Chen Pengfei, Zhang He, Gao Zhuye, Shi Dazhuo, Zhang Jie
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Front Pharmacol. 2024 Dec 17;15:1478558. doi: 10.3389/fphar.2024.1478558. eCollection 2024.
Salvianolate for injection (SFI) is a widely used treatment for acute myocardial infarction (AMI). This study aims to assess the efficacy and safety of SFI in treating AMI by synthesizing evidence from published randomized controlled trials (RCTs).
Seven databases were searched for relevant RCTs published up to 1 July 2024. Two investigators independently conducted the literature searches, data extraction, and quality assessment. Subgroup and sensitivity analyses were performed to address potential heterogeneity. Data analyses were conducted using RevMan 5.4 software.
Thirty RCTs with a total of 3,931 participants were included in the study and analyzed. The results revealed that SFI significantly reduced major adverse cardiac events (MACEs) (RR = 0.34, 95% CI: 0.24 to 0.49, < 0.05). In addition, SFI lowered creatine kinase-MB (CK-MB) (MD = -5.65, 95% CI: -9.55 to -1.76, < 0.05) and improved left ventricular ejection fraction (LVEF) (MD = 6.2, 95% CI: 4.82 to 7.57, < 0.05). Further reductions were observed in C-reactive protein (CRP) (MD = -6.17, 95% CI: -8.11 to -4.23, < 0.05), malondialdehyde (MDA) (MD = -1.95, 95% CI: -2.08 to -1.83, < 0.05), and endothelin-1 (ET-1) (MD = -12.27, 95% CI: -17.13 to -7.40, < 0.05). The incidence of adverse events did not significantly differ between the EG and CG [RR = 0.74, 95% CI: 0.42 to 1.33, = 0.32].
This study suggests that SFI may be a promising alternative therapy for treating AMI without increasing the risk of adverse events. However, our findings may be limited by the quality of the existing studies. High-quality RCTs are needed to provide more robust evidence.
https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024567279.
注射用丹参多酚酸盐（SFI）是治疗急性心肌梗死（AMI）的一种广泛应用的疗法。本研究旨在通过综合已发表的随机对照试验（RCT）的证据，评估SFI治疗AMI的疗效和安全性。
检索了7个数据库，以查找截至2024年7月1日发表的相关RCT。两名研究者独立进行文献检索、数据提取和质量评估。进行亚组分析和敏感性分析以解决潜在的异质性。使用RevMan 5.4软件进行数据分析。
本研究纳入并分析了30项RCT，共3931名参与者。结果显示，SFI显著降低了主要不良心脏事件（MACE）（RR = 0.34，95%CI：0.24至0.49，P < 0.05）。此外，SFI降低了肌酸激酶同工酶（CK-MB）（MD = -5.65，95%CI：-9.55至-1.76，P < 0.05），并改善了左心室射血分数（LVEF）（MD = 6.2，95%CI：4.82至7.57，P < 0.05）。还观察到C反应蛋白（CRP）（MD = -6.17，95%CI：-8.11至-4.23，P < 0.05）、丙二醛（MDA）（MD = -1.95，95%CI：-2.08至-1.83，P < 0.05）和内皮素-1（ET-1）（MD = -12.27，95%CI：-17.13至-7.40，P < 0.05）进一步降低。试验组和对照组之间不良事件的发生率没有显著差异[RR = 0.74，95%CI：0.42至1.33，P = 0.32]。
本研究表明，SFI可能是一种有前景的治疗AMI的替代疗法，且不会增加不良事件的风险。然而，我们的研究结果可能受到现有研究质量的限制。需要高质量的RCT来提供更有力的证据。
