代综方改善38例代谢综合征糖脂代谢异常的临床研究

Clinical Research of Daizongfang in Treatment for 38 Cases of Metabolic Syndrome with Glucose and Lipid Disorder

目的:观察代综方颗粒治疗代谢综合征(metabolic syndrome,MS)糖脂代谢紊乱的临床安全性和有效性。方法:采用自身前后对照的方法,给予MS患者代综方配方颗粒剂治疗8周。治疗前后分别观察血尿常规、肝肾功能、心电图、肝脏超声及腰围、体重指数、血糖、血脂、血压、空腹胰岛素、空腹c肽和中医临床症状。填写病例观察表,录入epidata数据库,复核数据剔除不合格病例,SPSS 17.0统计分析。结果:(1)完成45例,脱落1例、不合格6例,共38例纳入统计分析;(2)体重、腰围、体质指数(BMI)较疗前降低(P<0.001);(3)改善血糖异常,空腹血糖(FBG)、餐后2 h血糖(PBG-2h)、糖化血红蛋白(Hb A1c)较治疗前降低(P<0.001);(4)改善MS患者胰岛素抵抗水平,增加胰岛素敏感性指数(ISI)(P<0.05);(5)改善血脂异常,甘油三酯(TG)、胆固醇(TC)、低密度脂蛋白(LDL-C)较疗前降低,高密度脂蛋白(HDL-C)升高;(6)治疗后高血压患者血压降低(P<0.001);(7)治疗后临床症状、体征改善明显,证候积分改善有效率为97.37%;(8)治疗前后比较,安全性指标未见异常。结论:代综方颗粒能够降低代谢综合征高血糖、高血脂患者的血糖血脂水平,改善代谢紊乱,安全有效。

Objective： To observe the clinical safety and efficacy of Daizongfang in the treatment of glucose and lipid disorder in metabolic syndrome. Methods： Self-controlled method was adopted in the study. Patients with MS were given Daizongfang as the treatment for 8 weeks. Before and after the 8-week treatment,the patients were followed up for the observation of blood and urine routine examination,liver and kidney function,the electrocardiogram,liver ultrasound,and waist circumference,body mass index,blood glucose,blood lipids,blood pressure and clinical symptoms of Chinese medicine. Fill out the case report form and put the data into the Epi Data database and check the data to eliminate unqualified cases. SPSS 17. 0 statistical software was applied for data analysis. Results：（1）45 cases were completed in the study,among which 1 case lost,6 cases unqualified,and so finally 38 cases were included in the statistical analysis.（2）The body weight,waist circumference and body mass index（ BMI） decreased as compared with those before treatment（ P〈0. 001）. Glucose disorder was improved and fasted blood glucose（ FBG）,2 h postprandial blood sugar（ PBG） and glycosylated hemoglobin（ Hb A1c） decreased as compared with those before treatment（ P〈0. 001）.（4）The insulin resistance level was reduced and insulin sensitivity index（ ISI） increased in patients with metabolic syndrome（ P〈0. 05）.（5）Triglyceride（ TG）,cholesterol（ TC）,low density lipoprotein（ LDL-C） decreased and high density lipoprotein（ HDL-C） increased as compared with those before treatment（ P〈0. 001）.（6）The blood pressure in hypertension patients decreased after treatment（ P〈0. 001）.（7）The clinical symptoms and signs were significantly improved after treatment with symptom score improvement rate up to 97. 37%.（8）Compared with before treatment,no abnormal safety indices were observed. Conclusion： The therapeutic effect of Daizongfang in the treatment of MS is accurate,which can improve the disorder of glucose and lipid metabolism and it is safe and effective.