中医药干预心肌梗死合并高脂血症患者的队列研究

Cohort study on intervention effects of traditional Chinese medicine on the combination disease of myocardial infarction and hyperlipidemia

目的:探讨中医药干预心肌梗死合并高脂血症患者的真实世界疗效。方法:采用队列研究设计。住院期间以应用中药注射剂≥7d为暴露组。随访期间以应用中成药和中药汤剂≥28d为暴露组。收集患者住院和随访期间的一般资料(姓名、年龄、性别和合并症等)、中药使用情况和终点事件发生情况。运用多元L o g i s t i c回归探讨中医药干预与心肌梗死合并高脂血症患者终点事件发生的相关性。结果:共纳入707例急性心肌梗死合并高脂血症患者,完成随访538例。住院期间中医药干预(OR=2.641,95%CI=1.757-3.972)、年龄(OR=1.061,95%CI=1.027-1.097)、抗心肌缺血治疗(OR=2.928,95%CI=1.300-6.595)是心源性死亡的相关因素,中医药干预(OR=2.051,95%CI=1.323-3.180)、年龄(OR=1.052,95%CI=1.016-1.089)、抗心肌缺血治疗(OR=2.621,95%CI=1.102-6.235)是心源性休克的相关因素,中医药干预(OR=1.732,95%CI=1.123-2.669)、血脂异常(OR=2.125,95%CI=1.115-4.049)是严重心律失常的相关因素。随访期间中医药干预(OR=1.341,95%CI=1.074-1.675)、年龄(OR=1.051,95%CI=1.022-1.081)、糖尿病(OR=2.769,95%CI=1.618-4.738)、抗栓治疗(OR=0.256,95%CI=0.117-0.560)是心源性死亡的相关因素,中医药干预(OR=1.575,95%CI=1.224-2.027)、年龄(OR=1.037,95%CI=1.007-1.068)、性别(OR=0.373,95%CI=0.193-0.721)、抗栓治疗(OR=0.346,95%CI=0.136-0.882)是再梗死和脑卒中复合终点事件的相关因素。结论:中医药干预能够减少心肌梗死合并高脂血症患者住院期间心源性死亡、心源性休克、严重心律失常和随访期间心源性死亡、再梗死和脑卒中复合终点事件的发生。

Objective： To explore the actual therapeutic effects of traditional Chinese medicine（TCM） on the combination disease of myocardial infarction（MI） and hyperlipidemia. Methods： This study was designed as a retrospective cohort study. The application of TCM injection more than seven days while in hospital, was divided into the exposed group. The application of Chinese patent medicine or decoction more than twenty-eight days while in follow-up period, was divided into the exposed group. The general information（name, age, gender and complications, etc） and the situation of TCM and outcome of patients while in hospital and follow-up period, were collected. The correlation between TCM and the outcome events of patients with the combination disease of myocardial infarction（MI） and hyperlipidemia was analyzed, by using multiple logistic regression method. Results： A total of 707 patients with the combination disease of myocardial infarction（MI） and hyperlipidemia were enrolled and 538 cases were followed up. While in hospital, TCM（OR=2.641, 95%CI=1.757-3.972）, age（OR=1.061, 95%CI=1.027-1.097） and treatment of anti-myocardial ischemia（OR=2.928, 95%CI=1.300-6.595） were relevant factors of cardiac death. TCM（OR=2.051, 95%CI=1.323-3.180）, age（OR=1.052, 95%CI=1.016-1.089） and anti-myocardial ischemia（OR=2.621, 95%CI=1.102-6.235） were relevant factors of cardiogenic shock. TCM（OR=1.732, 95%CI=1.123-2.669） and dyslipidemia（OR=2.125, 95%CI=1.115-4.049） were related to severe arrhythmia. During the follow-up period, TCM（OR=1.341, 95%CI=1.074-1.675）, age（OR=1.051, 95%CI=1.022-1.081）, diabetes（OR=2.769, 95%CI=1.618-4.738） and antithrombotic therapy（OR=0.256, 95%CI=0.117-0.560） were associated with cardiac death. TCM（OR=1.575, 95%CI=1.224-2.027）, age（OR=1.037, 95%CI=1.007-1.068）, male（OR=0.373, 95%CI=0.193-0.721） and antithrombotic therapy（OR=0.346, 95%CI=0.136-0.882） were relevant factors of composite outcome events of recurrence of infarction and stroke. Conclusion： TCM significantly decreased the incidence of cardiac death, cardiogenic shock and severe arrhythmia while in hospital, and cardiac death, outcome events of recurrence of infarction and stroke during the follow-up period, for patients with the combination disease of myocardium infarction（MI） and hyperlipidemia.