【作者】 隋艳波；

【导师】 刘莉；

【作者基本信息】 黑龙江中医药大学 ， 中医学， 2008， 硕士

【摘要】 目的:本课题在论证冠心病稳定型心绞痛(心阴不足兼心血瘀阻证)基本病机和养阴活血基本治法基础上,观察复方广枣胶囊对冠心病心绞痛(心阴不足兼心血瘀阻证)患者症状和血清IL-6水平的影响,初步评价其临床安全性和有效性并探讨其部分临床作用机制。方法:本研究采用区组随机、双盲单模拟、阳性药平行对照的设计方法。共纳入心阴不足兼心血瘀阻证冠心病稳定型心绞痛患者92例,随机分为试验组59例,对照组33例。两组在年龄、性别、病程、病情等一般临床资料方面差异无统计学意义。试验组予复方广枣胶囊,对照组予滋心阴胶囊治疗,疗程28天。治疗前后观察心绞痛症状、中医症状、硝酸甘油停减率、心电图和和血清IL-6水平及血常规、尿常规、便常规、肝功、肾功等安全性指标的变化。结果:试验组患者心绞痛症状疗效、心电图疗效、硝酸甘油停减率的总有效率分别为83.96%、66.98%、94.12%:优于对照组的83.02%、60.00%、93.75%,但两组间比较无统计学差异(P＞0.05)。各项中医症状疗效两组间比较无统计学差异(P＞0.05)。安全性评价方面,此次临床试验未见与临床试验用药有关的安全性异常指标或异常加重指标,提示本品有较好的安全性。炎症反应方面,疗后两组血清IL-6水平均较前降低,与疗前比较差异有显著统计学意义(P＜0.01),两组对炎症反应的改善作用经q检验,差异无统计学意义(P＞0.05)。结论:1.复方广枣胶囊是治疗冠心病稳定型心绞痛的一个安全、有效制剂。2.养阴活血法是治疗稳定型心绞痛心阴不足心血瘀阻证的有效治法。3.复方广枣胶囊能显著降低稳定型心绞痛患者血清IL-6水平,抑制血管内皮炎症反应,这可能是其治疗冠心病心绞痛的作用机制之一。更多还原

【Abstract】 Objective:To discuss the elementary pathogenesis of stable angina pectoris with the syndrome of Yin deficiency and blood stasis and the method of supplementing Yin and promoting blood flow to treat angina pectoris,study the curative effect mechanism of Compound Guangzao capsule on clinical symptom and IL-6 level in patients and discuss part of its clinical mechanism.Methods:According to the principle of block-radomize,double-blind, single-simulate,parallel contrast controlled design,we select a total of 92 angina pectoris patients with the syndrome of Yin insufficiency and blood stasis were observed.They were divided into two groups at random.The treatment group and the control group had 59 and 33 patients.There was no obvious difference in age,sex,illness course and severity degree between the two groups.The treatment group received Complex Guangzao capsule treatment.The control group received Zixinyin capsule.The changes of clinical symptoms and laboratory indexes in all patients were observed before and after treatment.Results:The treatment group was better than control group in overall effective rates of angina pectoris(83.96%vs 83.02%),electrocadiogram effective rate(66.98%vs 60.00%)and the reducing use rate of Nitroglycerin (89.62%vs 84.91%).At the aspect of treatment effect of traditional medicine,both groups could ameliorate the traditional Chinese medicine symptoms of angina pectoris of type Yin insufficiency and blood stasis such as chest pain,chest distress,cardiopalmus and so on.But between the experiment and control groups there was no significant difference.But there was no statistical difference between the two groups(P＞0.05).In Inflammatory reaction,IL-6 decreased.They were better and had remarkable difference than before treatment(P＜0.01).Compared between the two groups,there was no statistical difference.In side effects,no obvious and serious side effects were found.Conclusions:1.Compound Guangzao capsule is a safe and effective preparation on the treatment of stable angina patients.2.The methods of Supplement yin and promoting blood circulation are effective in treatment of stable angina patients with heart Yin insufficiency and blood stasis.3.Compound Guangzao capsule can decrease the consistency of IL-6 and Inhibiting the Inflammatory reaction of blood vessel endothelium remarkably in the stable angina patients,which may be one of mechanism action to treat coronary heart disease myocardial ischemia.更多还原