Abstract:

Objective　To analyze the clinical effect of Qiliqiangxin capsules on patients with heart failure complicated with atrial fibrillation with Yang-deficiency and water-generalized syndrome. Methods　This study was a randomized controlled trial. From August 2022 to February 2024, 78 patients with heart failure complicated with atrial fibrillation with Yang-deficiency and water-generalized syndrome in the Internal Medicine Department of Hanzhong Hospital of Traditional Chinese Medicine were divided into a western medicine group and a combined group with 39 cases in each group by the random number table method. In the western medicine group, there were 20 males and 19 females, aged (61.84±4.55) years, the duration of heart failure was (2.95±0.66) years, and the frequency of atrial fibrillation was (4.93±1.33) times/week. In the combined group, there were 22 males and 17 females, aged (62.12±4.23) years, the duration of heart failure was (3.11±0.51) years, and the frequency of atrial fibrillation was (5.13±1.47) times/week. The western medicine group received basic treatment combined with oral sacubactril/valsartan sodium tablets, and the initial dose of sacubactril/valsartan sodium tablets was 50 mg/time, twice a day, whose dosage was increased according to the therapeutic effect (the initial dose as a single increase), but was not more than 4 times of the initial dose. The combined group was supplemented with Qiliqiangxin capsules on the basis of the western medicine group, 1.2 g/time, 3 times/day. Both groups were treated for 8 weeks. The effects of the two groups were compared, as well as the indexes of cardiac function, electrocardiogram, and myocardial injury before and after treatment, and the occurrence of adverse reactions during treatment. Chi-square test and t test were used for statistical analysis. Results　The total effective rate of the combined group was higher than that of the western medicine group [94.87% (37/39) vs. 76.92% (30/39)], with a statistically significant difference (χ2=5.186, P=0.023). After treatment, the left ventricular end-systolic diameter, QT dispersion, maximum P-wave duration, P-wave dispersion, and serum matrix metalloproteinase-9, soluble growth stimulation-expression gene 2 protein, and growth differentiation factor 15 levels in the combined group were lower than those in the western medicine group [(35.34±2.52) mm vs. (39.08±2.50) mm, (62.56±5.41) ms vs. (68.82±5.25) ms, (102.43±12.87) ms vs. (113.96±11.46) ms, (28.20±3.98) ms vs. (32.97±3.26) ms, (37.90±5.46) µg/L vs. (51.02±5.52) µg/L, (15.34±3.48) µg/L vs. (19.91±3.45) µg/L, (143.85±19.32) ng/L vs. (173.14±18.31) ng/L]; the cardiac index and left ventricular ejection fraction were higher than those in the western medicine group [(3.23±0.51) L/min vs. (2.91±0.43) L/min, (44.51±3.52)% vs. (38.72±3.46)%], with statistically significant differences (all P<0.001). During treatment, the treatment was not terminated due to obvious adverse reactions in both groups, and there was no statistically significant difference in the incidence of adverse reactions between the two groups [12.82% (5/39) vs 7.69% (3/39)] (χ²=0.139, P=0.709). Conclusion　On the basis of basic treatment and sacubactril/valsartan sodium tablets, Qiliqiangxin capsules has higher efficacy in patients with heart failure complicated with atrial fibrillation with Yang-deficiency and water-generalized syndrome, which can improve the cardiac function and electrocardiogram indexes, alleviate the myocardial injury, and has higher safety.

Key words:

Heart failure, Atrial fibrillation, Yang-deficiency and water-generalized syndrome, Qiliqiangxin , capsules, Heart function,  , Electrocardiogram, Myocardial injury

摘要：

目的　分析心力衰竭合并心房颤动阳虚水泛证患者应用芪苈强心胶囊佐治的临床效果。方法　本研究为随机对照试验。选取2022年8月至2024年2月于汉中市中医医院内科接受治疗的78例心力衰竭合并心房颤动阳虚水泛证患者，采用随机数字表法分为西医组、联合组，各39例。西医组男20例，女19例，年龄（61.84±4.55）岁，心力衰竭病程（2.95±0.66）年，心房颤动发作频率（4.93±1.33）次/周。联合组男22例，女17例，年龄（62.12±4.23）岁，心力衰竭病程（3.11±0.51）年，心房颤动发作频率（5.13±1.47）次/周。西医组接受基础治疗联合口服沙库巴曲缬沙坦钠片治疗，沙库巴曲缬沙坦钠片初始服用剂量为50 mg/次，2次/d。根据疗效提高用药剂量（以初始剂量为单次增加量），最多不超过初始剂量的4倍。联合组在西医组的基础上辅以口服芪苈强心胶囊治疗，1.2 g/次，3次/d。两组均持续治疗8周。比较两组疗效、治疗前后心功能、心电图、心肌损伤指标及治疗期间不良反应发生情况。采用χ²检验、校正χ²检验、t检验进行统计分析。结果　联合组治疗总有效率高于西医组［94.87%（37/39）比76.92%（30/39）］，差异有统计学意义（χ²=5.186，P=0.023）。治疗后，联合组的左心室收缩末期内径、QT离散度、最大P波时限、P波离散度和血清基质金属蛋白酶-9、可溶性生长刺激表达基因2蛋白、生长分化因子-15水平均低于西医组［（35.34±2.52）mm比（39.08±2.50）mm、（62.56±5.41）ms比（68.82±5.25）ms、（102.43±12.87）ms比（113.96±11.46）ms、（28.20±3.98）ms比（32.97±3.26）ms、（37.90±5.46）µg/L比（51.02±5.52）µg/L、（15.34±3.48）µg/L比（19.91±3.45）µg/L、（143.85±19.32）ng/L比（173.14±18.31）ng/L］；心脏指数、左心室射血分数均高于西医组［（3.23±0.51）L/min比（2.91±0.43）L/min、（44.51±3.52）%比（38.72±3.46）%］，差异均有统计学意义（均P<0.001）。治疗期间，两组均未因明显不良反应而终止治疗。两组不良反应总发生率比较［12.82%（5/39）比7.69%（3/39）］，差异无统计学意义（χ²=0.139，P=0.709）。结论　芪苈强心胶囊佐治心力衰竭合并心房颤动阳虚水泛证患者，疗效较好，可改善患者的心功能、心电图指标，缓解心肌损伤，安全性良好。

关键词:

心力衰竭, 心房颤动, 阳虚水泛证, 芪苈强心胶囊, 心功能, 心电图, 心肌损伤