OBJECTIVE To study the therapeutic effect of Hongqi Shenmai Drink on heart failure (HF) after acute myocardial infarction (AMI) with qi-yin deficiency and blood stasis, and its regulatory effect on serum secretory phosphoprotein 1 (SPP1) in AMI-HF patients.

METHODS Seventy-six patients with AMI-HF of qi-yin deficiency and blood stasis type were enrolled in this study from three centers: Affiliated Hospital of Integrated Traditional and Western Medicine, Nanjing University of Chinese Medicine; Hangzhou Xiaoshan Hospital of Traditional Chinese Medicine; and Changzhou Hospital of Traditional Chinese Medicine. They were randomly divided into a traditional Chinese medicine (TCM) group and a control group, with 38 patients in each group. During the treatment period, 4 patients in the TCM group and 3 patients in the control group dropped out. The control group received conventional Guideline-directed medical therapy (GDMT), while the TCM group received GDMT plus Hongqi Shenmai Drink. The treatment course for both groups was 12 weeks. The TCM syndrome scores of the two groups of patients were compared before and after treatment, and the clinical efficacy and readmission rate were assessed. Echocardiography was used to assess cardiac structure and function. ELISA was used to detect changes in serum SPP1, N-terminal pro-brain natriuretic peptide (NT-proBNP), interleukin-1β (IL-1β), type Ⅰ collagen α1 (COL1α1), and matrix metalloproteinase 9 (MMP9) levels. The 6-minute walk test (6MWT) was used to assess exercise tolerance, and the Minnesota living with heart failure questionnaire (MLHFQ) was used to assess patients' quality of life. Adverse reactions were monitored in both groups during treatment.

RESULTS After treatment, the TCM syndrome scores of both groups decreased significantly (P < 0.01), with the TCM group showing a significantly lower score than the control group (P < 0.01). The total effective rate of TCM clinical efficacy in the TCM group was superior to that in the control group (P < 0.05), and the readmission rate in the TCM group was significantly lower than that in the control group (P < 0.01). Left ventricular end diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF), 6MWT, and MLHFQ scores improved in both groups (P < 0.01), with the TCM group showing superior improvement compared to the control group (P < 0.05, P < 0.01). Serum levels of NT-proBNP, IL-1β, COL1α1, and MMP9 decreased in both groups (P < 0.05, P < 0.01). Serum SPP1 levels were significantly decreased in the TCM group (P < 0.01), and serum levels of NT-proBNP, IL-1β, COL1α1, and MMP9 in the TCM group were significantly lower than those in the control group (P < 0.01). The change in SPP1 (ΔSPP1) showed a negative correlation with the change in the cardiac function ΔLVEF (r=-0.42, P < 0.01), and a positive correlation with the myocardial fibrosis marker ΔCOL1α1 (r=0.58, P < 0.01) and the matrix degradation marker ΔMMP9 (r=0.51, P < 0.01). There was no significant difference in adverse reaction rates between the two groups during treatment (P > 0.05).

CONCLUSION Hongqi Shenmai Drink combined with GDMT can effectively improve clinical symptoms and cardiac function in patients with AMI-HF of qi-yin deficiency and blood stasis type, with good safety. Its mechanism may be related to the inhibition of SPP1-mediated inflammation-fibrosis pathway and the downregulation of IL-1β, COL1α1, and MMP9 expression.