Li Qing, Su Lishuo, Zhou Ruijuan, Tang E, Liu Yu, Cheng Tao, Wang Shuai, Zhao Zhiqiang, Wang Xianliang, Mao Jingyuan
Department of Cardiovascular Diseases, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Evid Based Complement Alternat Med. 2022 Aug 22;2022:1486366. doi: 10.1155/2022/1486366. eCollection 2022.
Heart failure with preserved ejection fraction (HFpEF) is a large subtype of heart failure (HF) characterized by exercise intolerance and reduced quality of life. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but the overall quality of evidence is low. This study aimed to determine the safety and efficacy of Yangyin Shuxin (YYSX) decoction in the treatment of HFpEF.
A prospective, single-blind, single-center, randomized controlled clinical study was conducted. 64 patients with HFpEF were randomly assigned to receive oral YYSX decoction (150 ml, twice a day) combined with conventional Western treatment or conventional Western treatment alone at a ratio of 1 : 1. The course of treatment was 2 weeks, and the follow-up was 3 months. The primary outcome was peak oxygen uptake (peak VO) measured by the cardiopulmonary exercise test (CPET). Furthermore, the safety of YYSX decoction was assessed.
63 patients (31 in the YYSX group and 32 in the control group) were included in the full analysis set. The peak VO of the YYSX group was significantly higher than that of the control group (12.04 ± 3.41 vs. 11.02 ± 3.33, = 0.013) after 2 weeks. The maximum voluntary ventilation (MVV) was significantly higher in the YYSX group compared with the control group ( < 0.05). The YYSX group had a higher EQ-visual analogue scale (EQ-VAS) score (71.13 ± 13.95 vs. 70.94 ± 13.70, < 0.05) and a lower TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) score (49.74 ± 24.73 vs. 64.16 ± 27.15, < 0.05) than the control group. There was no statistical difference between two groups ( = 0.160), although 51.61% of patients in the YYSX group showed a decrease in brain natriuretic peptide (BNP) levels of at least 30%, compared with 37.50% of patients in the control group. No serious adverse events were reported in either group, but systolic and diastolic blood pressure decreased and serum sodium levels increased slightly in the control group.
The YYSX decoction combined with conventional Western treatment was superior to the conventional Western treatment alone in improving exercise tolerance, quality of life, and cardiopulmonary function of patients with HFpEF. YYSX decoction is safe and may prevent a drop in blood pressure and sodium retention. Trial Registration. Chinese Clinical Trial Registry (www.chictr.org/cn/, No. ChiCTR-IOR-17014206).
射血分数保留的心力衰竭（HFpEF）是心力衰竭（HF）的一个主要亚型，其特征为运动耐量下降和生活质量降低。研究表明，中药联合西医常规治疗对改善HFpEF患者的运动耐量和生活质量有良好效果，但证据的总体质量较低。本研究旨在确定养阴舒心（YYSX）汤治疗HFpEF的安全性和有效性。
进行一项前瞻性、单盲、单中心、随机对照临床研究。64例HFpEF患者按1∶1的比例随机分为两组，分别接受口服YYSX汤（150 ml，每日2次）联合西医常规治疗或单纯西医常规治疗。疗程为2周，随访3个月。主要结局指标为通过心肺运动试验（CPET）测量的峰值摄氧量（peak VO）。此外，评估YYSX汤的安全性。
63例患者（YYSX组31例，对照组32例）纳入全分析集。2周后，YYSX组的peak VO显著高于对照组（12.04±3.41 vs. 11.02±3.33，P = 0.013）。YYSX组的最大自主通气量（MVV）显著高于对照组（P < 0.05）。YYSX组的EQ视觉模拟量表（EQ-VAS）评分较高（71.13±13.95 vs. 70.94±13.70，P < 0.05），中医四维诊断信息量表（TCMFDIS）评分低于对照组（49.74±24.73 vs. 64.16±27.15，P < 0.05）。两组间无统计学差异（P = 0.160），尽管YYSX组51.61%的患者脑钠肽（BNP）水平至少降低30%，而对照组为37.50%。两组均未报告严重不良事件，但对照组收缩压和舒张压下降，血清钠水平略有升高。
YYSX汤联合西医常规治疗在改善HFpEF患者的运动耐量、生活质量和心肺功能方面优于单纯西医常规治疗。YYSX汤安全，可能预防血压下降和钠潴留。试验注册。中国临床试验注册中心（www.chictr.org/cn/，注册号：ChiCTR-IOR-17014206）。
