四逆散合真武汤对糖尿病肾病合并冠心病的疗效观察及抗炎机制研究
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摘要
[目的]验证四逆散合真武汤加减方治疗糖尿病肾病合并冠心病的中医药优势,从少阴病的理法方药探讨糖尿病心肾同病的中医病因病机及证治规律。揭示其抗微炎症的作用机理。
[方法]将符合糖尿病肾病合并冠心病诊断标准的患者62例,随机分为治疗组和对照组,两组在西药常规治疗下,治疗组加服四逆散合真武汤加减方,对照组给予常规西药治疗,不服用中药,两组均连续治疗。评价两组综合疗效以及主要症状积分变化,双抗夹心ELISA法检测治疗前后患者血清sCD14变化。并观察CRP、FIB、心电图、尿微量白蛋白、BUN、Scr、甘油三酯、总胆固醇、低密度脂蛋白、高密度脂蛋白、载脂蛋白a、糖化血红蛋白、血分析、肝功能等指标的变化。
[结果](1)治疗组综合疗效总有效率为78.1%,对照组有效率为60.0%,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),治疗组改善更明显(P<0.05)；治疗组中医证候积分评价总有效率为90.6%,对照组总有效率为60.6%,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)两组治疗后血清sCD14均有显著下降(P<0.05),治疗组与对照组比较亦有显著性差异；治疗前糖尿病肾病Ⅳ期患者的sCD14明显高于糖尿病肾病Ⅲ期患者(P<0.05)；两组治疗后糖尿病肾病Ⅲ期和Ⅳ期患者的sCD14分别较前均有明显下降(P<0.01),其中治疗组Ⅲ期下降更明显,与对照组比较有显著差异(P<0.05)；(4)治疗后两组CRP、FIB均较治疗前明显下降(P<0.05),FIB组间比较也有显著性差异(P<0.05)；(5)心电图疗效比较两组无显著差异(P>0.05)(6)治疗后两组尿微量白蛋白均较治疗前明显下降(P<0.05),组间比较也有显著性差异(P<0.05)；治疗后治疗组Scr显著下降(P<0.01),与对照组比较亦有显著性差异(P<0.05)。两组BUN无显著性差异(P>0.05)。(7)两组治疗后TC、TG水平均明显下降(P<0.05),但组间对比无明显差异(P>0.05),两组治疗后LDL水平均未见明显下降(P>0.05)；两组治疗后HDL显著升高(P<0.01),两组治疗后ApoA水平均显著升高(P<0.05)组间比较也有显著性差异(P<0.05)；(8)两组血分析和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。
[结论](1)心肾阳虚,少阴枢机不利是糖尿病心肾同病的主要病机,根据病机治以温肾助阳,疏通气机,活血利水为法。(2)四逆散合真武汤加减方可明显降低糖尿病心肾同病患者血清可溶性CD14的水平,减少尿微量白蛋白,从而具有减轻血管炎症反应、保护心肾功能的作用。(3)四逆散合真武汤加减方能显著降低血浆纤维蛋白原水平,减轻DM患者血液高凝、高粘、高聚倾向,从而改善微循环,从而防止各种血栓性疾病的发生。(4)四逆散合真武汤加减方能辅助改善血脂,能显著升高载脂蛋白a的水平,临床使用安全。(5)四逆散合真武汤加减方能明显缓解糖尿病心肾同病患者临床症状,提高患者生活质量。
Objective
This study aimed to validate the excellence of TCM treatment for the patients of DN(diabetic nephropathy) with CHD (coronary heart disease) using the decoction modify Si Ni San and Zhen Wu Tang. To discuss the pathogen and pathogenesis of TCM and the law of differentiation on the DM (diabetes mellitus) with the pattern of both disease of the heart and kidney from the theory.method, formula and herb of Shao Yin disease. To reveal the mechanism of fight back the inflammation
Methods
62 patients measure up to the standard of diagnose of DN(diabetic nephropathy) with CHD (coronary heart disease) were in a randomized, controlled study and divided into treatment group and control group. Based on the conventional therapy, nothing were added to the control group while modified Si Ni San and Zhen Wu Tang were supplied to the treatment group. Treating were constant for both of the groups. Comprehensive effect and clinical symptoms on patients of two groups were evaluated from the change of serum soluble cluster of differentiation 14(sCD14) tested by ELISA. In addition, some important indicators, such as CRP(C-reactive protein), FIB(fibrinogen), ApoA(apolipoprotein A),MA(microalbuminuria), BUN (blood urea nitrogen), Scr(serum creatinine),HbAlc (glucosylated hemoglonbin), TG(Triglyceride),TC(Total cholesterol), LDL(Low-density lipoprotein), HDL(High-densitylipoprotein), ECG(electrocardiogram), BRT(Blood Routine Test), the function of liver and so on were contrasted between two groups as well as in the own control.
Results
(1)The clinical comprehensive curative rates in the treatment group was 78.1% while the control group was 60.0%, there were no statistical significant difference between the 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), and the treatment group decreased significantly (P<0.05); The clinical efficacy on symptoms of TCM was 90.6% in the treatment group and 60.6% in the control group, there were statistical significant difference between the two groups (P<0.05); Compared with the control group, each symptom score in the treatment group improved inordinately after treatment;(3)The level of sCD14 decreased significantly in both groups(P<0.05),and there were statistical significant difference between two groups; Compared with patients with early stage diabetic nephropath level of sCD14 with diabetic nephropathy and overt proteinuri is higher in pre-treatment; The levels of sCD14 decreased significantly in patients both early stage diabetic nephropathy and diabetic nephropathy and overt proteinuri after treatment(P<0.01), and the levels of early stage diabetic nephropathy in the treatment group decreased significantly(P<0.05) compared with the control group; (4) The levels of CRP and FIB decreased significantly in both groups (P<0.05), and there were statistical significant difference on FIB between the two groups (P<0.05); (5) There were no statistical significant difference between two groups on the changes of ECG(P>0.05); (6)The levels of MA decreased significantly in both groups after treatment(P<0.05), and there were statistical significant difference between two groups(P<0.05); The levels of BUN were not decreased significantly in both groups after the treatment (P>0.05) The level of SCr decreased significantly in both groups(P<0.05), and there were statistical significant difference between two groups; (7)The levels of TC and TG decreased significantly in both groups (P<0.05), but there were no statistical significant difference between the two groups (P>0.05). The levels of LDL were not decreased significantly in both groups after the treatment (P>0.05); The levels of HDL were increased significantly in both groups (P<0.01); The levels of ApoA were increased significantly in both groups (P<0.05); and there were statistical significant difference between two groups(P<0.05); (8)Indicators of safety,such as BRT and liver function unchanged in both groups during the test(P>0.05);and there were no obvious side-effect in the treatment group.
Conclusion
(1)Heart-kidney-yang deficiency and disfunction of Shao Yin is the major pathogenesis on the DM(diabetes mellitus) with the pattern of both disease of the heart and kidney. Treating methods such as warming the kidney to assist yang, regulate the qi activity, relieve the blood stasis and eliminate the fluid were supplied based on the pathogenesis. (2)Modified Si Ni San and Zhen Wu Tang has the function of reducing vascular inflammation and protecting the heart and kidney by reducing the levels of CD14 and MA for the pationts of DM with the pattern of both disease of the heart and kidney. (3) Microcirculation was improved and the occurrence of thrombotic diseases was prevented by modified Si Ni San and Zhen Wu Tang.Because the decoction can significantly decrease the level of plasma FIB, reduce the concretion, sticky and concentrate of the blood. (4) Modified Si Ni San and Zhen Wu Tang has a role in regulating blood lipids, can significantly increase the level of ApoA. The decoction is safe to use on the clinic. (5) Modified Si Ni San and Zhen Wu Tang can improve clinical symptoms in persons with DM with the pattern of both disease of the heart and kidney.
[方法]将符合糖尿病肾病合并冠心病诊断标准的患者62例,随机分为治疗组和对照组,两组在西药常规治疗下,治疗组加服四逆散合真武汤加减方,对照组给予常规西药治疗,不服用中药,两组均连续治疗。评价两组综合疗效以及主要症状积分变化,双抗夹心ELISA法检测治疗前后患者血清sCD14变化。并观察CRP、FIB、心电图、尿微量白蛋白、BUN、Scr、甘油三酯、总胆固醇、低密度脂蛋白、高密度脂蛋白、载脂蛋白a、糖化血红蛋白、血分析、肝功能等指标的变化。
[结果](1)治疗组综合疗效总有效率为78.1%,对照组有效率为60.0%,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),治疗组改善更明显(P<0.05)；治疗组中医证候积分评价总有效率为90.6%,对照组总有效率为60.6%,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)两组治疗后血清sCD14均有显著下降(P<0.05),治疗组与对照组比较亦有显著性差异；治疗前糖尿病肾病Ⅳ期患者的sCD14明显高于糖尿病肾病Ⅲ期患者(P<0.05)；两组治疗后糖尿病肾病Ⅲ期和Ⅳ期患者的sCD14分别较前均有明显下降(P<0.01),其中治疗组Ⅲ期下降更明显,与对照组比较有显著差异(P<0.05)；(4)治疗后两组CRP、FIB均较治疗前明显下降(P<0.05),FIB组间比较也有显著性差异(P<0.05)；(5)心电图疗效比较两组无显著差异(P>0.05)(6)治疗后两组尿微量白蛋白均较治疗前明显下降(P<0.05),组间比较也有显著性差异(P<0.05)；治疗后治疗组Scr显著下降(P<0.01),与对照组比较亦有显著性差异(P<0.05)。两组BUN无显著性差异(P>0.05)。(7)两组治疗后TC、TG水平均明显下降(P<0.05),但组间对比无明显差异(P>0.05),两组治疗后LDL水平均未见明显下降(P>0.05)；两组治疗后HDL显著升高(P<0.01),两组治疗后ApoA水平均显著升高(P<0.05)组间比较也有显著性差异(P<0.05)；(8)两组血分析和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。
[结论](1)心肾阳虚,少阴枢机不利是糖尿病心肾同病的主要病机,根据病机治以温肾助阳,疏通气机,活血利水为法。(2)四逆散合真武汤加减方可明显降低糖尿病心肾同病患者血清可溶性CD14的水平,减少尿微量白蛋白,从而具有减轻血管炎症反应、保护心肾功能的作用。(3)四逆散合真武汤加减方能显著降低血浆纤维蛋白原水平,减轻DM患者血液高凝、高粘、高聚倾向,从而改善微循环,从而防止各种血栓性疾病的发生。(4)四逆散合真武汤加减方能辅助改善血脂,能显著升高载脂蛋白a的水平,临床使用安全。(5)四逆散合真武汤加减方能明显缓解糖尿病心肾同病患者临床症状,提高患者生活质量。
Objective
This study aimed to validate the excellence of TCM treatment for the patients of DN(diabetic nephropathy) with CHD (coronary heart disease) using the decoction modify Si Ni San and Zhen Wu Tang. To discuss the pathogen and pathogenesis of TCM and the law of differentiation on the DM (diabetes mellitus) with the pattern of both disease of the heart and kidney from the theory.method, formula and herb of Shao Yin disease. To reveal the mechanism of fight back the inflammation
Methods
62 patients measure up to the standard of diagnose of DN(diabetic nephropathy) with CHD (coronary heart disease) were in a randomized, controlled study and divided into treatment group and control group. Based on the conventional therapy, nothing were added to the control group while modified Si Ni San and Zhen Wu Tang were supplied to the treatment group. Treating were constant for both of the groups. Comprehensive effect and clinical symptoms on patients of two groups were evaluated from the change of serum soluble cluster of differentiation 14(sCD14) tested by ELISA. In addition, some important indicators, such as CRP(C-reactive protein), FIB(fibrinogen), ApoA(apolipoprotein A),MA(microalbuminuria), BUN (blood urea nitrogen), Scr(serum creatinine),HbAlc (glucosylated hemoglonbin), TG(Triglyceride),TC(Total cholesterol), LDL(Low-density lipoprotein), HDL(High-densitylipoprotein), ECG(electrocardiogram), BRT(Blood Routine Test), the function of liver and so on were contrasted between two groups as well as in the own control.
Results
(1)The clinical comprehensive curative rates in the treatment group was 78.1% while the control group was 60.0%, there were no statistical significant difference between the 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), and the treatment group decreased significantly (P<0.05); The clinical efficacy on symptoms of TCM was 90.6% in the treatment group and 60.6% in the control group, there were statistical significant difference between the two groups (P<0.05); Compared with the control group, each symptom score in the treatment group improved inordinately after treatment;(3)The level of sCD14 decreased significantly in both groups(P<0.05),and there were statistical significant difference between two groups; Compared with patients with early stage diabetic nephropath level of sCD14 with diabetic nephropathy and overt proteinuri is higher in pre-treatment; The levels of sCD14 decreased significantly in patients both early stage diabetic nephropathy and diabetic nephropathy and overt proteinuri after treatment(P<0.01), and the levels of early stage diabetic nephropathy in the treatment group decreased significantly(P<0.05) compared with the control group; (4) The levels of CRP and FIB decreased significantly in both groups (P<0.05), and there were statistical significant difference on FIB between the two groups (P<0.05); (5) There were no statistical significant difference between two groups on the changes of ECG(P>0.05); (6)The levels of MA decreased significantly in both groups after treatment(P<0.05), and there were statistical significant difference between two groups(P<0.05); The levels of BUN were not decreased significantly in both groups after the treatment (P>0.05) The level of SCr decreased significantly in both groups(P<0.05), and there were statistical significant difference between two groups; (7)The levels of TC and TG decreased significantly in both groups (P<0.05), but there were no statistical significant difference between the two groups (P>0.05). The levels of LDL were not decreased significantly in both groups after the treatment (P>0.05); The levels of HDL were increased significantly in both groups (P<0.01); The levels of ApoA were increased significantly in both groups (P<0.05); and there were statistical significant difference between two groups(P<0.05); (8)Indicators of safety,such as BRT and liver function unchanged in both groups during the test(P>0.05);and there were no obvious side-effect in the treatment group.
Conclusion
(1)Heart-kidney-yang deficiency and disfunction of Shao Yin is the major pathogenesis on the DM(diabetes mellitus) with the pattern of both disease of the heart and kidney. Treating methods such as warming the kidney to assist yang, regulate the qi activity, relieve the blood stasis and eliminate the fluid were supplied based on the pathogenesis. (2)Modified Si Ni San and Zhen Wu Tang has the function of reducing vascular inflammation and protecting the heart and kidney by reducing the levels of CD14 and MA for the pationts of DM with the pattern of both disease of the heart and kidney. (3) Microcirculation was improved and the occurrence of thrombotic diseases was prevented by modified Si Ni San and Zhen Wu Tang.Because the decoction can significantly decrease the level of plasma FIB, reduce the concretion, sticky and concentrate of the blood. (4) Modified Si Ni San and Zhen Wu Tang has a role in regulating blood lipids, can significantly increase the level of ApoA. The decoction is safe to use on the clinic. (5) Modified Si Ni San and Zhen Wu Tang can improve clinical symptoms in persons with DM with the pattern of both disease of the heart and kidney.
引文
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