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
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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。
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 year
Objective: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.
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。
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 year
Objective: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.
引文
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2 The European Society of Cardiology.Eur Heart J,1997;18:394-413
3 戴闺柱.心力衰竭诊断和治疗研究进展.中华心血管杂志,2003,9(9):31
4 Darius H.J Cardiovasc Pharmacol,1999;34:15-20
5 鲜玉琼,郑昌柱,许秀丽,等.Vit C及非洛地平对急性心梗溶栓治疗中再灌注损伤的保护作用[J].中华医学实践杂志,2004,3(9):772-776
6 Boersma E,Akkerhuis KM,Theroux P,etal,Platelet receptor G PⅡb/Ⅲa receptor inhibition in nonST-elevation acute coronary syndrome:early benefit during medical treat ment only with additional protection during percutaneous coronary intervention(J).Circulation,1999,100:2045-2048
7 Sheperd J,Cobbe SM,Ford 1,et al.N Engl J Med,1995;333:1301-1307
8 Heeschen C,Hamm CW,Laufs U,etal..Circulation,2002;105:1446-1452
9 The Heart Outcomes Prevention Evaluation Study Investigators.N Engl J Med,2000;342:145-153
10 Herrigton DM,Reboussin DM,Brosnihan KB,etal.N Engl J Med,2000;343:522-529
11 翁维良.活血化瘀研究的成就[J].中西医结合杂志1988,8(特):26
12 王受益.中国中西医结合第二届全国心血管病防治学术交流会议纪要[J].中西医结合杂志,1991,11(5):318
13 徐凤芹,陈可远,马晓昌,等.芎芍胶囊治疗冠心病心绞痛的临床观察[J].中国中西医结合杂志,2003,23(1):17
14 翁维良.活血化瘀研究的成就[J].中西医结合杂志 1988,8(特):26
14 秦万章.血瘀和活血化瘀的研究进展及前景[J].中医杂志.1980,21(9):713
15 行清椿,赵国华,冯晓东.复方丹参注射液择时治疗冠心病心绞痛血瘀证80例[J].中国中西医结合杂志,1998.18(8):506-507
16 张人伟,张元玲,王杰生,等.灯盏花黄酮类成分分离鉴定[J].中草药,1988,19(5):199-201.
17 林雄,褚克丹.灯盏花素的药理学研究进展[J].海峡药学,2005,17(6):5-8
18 叶勇.丹参有效成分分离的研究进展.药品评价,2005,2(2):146
19 Pu ZM,ZhuW L,J in Z Y,et al.Effect of Tet ram ethyl Pyrazine on Co ronary V asocon st rict ion In2duced by Endo thelin- 1 in Dogs[J].ACTA ACADEMIA EM ED IC INA E S IN ICA E(中国医学科学院学报),1996,18(2):133-137.
20 欧阳静萍,王保华,刘永明,等.阿魏酸钠对高脂血症家兔动脉粥样硬化形成的影响及其机制的研究[J].中国药理学通报,2002,18(2):207-210
21 杨守忠,石东起,姜东怀,等.葛根素治疗不稳定型心绞痛的疗效观察[J].临床荟萃,1999,14(18):842-843.
22 陈炳旺等 冠心病中医实证血流变学变化的临床研究.福建中医学院学报,2000,10(1):1-2
23 周中山 冠心病心绞痛中医证型与血流变学的相关性研究.湖南中医药导报,2001,7(7):360-361
1 Celermajer D.Endothelial dysfunction:Does it matter? Is it reversible[J]?J Am Coll Cardiol,1997,30:325-333.
2 Schachinger V,Zeiher AM.Quantitative assessment of coronary vasoreachvity in humans in vivo.Importance of baseline vasomotor tone in atherosclerosis.Circulation 1995:92(8):2087-94
3 Drexler H,Hornig B.Endothelial disfunction in human disease[J].J MOL Cell Cardiol,1999,31:51-60
4 Celermajer DS.Endothelial dysfunction:Do it matter? Is it reversible?[J].J Am Coll Cardiol,1997,30:325-333
5 Rajagopalan S,Harrison DG.Reversing endothelial dysfunction[J]Circulation,1996,94:240-243
6 Shimokawa H.Primary endothelial dysfunction:atherosclerosis[J].J Mol Cell Cardiol,1999,31:23-37
7 李晓等.血管内皮细胞损伤与血瘀证[J].中国中西医结合杂志,2000,20(2):154-156
8 杨惠霞等.血栓调节蛋白与临床[J].现代中西医结合杂志,2001,(10)19:1908-1910]
9 Vanhotte PM.Endothelial dysfunction and atherosclerosis.Eu Heart 1997;18(Suppl E):E19-E29.
10 Hillis GS,Flapan AD.Cell adhesion molecules incardiovascular disease:a clinical perspective.Heart 1998;79(5):429-431.
11 蔡钦朝,王琼华,吴云志,血瘀证患者血管内皮分泌功能的观察,安徽中医学院学报,1998,17(2):61-62
12 王奇,陈云波,赖世隆等,血府逐瘀汤对血瘀证兔血清损伤的血管内皮细胞的形态学影响,广州中医药大学学报,2001,18(2);106-108
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28 谢梅林,顾振纶,周文轩等,消瘀斑对粥样硬化兔血管壁组织ET-1mRNA和NOSmRNA表达的影响,中草药,1999,25(11);834-847
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2 The European Society of Cardiology.Eur Heart J,1997;18:394-413
3 戴闺柱.心力衰竭诊断和治疗研究进展.中华心血管杂志,2003,9(9):31
4 Darius H.J Cardiovasc Pharmacol,1999;34:15-20
5 鲜玉琼,郑昌柱,许秀丽,等.Vit C及非洛地平对急性心梗溶栓治疗中再灌注损伤的保护作用[J].中华医学实践杂志,2004,3(9):772-776
6 Boersma E,Akkerhuis KM,Theroux P,etal,Platelet receptor G PⅡb/Ⅲa receptor inhibition in nonST-elevation acute coronary syndrome:early benefit during medical treat ment only with additional protection during percutaneous coronary intervention(J).Circulation,1999,100:2045-2048
7 Sheperd J,Cobbe SM,Ford 1,et al.N Engl J Med,1995;333:1301-1307
8 Heeschen C,Hamm CW,Laufs U,etal..Circulation,2002;105:1446-1452
9 The Heart Outcomes Prevention Evaluation Study Investigators.N Engl J Med,2000;342:145-153
10 Herrigton DM,Reboussin DM,Brosnihan KB,etal.N Engl J Med,2000;343:522-529
11 翁维良.活血化瘀研究的成就[J].中西医结合杂志1988,8(特):26
12 王受益.中国中西医结合第二届全国心血管病防治学术交流会议纪要[J].中西医结合杂志,1991,11(5):318
13 徐凤芹,陈可远,马晓昌,等.芎芍胶囊治疗冠心病心绞痛的临床观察[J].中国中西医结合杂志,2003,23(1):17
14 翁维良.活血化瘀研究的成就[J].中西医结合杂志 1988,8(特):26
14 秦万章.血瘀和活血化瘀的研究进展及前景[J].中医杂志.1980,21(9):713
15 行清椿,赵国华,冯晓东.复方丹参注射液择时治疗冠心病心绞痛血瘀证80例[J].中国中西医结合杂志,1998.18(8):506-507
16 张人伟,张元玲,王杰生,等.灯盏花黄酮类成分分离鉴定[J].中草药,1988,19(5):199-201.
17 林雄,褚克丹.灯盏花素的药理学研究进展[J].海峡药学,2005,17(6):5-8
18 叶勇.丹参有效成分分离的研究进展.药品评价,2005,2(2):146
19 Pu ZM,ZhuW L,J in Z Y,et al.Effect of Tet ram ethyl Pyrazine on Co ronary V asocon st rict ion In2duced by Endo thelin- 1 in Dogs[J].ACTA ACADEMIA EM ED IC INA E S IN ICA E(中国医学科学院学报),1996,18(2):133-137.
20 欧阳静萍,王保华,刘永明,等.阿魏酸钠对高脂血症家兔动脉粥样硬化形成的影响及其机制的研究[J].中国药理学通报,2002,18(2):207-210
21 杨守忠,石东起,姜东怀,等.葛根素治疗不稳定型心绞痛的疗效观察[J].临床荟萃,1999,14(18):842-843.
22 陈炳旺等 冠心病中医实证血流变学变化的临床研究.福建中医学院学报,2000,10(1):1-2
23 周中山 冠心病心绞痛中医证型与血流变学的相关性研究.湖南中医药导报,2001,7(7):360-361
1 Celermajer D.Endothelial dysfunction:Does it matter? Is it reversible[J]?J Am Coll Cardiol,1997,30:325-333.
2 Schachinger V,Zeiher AM.Quantitative assessment of coronary vasoreachvity in humans in vivo.Importance of baseline vasomotor tone in atherosclerosis.Circulation 1995:92(8):2087-94
3 Drexler H,Hornig B.Endothelial disfunction in human disease[J].J MOL Cell Cardiol,1999,31:51-60
4 Celermajer DS.Endothelial dysfunction:Do it matter? Is it reversible?[J].J Am Coll Cardiol,1997,30:325-333
5 Rajagopalan S,Harrison DG.Reversing endothelial dysfunction[J]Circulation,1996,94:240-243
6 Shimokawa H.Primary endothelial dysfunction:atherosclerosis[J].J Mol Cell Cardiol,1999,31:23-37
7 李晓等.血管内皮细胞损伤与血瘀证[J].中国中西医结合杂志,2000,20(2):154-156
8 杨惠霞等.血栓调节蛋白与临床[J].现代中西医结合杂志,2001,(10)19:1908-1910]
9 Vanhotte PM.Endothelial dysfunction and atherosclerosis.Eu Heart 1997;18(Suppl E):E19-E29.
10 Hillis GS,Flapan AD.Cell adhesion molecules incardiovascular disease:a clinical perspective.Heart 1998;79(5):429-431.
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