【摘要】：目的:觀察代綜方顆粒治療代謝綜合征(metabolic syndrome,MS)糖脂代謝紊亂的臨床安全性和有效性。方法:采用自身前后對照的方法,給予MS患者代綜方配方顆粒劑治療8周。治療前后分別觀察血尿常規(guī)、肝腎功能、心電圖、肝臟超聲及腰圍、體重指數(shù)、血糖、血脂、血壓、空腹胰島素、空腹c肽和中醫(yī)臨床癥狀。填寫病例觀察表,錄入epidata數(shù)據(jù)庫,復核數(shù)據(jù)剔除不合格病例,SPSS 17.0統(tǒng)計分析。結(jié)果:(1)完成45例,脫落1例、不合格6例,共38例納入統(tǒng)計分析;(2)體重、腰圍、體質(zhì)指數(shù)(BMI)較療前降低(P0.001);(3)改善血糖異常,空腹血糖(FBG)、餐后2 h血糖(PBG-2h)、糖化血紅蛋白(Hb A1c)較治療前降低(P0.001);(4)改善MS患者胰島素抵抗水平,增加胰島素敏感性指數(shù)(ISI)(P0.05);(5)改善血脂異常,甘油三酯(TG)、膽固醇(TC)、低密度脂蛋白(LDL-C)較療前降低,高密度脂蛋白(HDL-C)升高;(6)治療后高血壓患者血壓降低(P0.001);(7)治療后臨床癥狀、體征改善明顯,證候積分改善有效率為97.37%;(8)治療前后比較,安全性指標未見異常。結(jié)論:代綜方顆粒能夠降低代謝綜合征高血糖、高血脂患者的血糖血脂水平,改善代謝紊亂,安全有效。
[Abstract]:Objective: to observe the clinical safety and efficacy of Daizhuangfang granule in the treatment of glucose and lipid metabolic disorder in metabolic syndrome (MS). Methods: the patients with MS were treated with comprehensive prescription granules for 8 weeks. Blood routine, liver and kidney function, electrocardiogram, liver ultrasound and waist circumference, body mass index, blood glucose, blood lipid, blood pressure, fasting insulin, fasting c-peptide and clinical symptoms of TCM were observed before and after treatment. Fill out the case observation form, input into the epidata database, and check the data to eliminate the unqualified cases and the statistical analysis of SPSS 17.0. Results: (1) 45 cases were completed, 1 case was lost, 6 cases were not qualified, 38 cases were included in statistical analysis, (2) body weight, waist circumference and body mass index (BMI) decreased compared with those before treatment (P0. 001); (3). Fasting blood glucose (FBG),) 2 h postprandial blood glucose (PBG-2h), glycosylated hemoglobin (HbA1c) decreased compared with pre-treatment (P0.001); (4) to improve insulin resistance in MS patients, and increased insulin sensitivity index (ISI) (P0.05); (5) to improve dyslipidemia. Triglyceride (TG), cholesterol (TC), low density lipoprotein (LDL-C) was lower and high density lipoprotein (HDL-C) was higher than that before treatment. (6) after treatment, the clinical symptoms and signs of hypertension patients decreased significantly after treatment (P0.001); (7). The effective rate of syndromes integral improvement was 97.37. (8) there was no abnormal safety index before and after treatment. Conclusion: Daizhuofang granule can reduce hyperglycemia and hyperlipidemia in patients with metabolic syndrome, improve metabolic disorder, and be safe and effective.
【作者單位】： 中國中醫(yī)科學院廣安門醫(yī)院;保定市第一中醫(yī)院;南京市中醫(yī)院;北京市密云縣河南寨社區(qū);
【基金】：國際科技合作項目(2010DFA31620) 科技部重大新藥創(chuàng)制項目(2011ZX09102-011-08)
【分類號】：R259

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