糖尿病性冠心病中医多中心临床诊疗方案研究
摘    要
    糖尿病性冠心病是指长期的糖代谢紊乱造成冠脉血管粥样硬化从而使血管狭窄或阻塞，最终导致心肌缺血缺氧甚至坏死而引起的心脏病。其较单纯冠心病患者室性心律失常的发生率高，糖尿病对冠心病患者心电学产生多方面的影响，是冠心病预后不良的高危因素。中医药对糖尿病性冠心病的治疗和碎死预防具有一定优势，可改善临床症状，提高患者生活质量，从整体方面来调整机体的功能紊乱。研究糖尿病性冠心病病人QT离散度、心率变异性、平板运动试验等心电信息对判断疾病的预后、指导临床用药、评价新药的疗效有很大的帮助。
    目的:本课题拟通过运用冠心消渴安颗粒剂对糖尿病性冠心病患者治疗前后
QT离散度、心率变异性、平板运动试验等心电信息检测，为糖尿病性冠心病运用中医药治疗找到合理用药依据。
    方法:选取河南中医学院第一附属医院门诊或住院符合诊疗标准的60例糖尿病性冠心病患者，参照随机数字表，依次随机分为对照组或治疗组，每组各30例。治疗组在常规治疗的基础上应用导师研制的冠心消渴安颗粒剂，对照组常规治疗，疗程均为1个月。分别测定治疗前后两组患者QT离散度、心率变异性、平板运动试验及其血糖指标的结果，比较其差异性，并作出统计学分析。
    结果:(1)治疗前，两组患者在性别、年龄及病程方面经统计学处理，无显著
性差异护（p>0.05），具有可比性。(2)治疗后，与治疗前相比，两组患者心电信息指标有明显改善，均P<0.05。(3)治疗后，冠心消渴安颗粒剂治疗组心电信息指标与对照组比较，提高显著，有明显差异，P<0.05。
    结论:本临床研究表明冠心消渴安颗粒剂能明显改善糖尿病性冠心病患者的主要临床症状，并可改善患者的各项心电信息指标，证实其有提高糖尿病性冠心病病人生活质量，改善病人预后的作用;进一步证实QT离散度与心率变异性分析、平板运动试验联合应用可以预测糖尿病性冠心病患者恶性心律失常和心脏碎死的发生，同时有助于指导糖尿病性冠心病的中医药治疗。
    关键词:冠心消渴安颗粒剂;糖尿病性冠心病;QT离散度;心率变异性分析;
Abstract
    Diabetic coronary heart disease refers to the dysfunction of long-term glucose metabolism, resulting in coronary atherosclerosis, vascular stenosis or occlusion,which lead to myocardial ischemia, hypoxia or necrosis. The prevalence of ventricular arrhythmia of the patient with diabetic coronary heart disease is higher than that of the patient with coronary heart disease alone. Diabetes produces various effects on the electrocardiology of the patient with diabetic coronary heart disease which is a high risk factor after the healing of the coronary heart disease. Chinese medicine has certain advantages on the treatment of the diabetic coronary heart disease and the prevention of the sudden death. It can improve the clinical symptoms and the quality of life for patients so as to adjust the body's dysfunction from an overall perspective.The study on QT dispersion, heart rate variability, ECG treadmill exercise test and other ECG informations of the diabetic patients with coronary heart disease is very helpful to determine the prognosis of the disease, guide clinical medicine, and evaluate the efficacy of new drugs.
    Objective: Through the use of Guanxinxiaokean Granules and the test on QT dispersion, heart rate variability, treadmill exercise test and other ECG informations before and after the treatment of diabetic patients with coronary heart disease, this essay is supposed to find the base of the rational TCM therapy for the patients of diabetic coronary heart disease.
    Methords: Select 60 cases of diabetic patients with coronary heart disease who meet the criteria for diagnosis in the First Affiliated Hospital of Henan College clinic or hospital. Then they are divided randomly into treatment group or control group according to the treatment order, 30 cases in each group. Based on the conventional treatment, the treatment group takes Guanxinxiaokean Granules developed by a mentor, while the control group takes the conventional treatment. The course of treatment is a month. Measure and compare the QT dispersion, the heart rate variability, and the results of treadmill exercise test in two groups of patients before and after the treatment,and make a statistical analysis.
    Results: (1)Before the treatment, the two groups of patients in terms of gender, age, duration, etc. Statistically, all P>0.05, no significant differences which were comparable. (2) after the treatment, comparing with the treatment before, the two groups of patients' ECG information indicators improved significantly, both P<0.01. (3) After the treatment, comparing with the ECG information indicators of the control group, the treatment group improved significantly with significant differences,P<0.05.
    Conclusion: This clinical study showed that Guanxinxiaokean Granules can significantly improve the major clinical  symptoms  of the patients  with diabetic coronary heart disease, and improve the patients' ECG information indicators which confirm that it can improve the quality of life for diabetic patients with coronary heart disease, and improve patient prognostic role; It further confirms QT dispersion and heart rate variability analysis, combined with treadmill exercise test can predict  the occurrence of malignant arrhythmias and sudden cardiac death of the diabetic patients with coronary heart disease, as well it can help to guide the TCM treatment for the patients of diabetic coronary heart disease.
Key words:dispersion; heart Guanxinxiaokean  Granules;  diabetic  coronary  heart disease;  QT rate variability analysis; treadmill exercise test
目    录
摘    要 I
Abstract II
前    言 1
对象与方法 3
1研究对象 3
2诊断标准 3
2.1糖尿病的诊断 3
2.2冠心病的诊断 3
2.3糖尿病性冠心病的诊断:糖尿病伴发或者并发冠心病者。 4
3病例的纳入与排出标准 4
3.1病历纳入标准 4
3.2病例排除标准(包括不适应症或剔除标准) 4
4研究方法 5
4.1病例来源 5
4.2病例分组 5
4.3一般资料分析 5
4.4治疗方法 6
5观察指标及检测方法 6
6疗效评定标准 7
7统计方法 7
结    果 8
1两组总体疗效 8
2 QT间期离散度 8
3心率变异性(HRV) 8
4平板运动试验 9
5治疗前后血糖 9
理论探讨 11
1中医学对糖尿病性冠心病的认识 11
2中医学对糖尿病性冠心病病因病机的研究现状 12
3糖尿病性冠心病中医辨证分型研究进展 12
4糖尿病性冠心病的中医药治疗研究现状 13
4.1辨证分型论治 13
4.2辨证与辨病相结合分型论治 14
4.3专方治疗 14
4.4中成药治疗 15
5中医药治疗糖尿病性冠心病的实验研究 15
6现代医学对糖尿病性冠心病的研究现状 16
7现代医学对心电信息相关指标的研究现状 17
8糖尿病性冠心病与心电信息的相关性研究 19
9导师对糖尿病性冠心病的认识及对心电信息的相关研究 19
10冠心消渴安颗粒剂方义分析及单味药现代药理研究 20
10.1冠心消渴安颗粒剂方义分析 20
10.2单味药现代药理研究 21
结    论 23
致    谢 24
参考文献 25
附录一文献综述 28
附录二SPSS19.0统计分析过程 46