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醒脑静注射液用于急性缺血性脑卒中急救治疗的疗效与安全性:一项系统评价和Meta分析

Efficacy and Safety of Xingnaojing Injection for Emergency Treatment of Acute Ischemic Stroke: A Systematic Review and Meta-Analysis.

作者信息

Wang Liuding, Fan Xueming, Chen Yifan, Liang Xiao, Shen Wei, Zhang Yunling

机构信息

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

出版信息

Front Pharmacol. 2022 Mar 24;13:839305. doi: 10.3389/fphar.2022.839305. eCollection 2022.

Abstract

Xingnaojing injection (XNJ) is derived from a traditional Chinese prescription named Angong Niuhuang pill. As an adjuvant treatment widely used in acute ischemic stroke (AIS), XNJ has proven to be effective with certain clinical evidence. The aim of this study is to collect the latest evidence and evaluate efficacy and safety of XNJ for emergency treatment of AIS. We searched seven literature databases and two clinical trial registries from their inception to November 14, 2021 for randomized controlled trials (RCTs) examining the efficacy of XNJ for AIS. Two reviewers independently selected relevant trials, extracted data, and assessed the risk of bias. We pooled data into a meta-analysis using RevMan 5.4 software. Thirty-eight RCTs were included in this review, with a total of 3,677 participants. XNJ plus conventional treatments (CTs) showed a significant advantage, compared with CTs alone, in improving functional independence at 14 days ( = 1.70, 95% = 1.03 to 2.81, = 0.04), neurological function ( = -3.81, 95% = -5.25 to -2.38, < 0.00001; = -3.75, 95% = -4.92 to -2.59, < 0.00001; = -3.74, 95% = -5.48 to -2.00, < 0.0001; = -1.97, 95% = -3.25 to -0.69, = 0.003), and activities of daily living on the Barthel index ( = 9.97, 95% = 9.29 to 10.65, < 0.00001; = 10.04, 95% = 5.82, to 14.26, < 0.00001). In addition, the results showed that XNJ plus CTs was superior to CTs alone in reducing IL-6, TNF-α, hs-CRP, and MMP-9. Regarding safety of XNJ, the incidence of adverse reactions in the XNJ group was lower than that in the control group ( = 0.57, 95% = 0.38 to 0.87, = 0.009). The certainty of evidence was evaluated as low or very low for all. XNJ appears to be effective and safe for emergency treatment of AIS. The first 72 h after the onset of stroke, in particular the first 6 hours, may be the optimum initiation time. However, further high-quality RCTs are warranted to determine an appropriate initiation time. [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=233211], identifier [CRD42021233211].

摘要

醒脑静注射液(XNJ)源自传统中药方剂安宫牛黄丸。作为一种广泛应用于急性缺血性脑卒中(AIS)的辅助治疗药物,XNJ已被证明具有一定的临床疗效。本研究旨在收集最新证据,评估XNJ用于AIS急救治疗的疗效和安全性。我们检索了7个文献数据库和2个临床试验注册库,检索时间从建库至2021年11月14日,以查找检验XNJ治疗AIS疗效的随机对照试验(RCT)。两名研究者独立筛选相关试验、提取数据并评估偏倚风险。我们使用RevMan 5.4软件将数据汇总进行荟萃分析。本综述纳入了38项RCT,共3677名参与者。与单纯常规治疗(CT)相比,XNJ联合CT在改善14天时的功能独立性(比值比=1.70,95%置信区间=1.03至2.81,P=0.04)、神经功能(平均差=-3.81,95%置信区间=-5.25至-2.38,P<0.00001;平均差=-3.75,95%置信区间=-4.92至-2.59,P<0.00001;平均差=-3.74,95%置信区间=-5.48至-2.00,P<0.0001;平均差=-1.97,95%置信区间=-3.25至-0.69,P=0.003)以及Barthel指数的日常生活活动能力(平均差=9.97,95%置信区间=9.29至10.65,P<0.00001;平均差=10.04,95%置信区间=5.82至14.26,P<0.00001)方面具有显著优势。此外,结果表明XNJ联合CT在降低白细胞介素-6、肿瘤坏死因子-α、高敏C反应蛋白和基质金属蛋白酶-9方面优于单纯CT。关于XNJ的安全性,XNJ组的不良反应发生率低于对照组(比值比=0.57,95%置信区间=0.38至0.87,P=0.009)。所有证据的确定性评估为低或极低。XNJ似乎对AIS的急救治疗有效且安全。卒中发作后的前72小时,尤其是前6小时,可能是最佳起始时间。然而,需要进一步开展高质量的RCT来确定合适的起始时间。[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=233211],标识符[CRD42021233211]

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69d3/8987164/86398cf7f839/fphar-13-839305-g001.jpg

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