Background: Shenfu injection is a traditional Chinese medicine formulation that alleviates ischemia-reperfusion injury through multiple pharmacologic effects. However, no data are available regarding its efficacy in patients with myocardial infarction. We aimed to examine the effects of Shenfu injection on infarct size in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Methods: From April 2016 to February 2018, 40 patients with first-time anterior STEMI undergoing primary PCI within 6 h of symptom onset were randomized 1:1 to intravenous Shenfu injection (80 ml Shenfu injection + 70 ml 5% glucose injection) or placebo (150 ml 5% glucose injection) before reperfusion. Treatment started before PCI and maintained for 5 days after PCI. The primary end point was infarct size assessed by CK-MB area under the curve (AUC) over 72 h and cardiac magnetic resonance (CMR) imaging 4 ± 1 days after PCI.

Results: Infarct size by area under the curve for CK-MB over 72 h did not differ between the Shenfu injection and placebo groups (5602.5 [3539.4–7526.4] vs. 6403.2 [2234.4–8340.6] ng·h/ml, P = 0.82). Among 32 patients who underwent CMR Imaging, a nominal reduction in infarct size was observed in the Shenfu injection group compared with the placebo group (23.9 [15.2–28.5] % vs. 27 [21.9–31.9] %, P = 0.42). After excluding patients with no or minimal infarct, there was a trend toward reduction in infarct size in the Shenfu injection group (24.1 [20.3–29.3] % vs. 29.1 [24.5–32] %, P = 0.18). Incidence of adverse events was similar between the groups.

Conclusions: This pilot study showed that the use of Shenfu injection was safe but did not reduce infarct size by CMR Imaging and CK-MB release kinetics in reperfused patients with STEMI. Larger studies (confining to patients with extensive infarct size) to evaluate the efficacy of Shenfu injection on reperfusion injury are warranted.

Clinical Trail Registration:clinicaltrials.gov, identifier: NCT02709798.

背景：参附注射液是一种通过多种药理作用减轻缺血再灌注损伤的中药制剂。然而，没有关于其对心肌梗塞患者疗效的数据。我们旨在检查参附注射液对接受直接经皮冠状动脉介入治疗 (PCI) 的 ST 段抬高型心肌梗死 (STEMI) 患者梗死面积的影响。

方法：2016 年 4 月至 2018 年 2 月，40 例首次前路 STEMI 患者在症状出现 6 h 内接受直接 PCI，按 1:1 随机分配至静脉参附注射液（参附注射液 80 ml + 5% 葡萄糖注射液 70 ml）或安慰剂（150 ml 5% 葡萄糖注射液）再灌注前。在 PCI 前开始治疗并在 PCI 后维持 5 天。主要终点是通过 72 小时内 CK-MB 曲线下面积 (AUC) 和 PCI 后 4 ± 1 天的心脏磁共振 (CMR) 成像评估梗死面积。

结果： 72 小时内 CK-MB 曲线下面积的梗塞面积在参附注射液组和安慰剂组之间没有差异（5602.5 [3539.4–7526.4] vs. 6403.2 [2234.4–8340.6] ng·h/ml， 磷= 0.82）。在接受 CMR 成像的 32 名患者中，与安慰剂组相比，参附注射液组的梗死面积明显减少（23.9 [15.2–28.5] % vs. 27 [21.9–31.9] %，磷= 0.42）。排除无梗死或极少梗死的患者后，参附注射液组的梗死面积有减小的趋势（24.1 [20.3-29.3] % vs. 29.1 [24.5-32] %，磷= 0.18）。两组间不良事件的发生率相似。

结论：该初步研究表明，使用参附注射液是安全的，但不能通过 CMR 成像和 CK-MB 释放动力学减少再灌注 STEMI 患者的梗死面积。需要进行更大规模的研究（仅限于梗死面积大的患者）来评估参附注射液对再灌注损伤的疗效。

临床试验注册：临床试验.gov，标识符：NCT02709798。