2025 年第 12 期 第 20 卷

芪参颗粒治疗射血分数保留型心力衰竭的临床对照研究

A controlled clinical study of Qishen granules in the treatment of heart failure with preserved ejection fraction

作者：孙瑞李蒙吴卓然肖狄郭淑贞张立晶

英文作者：Sun Rui Li Meng Wu Zhuoran Xiao Di Guo Shuzhen Zhang Lijing

单位：北京中医药大学东直门医院心内科，北京100700

英文单位：Department of Cardiology Dongzhimen Hospital Beijing University of Chinese Medicine Beijing 100700 China

关键词：射血分数保留型心力衰竭；芪参颗粒；炎症

英文关键词：Heartfailurewithpreservedejectionfraction;Qishengranules;Inflammation

• 摘要：

• 目的 观察芪参颗粒治疗射血分数保留型心力衰竭（HFpEF）患者的有效性和安全性及其抗炎效果。方法 选取2023年12月至2024年10月北京中医药大学东直门医院收治的HFpEF患者80例，采用区组随机将患者分为观察组和对照组，每组各40例。所有患者均给予标准心力衰竭治疗，对照组和观察组分别加服安慰剂和芪参颗粒治疗，共服药12周。比较2组患者N末端B型脑钠肽前体（NT-proBNP）下降有效率、纽约心脏病协会心功能分级、堪萨斯城心肌病问卷（KCCQ-12)评分、中医证候积分、6 min步行试验（6MWT）距离、超声心动图指标、炎症探索性指标、安全性评价。结果 2组患者一般资料比较差异均无统计学意义（均P＞0.05）。治疗12周后，观察组NT-proBNP、高敏C反应蛋白、可溶性肿瘤生成抑制因子2、肿瘤坏死因子α均低于对照组［（921±212）ng/L比（1 054±305）ng/L、（3.2±1.3）mg/L比（4.1±2.0）mg/L、（19±4）ng/L比（21±4）ng/L、（34±8）mg/L比（40±10）mg/L］，NT-proBNP下降有效率、心功能改善总有效率、6MWT距离高于/长于对照组［60.0%（24/40）比37.5%（15/40）、67.5%（27/40）比35.0%（14/40）、（348±62）m比（315±51）m］，差异均有统计学意义（均P＜0.05）。治疗8周和12周后，观察组患者KCCQ-12评分均高于对照组，中医证候积分均低于对照组，差异均有统计学意义（均P<0.05）。2组患者安全性指标方面比较差异均无统计学意义（均P＞0.05）。结论 芪参颗粒可提高HFpEF患者NT-proBNP下降有效率，改善心功能、运动耐量及生活质量，降低炎症因子水平，且安全性良好。

• Objective To observe the efficacy, safety and anti-inflammatory effect of Qishen granules in the treatment of heart failure with preserved ejection fraction (HFpEF). Methods A total of 80 HFpEF patients admitted to Dongzhimen Hospital, Beijing University of Chinese Medicine from December 2023 to October 2024 were selected. The patients were divided into observation group and control group by block randomization, with 40 cases in each group. All patients were given standard heart failure treatment, and the control group and the observation group were treated with placebo and Qishen granules, respectively, for 12 weeks. The decline rate of N-terminal pro-brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score, traditional Chinese medicine syndrome score, 6 min walk test (6MWT) distance, echocardiographic indicators, inflammatory exploratory indicators and safety evaluation were compared between the two groups. Results There were no significant differences in general data between the two groups (all P＞0.05). After 12 weeks of treatment, the levels of NT-proBNP, high-sensitivity C-reactive protein, soluble tumor suppressor 2, and tumor necrosis factor-α in the observation group were lower than those in the control group ［（921±212）ng/L vs （1 054±305）ng/L, （3.2±1.3）mg/L vs （4.1±2.0）mg/L, （19±4）ng/L vs （21±4）ng/L, （34±8）mg/L vs （40±10）mg/L］, and the effective decline rate of NT-proBNP, the total effective rate of cardiac function improvement, and 6MWT distance were higher/longer than those in the control group ［60.0%（24/40） vs 37.5%（15/40）, 67.5%（27/40） vs 35.0%（14/40）, （348±62）m vs （315±51）m］(all P＜0.05). After 8 and 12 weeks of treatment, the KCCQ-12 scores of the observation group were higher than those of the control group, and the traditional Chinese medicine syndrome scores were lower than those of the control group (all P＜0.05). There were no significant differences in the safety indicators between the two groups (all P＞0.05). Conclusion Qishen granules can improve the rate of NT-proBNP decline in patients with HFpEF, improve cardiac function, exercise tolerance and quality of life, reduce the levels of inflammatory factors, and has good safety.