Objective  To study the traditional Chinese medicine (TCM) syndromes of patients with chronic heart failure (CHF) combined with diuretic resistance by using the Wenyang Huayin Yangxin Prescription, and to observe its therapeutic efficacy.

Methods  A total of 68 CHF patients complicated with diuretic resistance and who had Yangqi deficiency and presenting blood stasis syndrome combined with Tanyin were randomly assigned to a control group and an observation group. The control group was given intravenous furosemide (≥ 80 mg/d) via infusion pump in addition to standard Western medical treatment, while the observation group was given intravenous furosemide (< 80 mg/d) via infusion pump along with the Wenyang Huayin Yangxin Prescription (30 g Astragalus, 15 g Poria, 15 g Baizhu, 15 g Chuanxiong, 10 g Danfu tablet, 10 g Cassia, 10 g Alisma, and 10 g Zhimu). The quantitative index of diuretic resistance was used as the primary outcome measure. In addition, the differences between the two groups in TCM syndromes, cardiac function-related indicators, incidence of endpoint events, and readmission rate were compared.

Results  After 2 weeks of treatment, the filtration sodium excretion fraction (FENa) in the observation group was (0.18 ± 0.04)%, while that of the control group was (0.16 ± 0.03)%, showing a statistically significant difference (P = 0.037). The 24-hour urine volume and urine Na⁺/K⁺ ratio in the observation group increased significantly from baseline levels and were higher than those in the control group (P < 0.05). The differences in the changes of 24-hour urine volume, urine sodium, FENa, and urine Na⁺/K⁺ ratio between the two groups were statistically significant (P < 0.05). The TCM syndrome scores decreased in both groups after 2 weeks of treatment, with the observation group showing a significantly greater reduction compared with the control group (P < 0.001). The differences in the changes of TCM syndrome scores between the two groups were statistically significant (P < 0.001). After 2 weeks of treatment, the observation group showed significant improvements in palpitations, shortness of breath, facial and limb edema, spontaneous sweating, chest tightness (pain), asthma, and oliguria compared with the baseline data (P < 0.05), while the control group showed improvements only in facial and limb edema, asthma, and oliguria (P < 0.05). Except for the asthma syndrome after 2 weeks of treatment, the observation group showed better outcomes in spontaneous sweating, chest tightness (pain), asthma, and oliguria at various time points after treatment compared with the control group (P < 0.05). After 2 weeks of treatment, the observation group had significantly better cardiac output (CO) and stroke volume (SV) compared with those of the control group (P < 0.05). The differences in the changes in N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), SV, and CO between the two groups were statistically significant (P < 0.05). After 24 weeks of follow-up, no significant differences in the incidence of end-point events or readmission rates between the two groups were observed.

Conclusion  The Wenyang Huayin Yangxin Prescription, combined with low-dose intravenous furosemide administered through an infusion pump, can improve the TCM syndromes of patients with Yangqi deficiency and blood stasis syndrome combined with Tanyin in addition to CHF complicated by diuretic resistance. This treatment improves the patients' heart function and diuretic resistance, reduces the intravenous dosage of diuretic, and enhances clinical efficacy. This approach should be more widely applied in clinical settings.