天津中医药2025，Vol.42Issue(9)：1096-1105,10.DOI:10.11656/j.issn.1672-1519.2025.09.03
芪参益气滴丸治疗急性冠脉综合征PCI术后气虚血瘀证女性患者的临床预后研究
Prospective cohort study on the prognosis of Qishen Yiqi Dropping Pill in treating female patients with qi deficiency and blood stasis syndrome after percutaneous coronary intervention for acute coronary syndrome
摘要
Abstract
[Objective]To observe the clinical efficacy of Qishen Yiqi Dropping Pills(QSYQ)in female patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).[Methods]Female patients with qi deficiency and blood stasis syndrome after first PCI for ACS in 40 tertiary medical institutions from February 2012 to December 2015 were included,divided into QSYQ group and the conventional treatment group with QSYQ as the exposure factor,followed up until December 2018,36 months.Primary endpoints:cardiogenic death,non-fatal myocardial infarction,emergency revascularization;secondary endpoints:readmission due to ACS,heart failure,stroke,other thrombotic events.Adverse eventsand were recorded,and quality of life was assessed by Seattle Angina Questionnaire(SAQ)at 12 months.Cox proportional hazards regression model,Kaplan-Meier survival curve,restricted mean survival time(RMST)analysis were used for endpoints analysis,with sensitivity analysis by propensity score matching(PSM);quality of life was analyzed by generalized estimating equation(GEE).[Results]The 285 patients completed the follow-up,including 152 patients in the QSYQ group and 133 patients in the conventional treatment group.After adjusting for confounding factors by Cox regression,QSYQ group had a lower risk of the primary endpoint[HR=0.47,95％CI(0.25,0.90),P=0.021];Kaplan-Meier survival curve showed lower cumulative incidence of primary endpoint in QSYQ growp(P＜0.05);RMST analysis indicated longer survival time in QSYQ group within 710 days(P＜0.05);sensitivity analysis showed consistent effect size of primary endpoint[HR=0.38,95％CI(0.17,0.88),P=0.024];no significant differences in secondary endpoint(P＞0.05).SAQ scores in QSYQ group were higher at the 6 and 12 month of follow-up(P＜0.05);no significant differences in adverse events between the two groups(P＜0.05).[Conclusion]On the basis of conventional treatment,QSYQ can improve the prognosis of female patients with qi deficiency and blood stasis syndrome after ACS PCI,increase SAQ scores,with good safety,worthy of clinical promotion.关键词
急性冠脉综合征/女性/经皮冠状动脉介入/芪参益气滴丸/终点事件Key words
acute coronary syndrome/female/percutaneous coronary intervention/Qishen Yiqi Dropping Pill/endpoint分类
医药卫生引用本文复制引用
杨芙蓉,杨严凯,崔卓睿,蔡雅杰,于燕乔,白瑞娜,杨巧宁..芪参益气滴丸治疗急性冠脉综合征PCI术后气虚血瘀证女性患者的临床预后研究[J].天津中医药,2025,42(9):1096-1105,10.基金项目
国家中医药行业科研专项(201007001) （201007001）
中国中医科学院西苑医院名老中医经验传承研究专项(XYZX0101-01) （XYZX0101-01）
中华中医药学会青年求实项目(2022-QNQSDEP-01) （2022-QNQSDEP-01）
中医药临床科研一体化平台建设专项(XYZX0405-32). （XYZX0405-32）
