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| 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 |
| Hits 506 Download times 194 Received:March 30, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.09.03 |
| Key Words
acute coronary syndrome;female;percutaneous coronary intervention;Qishen Yiqi Dropping Pill;endpoint |
| Author Name | Affiliation | E-mail | | YANG Furong | Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China | | | YANG Yankai | Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China | | | CUI Zhuorui | Graduate School, Beijing University of Chinese Medicine, Beijing 100105, China | | | CAI Yajie | Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China | | | YU Yanqiao | Graduate School, Beijing University of Chinese Medicine, Beijing 100105, China | | | BAI Ruina | Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China | | | YANG Qiaoning | The Institute of Clinical Pharmacology, China Academy of Chinese Medical Sciences, Beijing 100091, China | yangqiaoning2008@126.com |
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| Abstract
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| [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. |
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