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

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

摘要:

[目的] 观察芪参益气滴丸治疗急性冠脉综合征（ACS）合并经皮冠状动脉介入（PCI）术后女性患者的临床疗效。[方法] 采用前瞻性队列研究设计，纳入2012年2月——2015年12月共40家三级医疗机构中ACS首次行PCI治疗后中医辨证为气虚血瘀证的女性患者，芪参益气滴丸用药为暴露因素，分为芪参益气滴丸组和常规治疗组，于2018年12月完成36个月的随访。主要终点包括心源性死亡、非致死性心肌梗死和紧急血运重建，次要终点为因ACS再住院、心力衰竭、卒中和其他血栓事件。用西雅图心绞痛量表（SAQ）用于评估生活质量，不良事件用于评估安全性，随访12个月。终点事件采用比例风险回归模型（Cox）和Kaplan-Meier（K-M）生存曲线、限制平均生存时间（RMST）分析，并采用倾向性评分进行敏感性分析，生活质量评估采用广义估计方程（GEE）分析。[结果] 285例患者完成随访，其中芪参益气滴丸组152例、常规治疗组133例。终点事件方面，Cox回归校正混杂因素后芪参益气滴丸组主要终点事件发生风险较低[校正后HR=0.47，95%CI（0.25，0.90），P=0.021]；K-M生存曲线亦提示芪参益气滴丸组主要终点累积事件发生率较低（P<0.05），RMST分析芪参益气滴丸组在时间限定为710 d内生存时间较常规治疗组延长50.24 d（P<0.05）；敏感性分析结果显示芪参益气滴丸组主要终点事件发生风险较低[HR=0.38，95%CI（0.17，0.88），P=0.024]；次要终点事件差异均无统计学意义（P>0.05）。生活质量方面，与常规治疗组相比，芪参益气滴丸组在随访第6、12个月SAQ评分升高（P<0.05）；安全性方面，两组间不良事件差异无统计学意义（P>0.05）。[结论] 在常规治疗基础上，芪参益气滴丸可以改善ACS合并PCI术后气虚血瘀证女性患者的预后，提高SAQ评分，且安全性较好，值得临床推广。

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.