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皂苷注射液治疗急性心肌梗死的疗效与安全性:一项随机对照试验的系统评价与Meta分析

Efficacy and safety of saponin injection in the treatment of acute myocardial infarction: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Chen Pengfei, Gao Zhuye, Guo Ming, Pan Deng, Zhang He, Du Jianpeng, Shi Dazhuo

机构信息

Xiyuan Hospital, Cohina Academy of Chinese Medical Sciences, Beijing, China.

Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Front Pharmacol. 2024 Mar 21;15:1353662. doi: 10.3389/fphar.2024.1353662. eCollection 2024.

Abstract

This study aimed to assess the efficacy and safety of saponin (PNS) injection, when combined with conventional treatment (CT), for acute myocardial infarction (AMI). Comprehensive searches were conducted in seven databases from inception until 28 September 2023. The search aimed to identify relevant randomized controlled trials (RCTs) focusing on PNS injection in the context of AMI. This meta-analysis adhered to the PRISMA 2020 guidelines, and its protocol was registered with PROSPERO (number: CRD42023480131). Twenty RCTs involving 1,881 patients were included. The meta-analysis revealed that PNS injection, used adjunctively with CT, significantly improved treatment outcomes compared to CT alone, as evidenced by the following points: (1) enhanced total effective rate [OR = 3.09, < 0.05]; (2) decreased incidence of major adverse cardiac events [OR = 0.32, < 0.05]; (3) reduction in myocardial infarct size [MD = -6.53, < 0.05]; (4) lower ST segment elevation amplitude [MD = -0.48, < 0.05]; (5) mitigated myocardial injury as indicated by decreased levels of creatine kinase isoenzymes [MD = -11.19, < 0.05], cardiac troponin T [MD = -3.01, < 0.05], and cardiac troponin I [MD = -10.72, < 0.05]; (6) enhanced cardiac function, reflected in improved brain natriuretic peptide [MD = -91.57, < 0.05], left ventricular ejection fraction [MD = 5.91, < 0.05], left ventricular end-diastolic dimension [MD = -3.08, < 0.05], and cardiac output [MD = 0.53, < 0.05]; (7) reduced inflammatory response, as shown by lower levels of C-reactive protein [MD = -2.99, < 0.05], tumor necrosis factor-α [MD = -6.47, < 0.05], interleukin-6 [MD = -24.46, < 0.05], and pentraxin-3 [MD = -2.26, < 0.05]; (8) improved vascular endothelial function, demonstrated by decreased endothelin-1 [MD = -20.56, < 0.05] and increased nitric oxide [MD = 1.33, < 0.05]; (9) alleviated oxidative stress, evidenced by increased superoxide dismutase levels [MD = 25.84, < 0.05]; (10) no significant difference in adverse events [OR = 1.00, = 1.00]. This study highlighted the efficacy and safety of adjunctive PNS injections in enhancing AMI patient outcomes beyond CT alone. Future RCTs need to solidify these findings through rigorous methods. : (https://www.crd.york.ac.uk/PROSPERO/), identifier (CRD42023480131).

摘要

本研究旨在评估人参皂苷(PNS)注射液联合常规治疗(CT)对急性心肌梗死(AMI)的疗效和安全性。从数据库建库至2023年9月28日,在七个数据库中进行了全面检索。检索旨在识别聚焦于AMI背景下PNS注射液的相关随机对照试验(RCT)。本荟萃分析遵循PRISMA 2020指南,其方案已在国际前瞻性注册系统(PROSPERO)注册(注册号:CRD42023480131)。纳入了20项涉及1881例患者的RCT。荟萃分析显示,与单纯CT相比,PNS注射液联合CT显著改善了治疗效果,具体如下:(1)提高总有效率[比值比(OR)=3.09,P<0.05];(2)降低主要不良心脏事件发生率[OR = 0.32,P<0.05];(3)减小心肌梗死面积[平均差(MD)=-6.53,P<0.05];(4)降低ST段抬高幅度[MD = -0.48,P<0.05];(5)减轻心肌损伤,表现为肌酸激酶同工酶水平降低[MD = -11.19,P<0.05]、心肌肌钙蛋白T降低[MD = -3.01,P<0.05]和心肌肌钙蛋白I降低[MD = -10.72,P<0.05];(6)改善心功能,表现为脑钠肽改善[MD = -91.57,P<0.05]、左心室射血分数改善[MD = 5.91,P<0.05]、左心室舒张末期内径减小[MD = -3.08,P<0.05]和心输出量增加[MD = 0.53,P<0.05];(7)减轻炎症反应,表现为C反应蛋白水平降低[MD = -2.99,P<0.05]、肿瘤坏死因子-α降低[MD = -6.47,P<0.05]、白细胞介素-6降低[MD = -24.46,P<0.05]和五聚素-3降低[MD = -2.26,P<0.05];(8)改善血管内皮功能,表现为内皮素-1降低[MD = -20.56,P<0.05]和一氧化氮增加[MD = 1.33,P<0.05];(9)减轻氧化应激,表现为超氧化物歧化酶水平增加[MD = 25.84,P<0.05];(10)不良事件无显著差异[OR = 1.00,P = 1.00]。本研究强调了辅助使用PNS注射液在改善AMI患者预后方面优于单纯CT的疗效和安全性。未来的RCT需要通过严谨的方法来巩固这些发现。(https://www.crd.york.ac.uk/PROSPERO/),标识符(CRD42023480131)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbf4/10991745/43246ececdad/fphar-15-1353662-g001.jpg

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