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血塞通软胶囊治疗缺血性脑卒中患者的有效性和安全性:系统评价和荟萃分析。

The efficacy and safety of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke: systematic review and meta-analysis.

机构信息

Department of Neurology, Beijing University of Chinese Medicine, Dongfang Hospital, Beijing, China.

Department of Traditional Chinese Medicine (Acupuncture), The First Medical Center of PLA General Hospital, Beijing, China.

出版信息

Ann Palliat Med. 2022 Aug;11(8):2695-2708. doi: 10.21037/apm-22-748.

Abstract

BACKGROUND

Ischaemic stroke is a common neurological disease and a leading cause of severe disability and death in developed countries. In most cases, stroke is thought to be a multifactorial disorder or complex trait for which classic patterns of inheritance cannot be shown. Xuesaitong is one of the most commonly used medicines for treating ischemic stroke in China. However, compared to the conventional therapy, the effectiveness and safety of Xuesaitong for ischemic stroke needs to be further systematically reviewed and determined.

METHODS

Relevant randomized controlled trials (RCTs) examining the use of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke were identified from databases, including the China National Knowledge Infrastructure, Wanfang, PubMed, Embase, and Web of Science databases. Next, 2 researchers independently extracted information from the included studies, analyzed the data using STATA 15.0 software, and evaluated the quality of the included studies using RevMan 5.3.

RESULTS

A total of 17 RCTs (comprising 1,942 patients with ischemic stroke) were included in the meta-analysis. The meta-analysis results showed that the Xuesaitong soft capsule treatment increased patients' total effective rate compared to conventional or other drug treatments, and improved patients' Clinical Severity Score (CSS scores) or Barthel index (BI) score. A further subgroup analysis stratified by different treatment times showed that Xuesaitong soft capsule treatment at 4 and 8 weeks improved CSS scores more than treatment at 2 weeks in patients with ischemic stroke. Additionally, the Xuesaitong soft capsule also significantly improved plasma viscosity, whole-blood viscosity at high and low shear rates, fibrinogen, hematocrit, and the effect on traditional Chinese medicine (TCM) single symptoms or signs in patients with ischemic stroke.

DISCUSSION

In summary, compared to conventional or other drug treatments, the Xuesaitong soft capsule treatment was beneficial in improving patients' TCM symptoms (e.g., crooked mouth and tongue, and dizziness) and various indicators. Further, Xuesaitong soft capsule may be a safe and effective drug for the treatment of ischemic stroke. And large-scale randomized clinical trials are needed to further confirm our findings.

摘要

背景

缺血性脑卒中是一种常见的神经系统疾病,也是发达国家严重残疾和死亡的主要原因。在大多数情况下,脑卒中被认为是一种多因素疾病或复杂特征,无法表现出经典的遗传模式。血栓通是中国治疗缺血性脑卒中最常用的药物之一。然而,与传统疗法相比,血栓通治疗缺血性脑卒中的有效性和安全性需要进一步系统地评价和确定。

方法

从中国知网、万方、PubMed、Embase 和 Web of Science 等数据库中检索了评估血栓通软胶囊治疗缺血性脑卒中患者的随机对照试验(RCT)。然后,由 2 位研究者独立提取纳入研究的信息,使用 STATA 15.0 软件进行数据分析,并使用 RevMan 5.3 评价纳入研究的质量。

结果

共纳入 17 项 RCT(共 1942 例缺血性脑卒中患者)进行荟萃分析。荟萃分析结果显示,与常规治疗或其他药物治疗相比,血栓通软胶囊治疗可提高患者的总有效率,并改善患者的临床严重程度评分(CSS 评分)或巴氏指数(BI)评分。进一步的亚组分析显示,血栓通软胶囊治疗 4 周和 8 周可改善 CSS 评分,优于治疗 2 周。此外,血栓通软胶囊还可显著改善缺血性脑卒中患者的血浆黏度、高低切全血黏度、纤维蛋白原、红细胞压积,以及对中医单项症状或体征的疗效。

讨论

总之,与常规治疗或其他药物治疗相比,血栓通软胶囊治疗有利于改善患者的中医症状(如口眼歪斜、头晕等)和各项指标。此外,血栓通软胶囊可能是治疗缺血性脑卒中的一种安全有效的药物。需要进一步开展大规模随机临床试验来验证我们的研究结果。

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