消糖降压汤治疗2型糖尿病合并高血压阴虚阳亢夹瘀证的临床研究
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摘要
目的：探讨中医学对2型糖尿病合并高血压阴虚阳亢夹瘀证的认识,通过临床研究,观察导师经验方消糖降压汤改善2型糖尿病合并高血压阴虚阳亢夹瘀证患者症状、体征、血糖、血压、糖化血红蛋白、血脂、血液流变学、胰岛素抵抗指数和胰岛p细胞功能指数等方面的影响,评价其临床疗效和安全性,探讨其防治本病的机理,为临床应用提供客观依据。
方法：采用随机平行对照的研究方法,将符合2型糖尿病合并高血压阴虚阳亢夹瘀证诊断标准的患者,随机分为治疗组和对照组。在基础治疗和西药降糖降压治疗的基础上,治疗组给予中药消糖降压汤水煎剂每日一剂,疗程3月。治疗前后两组分别评价其症状、体征、血糖、血压、糖化血红蛋白、血脂、胰岛素敏感指数(IAI)、血液流变学等指标,以及患者的不良反应、依从性。全部数据以SPSS17.0统计软件进行统计学分析。
结果：确诊并纳入的2型糖尿病合并高血压阴虚阳亢夹瘀证患者60例(治疗组30例,对照组30例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性。①对症状体征的改善作用：治疗组患者治疗后症状有明显改善,总有效率90.0%；对照组总有效率73.33%。治疗组中医症状改善情况优于对照组(P<0.05)。②降糖降压效果：治疗组与对照组患者血糖、血压、糖化血红蛋白均明显降低,与治疗前比较均有显著性差异(P<0.01)；治疗组治疗后空腹血糖改善较对照组有显著差异(P<0.01),治疗组餐后血糖、糖化血红蛋白、血压改善较对照组有差异(P<0.05)。③调脂效果：治疗组患者TC、TG、LDL-C与治疗前比较均下降(P<0.01),HDL-C与治疗前比较升高(P<0.01)；对照组患者TC水平下降(P<0.01),HDL-C水平升高(P<0.01),但TG、LDL-C与治疗前比较无明显差异。组间比较TC、HDL-C的改善情况两组无明显差异。④血液流变学：治疗组治疗后全血粘度(高切、中切、低切)、血浆粘度较治疗前均下降(P<0.05),对照组全血粘度(中切)和血浆粘度较治疗前均下降(P<0.05),但血浆粘度(高切、低切)治疗前后无差异。组间比较治疗组全血粘度(中切)的下降幅度较对照组有显著差异(P<0.01),但血浆粘度的下降水平两组无明显差异(P>0.05)。两组红细胞压积治疗前后均无明显变化。⑤空腹胰岛素：治疗后两组患者空腹胰岛素、HOMA2-IR均有所降低(P<0.01),治疗后两组患者HOMA2-%B指数有所升高,与治疗前比较均有显著性差异(P<0.01)。⑥安全性指标：肝肾功能检查均在正常范围。两组均未见不良反应。
结论：从初步临床研究来看,西药治疗合用消糖降压汤效果优于单纯西药治疗,中药治疗既可改善2型糖尿病合并高血压阴虚阳亢夹瘀证患者的临床症状,降低血糖、血压,调节血脂,还能改善血液流变学,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
Purpose-To investigate in medicine for type2diabetes mellitus complicating hypertension, through clinical studies, observation the mentor experience regimen Xiaotangjiangya decoction to improve type2diabetes mellitus complicating hypertension patients in symptoms, signs, blood sugar, blood pressure, glycosylated hemoglobinthe impact of blood lipids, blood rheology, insulin resistance index and pancreatic β-cell function index.To evaluate the clinical efficacy and safety, explore the mechanism of prevention and treatment of this disease,and to provide an objective basis for clinical application.
Method:Randomized controlled study, would be consistent with type2diabetes mellitus complicating hypertension patients diagnostic criteria, were randomly divided into a treatment group and a control group. Decoct Chinese medicine Xiaotangjiangya decoction for treatment group of a daily regimen for three months on the basis of the basic treatment including hypoglycemic and antihypertensive medicine treatment. Before and after treatment were evaluated its symptoms, signs, blood sugar, blood pressure, glycosylated hemoglobin, lipids, insulin sensitivity index (IAI), hemorheological indicators, as well as in patients with adverse reactions, compliance. All data SPSS17.0statistical software for statistical analysis.
Conclusion:Diagnosis and inclusion of type2diabetes mellitus complicating hypertension in patients of60cases (30cases of the treatment group and the control group of30patients), gender, age, duration before treatment, baseline data were statistically nosignificant differences comparable.①on the symptoms and signs of improvement:the treatment group patients symptoms markedly improved, the total effective rate was90.00%; control group, the total effective rate was73.33%. The TCM symptoms improve treatment group than the control group (P<0.01).②hypoglycemic antihypertensive effect:the treatment group and the control group of patients with blood glucose, blood pressure, glycated hemoglobin were significantly reduced compared with before treatment group showed a significant difference (P<0.01); fasting glucose improved in the treatment group compared with the control group significantly differences (P <0.01), treatment group, postprandial blood glucose, glycosylated hemoglobin, blood pressure improvement compared with the control group, differences (P<0.05).③lipid effect:patients treated with TC, TG, LDL-C treatment compared with the control group decreased (P<0.01), HDL-C increased (P<0.01) before treatment; patients in the control group TC levels decreased (P<0.01), HDL-C levels increased(P<0.01), but no significant difference in the TG, LDL-C before treatment. The comparison between groups TC, HDL-C, to improve the situation was no significant difference between the two groups.④the hemorheological:treatment group after treatment, whole blood viscosity (high cut, middle cut, low cut), plasma viscosity than before treatment decreased (P<0.05), whole blood viscosity control group (in middle cut) and plasma viscosity before treatment decreased (P<0.05), plasma viscosity (high cut, low cut) before and after treatment was no fifference. The decline of the treatment group, whole blood viscosity (excised) between the two groups compared with the control group had significant differences (P＜0.01), plasma viscosity decreased levels of the two groups was no significant difference (P>0.05). The two sets of hematocrit were no significant changes before and after treatment⑤FINS, HOMA2-IR, HOMA2-%B:After treatment, FINS and HOMA2-IR than treatment significantly lower (P<0.01), and HOMA2-%B than treatment also significantly higher (P<0.01).⑥security indicators:liver and kidney function tests were within the normal range. Both groups were no adverse reactions.
Conclusion:View from preliminary clinical studies, treatment with Western medicine combination Xiaotangjiangya decoction effect better than the only western medicine, Chinese medicine treatment can improve the clinical symptoms of patients with hypertension and type2diabetes, lower blood sugar, blood pressure, regulate blood lipids,can improve blood rheology and safe, effective, and has a broad application prospects, and worthy of further study.
方法：采用随机平行对照的研究方法,将符合2型糖尿病合并高血压阴虚阳亢夹瘀证诊断标准的患者,随机分为治疗组和对照组。在基础治疗和西药降糖降压治疗的基础上,治疗组给予中药消糖降压汤水煎剂每日一剂,疗程3月。治疗前后两组分别评价其症状、体征、血糖、血压、糖化血红蛋白、血脂、胰岛素敏感指数(IAI)、血液流变学等指标,以及患者的不良反应、依从性。全部数据以SPSS17.0统计软件进行统计学分析。
结果：确诊并纳入的2型糖尿病合并高血压阴虚阳亢夹瘀证患者60例(治疗组30例,对照组30例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性。①对症状体征的改善作用：治疗组患者治疗后症状有明显改善,总有效率90.0%；对照组总有效率73.33%。治疗组中医症状改善情况优于对照组(P<0.05)。②降糖降压效果：治疗组与对照组患者血糖、血压、糖化血红蛋白均明显降低,与治疗前比较均有显著性差异(P<0.01)；治疗组治疗后空腹血糖改善较对照组有显著差异(P<0.01),治疗组餐后血糖、糖化血红蛋白、血压改善较对照组有差异(P<0.05)。③调脂效果：治疗组患者TC、TG、LDL-C与治疗前比较均下降(P<0.01),HDL-C与治疗前比较升高(P<0.01)；对照组患者TC水平下降(P<0.01),HDL-C水平升高(P<0.01),但TG、LDL-C与治疗前比较无明显差异。组间比较TC、HDL-C的改善情况两组无明显差异。④血液流变学：治疗组治疗后全血粘度(高切、中切、低切)、血浆粘度较治疗前均下降(P<0.05),对照组全血粘度(中切)和血浆粘度较治疗前均下降(P<0.05),但血浆粘度(高切、低切)治疗前后无差异。组间比较治疗组全血粘度(中切)的下降幅度较对照组有显著差异(P<0.01),但血浆粘度的下降水平两组无明显差异(P>0.05)。两组红细胞压积治疗前后均无明显变化。⑤空腹胰岛素：治疗后两组患者空腹胰岛素、HOMA2-IR均有所降低(P<0.01),治疗后两组患者HOMA2-%B指数有所升高,与治疗前比较均有显著性差异(P<0.01)。⑥安全性指标：肝肾功能检查均在正常范围。两组均未见不良反应。
结论：从初步临床研究来看,西药治疗合用消糖降压汤效果优于单纯西药治疗,中药治疗既可改善2型糖尿病合并高血压阴虚阳亢夹瘀证患者的临床症状,降低血糖、血压,调节血脂,还能改善血液流变学,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
Purpose-To investigate in medicine for type2diabetes mellitus complicating hypertension, through clinical studies, observation the mentor experience regimen Xiaotangjiangya decoction to improve type2diabetes mellitus complicating hypertension patients in symptoms, signs, blood sugar, blood pressure, glycosylated hemoglobinthe impact of blood lipids, blood rheology, insulin resistance index and pancreatic β-cell function index.To evaluate the clinical efficacy and safety, explore the mechanism of prevention and treatment of this disease,and to provide an objective basis for clinical application.
Method:Randomized controlled study, would be consistent with type2diabetes mellitus complicating hypertension patients diagnostic criteria, were randomly divided into a treatment group and a control group. Decoct Chinese medicine Xiaotangjiangya decoction for treatment group of a daily regimen for three months on the basis of the basic treatment including hypoglycemic and antihypertensive medicine treatment. Before and after treatment were evaluated its symptoms, signs, blood sugar, blood pressure, glycosylated hemoglobin, lipids, insulin sensitivity index (IAI), hemorheological indicators, as well as in patients with adverse reactions, compliance. All data SPSS17.0statistical software for statistical analysis.
Conclusion:Diagnosis and inclusion of type2diabetes mellitus complicating hypertension in patients of60cases (30cases of the treatment group and the control group of30patients), gender, age, duration before treatment, baseline data were statistically nosignificant differences comparable.①on the symptoms and signs of improvement:the treatment group patients symptoms markedly improved, the total effective rate was90.00%; control group, the total effective rate was73.33%. The TCM symptoms improve treatment group than the control group (P<0.01).②hypoglycemic antihypertensive effect:the treatment group and the control group of patients with blood glucose, blood pressure, glycated hemoglobin were significantly reduced compared with before treatment group showed a significant difference (P<0.01); fasting glucose improved in the treatment group compared with the control group significantly differences (P <0.01), treatment group, postprandial blood glucose, glycosylated hemoglobin, blood pressure improvement compared with the control group, differences (P<0.05).③lipid effect:patients treated with TC, TG, LDL-C treatment compared with the control group decreased (P<0.01), HDL-C increased (P<0.01) before treatment; patients in the control group TC levels decreased (P<0.01), HDL-C levels increased(P<0.01), but no significant difference in the TG, LDL-C before treatment. The comparison between groups TC, HDL-C, to improve the situation was no significant difference between the two groups.④the hemorheological:treatment group after treatment, whole blood viscosity (high cut, middle cut, low cut), plasma viscosity than before treatment decreased (P<0.05), whole blood viscosity control group (in middle cut) and plasma viscosity before treatment decreased (P<0.05), plasma viscosity (high cut, low cut) before and after treatment was no fifference. The decline of the treatment group, whole blood viscosity (excised) between the two groups compared with the control group had significant differences (P＜0.01), plasma viscosity decreased levels of the two groups was no significant difference (P>0.05). The two sets of hematocrit were no significant changes before and after treatment⑤FINS, HOMA2-IR, HOMA2-%B:After treatment, FINS and HOMA2-IR than treatment significantly lower (P<0.01), and HOMA2-%B than treatment also significantly higher (P<0.01).⑥security indicators:liver and kidney function tests were within the normal range. Both groups were no adverse reactions.
Conclusion:View from preliminary clinical studies, treatment with Western medicine combination Xiaotangjiangya decoction effect better than the only western medicine, Chinese medicine treatment can improve the clinical symptoms of patients with hypertension and type2diabetes, lower blood sugar, blood pressure, regulate blood lipids,can improve blood rheology and safe, effective, and has a broad application prospects, and worthy of further study.
引文
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