(jì)學(xué)意義(P0.05)；兩組Ln(HOMA-IR)、FINS治療前后比較差異無統(tǒng)計(jì)學(xué)意義(P0.05)。4.試驗(yàn)組TC治療前后比較差異有統(tǒng)計(jì)學(xué)意義(P0.05),對(duì)照組差異無統(tǒng)計(jì)學(xué)意義(P0.05)；兩組TG、HDL-C、LDL-C治療前后比較差異均無統(tǒng)計(jì)學(xué)意義(P0.05)。5.兩組治療前后中醫(yī)證候均有顯著改善(P0.01),但試驗(yàn)組明顯優(yōu)于對(duì)照組(P0.01)。6.此次研究過程中,安全性指標(biāo)未見明顯異常,不良反應(yīng)發(fā)生率低。結(jié)論：三才粉劑能顯著降低患者的血糖和糖化血紅蛋白,其降糖效果與二甲雙胍相當(dāng)。三才粉劑能明顯改善患者的臨床癥狀,且能增加胰島素敏感性、改善胰島β細(xì)胞功能、降低總膽固醇,無明顯不良反應(yīng),是控制血糖和調(diào)節(jié)血脂的有效中藥粉劑。
[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.
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R587.1

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