中医杂志2026，Vol.67Issue(11)：1178-1184,7.DOI:10.13288/j.11-2166/r.2026.11.009
心梗2号颗粒剂对ST段抬高型心肌梗死PCI术后气虚血瘀证患者左心室重构的影响
Effect of Xingeng No.Ⅱ Granules(心梗2号颗粒剂)on Left Ventricular Remodeling in Patients of ST-Segment Elevation Myocardial Infarction with Qi Deficiency and Blood Stasis Syndrome after PCI:An Open-Labbled Randomized-Controlled Trial
摘要
Abstract
Objective To observe the effectiveness and safety of Xingeng No.Ⅱ Granules(心梗2号颗粒剂)in preventing and treating left ventricular remodeling in patients with qi deficiency and blood stasis syndrome following percutaneous coronary intervention(PCI)for ST-segment elevation myocardial infarction(STEMI).Methods In this randomized controlled trial,patients with qi deficiency and blood stasis syndrome after PCI for STEMI were randomly assigned to treatment group and control group at a 1∶1 ratio,with 66 patients in each group.In the control group,patients only received conventional western medicine after surgery,while the treatment group additionally received the granules(8 g per dose,twice daily),for a treatment duration of 8 weeks in both groups.The primary outcome was the incidence of left ventricular remodeling within 6 months after surgery.The secondary outcomes were the incidence of major adverse cardiovascular and cerebrovascular events(MACCE)within 6 months,all-cause mortality,stent thrombosis,BARC Ⅲ and Ⅴ bleeding events,rehospitalization due to acute heart failure,and severe complications of STEMI.Traditional Chinese medicine(TCM)syndrome scores at 1 day and 1,2,and 6 months after surgery was evaluated.Adverse events during the study were recorded to evaluate safety.Results Six cases dropped out from both the treatment group and the control group.The full analysis set(FAS)analysis showed that the incidence of left ventricular remodeling in the treatment group was 16.67％(11/66),significantly lower than 40.91％(27/66)in the control group(P=0.004).The per protocol set(PPS)analysis also showed lower incidence of left ventricular re-modeling in the treatment group(20.37％,11/54)than in the control group(49.09％,27/55)with significant difference(P=0.002).Within 6 month after surgery,0 patients in the treatment group and 4 out of 60 patients(6.67％)in the control group were readmitted to hospital for acute heart failure,with significantly higher rate in the control group(P=O.042).Neither group of patients experienced recurrent myocardial infarction,target vessel revas-cularization,in-stent thrombosis,or severe complications of STEMI.There was no statistically significant difference between groups in the incidence of stroke,cardiovascular mortality,all-cause mortality,BARC Ⅲ and Ⅴ bleeding events(P＞0.05).At 1 day after surgery,there was no statistically significant difference in TCM syndrome score between the groups(P＞0.05);while 1,2 and 6 months after surgery,TCM syndrome score in the treatment group was significantly lower than that in the control group(P＜0.05).Analysis of the safety dataset(SS)showed that the incidence of adverse events in the treatment group was 7.41％(4/60),while in the control group it was 16.36％(9/57),showing no statistically significant difference(P=0.117).Conclusion In addition to conventional western medicine,Xingeng No.Ⅱ Granules can reduce the incidence of left ventricular remodeling and the incidence of rehospi-talization due to acute heart failure in STEMI patients with qi deficiency and blood stasis syndrome after PCI,with good safety profile.关键词
ST段抬高型心肌梗死/左心室重构/气虚血瘀证/随机对照试验/心梗2号颗粒剂Key words
ST-segment elevation myocardial infarction/left ventricular remodeling/qi deficiency and blood stasis syndrome/randomized controlled trials/Xingeng No.Ⅱ Granules(心梗2号颗粒剂)引用本文复制引用
杨春昆,朱勤伟,潘清泉,李军..心梗2号颗粒剂对ST段抬高型心肌梗死PCI术后气虚血瘀证患者左心室重构的影响[J].中医杂志,2026,67(11):1178-1184,7.基金项目
国家自然科学基金(81973836) （81973836）
中国中医科学院科技创新项目(CI2021A00902) （CI2021A00902）
