温肾健脾法对脾肾阳虚型糖尿病疗效及生存质量的临床研究
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摘要
目的
观察温肾健脾法对脾肾阳虚型糖尿病患者的临床疗效及生存质量的影响,系统地探讨其中医发病机制及加味真武汤治疗的作用机理。
方法
将82例糖尿病患者,按照随机、对照的原则分为治疗组、对照组,两组均予糖尿病基础治疗。治疗组在西医常规治疗基础上服用加味真武汤。对照组予阿司匹林肠溶片及贝那普利片治疗。两组均连续治疗6周。评价两组综合疗效以及主要症状积分变化,观察空腹血糖(FBG)、餐后2小时血糖(P2hBG)、糖化血红蛋白(HbAlc)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、纤维蛋白原(FIB)、C反应蛋白(CRP)等指标变化。采用DSQL问卷对治疗前后生存质量的改变进行评价。
结果
(1)ITT分析显示,治疗组综合疗效总有效率为75.0%,对照组有效率为53.8%,两组对比无显著性差异(P>0.05)；PP分析显示,治疗组综合疗效总有效率为76.9%,对照组有效率为55.3%,两组对比无显著性差异(P>0.05)；(2)治疗后两组中医症状积分均显著改善(P<0.05,P<0.01),治疗组改善更明显；治疗组中医证候积分评价总有效率为92.3%,对照组总有效率为73.7%,组间对比有显著性差异(P<0.05)；治疗组治疗后各症状评分较对照组有不同程度改善；(3)治疗后两组FBG、P2hBG、HbAlc均明显下降(P<0.05,P<0.01),但组间对比无显著性差异(P>0.05)；(4)治疗组治疗后FINS、HOMA-IR显著下降(P<0.01),与对照组比较亦有显著性差异,对照组上述指标无明显改善(P>0.05)；(5)两组治疗后TC、TG、LDL水平均明显下降(P<0.01),但组间对比无明显差异(P>0.05)；治疗组治疗后HDL显著升高(P<0.01),而对照组治疗前后HDL无显著性差异(P>0.05)；(6)治疗后两组CRP、FIB均较治疗前明显下降(P<0.05,P<0.01),组间比较也有显著性差异(P<0.05)；(7)治疗组在改善肾功能方面优于对照组(P<0.01),两组肝功能等安全性指标无显著改变(P>0.05)治疗组无明显不良反应；(8)生存质量分析,对照组治疗后治疗维度评分高于治疗前,且差异有显著性(P<0.05),心理、社会维度评分及总积分有上升趋势,而生理维度评分有所下降,但与治疗前对比均无显著性差异(P>0.05)；治疗组治疗后生理、心理、治疗维度及总积分与治疗前比较差异有显著性(P<0.05,P<0.01),与对照组比较亦有显著性差异(P<0.01),而社会维度无显著改善(P>0.05)。
结论
(1)脾肾阳虚是糖尿病及其慢性并发症的主要病机；(2)生存质量是评价中医药防治糖尿病及其慢性并发症疗效的较理想指标；(3)以温肾健脾治则组方的加味真武汤能够改善糖尿病及其慢性并发症患者的临床症状,提高患者的生存质量；(4)加味真武汤能辅助降低血糖,控制血糖波动,改善胰岛素抵抗,增强胰岛素敏感性；(5)加味真武汤对血脂有双向调节作用,能显著降低血浆CRP水平,从而具有减轻血管炎症反应、保护血管内皮功能的作用；(6)加味真武汤能显著降低血浆FIB水平,改善微循环,防止血栓性疾病的发生；(7)加味真武汤对肾功能有一定的保护作用,安全有效,无明显毒副作用,值得临床推广。
Objective
This study aimed to evaluate the efficacy of treatment for warming Shen and invigoration Pi in treating patients of diabetic and its effect on patients'Quality of Life (QOL). To systematically explore the mechanism of traditional Chinese medicine (TCM) on the illness and the mechanism of Modified Zhen Wu Tang on preventing and treating
Methods
82 patients of diabetic were enrolled in a randomized, controlled study and divided into treatment group and control group, both groups received conventional therapy. Patients in the treatment group took Modified Zhen Wu Tang on the basis of conventional western treatment, while members of control group were treated with Aspirin enteric-coated tablets and Benazepril tablets. The test cycle was 6 weeks. And than evaluated the comprehensive effect on patients of two groups, In addition, all patients'clinical symptoms and some important indicators, such as Fasting blood glucose (FBG),2-hour postprandial blood glucose (P2hBG), glycosylated hemoglobin (HbAlc), fasting insulin (FINS), insulin resistance index (HOMA-IR), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), fibrinogen (FIB), C-reactive protein (CRP) were contrasted between two groups as well as in the own control. The patients'QOL was evaluated by DSQL Scale.
Results
(1) The clinical comprehensive curative rates in the treatment group was 76.9% and in the control group was 55.3%, there were no statistical significant difference between two groups (P>0.05); (2) Compared with pre-treatment, the total scores of symptoms in two groups were significantly decreased after treatment(P<0.05, P<0.01), and the treatment group decreased significantly (P<0.01); The clinical efficacy on symptoms of TCM was 92.3% in the treatment group and 73.7% In the control group, there were statistical significant difference between two groups (P<0.05); Compared with the control group, each symptom score in the treatment group improved inordinately after treatment; (3)The levels of FBG, P2hBG, HbA1c decreased significantly in both groups after treatment(P<0.05, P<0.01), but there were no statistical significant difference between two groups (P>0.05); (4) There were statistical significant difference on FINS and HOMA-IR in the own control of the treatment group (P<0.01), but there were'nt it in the control group(P>0.05), there were statistical significant difference between two groups before and after treatment; (5) The levels of TC、TG、LDL decreased significantly in both groups (P<0.01), but there were no statistical significant difference between two groups(P>0.05); The level of HDL increased significantly in the treatment group after treatment, but there was't it in the control group(P>0.05); (6)The levels of CRP and FIB decreased significantly in both groups after treatment (P<0.05, P<0.01), and there were statistical significant difference between two groups(P<0.05); (7)Renal function in the treatment group was improved more significantly compared to the control group(P<0.01), and other indicators of safety, such as liver function, remained unchanged in both groups during the test; (8)Analysis of QOL during treatment, the score on the treatment dimension in the control group increased significantly(P<0.05), and there were upward trends on the scores of the psychological, social and total dimension, while the physical dimension declined, however, there were no significant difference during treatment(P>0.05); Besides social dimension, the scores on the overall dimensions in the treatment group decreased significantly(P<0.01), and and there were statistical significant difference between two groups(P<0.05).
Conclusion
(1)Spleen-kidney-yang deficiency is the major mechanism of TCM on the diabetes and its chronic complications; (2)there is an ideal indicator on QOL to evaluate efficacy on the treatment of diabetes and its chronic complications with TCM; (3)With theoretical guidance of warming Shen and invigoration Pi, Modified Zhen Wu Tang can improve clinical symptoms and QOL in persons with diabetes and its chronic complications;(4)Modified Zhen Wu Tang, it can help patients to decrease blood sugar, control blood sugar fluctuations, improve insulin resistance, and increase insulin sensitivity; (5)Modified Zhen Wu Tang has a role in regulating blood lipids, can significantly decrease the level of plasma CRP, thereby reducing vascular inflammation and having the protection of the role of vascular endothelial function; (6) Modified Zhen Wu Tang can significantly decrease the level of plasma FIB, improve microcirculation and prevent the occurrence of thrombotic diseases; (7) Modified Zhen Wu Tang have a certain protective effect on renal function, the drug safe and effective, there is no obvious side effects, and it's worth-popularizing.
观察温肾健脾法对脾肾阳虚型糖尿病患者的临床疗效及生存质量的影响,系统地探讨其中医发病机制及加味真武汤治疗的作用机理。
方法
将82例糖尿病患者,按照随机、对照的原则分为治疗组、对照组,两组均予糖尿病基础治疗。治疗组在西医常规治疗基础上服用加味真武汤。对照组予阿司匹林肠溶片及贝那普利片治疗。两组均连续治疗6周。评价两组综合疗效以及主要症状积分变化,观察空腹血糖(FBG)、餐后2小时血糖(P2hBG)、糖化血红蛋白(HbAlc)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、纤维蛋白原(FIB)、C反应蛋白(CRP)等指标变化。采用DSQL问卷对治疗前后生存质量的改变进行评价。
结果
(1)ITT分析显示,治疗组综合疗效总有效率为75.0%,对照组有效率为53.8%,两组对比无显著性差异(P>0.05)；PP分析显示,治疗组综合疗效总有效率为76.9%,对照组有效率为55.3%,两组对比无显著性差异(P>0.05)；(2)治疗后两组中医症状积分均显著改善(P<0.05,P<0.01),治疗组改善更明显；治疗组中医证候积分评价总有效率为92.3%,对照组总有效率为73.7%,组间对比有显著性差异(P<0.05)；治疗组治疗后各症状评分较对照组有不同程度改善；(3)治疗后两组FBG、P2hBG、HbAlc均明显下降(P<0.05,P<0.01),但组间对比无显著性差异(P>0.05)；(4)治疗组治疗后FINS、HOMA-IR显著下降(P<0.01),与对照组比较亦有显著性差异,对照组上述指标无明显改善(P>0.05)；(5)两组治疗后TC、TG、LDL水平均明显下降(P<0.01),但组间对比无明显差异(P>0.05)；治疗组治疗后HDL显著升高(P<0.01),而对照组治疗前后HDL无显著性差异(P>0.05)；(6)治疗后两组CRP、FIB均较治疗前明显下降(P<0.05,P<0.01),组间比较也有显著性差异(P<0.05)；(7)治疗组在改善肾功能方面优于对照组(P<0.01),两组肝功能等安全性指标无显著改变(P>0.05)治疗组无明显不良反应；(8)生存质量分析,对照组治疗后治疗维度评分高于治疗前,且差异有显著性(P<0.05),心理、社会维度评分及总积分有上升趋势,而生理维度评分有所下降,但与治疗前对比均无显著性差异(P>0.05)；治疗组治疗后生理、心理、治疗维度及总积分与治疗前比较差异有显著性(P<0.05,P<0.01),与对照组比较亦有显著性差异(P<0.01),而社会维度无显著改善(P>0.05)。
结论
(1)脾肾阳虚是糖尿病及其慢性并发症的主要病机；(2)生存质量是评价中医药防治糖尿病及其慢性并发症疗效的较理想指标；(3)以温肾健脾治则组方的加味真武汤能够改善糖尿病及其慢性并发症患者的临床症状,提高患者的生存质量；(4)加味真武汤能辅助降低血糖,控制血糖波动,改善胰岛素抵抗,增强胰岛素敏感性；(5)加味真武汤对血脂有双向调节作用,能显著降低血浆CRP水平,从而具有减轻血管炎症反应、保护血管内皮功能的作用；(6)加味真武汤能显著降低血浆FIB水平,改善微循环,防止血栓性疾病的发生；(7)加味真武汤对肾功能有一定的保护作用,安全有效,无明显毒副作用,值得临床推广。
Objective
This study aimed to evaluate the efficacy of treatment for warming Shen and invigoration Pi in treating patients of diabetic and its effect on patients'Quality of Life (QOL). To systematically explore the mechanism of traditional Chinese medicine (TCM) on the illness and the mechanism of Modified Zhen Wu Tang on preventing and treating
Methods
82 patients of diabetic were enrolled in a randomized, controlled study and divided into treatment group and control group, both groups received conventional therapy. Patients in the treatment group took Modified Zhen Wu Tang on the basis of conventional western treatment, while members of control group were treated with Aspirin enteric-coated tablets and Benazepril tablets. The test cycle was 6 weeks. And than evaluated the comprehensive effect on patients of two groups, In addition, all patients'clinical symptoms and some important indicators, such as Fasting blood glucose (FBG),2-hour postprandial blood glucose (P2hBG), glycosylated hemoglobin (HbAlc), fasting insulin (FINS), insulin resistance index (HOMA-IR), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), fibrinogen (FIB), C-reactive protein (CRP) were contrasted between two groups as well as in the own control. The patients'QOL was evaluated by DSQL Scale.
Results
(1) The clinical comprehensive curative rates in the treatment group was 76.9% and in the control group was 55.3%, there were no statistical significant difference between two groups (P>0.05); (2) Compared with pre-treatment, the total scores of symptoms in two groups were significantly decreased after treatment(P<0.05, P<0.01), and the treatment group decreased significantly (P<0.01); The clinical efficacy on symptoms of TCM was 92.3% in the treatment group and 73.7% In the control group, there were statistical significant difference between two groups (P<0.05); Compared with the control group, each symptom score in the treatment group improved inordinately after treatment; (3)The levels of FBG, P2hBG, HbA1c decreased significantly in both groups after treatment(P<0.05, P<0.01), but there were no statistical significant difference between two groups (P>0.05); (4) There were statistical significant difference on FINS and HOMA-IR in the own control of the treatment group (P<0.01), but there were'nt it in the control group(P>0.05), there were statistical significant difference between two groups before and after treatment; (5) The levels of TC、TG、LDL decreased significantly in both groups (P<0.01), but there were no statistical significant difference between two groups(P>0.05); The level of HDL increased significantly in the treatment group after treatment, but there was't it in the control group(P>0.05); (6)The levels of CRP and FIB decreased significantly in both groups after treatment (P<0.05, P<0.01), and there were statistical significant difference between two groups(P<0.05); (7)Renal function in the treatment group was improved more significantly compared to the control group(P<0.01), and other indicators of safety, such as liver function, remained unchanged in both groups during the test; (8)Analysis of QOL during treatment, the score on the treatment dimension in the control group increased significantly(P<0.05), and there were upward trends on the scores of the psychological, social and total dimension, while the physical dimension declined, however, there were no significant difference during treatment(P>0.05); Besides social dimension, the scores on the overall dimensions in the treatment group decreased significantly(P<0.01), and and there were statistical significant difference between two groups(P<0.05).
Conclusion
(1)Spleen-kidney-yang deficiency is the major mechanism of TCM on the diabetes and its chronic complications; (2)there is an ideal indicator on QOL to evaluate efficacy on the treatment of diabetes and its chronic complications with TCM; (3)With theoretical guidance of warming Shen and invigoration Pi, Modified Zhen Wu Tang can improve clinical symptoms and QOL in persons with diabetes and its chronic complications;(4)Modified Zhen Wu Tang, it can help patients to decrease blood sugar, control blood sugar fluctuations, improve insulin resistance, and increase insulin sensitivity; (5)Modified Zhen Wu Tang has a role in regulating blood lipids, can significantly decrease the level of plasma CRP, thereby reducing vascular inflammation and having the protection of the role of vascular endothelial function; (6) Modified Zhen Wu Tang can significantly decrease the level of plasma FIB, improve microcirculation and prevent the occurrence of thrombotic diseases; (7) Modified Zhen Wu Tang have a certain protective effect on renal function, the drug safe and effective, there is no obvious side effects, and it's worth-popularizing.
引文
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