通冠胶囊在PCI血运重建过程中心肌保护作用的研究
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摘要
研究背景
冠心病血运重建术中伴随着短暂的心肌缺血损伤。近年来,越来越多的研究发现经皮冠状动脉介入治疗PCI术后心肌损伤标志物增高者,其再发心脏事件及死亡率变增高,其预后不良。当前PCI血运重建过程心肌保护的研究局限较多。
中医治疗冠心病获得愈来愈多好的效果,作用机制的研究日渐深入。中医药治疗的发掘潜力大,中西医结合研究的的切入点可以选择再灌注治疗后研究相对较薄弱的环节。本研究选择了对PCI血运重建中心肌损伤的保护作用。
益气活血的中成药通冠胶囊经系列研究证明在PCI血运重建后具有广泛而良好的临床作用,能改善各项生化指标、心功能及生命质量作用明显。因此,本研究假设通冠胶囊在PCI围术期可能具有对缺血性心肌损伤有确切的保护作用。
研究目的
研究通冠胶囊在PCI血运重建过程中的心肌保护作用,探讨中医辨证论治在PCI围术期的治疗作用及其作用机制。
研究方法
选取广东省中医院ICU和心脏中心的符合纳入标准的拟行PCI术血运重建的患者共30例,投币法随机归入两组,实验组18例,对照组12例。实验组在行PCI血运重建术之前接受通冠胶囊口服治疗,对照组不予此项干预。记录PCI血运重建过程中的冠脉内心电图变化,检测术后3小时、18小时血浆心肌损伤标志物水平。观察两组间所有指标的差异作统计学处理。
研究结果
两组术前各项参数及手术相关参数组间差异比较无统计学意义(P＞0.05)。实验组PCI术后冠脉内心电图ST段最大抬高幅度明显低于对照组(P=0.04);实验组术后T波最大高度绝对值明显小于对照组(P=0.04);实验组术后3小时、18小时的血浆CTNI、CKMB、CK、LDH、AST水平均低于对照组,其中术后18小时CKMB水平差异显著(P=0.03),其余指标组间差异无统计学意义(P＞0.05)。对照组CTNI、CKMB、CK三个心肌损伤标志物水平术后呈升高趋势(前后比较P＞0.05,差异无统计学意义),实验组变化平稳,无升高趋势。
研究结论
1、术前服用通冠胶囊3粒/次×3次(1日)以上再择期进行PCI血运重建,可以减少PCI术中的心肌损伤程度,通冠胶囊的益气活血作用在PCI血运重建过程中具有心肌保护作用。2、本研究以PCI血运重建过程中的心肌保护作为中西医结合的切入点,根据PCI围术期气虚血瘀证为主的中医证型特点,以益气活血为法辨证治疗,初步证实了中医药辨证论治起到的心肌保护作用,对中西医两种不同体系医学治疗冠心病的结合方向作了一定程度的摸索。
Background
Myocardial injury is a common complications during Percutaneous Coronary Intervention(PCI) for myocardial revascularization. In recent years an increasing number of study found that mortality and recurrence rate of cardiac events increased in patients that markers of myocardial injury elevation after percutaneous coronary intervention, suggesting a poor prognosis. But, there are many limitations of the current studies on myocardial cytoprotection during PCI for myocardial revascularization. It is the Weak links of the current study on percutaneous coronary intervention perioperative. There is a significant effect in Traditional Chinese Medicine (TCM) treatment of coronary heart disease. However, compared with the constantly improving diagnosis and treatment system of acute conoary syndrome under the guidance of the Evidence-based medicine, Traditional Chinese Medicine develop much slowly. People think it may have great potential for development of traditional Chinese medicine treatment. We can choose the weak links of the current study on the percutaneous coronary intervention perioperative, such as myocardial cytoprotection during percutaneous coronary intervention, as a crossing of traditional Chinese medicine and western medicine.
After a series of studies have proven that, Tong-guan Capsules, which is a proprietary Chinese medicine with effect of Yi-Qi-Huo-Xue(Terminology of TCM) , Can play extensive clinical role during percutaneous coronary intervention for myocardial revascularization. It can improve various biochemical markers, cardiac function and quality of life in patients that have been treat by percutaneous coronary intervention, which clearly prompts us that it is a possibility that Tong-guan Capsules may play the role of myocardial cytoprotection during PCI.
Objective
The objective of this research is to study the myocardial cytoprotection of Tong-guan Capsules during percutaneous coronary intervention for myocardial revascularization. For in-depth study, it is also the objective that to study the TCM Differential Treatment on PCI perioperative.
Methods
According to diagnosis standard and bring-into standard, 30 patients that hospitalized to accept percutaneous coronary intervention myocardial revascularization in the ICU and Heart Center of TCM Hospital of Guangdong Province were recorded finally. They were randomly divided into two groups for compare, as 18 cases of the experimental group and 12 cases of the control group. Patients belong to the experimental group accepted the treatment with Tong-guan Capsules before percutaneous coronary intervention, while the ones of the control group accepted the treatment without Tong-guan Capsules to make different. To record the change of Intracoronary ECG(IC-ECG) during PCI operation, and to test the level of myocardial injury markers at the time of 3 hours and 18 hours after percutaneous coronary intervention for each patient. To compare difference between the two groups for statistically calculation.
Result
The parameters of the two groups before percutaneous coronary intervention between the comparison group was not significant (P> 0.05). The parameters for the operation of percutaneous coronary intervention between the comparison group was not significant (P> 0.05) either. The largest ST-segment elevation margin recorded by Intracoronary ECG of the experimental group was clearly lower than that of the control group, and the difference was significant (P=0. 04) . T-wave maximum height of the absolute value after percutaneous coronary intervention recorded by Intracoronary ECG of the experimental group was clearly lower than that of the control group, and the difference was significant (P=0.04) . In that part of myocardial injury markers, all the levels of troponin I (cTNI) , creatine kinase-MB (CKMB), creatine kinase (CK) , lactate dehydrogenase ( LDH ) and aspartate aminotransferase (AST) of the experimental group, either at the time of 3 hours after PCI operation or at the time of 18 hours after operation, were lower than those of the control group, with a significant difference in creatine kinase-MB level at the time of 18 hours after operation (P=0. 03) . But the differences between the comparison group for the levels of remaining myocardial injury markers were not significant (P>0.05). Levels of three myocardial injury markers as troponin I, creatine kinase-MB, creatine kinase had a trend of increased (the differences between the Levels before PCI operation and after PCI were not significant, with P>0. 05), while changes in the experimental group were smooth and without increasing trend.
Conclusion
1. In the treatment of Tong-guan Capsules for more than a day (Sig: 3 pills po tid) before PCI, the extent of myocardial injury during myocardial revascularization could be reduced clearly. The effect of Yi-Qi-Huo-Xue in Tong-guan Capsules plays the role of myocardial cytoprotection during percutaneous coronary intervention.
2. This reseach has choosen myocardial cytoprotection during percutaneous coronary intervention for the entry point to integrate the traditional Chinese medicine and western medicine. According to that the syndrome-types features in traditional Chinese Medicine on PCI perioperative mainly is the syndrome of Qi-Xu-Xue-Yu in TCM, the reseach confirmed the preliminary conclusion that there is myocardial cytoprotection with the traditional Chinese medicine differential treatment on percutaneous coronary intervention perioperative. This reseach had maken a mild exploratory study on the way to integrate the traditional Chinese medicine and western medicine for treatment to coronary heart disease.
冠心病血运重建术中伴随着短暂的心肌缺血损伤。近年来,越来越多的研究发现经皮冠状动脉介入治疗PCI术后心肌损伤标志物增高者,其再发心脏事件及死亡率变增高,其预后不良。当前PCI血运重建过程心肌保护的研究局限较多。
中医治疗冠心病获得愈来愈多好的效果,作用机制的研究日渐深入。中医药治疗的发掘潜力大,中西医结合研究的的切入点可以选择再灌注治疗后研究相对较薄弱的环节。本研究选择了对PCI血运重建中心肌损伤的保护作用。
益气活血的中成药通冠胶囊经系列研究证明在PCI血运重建后具有广泛而良好的临床作用,能改善各项生化指标、心功能及生命质量作用明显。因此,本研究假设通冠胶囊在PCI围术期可能具有对缺血性心肌损伤有确切的保护作用。
研究目的
研究通冠胶囊在PCI血运重建过程中的心肌保护作用,探讨中医辨证论治在PCI围术期的治疗作用及其作用机制。
研究方法
选取广东省中医院ICU和心脏中心的符合纳入标准的拟行PCI术血运重建的患者共30例,投币法随机归入两组,实验组18例,对照组12例。实验组在行PCI血运重建术之前接受通冠胶囊口服治疗,对照组不予此项干预。记录PCI血运重建过程中的冠脉内心电图变化,检测术后3小时、18小时血浆心肌损伤标志物水平。观察两组间所有指标的差异作统计学处理。
研究结果
两组术前各项参数及手术相关参数组间差异比较无统计学意义(P＞0.05)。实验组PCI术后冠脉内心电图ST段最大抬高幅度明显低于对照组(P=0.04);实验组术后T波最大高度绝对值明显小于对照组(P=0.04);实验组术后3小时、18小时的血浆CTNI、CKMB、CK、LDH、AST水平均低于对照组,其中术后18小时CKMB水平差异显著(P=0.03),其余指标组间差异无统计学意义(P＞0.05)。对照组CTNI、CKMB、CK三个心肌损伤标志物水平术后呈升高趋势(前后比较P＞0.05,差异无统计学意义),实验组变化平稳,无升高趋势。
研究结论
1、术前服用通冠胶囊3粒/次×3次(1日)以上再择期进行PCI血运重建,可以减少PCI术中的心肌损伤程度,通冠胶囊的益气活血作用在PCI血运重建过程中具有心肌保护作用。2、本研究以PCI血运重建过程中的心肌保护作为中西医结合的切入点,根据PCI围术期气虚血瘀证为主的中医证型特点,以益气活血为法辨证治疗,初步证实了中医药辨证论治起到的心肌保护作用,对中西医两种不同体系医学治疗冠心病的结合方向作了一定程度的摸索。
Background
Myocardial injury is a common complications during Percutaneous Coronary Intervention(PCI) for myocardial revascularization. In recent years an increasing number of study found that mortality and recurrence rate of cardiac events increased in patients that markers of myocardial injury elevation after percutaneous coronary intervention, suggesting a poor prognosis. But, there are many limitations of the current studies on myocardial cytoprotection during PCI for myocardial revascularization. It is the Weak links of the current study on percutaneous coronary intervention perioperative. There is a significant effect in Traditional Chinese Medicine (TCM) treatment of coronary heart disease. However, compared with the constantly improving diagnosis and treatment system of acute conoary syndrome under the guidance of the Evidence-based medicine, Traditional Chinese Medicine develop much slowly. People think it may have great potential for development of traditional Chinese medicine treatment. We can choose the weak links of the current study on the percutaneous coronary intervention perioperative, such as myocardial cytoprotection during percutaneous coronary intervention, as a crossing of traditional Chinese medicine and western medicine.
After a series of studies have proven that, Tong-guan Capsules, which is a proprietary Chinese medicine with effect of Yi-Qi-Huo-Xue(Terminology of TCM) , Can play extensive clinical role during percutaneous coronary intervention for myocardial revascularization. It can improve various biochemical markers, cardiac function and quality of life in patients that have been treat by percutaneous coronary intervention, which clearly prompts us that it is a possibility that Tong-guan Capsules may play the role of myocardial cytoprotection during PCI.
Objective
The objective of this research is to study the myocardial cytoprotection of Tong-guan Capsules during percutaneous coronary intervention for myocardial revascularization. For in-depth study, it is also the objective that to study the TCM Differential Treatment on PCI perioperative.
Methods
According to diagnosis standard and bring-into standard, 30 patients that hospitalized to accept percutaneous coronary intervention myocardial revascularization in the ICU and Heart Center of TCM Hospital of Guangdong Province were recorded finally. They were randomly divided into two groups for compare, as 18 cases of the experimental group and 12 cases of the control group. Patients belong to the experimental group accepted the treatment with Tong-guan Capsules before percutaneous coronary intervention, while the ones of the control group accepted the treatment without Tong-guan Capsules to make different. To record the change of Intracoronary ECG(IC-ECG) during PCI operation, and to test the level of myocardial injury markers at the time of 3 hours and 18 hours after percutaneous coronary intervention for each patient. To compare difference between the two groups for statistically calculation.
Result
The parameters of the two groups before percutaneous coronary intervention between the comparison group was not significant (P> 0.05). The parameters for the operation of percutaneous coronary intervention between the comparison group was not significant (P> 0.05) either. The largest ST-segment elevation margin recorded by Intracoronary ECG of the experimental group was clearly lower than that of the control group, and the difference was significant (P=0. 04) . T-wave maximum height of the absolute value after percutaneous coronary intervention recorded by Intracoronary ECG of the experimental group was clearly lower than that of the control group, and the difference was significant (P=0.04) . In that part of myocardial injury markers, all the levels of troponin I (cTNI) , creatine kinase-MB (CKMB), creatine kinase (CK) , lactate dehydrogenase ( LDH ) and aspartate aminotransferase (AST) of the experimental group, either at the time of 3 hours after PCI operation or at the time of 18 hours after operation, were lower than those of the control group, with a significant difference in creatine kinase-MB level at the time of 18 hours after operation (P=0. 03) . But the differences between the comparison group for the levels of remaining myocardial injury markers were not significant (P>0.05). Levels of three myocardial injury markers as troponin I, creatine kinase-MB, creatine kinase had a trend of increased (the differences between the Levels before PCI operation and after PCI were not significant, with P>0. 05), while changes in the experimental group were smooth and without increasing trend.
Conclusion
1. In the treatment of Tong-guan Capsules for more than a day (Sig: 3 pills po tid) before PCI, the extent of myocardial injury during myocardial revascularization could be reduced clearly. The effect of Yi-Qi-Huo-Xue in Tong-guan Capsules plays the role of myocardial cytoprotection during percutaneous coronary intervention.
2. This reseach has choosen myocardial cytoprotection during percutaneous coronary intervention for the entry point to integrate the traditional Chinese medicine and western medicine. According to that the syndrome-types features in traditional Chinese Medicine on PCI perioperative mainly is the syndrome of Qi-Xu-Xue-Yu in TCM, the reseach confirmed the preliminary conclusion that there is myocardial cytoprotection with the traditional Chinese medicine differential treatment on percutaneous coronary intervention perioperative. This reseach had maken a mild exploratory study on the way to integrate the traditional Chinese medicine and western medicine for treatment to coronary heart disease.
引文
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