清心解瘀方对稳定性冠心病患者远期预后影响的前瞻性队列研究  

Effect of Qingxin Jieyu Formula on the Long-Term Prognosis of Patients with Stable Coronary Artery Disease:A Prospective Cohort Study

作　　者：石榴 高铸烨[2] 李金根 薛梅[2] 宋磊 李圣耀 尚青华[2] 宋烨闻 徐浩[2] 史大卓[2] SHI Liu;GAO Zhu-ye;LI Jin-gen;XUE Mei;SONG Lei;LI Sheng-yao;SHANG Qing-hua;SONG Ye-wen;XU Hao;SHI Da-zhuo(Graduate School,Beijing University of Chinese Medicine,Beijing 100029;Xiyuan Hospital,China Academy of Chinese Medical Sciences,National Clinical Research Center for Chinese Medicine Cardiology,Beijing 100091;Department of Cardiovascular,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国中医科学院西苑医院、国家中医心血管病临床医学研究中心,北京100091 [3]北京中医药大学东直门医院心血管科,北京100700

出　　处：《中国中西医结合杂志》2022年第11期1293-1299,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：中国中医科学院科技创新工程重大攻关项目(No.CI2021A00920);“重大新药创制”科技重大专项(No.2019ZX09201005-002-006);国家“十二五”科技支撑计划(No.2013BAI02B01);国家自然科学基金面上项目(No.82274508)。

摘　　要：目的评价清心解瘀方对稳定性冠心病(SACD)患者远期预后的影响。方法在清心解瘀方对SCAD患者1年临床终点事件影响的多中心、随机、双盲、安慰剂对照研究(QUEST试验)的基础上,最终纳入10家代表性三甲医院的916例SCAD患者,其中试验组455例接受常规治疗及清心解瘀方治疗,对照组461例接受常规治疗及安慰剂治疗。于2019年8-12月进行随访,记录患者终点事件。主要复合终点事件包括心源性死亡、非致命性心肌梗死和血运重建,次要复合终点事件包括全因死亡、卒中、因不稳定心绞痛/心力衰竭/恶性心律失常入院。结果患者平均随访时间为(43.2±11.8)个月,中位随访时间为45个月,完成随访患者775例(80.56%),试验组392例(86.15%),对照组383例(83.08%)。试验组主要复合终点事件的发生率(22例,5.61%)低于对照组[39例,10.18%,RR=0.55,95%CI(0.33~0.91),P=0.018];试验组联合终点事件发生率(40例,10.20%)低于对照组[66例,17.23%,RR=0.59,95%CI(0.41~0.85),P=0.004]。清心解瘀方是SCAD患者主要复合终点事件发生风险降低的独立影响因素[HR=0.50,95%CI(0.29~0.85),P=0.011],且在不同亚组人群的结果一致。结论常规治疗基础上加清心解瘀方可减低SCAD患者中位随访45个月主要复合终点事件和联合终点事件的发生风险。(No.ChiCTR-TRC-13004370)Objective To evaluate the effect of Qingxin Jieyu Formula(QXJYF)on the long-term prognosis of patients with stable coronary artery disease(SCAD).Methods Based on the multicenter,randomized,double-blinded,placebo-controlled study(QUEST Trial)of the effect of QXJYF on 1-year clinical endpoint events in SCAD,916 SACD patients were included from 10 representative 3A hospitals,455 patients in the treatment group were treated with conventional treatment and QXJYF,and 461 patients in the control group were treated with conventional treatment and placebo.This study was conducted for further follow-up from Aug,2019 to Dec,2019.The primary endpoint included the composite of cardiac death,nonfatal myocardial infarction,and coronary revascularization.The secondary endpoint included the composite of all-cause death,stroke,and admission for unstable angina or heart failure,or malignant arrhythmia.Results A total of 775(80.56%)patients completed follow-up,392 patients(86.15%)in the treatment group,383 patients(83.08%)in the control group,the mean follow-up period was(43.2±11.8)months,and the median follow-up period was 45 months.The incidence of the primary endpoint was lower in the treatment group than in the control group[22 patients(5.61%)vs.39 patients(10.18%),RR=0.55,95%CI(0.33~0.91),P=0.018].The incidence of the composite endpoint was lower in the treatment group than in the control group[40 patients(10.20%)vs.66 patients(17.23%),RR=0.59,95%CI(0.41~0.85),P=0.004].QXJYF was an independent influential factor in the reduced risk of the primary endpoint in SCAD patients[HR=0.50,95%CI(0.29~0.85),P=0.011],and the results were consistent across subgroups of the population.Conclusion The addition of QXJYF to conventional treatment reduced the risk of the primary endpoint and the composite endpoint at a median followup of 45 months in SCAD patients.(No.ChiCTR-TRC-13004370)

关 键 词：稳定性冠心病 清心解瘀方 心血管事件 远期预后 

分 类 号：R541.4[医药卫生—心血管疾病]