从脾胃论治冠心病不稳定型心绞痛的临床研究
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摘要
不稳定型心绞痛是冠状动脉粥样硬化性心脏病的一个类型,是介于稳定型心绞痛和急性心肌梗死之间的一种临床综合征,具有病变进展迅速、易演变为急性心肌梗死或猝死等特点,严重威胁人类健康。近几十年来,随着我国人民生活水平的提高,不稳定型心绞痛的发病率、死亡率均明显增加,已成为心血管研究领域的焦点之一。冠心病不稳定型心绞痛属中医“胸痹”“心痛”范畴,为本虚标实之证。其病住在心,脾胃与心有着密切的关系,其发病多由脾胃亏虚而来,脾胃损伤为病机的关键,其根本原因在于脾胃功能失调。气虚痰瘀是不稳定型心绞痛发生的重要病理基础,而调理脾胃又是治本之重点。治则须标本兼治,通补兼施。运用调脾化痰活血通络为基本大法,建立调脾通络颗粒,观察其治疗UA的临床疗效及用药安全性做出评价,并探讨其作用机理,为该药在临床上的应用提供科学的理论依据。
目的：观察调脾通络颗粒治疗冠心病不稳定型心绞痛气虚痰瘀证的临床疗效及用药安全性做出评价,观察其对Hcy、hs-CRP、血脂的影响,并探讨其疗效机理。
方法：所选病例均来源于2008年1月至2010年3月南京中医药大学第三附属医院心内科住院患者,选取数据完整者,共62例,随机分为治疗组(调脾通络颗粒)32例和对照组30例。所有病例均符合中华医学会心血管病学分会、中华心血管病杂志编辑委员会2007年制定的《不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南》中关于“不稳型心绞痛”的诊断标准；中医诊断标准参照2002年出版的《中药新药治疗冠心病心绞痛的临研究指导原则(试行)》拟定。治疗组和对照组患者在年龄、性别、病程、合并症、临床状况等方面经统计学分析无差异(P>0.05)具有可比性。治疗组在常规西药治疗基础上加用调脾通络颗粒,对照组予常规西药治疗基础上加用传统化瘀药血府逐瘀胶囊,两组疗程均为28天。观测两组患者治疗期间心率、血压等一般情况,用药前后心痛发作次数、持续时间、缓解时间及心电图、血脂及Hcy、hs-CRP的变化。统计法计量资料采用t检验,计数资料采用χ2检验,等级资料采用秩和检验。
结果：
1、两组患者治疗前后心绞痛改善情况比较：治疗组心绞痛总有效率93.75%,对照组心绞痛总有效率73.33%,经秩和检验,两组有显著差异(P<0.05),治疗组明显优于对照组。治疗后两组均能明显减少心绞痛发作频度,缩短心绞痛持续时间,与治疗前比较有显著性差异(P<0.01)。但治疗组疗效明显优于对照组,组间比较有显著性差异(P<0.05或P<0.01)。
2、两组患者治疗前后中医证候疗效比较：治疗组总有效率90.63%,对照组总有效率66.67%,经秩和检验,两组有显著差异(P<0.05),治疗组明显优于对照组。
3、两组患者治疗前后心电图改善情况比较：治疗组心电图总有效率71.87%,对照组心电图总有效率56.67%,经检验,两组有显著差异(P<0.05),治疗组明显优于对照组。
4、两组患者治疗前后hs-CRP、Hcy水平比较：两组治疗前后均有改善(P<0.01),具有统学意义；且治疗组治疗后与对照组比较,改善有统计学差异(P<0.01)。
5、两组患者治疗前后血脂比较：治疗后治疗组TC、TG、LDL-C、Lp(a)水平较治疗前明显下降(P<0.01或P<0.05),对照组TC、LDL-C、Lp(a)较治疗前明显下降(P<0.01),治疗组TC、LDL-C、Lp(a)水平下降幅度优于对照组(P<0.05)。
结论：本研究结果显示调脾通络颗粒对气虚痰瘀型不稳定型心绞痛有显著的临床疗效。能明显缓解心绞痛症状,改善心肌缺血,减少硝酸甘油用量,明显降低血总胆固醇、甘油三酯、低密度脂蛋白胆固醇、脂蛋白a,明显降低血浆超敏C反应蛋白、同型半胱氨酸,提高临床疗效和中医证候疗效,可推广用于临床。从脾胃论治冠心病不稳定型心绞痛丰富和发展了中医药治疗UAP的思路和方法,提高了中医药治疗心血管危重症的学术地位。其可能的作用机理为：
1调节脂质代谢。
2保护血管内皮细胞,抑制炎症反应,稳定易损斑块。
3抗凝、抗血小板聚集,抑制血栓行成。
Unstable angina which is a clinical syndrome between stable angina and acute myocardial infarction is one type of coronary atherosclerotic heart disease. It has the character of changing quickly, which could shift to sudden death or acute myocardial infraction, threatening the health of human. In recent decades, the incidence of unstable angina pectoris mortality was significantly increased with the improvement of living standards of our people, which has become one of the focuses in cardiovascular research field. Coronary heart disease and unstable angina belong to chest stuffiness and pain in Chinese medicine. Pathogenesis characteristic is deficiency in origin and excess in superficiality. The disease being located in heart, but there close relation between heart and spleen and stomach. The main cause of the disease is the deficiency of the spleen and stomach. Treatment based on differentiation of disease should regulate the spleen and stomach, for the basic pathogenesis of unstable angina can be divided into Qi deficiency, phlegm and stagnation of blood. So benefiting Qi, invigorating the spleen, promoting blood circulation to remove blood stasis, dredging the meridian are needed and provided a theoretical basis for the drug.
Objectives:To observe the effect and safety of Tiaopihuatang Granules treating unstable angina (syndromes of Qi deficiency, phlegm and stagnation of blood) and the impact of plasma Hs-CRP, serum homocysteine and blood lipid, discuss the mechanism of Tiaopihuatang Granules on treating unstable angina.
Methods:
All cases come from hospitalized sufferer with the date integrity in cardiovascular department of the Third affiliated hospital of Nanjing University of traditional Chinese medicine (TCM), from January 2008 to March 2009.62 cases of patients with UAP were randomly divided into treatment group (32 cases) and control group (30 cases). All patients'clinical symptoms conform to the diagnosis standard of unstable angina pectoris; and at the same time, conform to the syndromes of Qi deficiency, phlegm and stagnation of blood. The treatment group and the control group have no statistic difference in age, sex, the time of disease, complication and clinical symptoms (P>0.05). The patients in treatment group take Tiaopihuatang Granules plus standard western medicine the patients in control group take Xuefuzhuyu Capsules with standard western medicine. All clinical data were compared after 4 weeks'treatment. For all patients, general conditions, angina pectoris symptoms, ECG, syndromes and signs were observed. Further more, plasma Hs-CRP, serum homocysteine and blood lipids were tested before and after treatment. The statistic method: The data was analyzed after observation. The measurement data, enumeration data and the rank data were examined with Chi-square test, T-test and Wilcoxon signed rank test.
Result:
1 The clinical curative effective of angina pectoris syndromes, the total effective rate of the treatment group and the control group are 93.75% and 73.3% respectively, there are statistical different between the two groups(P<0.05). In effects of improvement of angina pectoris, the treatment group shows very significant difference on reduce the onset frequency and severity of angina pectoris than that of control group(P<0.05 or P<0.01).
2 In syndrome of TCM, the total effective rates of the treatment group and the control group are 90.63% and 66.67% respectively, there are statistical different between the two groups(P<0.05).
3 In electrocardiogram improvement, the total effective rates of the treatment group and the control group are 71.87% and 56.67% respectively, there are statistical difference between the two groups(P<0.05).
4 The clinical results show that plasma Hs-CRP and serum homocysteine level after treatment are lower than those before the treatment in the two groups (P<0.01). And the treatment group is superior to the control group(P<0.01).
5 The clinical results show that the level ofTC、TG、LDL-C、Lp(a) after treatment are lower than those before the treatment in the treatment group(P<0.05 or P<0.01). And the level of TC、LDL-C、Lp(a) after treatment are lower than those before the treatment in the control group(P<0.05), but the level of TC、LDL-C、Lp(a) has statistical difference comparing the treatment group with the control group(P<0.05).
Conclusion:
The study indicates that Tiaopihuatang Granules has favorable clinical curative effect on unstable angina pectoris patients with the syndromes of Qi deficiency, phlegm and stagnation of blood, can alleviate angina pectoris, improve blood supply of cardiac muscle and discontinue the rate of nitroglycerin. Tiaopihuatang Granules can reduce significantly the level of TC、TG、LDL-C、Lp(a) and the level of plasma Hs-CRP and serum homocysteine in the patients with unstable angina. The study abundances the research of TCM treatment on unstable angina, Tiaopihuatang Granules is worthy of using in the clinical practice widely. It's mechanism could relate to regulating blood lipid, preserving the function of vessel endothelia, restraining the inflammation reaction, increasing anti-coagulation activity, reducing the platelet adhesion and intervening thrombosis.
目的：观察调脾通络颗粒治疗冠心病不稳定型心绞痛气虚痰瘀证的临床疗效及用药安全性做出评价,观察其对Hcy、hs-CRP、血脂的影响,并探讨其疗效机理。
方法：所选病例均来源于2008年1月至2010年3月南京中医药大学第三附属医院心内科住院患者,选取数据完整者,共62例,随机分为治疗组(调脾通络颗粒)32例和对照组30例。所有病例均符合中华医学会心血管病学分会、中华心血管病杂志编辑委员会2007年制定的《不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南》中关于“不稳型心绞痛”的诊断标准；中医诊断标准参照2002年出版的《中药新药治疗冠心病心绞痛的临研究指导原则(试行)》拟定。治疗组和对照组患者在年龄、性别、病程、合并症、临床状况等方面经统计学分析无差异(P>0.05)具有可比性。治疗组在常规西药治疗基础上加用调脾通络颗粒,对照组予常规西药治疗基础上加用传统化瘀药血府逐瘀胶囊,两组疗程均为28天。观测两组患者治疗期间心率、血压等一般情况,用药前后心痛发作次数、持续时间、缓解时间及心电图、血脂及Hcy、hs-CRP的变化。统计法计量资料采用t检验,计数资料采用χ2检验,等级资料采用秩和检验。
结果：
1、两组患者治疗前后心绞痛改善情况比较：治疗组心绞痛总有效率93.75%,对照组心绞痛总有效率73.33%,经秩和检验,两组有显著差异(P<0.05),治疗组明显优于对照组。治疗后两组均能明显减少心绞痛发作频度,缩短心绞痛持续时间,与治疗前比较有显著性差异(P<0.01)。但治疗组疗效明显优于对照组,组间比较有显著性差异(P<0.05或P<0.01)。
2、两组患者治疗前后中医证候疗效比较：治疗组总有效率90.63%,对照组总有效率66.67%,经秩和检验,两组有显著差异(P<0.05),治疗组明显优于对照组。
3、两组患者治疗前后心电图改善情况比较：治疗组心电图总有效率71.87%,对照组心电图总有效率56.67%,经检验,两组有显著差异(P<0.05),治疗组明显优于对照组。
4、两组患者治疗前后hs-CRP、Hcy水平比较：两组治疗前后均有改善(P<0.01),具有统学意义；且治疗组治疗后与对照组比较,改善有统计学差异(P<0.01)。
5、两组患者治疗前后血脂比较：治疗后治疗组TC、TG、LDL-C、Lp(a)水平较治疗前明显下降(P<0.01或P<0.05),对照组TC、LDL-C、Lp(a)较治疗前明显下降(P<0.01),治疗组TC、LDL-C、Lp(a)水平下降幅度优于对照组(P<0.05)。
结论：本研究结果显示调脾通络颗粒对气虚痰瘀型不稳定型心绞痛有显著的临床疗效。能明显缓解心绞痛症状,改善心肌缺血,减少硝酸甘油用量,明显降低血总胆固醇、甘油三酯、低密度脂蛋白胆固醇、脂蛋白a,明显降低血浆超敏C反应蛋白、同型半胱氨酸,提高临床疗效和中医证候疗效,可推广用于临床。从脾胃论治冠心病不稳定型心绞痛丰富和发展了中医药治疗UAP的思路和方法,提高了中医药治疗心血管危重症的学术地位。其可能的作用机理为：
1调节脂质代谢。
2保护血管内皮细胞,抑制炎症反应,稳定易损斑块。
3抗凝、抗血小板聚集,抑制血栓行成。
Unstable angina which is a clinical syndrome between stable angina and acute myocardial infarction is one type of coronary atherosclerotic heart disease. It has the character of changing quickly, which could shift to sudden death or acute myocardial infraction, threatening the health of human. In recent decades, the incidence of unstable angina pectoris mortality was significantly increased with the improvement of living standards of our people, which has become one of the focuses in cardiovascular research field. Coronary heart disease and unstable angina belong to chest stuffiness and pain in Chinese medicine. Pathogenesis characteristic is deficiency in origin and excess in superficiality. The disease being located in heart, but there close relation between heart and spleen and stomach. The main cause of the disease is the deficiency of the spleen and stomach. Treatment based on differentiation of disease should regulate the spleen and stomach, for the basic pathogenesis of unstable angina can be divided into Qi deficiency, phlegm and stagnation of blood. So benefiting Qi, invigorating the spleen, promoting blood circulation to remove blood stasis, dredging the meridian are needed and provided a theoretical basis for the drug.
Objectives:To observe the effect and safety of Tiaopihuatang Granules treating unstable angina (syndromes of Qi deficiency, phlegm and stagnation of blood) and the impact of plasma Hs-CRP, serum homocysteine and blood lipid, discuss the mechanism of Tiaopihuatang Granules on treating unstable angina.
Methods:
All cases come from hospitalized sufferer with the date integrity in cardiovascular department of the Third affiliated hospital of Nanjing University of traditional Chinese medicine (TCM), from January 2008 to March 2009.62 cases of patients with UAP were randomly divided into treatment group (32 cases) and control group (30 cases). All patients'clinical symptoms conform to the diagnosis standard of unstable angina pectoris; and at the same time, conform to the syndromes of Qi deficiency, phlegm and stagnation of blood. The treatment group and the control group have no statistic difference in age, sex, the time of disease, complication and clinical symptoms (P>0.05). The patients in treatment group take Tiaopihuatang Granules plus standard western medicine the patients in control group take Xuefuzhuyu Capsules with standard western medicine. All clinical data were compared after 4 weeks'treatment. For all patients, general conditions, angina pectoris symptoms, ECG, syndromes and signs were observed. Further more, plasma Hs-CRP, serum homocysteine and blood lipids were tested before and after treatment. The statistic method: The data was analyzed after observation. The measurement data, enumeration data and the rank data were examined with Chi-square test, T-test and Wilcoxon signed rank test.
Result:
1 The clinical curative effective of angina pectoris syndromes, the total effective rate of the treatment group and the control group are 93.75% and 73.3% respectively, there are statistical different between the two groups(P<0.05). In effects of improvement of angina pectoris, the treatment group shows very significant difference on reduce the onset frequency and severity of angina pectoris than that of control group(P<0.05 or P<0.01).
2 In syndrome of TCM, the total effective rates of the treatment group and the control group are 90.63% and 66.67% respectively, there are statistical different between the two groups(P<0.05).
3 In electrocardiogram improvement, the total effective rates of the treatment group and the control group are 71.87% and 56.67% respectively, there are statistical difference between the two groups(P<0.05).
4 The clinical results show that plasma Hs-CRP and serum homocysteine level after treatment are lower than those before the treatment in the two groups (P<0.01). And the treatment group is superior to the control group(P<0.01).
5 The clinical results show that the level ofTC、TG、LDL-C、Lp(a) after treatment are lower than those before the treatment in the treatment group(P<0.05 or P<0.01). And the level of TC、LDL-C、Lp(a) after treatment are lower than those before the treatment in the control group(P<0.05), but the level of TC、LDL-C、Lp(a) has statistical difference comparing the treatment group with the control group(P<0.05).
Conclusion:
The study indicates that Tiaopihuatang Granules has favorable clinical curative effect on unstable angina pectoris patients with the syndromes of Qi deficiency, phlegm and stagnation of blood, can alleviate angina pectoris, improve blood supply of cardiac muscle and discontinue the rate of nitroglycerin. Tiaopihuatang Granules can reduce significantly the level of TC、TG、LDL-C、Lp(a) and the level of plasma Hs-CRP and serum homocysteine in the patients with unstable angina. The study abundances the research of TCM treatment on unstable angina, Tiaopihuatang Granules is worthy of using in the clinical practice widely. It's mechanism could relate to regulating blood lipid, preserving the function of vessel endothelia, restraining the inflammation reaction, increasing anti-coagulation activity, reducing the platelet adhesion and intervening thrombosis.
引文
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