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丹红注射液对不稳定型心绞痛患者炎症因子及血管内皮功能的疗效与安全性:一项随机临床试验的系统评价与Meta分析

Efficacy and safety of Danhong injection on inflammatory factors and vascular endothelial function in patients with unstable angina pectoris: a systematic review and meta-analysis of randomized clinical trials.

作者信息

Kan Zunqi, Yan Wenli, Chen Cong, Gao Huanyu, Song Yongmei

机构信息

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

School of Acupuncture-Moxibustion and Tuina, International Acupuncture and Moxibustion Innovation Institute, Beijing University of Chinese Medicine, Beijing, China.

出版信息

Front Pharmacol. 2025 Jun 13;16:1389746. doi: 10.3389/fphar.2025.1389746. eCollection 2025.

Abstract

BACKGROUND

Inflammatory factors and vascular endothelial damage are significantly involved in the development of unstable angina pectoris (UAP). Danhong injection (DHI) is a compound injection composed of and extracts. Several clinical studies have demonstrated DHI's efficacy for treating UAP, with potential pharmacological effects on inflammatory factors and vascular endothelial function. However, to date, the current evidence has not been systematically summarized and analyzed.

PURPOSE

This study provides a comprehensive overview of the most recent clinical findings and systematically analyzes the impact of DHI on inflammatory factors and vascular endothelial function among individuals diagnosed with UAP.

METHODS

We searched for randomized controlled trials (RCTs) conducted until January 2023 from two clinical trial registries and eight literature databases. The Cochrane Risk of Bias Tool 2.0 was utilized to assess the potential bias in the included trials, while the GRADE system was employed to evaluate the outcome quality.

RESULTS

We included 46 trials involving 4,601 patients with UAP. The meta-analysis results suggested that DHI significantly reduced the levels of high-sensitivity C-reactive protein (hs-CRP) (standard mean difference [SMD] = 1.34, 95% confidence interval [CI] [-1.77, -0.90], P < 0.00001), tumor necrosis factor-alpha (TNF-α) (SMD = -0.84, 95% CI [-1.54, -0.15], P = 0.02), interleukin-6 (IL-6) (SMD = -1.05, 95% CI [-1.86, -0.25], P = 0.01), endothelin/endothelin-1 (ET/ET-1) (SMD = -2.01, 95% CI [-2.57, -1.46], P < 0.00001), and homocysteine (Hcy) (SMD = -0.55, 95% CI [-0.71, -0.39], P < 0.00001) but increased the nitric oxide (NO) level (SMD = 1.51, 95% CI [1.04, 1.97], P < 0.00001) in patients with UAP. Twenty-one RCTs described adverse events.

CONCLUSION

DHI effectively and safely reduced hs-CRP, TNF-α, IL-6, ET/ET-1, and Hcy levels and increased the NO level in patients with UAP. However, considering the overall low quality of the original studies, future large-scale, high-quality RCTs are imperative to provide robust evidence for clinical practice.

SYSTEMATIC REVIEW REGISTRATION

identifier CRD42023391497.

摘要

背景

炎症因子和血管内皮损伤在不稳定型心绞痛(UAP)的发生发展中起重要作用。丹红注射液(DHI)是一种由[具体成分]提取物组成的复方注射液。多项临床研究已证明DHI治疗UAP的有效性,对炎症因子和血管内皮功能具有潜在药理作用。然而,迄今为止,现有证据尚未得到系统总结和分析。

目的

本研究全面概述了最新临床研究结果,并系统分析了DHI对诊断为UAP患者的炎症因子和血管内皮功能的影响。

方法

我们从两个临床试验注册库和八个文献数据库中检索截至2023年1月进行的随机对照试验(RCT)。采用Cochrane偏倚风险工具2.0评估纳入试验中的潜在偏倚,同时使用GRADE系统评估结果质量。

结果

我们纳入了46项试验,涉及4601例UAP患者。荟萃分析结果表明,DHI显著降低了UAP患者的高敏C反应蛋白(hs-CRP)水平(标准均差[SMD]=1.34,95%置信区间[CI][-1.77,-0.90],P<0.00001)、肿瘤坏死因子-α(TNF-α)水平(SMD=-0.84,95%CI[-1.54,-0.15],P=0.02)、白细胞介素-6(IL-6)水平(SMD=-1.05,95%CI[-1.86,-0.25],P=0.01)、内皮素/内皮素-1(ET/ET-1)水平(SMD=-2.01,95%CI[-2.57,-1.46],P<0.00001)和同型半胱氨酸(Hcy)水平(SMD=-0.55,95%CI[-0.71,-0.39],P<0.00001),但增加了一氧化氮(NO)水平(SMD=1.51,95%CI[1.04,1.97],P<0.00001)。21项RCT描述了不良事件。

结论

DHI有效且安全地降低了UAP患者的hs-CRP、TNF-α、IL-6、ET/ET-1和Hcy水平,并增加了NO水平。然而,考虑到原始研究的整体质量较低,未来有必要进行大规模、高质量的RCT,为临床实践提供有力证据。

系统评价注册

标识符CRD42023391497。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8915/12202559/3be34bb0a20f/fphar-16-1389746-g001.jpg

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