State Key Laboratory for Innovation and Transformation of Luobing Theory, Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.
School of Chinese Medicine, The University of Hong Kong, Hong Kong SAR, China.
Nat Med. 2024 Aug;30(8):2295-2302. doi: 10.1038/s41591-024-03169-2. Epub 2024 Aug 2.
Previous findings have indicated the potential benefits of the Chinese traditional medicine Qiliqiangxin (QLQX) in heart failure. Here we performed a double-blind, randomized controlled trial to evaluate the efficacy and safety of QLQX in patients with heart failure and reduced ejection fraction (HFrEF). This multicenter trial, conducted in 133 hospitals in China, enrolled 3,110 patients with HFrEF with NT-proBNP levels of ≥450 pg ml and left ventricular ejection fraction of ≤40%. Participants were randomized to receive either QLQX capsules or placebo (four capsules three times daily) alongside standard heart failure therapy. The trial met its primary outcome, which was a composite of hospitalization for heart failure and cardiovascular death: over a median follow-up of 18.3 months, the primary outcome occurred in 389 patients (25.02%) in the QLQX group and 467 patients (30.03%) in the placebo group (hazard ratio (HR), 0.78; 95% confidence interval (CI), 0.68-0.90; P < 0.001). In an analysis of secondary outcomes, the QLQX group showed reductions in both hospitalization for heart failure (15.63% versus 19.16%; HR, 0.76; 95% CI, 0.64-0.90; P = 0.002) and cardiovascular death (13.31% versus 15.95%; HR, 0.83; 95% CI, 0.68-0.996; P = 0.045) compared to the placebo group. All-cause mortality did not differ significantly between the two groups (HR, 0.84; 95% CI, 0.70-1.01; P = 0.058) and adverse events were also comparable between the groups. The results of this trial indicate that QLQX may improve clinical outcomes in patients with HFrEF when added to conventional therapy. ChiCTR registration: ChiCTR1900021929 .
先前的研究结果表明，中药芪苈强心（QLQX）对心力衰竭可能具有潜在益处。在这里，我们进行了一项双盲、随机对照试验，以评估 QLQX 在射血分数降低的心力衰竭（HFrEF）患者中的疗效和安全性。这项多中心试验在中国 133 家医院进行，共纳入 3110 名 HFrEF 患者，其 NT-proBNP 水平≥450pg/ml，左心室射血分数≤40%。参与者被随机分配接受 QLQX 胶囊或安慰剂（每日三次，每次四粒）联合标准心力衰竭治疗。该试验达到了主要终点，即心力衰竭住院和心血管死亡的复合终点：在中位随访 18.3 个月期间，QLQX 组有 389 名（25.02%）患者和安慰剂组有 467 名（30.03%）患者发生主要终点事件（风险比（HR），0.78；95%置信区间（CI），0.68-0.90；P<0.001）。在次要终点分析中，QLQX 组心力衰竭住院（15.63% 对 19.16%；HR，0.76；95%CI，0.64-0.90；P=0.002）和心血管死亡（13.31% 对 15.95%；HR，0.83；95%CI，0.68-0.996；P=0.045）的发生率均低于安慰剂组。两组的全因死亡率无显著差异（HR，0.84；95%CI，0.70-1.01；P=0.058），且两组的不良反应发生率也相似。该试验结果表明，与常规治疗相比，加用 QLQX 可能改善 HFrEF 患者的临床结局。 ChiCTR 注册号：ChiCTR1900021929 。
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