清热活血方治疗急性ST段抬高型心肌梗死的前瞻性、多中心队列研究

Qingre Huoxue Recipe(清热活血方)for Treatment of Acute ST Segment Elevation Myocardial Infarction:A Prospective Multicenter Cohort Study

目的探讨清热活血方对急性ST段抬高型心肌梗死(STEMI)患者随访1年时终点主要心血管事件(MACE)的影响。方法纳入在广州中医药大学第一附属医院住院的STEMI患者186例为观察组,在遵循西医指南规范化治疗基础上给予清热活血方治疗,每日1剂;同期纳入在南方五省共6家三级甲等西医院住院的STEMI患者176例为对照组,仅按西医指南规范化治疗。两组均治疗1周。以治疗1周后及发病30天、6个月、1年为时间点随访MACE发生情况。进一步行队列分组,以清热活血方治疗时间≥30天、<30天及无中药干预分为强暴露组(153例)、弱暴露组(33例)、非暴露组(176例),比较各组终点MACE发生情况,并采用COX回归模型分析生存时间与终点MACE及相关因素的关系。结果观察组与对照组的治疗1周后死亡率分别为1.1%(2/186)、1.7%(3/176),1年随访时死亡率分别为2.7%(5/186)、5.7%(10/176),两组比较差异均无统计学意义(P>0.05);观察组治疗1周后新发或加重心力衰竭、1年随访时因心力衰竭就诊或住院的比例均高于对照组(P<0.05)。Cox回归分析显示,应用清热活血方治疗是STEMI患者远期死亡的独立保护因素[HR=0.271(0.074,0.997),P=0.0495]。队列分组比较:1年随访时强暴露组患者1年内死亡率显著低于非暴露组(P<0.05),因心力衰竭就诊或住院发生率高于非暴露组(P<0.05),再发心肌梗死两组间比较差异无统计学意义(P>0.05);强暴露组死亡、再发心肌梗死、因心力衰竭就诊或住院发生率较弱暴露组均显著减少(P<0.05);弱暴露组再发心肌梗死、因心力衰竭就诊或住院发生率较非暴露组均升高(P<0.05),两组死亡率比较差异无统计学意义(P>0.05)。结论西医指南规范化治疗基础上加用清热活血方是STEMI患者远期死亡的独立保护因素,可使患者的预后得到最大获益。

Objectives To explore the effect of Qingre Huoxue Recipe(清热活血方)on major cardiovascular events(MACE)in patients with acute ST segment elevation myocardial infarction(STEMI)during one-year follow-up.Methods A total of 186 STEMI patients hospitalized in the First Affiliated Hospital of Guangzhou University of Chinese Medicine were included in the observation group,who were treated with standard treatment in combination with Qingre Huoxue Recipe,one dose per day;176 contemporaneous STEMI patients admitted to six grade III Level A hospitals in five southern provinces were included in the control group,who were treated with standard treatment in accordance with Western medicine guidelines.The treatment in both groups lasted for one week.The number of MACE was recorded after one-week treatment,and during follow-up of 30 days,six months and one year after the onset of STEMI.Furthermore,the cohort was divided into high exposure group(Qingre Huoxue Recipe≥30 days,153 cases),low exposure group(Qingre Huoxue Recipe<30 days,33 cases)and no exposure group(no Qingre Huoxue Recipe,176 cases)based on the treatment time of Qingre Huoxue Recipe,and the final number of MACE was compared between different exposure groups;the COX regression model was used to perform survival analysis,and the relation to final MACE and related factors.Results The mortality after one-week treatment in the observation group and control group was 1.1%(2/186)and 1.7%(3/176),respectively;the one-year mortality was 2.7%(5/186)and 5.7%(10/176),respectively(P>0.05).The number of new or worsening heart failure after one-week treatment,as well as the hospital admission times during one-year follow up were both higher in observation group than in the control group(P<0.05).Cox regression analysis showed that Qingre Huoxue Recipe was an independent protective factor for long-term mortality in STEMI patients(hazard ratio=0.271,95%confidence interval=0.074 to 0.997,P=0.0495).After one-year follow-up,the mortality rate was significantly lower in high exposure group than in no exposure group(P<0.05);the hospital admission times due to heart failure was higher(P<0.05),while the recurrence of myocardial infarction was not significantly different between groups(P>0.05).The mortality,recurrence of myocardial infarction,and hospitalization due to heart failure were significantly reduced in high exposure group compared to low exposure group(P<0.05).Compared to no exposure group,the low exposure group had higher recurrence rate of myocardial infarction,and hospitalization times due to heart failure(P<0.05),but the mortality was not significantly different(P>0.05).Conclusion Qingre Huoxue Recipe,in addition to standard treatment in accordance with Western medicine guidelines,is an independent protective factor for long-term mortality,and can maximize the prognosis of STEMI patients.