Key result
Yiqi Fumai lyophilized injection added to GDMT increased the proportion of patients with a ≥30% reduction in BNP at day 8 (55.21% vs 41.93%; RR 1.32; 95% CI 1.12-1.56; P<0.001).
Why the study?
Yiqi Fumai lyophilized injection is widely used in China for acute decompensated ischemic heart failure, but high-quality evidence evaluating its efficacy and safety was lacking.
Does Yiqi Fumai lyophilized injection reduce B-type natriuretic peptide levels in patients with acute decompensated ischemic heart failure?
RCT (n=666)
Open-label, blinded-outcome
1:1
Yes
Does Yiqi Fumai lyophilized injection reduce B-type natriuretic peptide levels in patients with acute decompensated ischemic heart failure?
Relative Risk: 1.32 (95% CI 1.12–1.56)
Absolute Event Rate: 55.21% vs 41.93%
p-value: p=<0.001
In patients with acute decompensated ischemic heart failure, adding Yiqi Fumai lyophilized injection to standard therapy significantly reduced BNP levels and improved symptoms and cardiac function, though it did not significantly affect clinical events.
Supports biomarker and symptom improvements in acute decompensated ischemic HF; extends adjunctive TCM evidence while leaving hard outcomes open.
BACKGROUND: Patients with acute decompensated ischemic heart failure (ADIHF) often present with severe clinical symptoms and poor quality of life. In China, Yiqi Fumai lyophilized injection (YQFM) is widely used in the treatment of ADIHF. However, high-quality evidence is still needed to support its efficacy and safety. PURPOSE: This study aims to assess the therapeutic efficacy and safety of YQFM in patients with ADIHF. STUDY DESIGN AND METHODS: By conducting a multicenter, open-label, blinded-outcome, randomized controlled trial, we recruited patients with ADIHF from 37 hospitals in 20 regions of China from October 2015 to October 2018. Patients were allocated in a 1:1 ratio to either the YQFM group or the control group. Both groups received guideline-directed medical therapy (GDMT), with the YQFM group additionally receiving YQFM for 7 days. The primary outcome included the proportion of patients with a decrease from baseline B-type natriuretic peptide (BNP) value ≥ 30% on day 8 post-randomization. We evaluated the left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, and composite endpoints. RESULTS: A total of 666 patients with ADIHF (332 in the YQFM group and 334 in the control group) were enrolled. The full analysis set (FAS) analysis revealed that the proportion of patients in the YQFM group with a reduction of at least 30% in BNP value on day 8 was higher than that in the control group (175 [55.21%] vs. 135 [41.93%], one-sided p < 0.001, two-sided p < 0.001; RR, 1.32 [95% CI, 1.12-1.56]). The YQFM group showed statistically significant improvements in LVEF, NYHA functional class, and MLHFQ scores compared to controls. There was no statistically significant difference between the two groups regarding composite endpoint events and adverse events during the follow-up period. CONCLUSIONS: Based on GDMT, the combined use of YQFM was associated with further reductions in BNP levels, improve quality of life and cardiac function in patients with ADIHF, without increasing safety risks. However, no significant differences were observed in clinical events, such as mortality or hospitalization, during the follow-up period.
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Wang et al. (2026) conducted an RCT in Acute decompensated ischemic heart failure (ADIHF) (n=666). Yiqi Fumai lyophilized injection (YQFM) vs. Guideline-directed medical therapy (GDMT) alone was evaluated on Proportion of patients with a decrease from baseline B-type natriuretic peptide (BNP) value ≥ 30% on day 8 post-randomization (RR 1.32, 95% CI 1.12-1.56, p=<0.001). Yiqi Fumai lyophilized injection added to GDMT increased the proportion of patients with a ≥30% reduction in BNP at day 8 (55.21% vs 41.93%; RR 1.32; 95% CI 1.12-1.56; P<0.001).
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