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注射用通脉粉针治疗冠心病心绞痛(血瘀证)的Ⅱ期临床研究

【作者】 邓丽娅

【导师】 刘永家;

【作者基本信息】 成都中医药大学 , 中西医结合临床, 2007, 硕士

【摘要】 冠心病是当今危害人类健康的非传染性疾病,其防治是当今世界各国卫生事业的重要内容。随着技术的进步、新药的开发和循证医学思想的引入,近年来在冠心病的预防和治疗方面已取得了长足的进展。目的:从临床症状、心电图、活动平板运动试验、血液流变学及肝肾功能等方面客观评价观察注射用通脉粉针治疗冠心病心绞痛(血瘀证)的有效性及安全性。方法:对符合冠心病心绞痛(血瘀证)诊断标准的72例患者采取随机分组、仿盲、阳性药平行对照设计,分为试验组1、试验组2与对照组共三组。试验组1、2用注射用通脉粉针的不同剂量治疗,对照组用注射用灯盏花素治疗,疗程14天,观察治疗前后各症状记分及相关检查变化情况。结果:(1)疾病综合疗效:试验组1、试验组2与对照组组间比较差异无统计意义(P>0.05);(2)心绞痛总疗效:试验组1、试验组2与对照组组间比较差异无统计意义(P>0.05);(3)心绞痛症状疗效:试验组1、试验组2与对照组组间比较差异无统计意义(P>0.05);(4)心电图疗效:试验组1、试验组2与对照组组间比较差异无统计意义(P>0.05);(5)三组病例治疗后中医各症状与治疗前比较均有明显改善;(6)安全性结果:安全性分析未见异常。结论:注射用通脉粉针治疗中医辨证为血瘀证的冠心病稳定型心绞痛可有效改善患者普通心电图心肌缺血表现,明显降低心绞痛发作频度、减轻心绞痛疼痛程度、缩短心绞痛持续时间,改善胸闷、心悸等症状,明显减少硝酸甘油用量.以上结果表明注射用通脉粉针能改善冠心病心绞痛(血瘀证)的临床症状,且比较安全。

【Abstract】 Nowadays,coronary heart disease(CHD) is one of main noncontagious diseases that endanger human’s health. Prevention and treatment of CHD have been taken predominant place in health service all over the world,and have been improved greatly with technological advance,development of new drug and the evolvement of evidence-based idea in recent yearObjective:To evaluate the efficacy of Tong Mai injection for treating stable angina pectoris with blood stasis in heart syndrome of TCM through investigating clinical syndrome,ECG, treadmill ECG test,blood lipid level,liver and kidney function, etc.Methods:72 cases of Stable angina coronary heart disease with heart blood stagnation syndrome were observed and randomly and averagely devided into treatment group 1,2 and control group.Treatment group were treated with Tong Mai injection, while control group were treated with Breviscapine injection. The period of treatment was 14 days.The symptoms and signs were observed both before and after treatment.The correlative eximations were taken both before and after treatment. Result:Effect of three groops and ECG days was no significant difference(P>0.05).The total effection of angina was no significant difference(P>0.05).The total effection of symptoms in chinese was no significant difference(P>0.05).The symptoms and signs,compared to these before treatment of the groups got better obviously.No obvious side effect was found.Conclusion:For the patient who is diagnosed Stable angina pectoris and with blood stasis in heart syndrome,Tong Mai injection can obviously improve the ischemic appearance of myocardium in ECG;obviously decrease angina pectoris attack frequency,alleviate chest pain -degree,shorten angina pectoris lasting time;relieve chest stuff and palpitation and decrease the dose of glonoine being taken.There are no significant adverse effects after taking the drugs.The result shows that Tong Mai injection is safe and effective for stable angina pectoris with syndrome of blood stasis in heart syndrome.

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