急性冠脉综合征介入治疗后病人血瘀证及其变量与临床结局的相关性研究

Correlation between the Severity and Its Variables of Blood Stasis Syndrome and the Clinical Outcome of Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention

目的探讨急性冠脉综合征(ACS)介入治疗病人血瘀证及其变量与临床结局的相关性及益气活血中药对血瘀证计分的影响。方法本研究为多中心、随机对照研究,选取808例ACS介入后病人随机分为对照组和治疗组。对照组采用西医常规治疗,治疗组在对照组基础上联合益气活血中药心悦胶囊和复方川芎胶囊,随访1年,观察血瘀证轻重、血瘀证各变量和终点事件,主要复合终点包括心血管死亡、非致命性心肌梗死、血运重建术[再次经皮冠状动脉介入术(PCI)、冠状动脉搭桥术(CABG)],次要复合终点包括脑卒中、因ACS再住院、心功能不全和其他血栓并发症,在介入治疗后1个月、3个月、6个月、9个月、12个月的变化。结果与介入治疗前相比,介入治疗后血瘀证计分明显降低;与对照组相比,治疗组治疗后3个月、6个月、9个月、12个月血瘀证计分降低(P<0.01);两组血瘀证计分与总复合终点事件发生与否呈正相关(P=0.013);血瘀证各变量中,无论对照组还是治疗组,心绞痛与总复合终点事件和主要复合终点事件的发生与否呈正相关(P=0.008),舌质紫暗或瘀斑与次要复合终点事件的发生与否呈正相关(P=0.011)。结论益气活血中药可进一步降低ACS病人介入治疗后血瘀证计分,血瘀证与ACS介入治疗后1年终点事件发生呈正相关,其中变量心绞痛和舌质紫暗或瘀斑是重要影响因素。

Objective To study relationship between the severity and its variables of blood stasis syndrome with the prognosis of patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI),and effect of Chinese herbs for nourishing qi and activating blood circulation on the scores of blood stasis syndrome.Methods Eight hundred and eight patients with ACS after successful PCI at 13 sites in China were randomly assigned to Western Medicine treatment group and Integrative treatment group(Chinese herbs for nourishing qi,Xinyue capsule and activating blood circulation,Fufang Chuanxiong capsule in adding to western medicine),and the period time for follow-up was 1-year.The score of blood stasis,5 variable quantities of blood stasis and end-point events(the primary endpoint was the composite of cardiac death,nonfatal recurrent myocardial infarction,or ischemia-driven revascularization;the secondary endpoint was the composite of readmission for ACS,stroke,or congestive heart failure)were observed at 1,3,6,9,12 month after PCI,respectively.Results As compared with data before PCI,the score of blood stasis syndrome was significantly decreased after PCI.The patients in integrative treatment group had lower score of blood stasis syndrome than that in western medicine treatment group(P<0.01).The score of blood stasis syndrome was positively related with total end pointevents in the two groups(P=0.013).Variable quantities showed blood stasis,angina were closely related with the total end point and the primary end point,respectively(P=0.008),and dark purple tongue was closely related with the secondary end points(P=0.011).Conclusion PCI and Chinese herbs for nourishing qi and activating blood circulation both decrease the score of blood stasis syndrome.The indence of 1 year end point event of ACS patients after PCI was closely related with blood stasis syndrome.The blood stasis syndrome such as angina and dark purple tongue were the key factors.