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清化瘀热方干预糖尿病心肌病瘀热证的临床研究
Clinical Research on Presciption of Removing Heat and Eliminating Blood Stasis to Interfere in the Syndrome Stagnated Heat of Diabetic Cardiomyopathy
【作者】 邵鑫；
【导师】 王旭；
【作者基本信息】 南京中医药大学 ， 中医内科学， 2010， 硕士
【摘要】 目的：探讨中医学对糖尿病心肌病的认识,采用清化瘀热方治疗糖尿病心肌病瘀热证。通过随机对照临床试验,观察清化瘀热方对糖尿病心肌病瘀热证患者血糖、血脂、血液流变学、炎症因子hs-CRP、IL-6、心脏彩超左室结构及功能等指标的影响,探讨其防治本病的机理。方法：采用随机对照的研究方法,将符合糖尿病心肌病瘀热证诊断标准的患者,随机分为治疗组和对照组。在生活方式干预和西药常规治疗的基础上,治疗组加用中药清化瘀热方水煎剂每日一剂,疗程3个月。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测血糖、糖化血红蛋白、血脂、血液流变学、炎症因子hs-CRP、IL-6、心脏彩超左室结构及功能等指标,以及患者的不良反应、依从性。全部数据以SPSS16.0统计软件进行统计学分析。结果：确诊并纳入的糖尿病心肌病瘀热证患者50例(治疗组25例,对照组25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(P>0.05)。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,总有效率为84.00%；对照组总有效率44.00%。治疗组中医症状改善情况明显优于对照组(P<0.01)。②降糖效果：治疗组与对照组患者餐后血糖、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、餐后血糖改善较对照组有显著差异(P<0.01),治疗组糖化血红蛋白改善较对照组有差异(P<0.05)。③调脂效果：治疗组患者治疗后TC、ApoB水平下降(P<0.05),TG、LDL-C、ApoB、ApoE、Lp (a)水平下降,与治疗前比较有显著性差异(P<0.01),HDL-C、ApoA与治疗前比较升高(P<0.01)。对照组患者治疗后TC、TG、LDL-C、ApoB、ApoE水平均较治疗前下降(P<0.05), HDL-C、ApoA水平升高(P<0.05)。组间比较治疗组HDL-C、ApoA水平改善较对照组具有显著性差异(P<0.01),TC、TG、LDL-C、ApoB、ApoE水平有差异(P<0.05),Lp(a)的改善情况两组无明显差异(P>0.05)。④血液流变学：治疗组治疗后全血粘度(高切、中切、低切5/s、低切1/s)、血浆粘度、血沉较治疗前均下降,有显著性差异(P<0.01),对照组全血粘度(低切1/s)和血沉较治疗前均明显下降(P<0.01),但全血粘度(高切、中切、低切5/s、血浆粘度)治疗前后无差异(P>0.05)。组间比较治疗组全血粘度(高切、中切、低切5/s)改善较对照组有差异(P<0.05),全血粘度(低切1/s)、血浆粘度、血沉较治疗前改善有显著性差异(P<0.01)。⑤炎症因子hs-CRP、IL-6：治疗组治疗后hs-CRP、IL-6均较治疗前降低,具有显著性差异(P<0.01),与对照组比较均有差异(P<0.05)；对照组IL-6较治疗前也有显著性改善(P<0.01),但hs-CRP无明显差异(P>0.05)。⑥左室结构指标：治疗后两组LAD、LVID、IVSD、LVPWd均明显降低,其中LAD、IVSD与治疗前比较均有差异(P<0.05), LVID、LVPWd与治疗前比较均有显著性差异(P<0.01)；对照组治疗后LVID、LVPWd与治疗前比较均有差异(P<0.05), LAD、IVSD与治疗前比较无明显差异(P>0.05)；两组间治疗后比较,治疗组LVID、IVSD改善较对照组有差异(P<0.05),治疗组LAD改善较对照组有显著性差异(P<0.01),但治疗前后IVSD无明显差异(P>0.05)。⑦左室功能指标：治疗后两组左室结构指标均明显降低,且与治疗前比较均有显著性差异(P<0.01)；对照组治疗后PeakA、E/A与治疗前比较有显著性差异(P<0.01),FS与治疗前比较有差异(P<0.05), EF、PeakE与治疗前比较无明显差异(P>0.05)；两组间治疗后比较,治疗组改善较对照组有显著性差异(P<0.01)。⑧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,西药治疗合用清化瘀热方效果优于单纯西药治疗,中药治疗既可改善糖尿病心肌病患者的临床症状,降低血糖,调节血脂,还能改善血液流变学、炎症反应、左室结构及功能指标,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
【Abstract】 Purpose:To discuss the understanding of traditional Chinese medicine about diabetic cardiomyopathy,using prescription of removing heat and eliminating blood stasis.To observe the therapeutic efficacy of this method in treating the syndrome stagnated heat of diabetic cardiomyopathy.Methods:A randomized,controlled trial was conducted 50 patients with the syndrome of stagnated heat of diabetic cardiomyopathy were randomly classified into two groups.On the basic of normal treatment and modern medicine,the patients of treated group (n=25) were treated by Chinese medicine while the patients of controlled group (n=25) were not.Three months was a course of treatment.The observed indexes included both curative effect indexes,such as clinical symptoms,FBG,PBG, HbAlc, blood fat, hemorheology and inflammatory factor hs-CRP,IL-6, index of left ventricular structure and function,and safety indexes,such as routine urine,blood and stool test,ECG,the function of liver and kidney and harmful reaction.The complete data carries on statistics analysis by the SPSS16.0 statistics software.Results:Prior treatment,the gender,age,course of disease of the two groups patients had no differeces.①The total effective rate of treated roup patients was 84.00%; while the controlled group was 44.44%.The treated group had an advantage than the controlled group(P<0.05).②The postprandial blood glucose, HbAlc of two groups were lowered(P<0.01). And the treated group had an advantage than the controlled group(P<0.05).③Compared with pre-treatment, in the treated group patients’TC、ApoB had a lowering(P<0.05),and TG,LDL-C,ApoB,ApoE,Lp (a) had a lowering and HDL-C, ApoA had marked increased(P<0.01), showing that the combination of Western medicine and chinese medicine has the function of adjusting fat and it does much better than using western medicine effected only in TC and HDL-C.④After treatment,the whole blood viscosity (highly cuts,middle cuts,lowly cuts5/s, lowly cutsl/s),the blood plasma viscosity and the ESR of the treated group dropped.The whole blood viscosity (lowly cutsl/s) and the ESR of the controlled group dropped.The dropping of the whole blood viscosity (lowly cutsl/s),the blood plasma viscosity and the ESR between treated group and controlled group had a remarkable difference (P<0.01), but the drop level of the whole blood viscosity (highly cuts,middle cuts,lowly cuts5/s),the blood plasma viscosity in the controlled group had no obvious difference.⑤Inflammatory hs-CRP, IL-6:After treatment, hs-CRP, IL-6 of treated group had a significant difference (P<0.01), compared with the control group were different (P<0.05).Compared with pre-treatment,IL-6 of the control group also significantly improved (P<0.01), but no significant difference in hs-CRP (P>0.05).⑥Left ventricular structure indicators:After treatment, LAD, LVID, IVSD, LVPWd were significantly decreased, LAD, IVSD were different compared with before treatment (P<0.05), LVID, LVPWd before treatment were significantly different (P<0.01); the control group after treatment LVID, LVPWd were different compared with before treatment (P<0.05), LAD, IVSD and treatment showed no difference (P>0.05); after treatment between the two groups, treatment group LVID, IVSD had more improvement than the control group (P<0.05), LAD to improve the treatment group than in the control group there was significant difference (P<0.01), but no significant difference before and after treatment IVSD (P>0.05).⑦Left ventricular function indicators:Indicators of left ventricular structure after treatment were significantly lower compared with before treatment and were significantly different (P<0.01); the control group after treatment PeakA,E/A there were significant differences (P<0.01), FS are different compared with before treatment (P<0.05), EF, PeakE and treatment showed no difference (P>0.05); comparison between the two groups after treatment, the treatment group improved significantly compared with the control group difference (P<0.01).⑧Safety indicators:Liver and kidney function tests were within normal range. Both groups were no adverse reactions.Conclusion:Chinese medicine of method in removing heat and eliminating stasis has sure curative effected in treating diabetic cardiomyopathy. It is worth studying deeply and developing further.