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银杏叶联合尼可地尔治疗射血分数保留的心力衰竭患者临床疗效的随机对照研究

A Randomized Controlled Study on the Clinical Efficacy of Ginkgo Biloba Combined with Nicorandil in Patients with HFmrEF.

作者信息

Gao Xiang, Liu Fangyuan, Han Xiaozhen, Tang Shan, Shen Dingding, Zhang Jia, Liu Chuanliang

机构信息

Department of Geratology, Weifang People's Hospital Affiliated with Shandong Second Medical University.

出版信息

Int Heart J. 2025;66(1):74-80. doi: 10.1536/ihj.24-316.

Abstract

This study aimed to explore the clinical efficacy of Ginkgo biloba combined with Nicorandil in patients with heart failure who have a mild decrease in ejection fraction (HFmrEF).A total of 316 patients with HFmrEF were selected and randomly assigned to either a control group or a combination of the Ginkgo biloba and Nicorandil group, each group consisting of 158 patients. The control group received standard secondary preventive treatment, while patients in the combination group received oral Ginkgo biloba and Nicorandil based on stable conventional treatment. Both groups were treated continuously for six months. The age, sex, body mass index (BMI), New York Heart Association cardiac function classification, history of coronary heart disease, hypertension, diabetes, atrial fibrillation, smoking, left ventricular ejection fractions (LVEF), heart rate, glycosylated hemoglobin (HbA1c), and combined drug use of the patients in the two groups were recorded. The efficacy endpoints were BMI, heart rate, blood lipid levels, fasting blood glucose, renal function, HbA1c, N-terminal pro-brain natriuretic peptide (NT-proBNP), LVEF, cardiopulmonary exercise testing parameters, 6-minute walking distance (6MWD), and the Kansas City Cardiomyopathy Questionnaire (KCCQ) score after six months of treatment. The incidence of adverse reactions in the two groups was recorded.After six months of treatment, the BMI, heart rate, NT-proBNP, low-density lipoprotein cholesterol, triglyceride, creatinine, fasting blood glucose, and HbA1c levels of patients in the Ginkgo biloba combined with Nicorandil group were lower than those in the control group (P < 0.05). The LVEF, high-density lipoprotein cholesterol, VO2peak, oxygen uptake efficiency slope, 6MWD, and KCCQ scores were higher in the Ginkgo biloba combined with Nicorandil group than in the control group (P < 0.05). There was no statistically significant difference between the two groups of patients (P > 0.05) in the incidence of hypotension, hypoglycemia, hypokalemia, headache, and hospitalization due to worsening heart failure.Ginkgo biloba combined with Nicorandil can effectively improve heart function, blood lipid levels, blood glucose levels, renal function, exercise tolerance, and health-related quality of life in patients with HFmrEF. Because there were no significant adverse reactions, they can be safely used.

摘要

本研究旨在探讨银杏叶提取物联合尼可地尔对射血分数轻度降低的心力衰竭(HFmrEF)患者的临床疗效。共选取316例HFmrEF患者,随机分为对照组和银杏叶提取物联合尼可地尔组,每组158例。对照组接受标准二级预防治疗,联合组患者在稳定的常规治疗基础上口服银杏叶提取物和尼可地尔。两组均连续治疗6个月。记录两组患者的年龄、性别、体重指数(BMI)、纽约心脏协会心功能分级、冠心病史、高血压、糖尿病、心房颤动、吸烟情况、左心室射血分数(LVEF)、心率、糖化血红蛋白(HbA1c)及联合用药情况。疗效终点为治疗6个月后的BMI、心率、血脂水平、空腹血糖、肾功能、HbA1c、N末端脑钠肽前体(NT-proBNP)、LVEF、心肺运动试验参数、6分钟步行距离(6MWD)及堪萨斯城心肌病问卷(KCCQ)评分。记录两组不良反应发生率。治疗6个月后,银杏叶提取物联合尼可地尔组患者的BMI、心率、NT-proBNP、低密度脂蛋白胆固醇、甘油三酯、肌酐、空腹血糖及HbA1c水平均低于对照组(P<0.05)。银杏叶提取物联合尼可地尔组的LVEF、高密度脂蛋白胆固醇、峰值摄氧量、摄氧效率斜率、6MWD及KCCQ评分高于对照组(P<0.05)。两组患者在低血压、低血糖、低钾血症、头痛及因心力衰竭恶化住院发生率方面差异无统计学意义(P>0.05)。银杏叶提取物联合尼可地尔可有效改善HFmrEF患者的心功能、血脂水平、血糖水平、肾功能、运动耐量及健康相关生活质量。由于无明显不良反应,可安全使用。

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