【目的】 评估四君子汤合丹参饮加减方联合西药治疗舒张性心力衰竭（DHF）气阴两虚夹瘀证患者的临床疗效及其对心功 能的影响。【方法】 采用前瞻性随机对照研究设计，依据随机数字表法将 2024年 3月至 2024年 9月郑州大学第一附属医院南 院区收治的80例DHF气阴两虚夹瘀证患者随机分为对照组和观察组，每组各40例。对照组给予常规西药治疗，观察组给予 四君子汤合丹参饮加减方联合西药治疗，治疗时间均为6周。观察2组患者治疗前后中医证候积分、心功能指标、Minnesota 心功能不全生命质量问卷（MLHFQ）评分和6 min步行距离（6MWD）的变化情况，比较2组患者的临床疗效，并进行安全性评 价。【结果】（1）疗效方面，治疗6周后，观察组的总有效率为95.00%（38/40），对照组为75.00%（30/40），组间比较（χ2 检验）， 观察组的疗效明显优于对照组（P＜0.05）。（2）中医证候积分方面，治疗后，2组患者的主症积分、次症积分及总积分均较治 疗前降低（P＜0.05），且观察组的降低幅度均明显优于对照组（P＜0.01）。（3）心功能指标方面，治疗后，2组患者的左室舒张 末期内径（LVEDD）、左室收缩末期内径（LVESD）均较治疗前降低（P＜0.05），左室射血分数（LVEF）均较治疗前升高（P＜ 0.05），且观察组对各项心功能指标的改善幅度均明显优于对照组（P＜0.01）。（4）生活质量和运动耐力方面，治疗2、4、6周 后，2组患者的 MLHFQ 评分均较前一观察时点降低（P＜0.05），6MWD 均较前一观察时点提高（P＜0.05），且观察组在治疗 2、4、6周后对MLHFQ评分的降低幅度及对6MWD的提高幅度均明显优于对照组（P＜0.05）。（5）安全性方面，治疗期间，观 察组的不良反应总发生率为12.50%（5/40），对照组为10.00%（4/40），组间比较，差异无统计学意义（P＞0.05）。【结论】 四君 子汤合丹参饮加减方联合西药治疗DHF气阴两虚夹瘀证患者，可明显缓解临床症状，改善心功能，提升生活质量及运动耐 力，疗效显著且安全性较高。

Objective To evaluate the clinical efficacy of Modified Si Junzi Decoction plus Danshen Decoction integrated with western medicine in treating patients with diastolic heart failure （DHF） of deficiency of qi and yin interweaved with blood stasis type， and to observe its impact on cardiac function. Methods A prospective randomized controlled trial design was conducted. Eighty DHF patients with deficiency of qi and yin interweaved with blood stasis syndrome admitted to the First Affiliated Hospital of Zhengzhou University from March 2024 to September 2024 were randomly divided into a control group and an observation group using a random number table，with 40 patients in each group. The control group received conventional western medicine treatment，while the observation group received Modified Si Junzi Decoction plus Danshen Decoction integrated with western medicine. The treatment duration for both groups was 6 weeks. Changes in traditional Chinese medicine （TCM） syndrome scores， cardiac function indicators， Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores，and 6-minute walking distance （6MWD） were observed before and after treatment. The clinical efficacy was compared between the two groups ， and clinical safety was evaluated. Results （1）Regarding efficacy， after 6 weeks of treatment，the total effective rate was 95.00% （38/40） in the observation group，significantly higher than 75.00% （30/40） in the control group. Intergroup comparison （by chi-square test） showed that the efficacy of the observation group was significantly superior to that of the control group （P＜0.05）.（2） Regarding TCM syndrome scores，after treatment，scores for primary symptoms and secondary symptoms，and their total scores were decreased in both groups compared to those before treatment （P＜0.05）， and the reductions were significantly greater in the observation group than in the control group （P＜0.01）.（3） Regarding cardiac function indicators， after treatment， left ventricular end-diastolic diameter （LVEDD） and left ventricular end-systolic diameter （LVESD） were decreased in both groups compared to those before treatment （P＜0.05）， while left ventricular ejection fraction （LVEF） was increased （P＜0.05）. The improvements in all cardiac function indicators were significantly greater in the observation group than in the control group （P＜0.01）.（4） Regarding quality of life and exercise tolerance，after 2，4，and 6 weeks of treatment，MLHFQ scores were decreased in both groups compared to the previous observation time point （P＜0.05），and 6MWD was increased （P＜0.05）. The reductions in MLHFQ scores and the increases in 6MWD were significantly greater in the observation group than in the control group at weeks 2， 4， and 6（P＜0.05）.（5） Regarding safety，the total incidence of adverse reactions during treatment was 12.50%（5/40） in the observation group and 10.00%（4/40） in the control group，with no statistically significant difference between the groups （P＞0.05）. Conclusion Modified Si Junzi Decoction plus Danshen Decoction integrated with western medicine can significantly alleviate clinical symptoms， improve cardiac function，enhance quality of life and exercise tolerance in DHF patients with deficiency of qi and yin interweaved with blood stasis syndrome，demonstrating notable efficacy and a favorable safety profile.

R259.416

河南省医学科技攻关计划（联合共建）项目（编号：LHGJ202101135）