活血化瘀中药注射液治疗急性心肌梗死与抗凝或抗血小板效果相当:随机临床试验的系统回顾和荟萃分析

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
Xueyan Sun, Jiaping Chen, Juju Shang, Hongxu Liu, Xiang Li, Yan Lou, Huiwen Zhou
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引用次数: 0

摘要

背景中药活血化瘀注射液(TCMi-ABC)具有相当的抗凝和抗血小板作用,在中国常用于急性心肌梗死(AMI)的辅助治疗。本研究旨在进行一项荟萃分析,以评估中药 ABC 与常规西药联合治疗在降低 AMI 相关死亡率方面的有效性和安全性。方法我们对 PubMed、Cochrane Library、EMBASE、Web of Science、CBM、万方数据和 CNKI 数据库进行了全面检索。纳入了研究中医药-中西医结合(包括丹红注射液、丹参酮 IIA 磺酸钠注射液、丹参注射液和葛根素注射液)治疗 AMI 的随机对照试验(RCT)。检索包括从数据库建立之初到 2022 年 12 月发表的研究。两位作者独立筛选 RCT、提取数据并评估偏倚风险。使用 RevMan 5.3 和 Stata 17.0 进行了 Meta 分析。结果 共有52项RCT纳入分析,涉及5363名患者,其中没有一项对所用中药-ABC产品的纯度或效力进行独立测试。19/52报告了随机序列生成。所有 RCT 均未充分说明分配隐藏。51/52项研究未对盲法进行评估。荟萃分析结果表明,与单独使用传统西药治疗相比,联合应用中医中药-ABC可显著降低AMI患者的院内死亡率[RR= 0.41, 95% CI (0. 29, 0. 59), P=0.05]。29,0.59),P <;0.05],降低了恶性心律失常的发生率[RR= 0.40,95% CI(0.26,0.61),P <;0.05],提高了左室射血分数(LVEF)[MD= 5.53,95% CI(3.81,7.26),P <;0.05]。两组的不良事件发生率无明显差异(P >0.05)。GRADE证据质量分类显示,院内死亡率、恶性心律失常和不良事件的证据质量为中等,而LVEF的证据质量为低。然而,由于随机化、盲法、分配隐藏等方法上的缺陷,以及对草药纯度/药效和活性成分克数的评估不足,这些发现需要通过高质量的临床试验来进一步验证:系统综述注册:[INPLASY],标识符[INPLASY202170082]
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Traditional chinese medicine injections with activating blood circulation, equivalent effect of anticoagulation or antiplatelet, for acute myocardial infarction: A systematic review and meta-analysis of randomized clinical trials

Background

Traditional Chinese medicine injection for Activating Blood Circulation (TCMi-ABC), which exhibits comparable anticoagulant and antiplatelet effects, is commonly used as an adjuvant treatment for acute myocardial infarction (AMI) in China.

Objective

The aim of this study was to conduct a meta-analysis to assess the efficacy and safety of TCMi-ABC in combination with conventional western medicine in reducing mortality associated with AMI.

Methods

We conducted a comprehensive search of PubMed, Cochrane Library, EMBASE, Web of Science, CBM, WanFang Data, and CNKI databases. Randomized controlled trials (RCTs) investigating the use of TCMi-ABC (including Danhong injection, sodium tanshinone IIA sulfonate injection, salvia miltiorrhiza ligupyrazine injection, and puerarin injection) for the treatment of AMI were included. The search included studies published from the inception of the databases up to December 2022. Two authors independently screened RCTs, extracted data, and assessed the risk of bias. Meta-analysis was performed using RevMan 5.3 and Stata 17.0. The quality of evidence was evaluated using the GRADE approach.

Results

A total of 52 RCTs involving 5363 patients were included in the analysis, none of which described independent testing of the purity or potency of the TCMi-ABC product used. 19/52 reported random sequence generation. All RCTs lack adequate description of allocation concealment. 51/52 failed to assess blinding. The meta-analysis results demonstrated that the combined application of TCMi-ABC, compared with conventional western medicine treatment alone, significantly reduced in-hospital mortality in AMI patients [RR= 0.41, 95% CI (0.29, 0.59), P < 0.05], decreased the incidence of malignant arrhythmia [RR= 0.40, 95% CI (0.26, 0.61), P < 0.05], and increased left ventricular ejection fraction (LVEF) [MD= 5.53, 95% CI (3.81, 7.26), P < 0.05]. There was no significant difference in the incidence of adverse events between the two groups (P > 0.05). The GRADE evidence quality classification indicated that the evidence for in-hospital mortality, malignant arrhythmia, and adverse events was of moderate quality, while the evidence for LVEF was of low quality.

Conclusion

TCMi-ABC demonstrates additional clinical value in reducing mortality and the risk of malignant arrhythmia in patients with AMI. However, further validation of these findings is warranted through high-quality clinical trials due to methodological weaknesses in randomization, blinding, allocation concealment, and insufficient assessing for the purity/potency of herbs and the gram amount of active constituents.

Systematic Review Registration: [INPLASY], identifier [INPLASY202170082]

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