Deng Bo, Wang Sibo, Wu Yujie, Wang Qiming, Qiao Rui, Zhang Xiwen, Lu Yuan, Wang Li, Gu Shunzhong, Zhang Yuqing, Li Kaiqiao, Yu Zongliang, Wu Lixing, Zhao Shengbiao, Zhou Shuanglin, Yang Yang, Wang Liansheng
Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
Department of Cardiology, Anqing Municipal Hospital Affiliated to Anhui Medical University, Anqing, Anhui 246003, China.
J Biomed Res. 2025 Jan 10;39(4):407-416. doi: 10.7555/JBR.38.20240325.
The current study aimed to evaluate the efficacy and safety of Compound Danshen Dripping Pills (CDDP) in improving cardiac function in patients with acute anterior ST-segment elevation myocardial infarction (AAMI). Between February 2021 and February 2023, 247 eligible patients with AAMI after primary percutaneous coronary intervention were enrolled and randomly assigned (1∶1) to receive CDDP ( = 126) or placebo ( = 121), with a follow-up of 48 weeks. Compared with the placebo group, the CDDP group demonstrated a significant increase in left ventricular ejection fraction values after 24 weeks of treatment (least squares mean: 3.31; 95% confidence interval [CI]: 1.72-4.90; < 0.001) and at the 48-week follow-up (least squares mean: 4.35; 95% CI: 2.76-5.94; < 0.001). Significant reductions in N-terminal pro-B-type natriuretic peptide levels were observed in both groups at the 24- and 48-week visits with no significant difference between the two groups ( > 0.1 for all). The incidence of major adverse cardiovascular and cerebrovascular events was 6.35% in the CDDP group and 5.79% in the placebo group ( = 0.822). Notably, no serious adverse events were attributed to CDDP. These findings suggest that CDDP may be well tolerated and could improve left ventricular ejection fraction in patients with AAMI at 24 and 48 weeks.
本研究旨在评估复方丹参滴丸（CDDP）改善急性前壁ST段抬高型心肌梗死（AAMI）患者心功能的疗效和安全性。2021年2月至2023年2月，纳入247例符合条件的接受直接经皮冠状动脉介入治疗后的AAMI患者，并随机（1∶1）分配接受CDDP治疗（n = 126）或安慰剂治疗（n = 121），随访48周。与安慰剂组相比，CDDP组在治疗24周后左心室射血分数值显著增加（最小二乘均值：3.31；95%置信区间[CI]：1.72 - 4.90；P < 0.001），在48周随访时也显著增加（最小二乘均值：4.35；95% CI：2.76 - 5.94；P < 0.001）。两组在24周和48周访视时N末端B型利钠肽前体水平均显著降低，两组间无显著差异（所有P > 0.1）。CDDP组主要心脑血管不良事件发生率为6.35%，安慰剂组为5.79%（P = 0.822）。值得注意的是，未发现由CDDP引起的严重不良事件。这些发现表明，CDDP耐受性良好，可在24周和48周时改善AAMI患者的左心室射血分数。
