正心泰颗粒用于气虚血瘀型急性ST段抬高型心肌梗死患者PCI术后微血管性心绞痛的临床观察 点击下载
论文标题: 正心泰颗粒用于气虚血瘀型急性ST段抬高型心肌梗死患者PCI术后微血管性心绞痛的临床观察
英文标题:
中文摘要: 目的 探讨正心泰颗粒用于气虚血瘀型急性ST段抬高型心肌梗死(STEMI)患者经皮冠状动脉介入治疗(PCI)术后微血管性心绞痛(MVA)的临床疗效和安全性。方法选取济南市第四人民医院(济南市心脑血管病医院)2022年3月-2025年3月收治的PCI术后发生MVA的气虚血瘀型STEMI患者,采用随机数字表法将其分为对照组和观察组,每组76例。对照组患者接受常规西药治疗并联合安慰剂,观察组患者在常规西药治疗的基础上加用正心泰颗粒(每次5mg,每天3次,持续8周)。比较两组患者的临床疗效(中医证候改善总有效率、西医临床疗效总有效率),检测其治疗前后的中医证候积分、心绞痛发生情况[每天心绞痛发作次数、每次持续时间、视觉模拟评分法(VAS)评分]和心功能指标[乳酸脱氢酶(LDH)、氨基末端B型脑钠肽前体(NT-proBNP)、左室舒张末内径(LVEDD)、左室收缩末内径(LVESD)、左室射血分数(LVEF)、心输出量(CO)、短轴缩短率(FS)]、凝血功能指标[凝血酶时间(TT)、凝血酶原时间(PT)、纤维蛋白原(FIB)]、纤溶标志物(D-二聚体)、血管内皮功能指标[血管内皮生长因子(VEGF)、一氧化氮(NO)、内皮素1(ET-1)]、心肌微循环血流动力学指标[舒张末期血流速度(EDV)、收缩期峰值血流速度(PSV)、阻力指数(RI)、搏动指数(PI)]水平,比较其生活质量[西雅图心绞痛量表(SAQ)评分]和不良反应发生情况。结果研究过程中,无患者脱落。观察组患者中医证候改善总有效率、西医临床疗效总有效率均显著高于对照组(93.42%vs.82.89%、94.74%vs.84.21%,P<0.05)。治疗前,两组患者各考察指标比较,差异均无统计学意义(P>0.05)。与治疗前比较,两组患者治疗后的中医证候积分,每天心绞痛发作次数及每次持续时间,VAS评分,LDH、NT-proBNP、FIB、D-二聚体、ET-1水平和LVEDD、LVESD、RI、PI均显著减少、缩短或降低(P<0.05);VEGF、NO水平,LVEF、CO、FS、TT、PT、EDV、PSV,心绞痛稳定度等5个维度的标准分及SAQ总分均显著升高或延长(P<0.05);且观察组上述指标(LVEF除外)的改善均显著优于同期对照组(P<0.05)。两组患者的不良反应总发生率比较,差异无统计学意义(P>0.05)。结论正心泰颗粒辅助常规西药治疗可显著缓解气虚血瘀型STEMI患者PCI术后MVA的相关症状,修复受损心功能,恢复凝血-纤溶系统平衡,改善血管内皮功能及心肌微循环灌注,显著提升患者生活质量,且安全性良好。
英文摘要: Abstract OBJECTIVE To investigate the clinical efficacy and safety of Zhengxintai granules as in the treatment of microvascular angina (MVA) following percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) and qi deficiency and blood stasis syndrome. METHODS Patients with STEMI and qi deficiency and blood stasis syndrome who underwent PCI and developed MVA and were admitted to the Jinan Fourth People’s Hospital (Jinan Cardiovascular Hospital) from March 2022 to March 2025 were selected, they were randomly divided into the control group and the observation group according to a random number table, with 76 cases in each group. Patients in the control group received conventional Western medicine treatment combined with a placebo, while patients in the observation group received Zhengxintai granules (5 mg per dose, three times daily, for 8 weeks) in addition to conventional Western medicine treatment. The clinical efficacy [including the total effective rate of traditional Chinese medicine (TCM) syndrome improvement and the total effective rates of Western clinical efficacy] was compared between the two groups. The following indicators were detected before and after treatment: TCM syndrome scores, angina pectoris episodes [daily attack frequency, duration per attack, Visual Analogue Scale (VAS) score], cardiac function indicators [lactate dehydrogenase (LDH), N-terminal pro-B-type natriuretic peptide (NT-proBNP), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), left ventricular ejection fraction (LVEF), cardiac output (CO), fractional shortening (FS)], coagulation function indicators [thrombin time (TT), prothrombin time (PT), fibrinogen (FIB)], fibrinolytic marker (D-dimer), vascular endothelial function indicators [vascular endothelial growth factor (VEGF), nitric oxide (NO), endothelin-1 (ET-1)] and myocardial microcirculation hemodynamic indicators [end-diastolic velocity (EDV), peak systolic velocity (PSV), resistance index (RI), pulsatility index (PI)]. The quality of life [Seattle Angina Questionnaire (SAQ) score] and the incidence of adverse reactions were also compared between the two groups. RESULTS There was no patient dropout during the entire course of the study. The total effective rates of improvement in TCM syndromes and the total effective rates of Western clinical efficacy in the observation group were significantly higher than those in the control group (93.42% vs. 82.89%, 94.74% vs. 84.21%, P<0.05). Before the treatment, the comparison of each examination indicator between the two groups showed no statistically significant differences (P>0.05). Compared with before treatment, the TCM syndrome scores, the number of daily angina pectoris attacks and the duration of each attack, the VAS scores, LDH, NT-proBNP, FIB, D-dimer, ET-1 levels, LVEDD, LVESD, RI and PI after treatment in both groups were significantly reduced, shortened or decreased (P<0.05); VEGF and NO levels, LVEF, CO, FS, TT, PT, EDV, PSV, and the standard scores of five dimensions including angina pectoris stability, as well as the total scores of SAQ, all significantly increased or prolonged (P<0.05). Furthermore, the improvements in the aforementioned indicators (except for LVEF) in the observation group were significantly greater than those in the control group (P<0.05). There was no statistically significant difference in the total incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS Zhengxintai granules, when used as an adjunct to conventional Western medicine, can significantly alleviate the related symptoms of MVA in STEMI patients with qi deficiency and blood stasis syndrome after PCI, repair damaged cardiac function, restore the balance of the coagulation-fibrinolysis system, improve vascular endothelial function and myocardial microcirculation perfusion, and significantly enhance the quality of life of patients
期刊: 2026年第37卷第15期
作者: 马文辉;张英;刘磊;于秀燕;陈亚丽;陈黎明
英文作者: MA Wenhui,ZHANG Ying,LIU Lei,YU Xiuyan,CHEN Yali,CHEN Liming
关键字: 正心泰颗粒;急性ST段抬高型心肌梗死;经皮冠状动脉介入治疗;微血管性心绞痛;气虚血瘀证;疗效;安全性
KEYWORDS: Zhengxintai granules; acute ST-segment elevation myocardial infarction; percutaneous coronary intervention; microvascular angina; qi deficiency and blood stasis syndrome; clinical efficacy; safety
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