目的 观察复心合剂联合西医治疗射血分数恢复型扩张型心肌病（DCM）心力衰竭阳虚水泛证患者的临 床疗效。方法 选择 2023 年 1 月至 2024 年 7 月在山东中医药大学附属医院就诊的 76 例射血分数恢复型 DCM 心力衰竭阳虚水泛证患者，采用随机数字表法分为观察组与对照组各 38 例。对照组给予常规西医治疗，观察 组在对照组基础上给予复心合剂治疗，疗程为 8 周。观察两组患者治疗前后左房超声参数[二维左房最大容积 （2D-LAVmax）、二维左房最小容积（2D-LAVmin）、二维左房容积指数（2D-LA-VI）]、左室超声参数[左心室舒 张末期内径（LVEDD）、左心室收缩末期内径（LVESD）和左心室射血分数（LVEF）]、左房应变及应变率参数[心 房收缩期左房平均负向应变峰值（meanSs）、心房舒张期左房平均正向应变峰值（meanSr）、左室舒张晚期左房平 均负向峰值应变率（meanSRa）和左室收缩期左房平均正向峰值应变率（meanSRs）]、左室心肌做功参数[左室心肌 整体做功指数（GWI）、整体有用功（GCW）及整体无用功（GWW）]、血管内皮功能指标[基质金属蛋白酶 9（MMP-9）、 可溶性生长刺激表达基因 2 蛋白（sST2）、降钙素基因相关肽（CGRP）]水平及中医证候评分变化情况，并评估 2 组患者的临床疗效及随访记录主要不良心血管事件（MACE）发生情况。结果 （1）治疗过程中，2 组均剔除 3 例， 对照组、观察组各完成研究 35 例。（2）治疗后，两组患者左房超声参数（2D-LAVmax、2D-LAVmin 和 2D-LA-VI）及 LVEDD、LVESD、GWW 水平均较治疗前降低（P＜0.05），左房应变及应变率参数（meanSs、 meanSr、meanSRa 和 meanSRs）及 LVEF、GWI、GCW 水平升高（P＜0.05）；观察组患者的各左房超声参数及 LVEDD、LVESD、GWW 水平均低于对照组（P＜0.05），各左房应变及应变率参数及 LVEF、GWI、GCW 水平 高于对照组（P＜0.05）。（3）治疗后，两组患者的血清 MMP-9、sST2 水平均较治疗前降低（P＜0.05），CGRP 水平 升高（P＜0.05）；观察组患者的血清 MMP-9、sST2 水平低于对照组（P＜0.05），CGRP 水平高于对照组（P＜ 0.05）。（4）治疗后，两组患者的中医证候（胸闷喘息、心悸乏力、下肢水肿、畏寒肢冷、总分）评分均较治疗 前降低（P＜0.05），且观察组患者的中医证候（胸闷喘息、心悸乏力、下肢水肿、畏寒肢冷、总分）评分明显低 于对照组（P＜0.05）。（5）治疗后，观察组患者的总有效率为 94.29%（33/35），高于对照组的 80%（28/35）（P＜ 0.05）。（6）观察组随访患者的 MACE 总发生率为 20.00%（7/35），低于对照组的 77.14%（27/35）（P＜0.05）。 结论 复心合剂联合西医治疗可有效改善射血分数恢复型 DCM 心力衰竭阳虚水泛证患者的左心重构，提高血 管内皮功能及心脏整体做功，抑制心肌纤维化，降低 MACE 发生率，临床疗效显著，安全性较高。

Objective To evaluate the clinical efficacy of Fuxin Mixture combined with conventional western medicine in treating heart failure with recovered ejection fraction in dilated cardiomyopathy（DCM） patients presenting yang deficiency causing edema syndrome. Methods Seventy-six DCM patients with heart failure with recovered ejection fraction presenting yang deficiency causing edema syndrome treated at the Affiliated Hospitial of Shandong University of Traditional Chinese Medicine from January 2023 to July 2024 were randomly divided into observation group（n=38） and control group（n=38）. The control group received conventional western treatment，while the observation group received additional Fuxin Mixture， both groups were treated for 8 weeks. Parameters assessed included left atrial ultrasound indices [2D maximum left atrial volume（2D-LAVmax），2D minimum left atrial volume（2D-LAVmin），2D left atrial volume index（2D-LA-VI）]，left ventricular ultrasound parameters [left ventricular end-diastolic dimension（LVEDD）， left ventricular end-systolic dimension（LVESD），left ventricular ejection fraction（LVEF）]，left atrial strain and strain rate parameters [mean peak negative strain during atrial systole（meanSs）， mean peak positive strain during atrial diastole（meanSr）， mean peak negative strain rate during late ventricular diastole（meanSRa）， mean peak positive strain rate during ventricular systole（meanSRs）]，left ventricular myocardial work indices [global work index（GWI）， global constructive work（GCW）， global wasted work（GWW）]， vascular endothelial function markers [matrix metalloproteinase-9（MMP-9），soluble suppression of tumorigenicity 2（sST2），calcitonin gene-related peptide（CGRP）]， traditional Chinese medicine（TCM） syndrome scores， clinical efficacy， and major adverse cardiovascular events （MACE）. Results（1）During the treatment，three case was excluded from both group，and these was 35 cases who completed the study in each group.（2）After treatment， the left atrial ultrasound parameters（2D-LAVmax， 2DLAVmin and 2D-LA-VI） and LVEDD，LVESD，GWW levels of both groups were significantly decreased compared with those before treatment（P＜0.05）， while the left atrial strain and strain rate parameters（meanSs， meanSr， meanSRa and meanSRs） and LVEF， GWI， GCW levels were significantly increased（P＜0.05）. The left atrial ultrasound parameters and LVEDD，LVESD，GWW levels of the observation group were significantly lower than those of the control group（P＜0.05），while the left atrial strain and strain rate parameters and LVEF，GWI，GCW levels were significantly higher than those of the control group（P＜0.05）.（3）After treatment，the serum levels of MMP-9 and sST2 in both groups were significantly decreased compared with those before treatment（P＜0.05），while the CGRP level was significantly increased（P＜0.05）. The serum levels of MMP-9 and sST2 in the observation group were significantly lower than those in the control group（P＜0.05），while the CGRP level was significantly higher than those of the control group（P＜0.05）.（4） After treatment， the scores of TCM syndromes（chest tightness and shortness of breath， palpitations and fatigue， lower extremity edema， cold aversion and cold limbs） in both groups were significantly lower than those before treatment（P＜0.05），and the scores of TCM syndromes in the observation group were significantly lower than those in the control group（P＜0.05）.（5） After treatment，the total effective rate of the observation group was 94.29%（33/35），which was significantly higher than that of the control group 80.00%（28/35） （P＜0.05）.（6） During the follow-up period，the total incidence of MACE in the observation group was 20.00%（7/35）which was significantly lower than that in the control group 77.14%（27/35）（P＜0.05）. Conclusion Fuxin Mixture combined with western medicine effectively improves left ventricular remodeling， enhances vascular endothelial function， optimizes myocardial work efficiency， inhibits myocardial fibrosis， reduces MACE incidence， and demonstrates significant clinical efficacy with favorable safety in treating heart failure with recovered ejection fraction DCM patients with yang deficiency causing edema syndrome.

R256.22

山东省自然科学基金面上项目（ZR2024MH244）；山东省自然科学基金联合基金重点支持项目（ZR2021LZY038）；山东省中医药科技 发展计划项目（2021M181）；山东省老年医学学会2021年科技攻关项目（LKJGG2021W106）；齐鲁流派中医学术流派传承项目（鲁卫函〔2022〕93号）； 山东省中医药特色疗法挖掘整理项目（3700020699）。