目的 探究通脉养心丸与沙库巴曲缬沙坦钠协同治疗慢性心力衰竭患者的临床疗效与安全性。方法 纳入2022年6月—2023年12月于武汉科技大学附属武汉市武昌医院收治的85例慢性心力衰竭患者，基于治疗方案差异分配至对照组（n=42）与治疗组（n=43）。对照组给药方案为沙库巴曲缬沙坦钠片口服给药，起始剂量50 mg/次，2次/d，，每两周实施剂量倍增调整，最终维持剂量200 mg/次，2次/d。治疗组在对照组治疗基础上加用通脉养心丸，40丸/次，2次/d。两组患者均实施为期6周的规范化治疗干预。观察两组患者临床疗效，比较治疗前后两组患者Lee氏心衰评分和健康调查简表（SF-36）评分，心功能指标左心室舒张末期内径（LVEDD）、左室后壁厚度（LVPW）和左室后壁厚度（LVPW），及血清细胞因子胱抑素C（Cys C）、可溶性髓系细胞表达触发受体-1（sTREM-1）和生长分化因子11（GDF11）水平。结果 治疗后，对照组与治疗组总有效率分别为80.95%、95.35%，组间对比有统计学差异（P＜0.05）。治疗后，两组患者Lee氏心衰评分显著下降，SF-36评分显著提升（P＜0.05）；与对照组比较，治疗组改善幅度具有显著优势（P＜0.05）。心脏彩超参数显示，两组患者LVEDD与LVPW均显著缩减，LVEF水平同步提升（P＜0.05）；治疗组LVEDD、LVPW、LVEF改善优于对照组（P＜0.05）。血清学检测结果显示，两组患者血清Cys C、sTREM-1及GDF11水平显著降低（P＜0.05）；治疗组细胞因子水平下降幅度显著优于对照组（P＜0.05）。结论 通脉养心丸联合沙库巴曲缬沙坦钠治疗慢性心力衰竭具有协同增效作用，同时还可改善患者心功能和生活质量，同步促进血清标志物水平复常，在提升疗效的同时未增加安全风险。

Objective To explore the therapeutic effect of Tongmai Yangxin Pills combined with sacubitril valsartan sodium in treatment of chronic heart failure. Methods Patients (85 cases) with chronic heart failure in Wuhan Wuchang Hospital Affiliated to Wuhan University of Science and Technology from June 2022 to December 2023 were divided into control (42 cases) and treatment (43 cases) group based on different treatments. Patients in the control group were po administered with Sacubitril Valsartan Sodium Tablets, the starting dose was 50 mg/time, twice daily, and the dose doubled once after 2 weeks, the final maintenance dose was 200 mg/time, twice daily. Patients in the treatment group were po administered with Tongmai Yangxin Pills on the basis of the control group, 40 pills/time, twice daily. Patients in two groups were treated for 6 weeks. After treatment, the clinical evaluations were evaluated, and the Lee's heart failure score and SF-36 score, the cardiac function indexes LVEDD, LVPW, and LVEF, and the levels of serum cytokine Cys C, sTREM-1, and GDF11 in two groups before and after treatment were compared. Results After treatment, the total effective rate of control group and treatment group was 80.95% and 95.35%, respectively, with statistical difference between the groups (P < 0.05). After treatment, Lee's heart failure score decreased significantly and SF-36 score increased significantly (P < 0.05). The improvement of treatment group was significantly superior (P < 0.05). Cardiac color ultrasound parameters showed that LVEDD and LVPW were significantly reduced in both groups, but LVEF levels were increased simultaneously (P < 0.05). The improvement of indexes in treatment group was significantly higher than that in control group (P < 0.05). Serological test results showed that the levels of serum Cys C, sTREM-1 and GDF11 in 2 groups were significantly decreased (P < 0.05). The decrease of all indexes in treatment group was significantly higher than that in control group (P < 0.05). Conclusion Tongmai Yangxin Pills combined with sakubatril valsartan sodium has a synergistic effect in the treatment of chronic heart failure, and can also improve the cardiac function and quality of life of patients, and promote the level of serum markers to normalize simultaneously, which improves the efficacy without increasing the safety risk.

R972

湖北省自然科学基金资助项目（2022CFC025）