West China School of Nursing, Sichuan University/Department of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Kunming Pharmaceutical, Inc., Kunming, China.
Ann Palliat Med. 2021 Sep;10(9):9523-9534. doi: 10.21037/apm-21-1828.
Due to constantly emerging new studies on Xuesaitong injection (XST) agent, it is necessary to summarize and analyze the latest published clinical research data to re-evaluate the clinical efficacy and safety of XST. This study mainly aimed to evaluate the clinical efficacy and safety of XST combined with western medicines (WM) for ischemic stroke treatment.
The related databases were searched to collect all randomized controlled trials (RCTs) comparing the combination of XST and WM with WM alone for the treatment of patients with ischemic stroke. Participant, intervention, comparison, outcome and study type (PICOS) was the inclusion criteria of all studies. The search for and data extraction of the included studies was performed by 2 researchers, who then conducted quality evaluation. The Cochrane Collaboration's risk of bias tool was used for the article evaluation. The software RevMan 5.3 and Stata 15.0 were used for pooled analysis.
A total of 12 RCTs were included involving 1,769 patients with ischemic stroke, which combined XST with WM therapy. Moreover, the funnel plot showed that there was no obvious publication bias in the included studies. Meta-analysis showed that the total effective rate in the XST combined with WM group was higher than that in the WM alone group [odds ratio (OR) =4.04, 95% confidence interval (CI): 2.86 to 5.73, P<0.001]. The National Institutes of Health Stroke Scale (NIHSS) score in the XST combined with WM group was significantly lower than that in the WM alone group [weighted mean difference (WMD) =-3.17, 95% CI: -4.14 to -2.20, P<0.001]. In addition, XST combined with WM significantly reduced the plasma viscosity, fibrinogen level, whole blood high shear viscosity, and whole blood low shear viscosity in patients with ischemic stroke (P<0.01). For the comparison of adverse reactions, the results showed that the adverse reactions among patients with ischemic stroke in the XST combined with WM group and in the WM group did not differ significantly.
Compared with single WM medication, XST combined with WM improves the total clinical effective rate, promotes the recovery of patients' neurological function, and has few adverse reactions and high safety in clinical application.
由于 XueSaiTong 注射液（XST）的新研究不断涌现，有必要对最新发表的临床研究数据进行总结和分析，以重新评估 XST 的临床疗效和安全性。本研究主要旨在评估 XST 联合西药（WM）治疗缺血性脑卒中的临床疗效和安全性。
检索相关数据库，收集比较 XST 联合 WM 与 WM 单独治疗缺血性脑卒中患者的所有随机对照试验（RCT）。所有研究的纳入标准为参与者、干预措施、比较、结局和研究类型（PICOS）。由 2 名研究人员对纳入研究进行检索和数据提取，然后进行质量评价。采用 Cochrane 协作风险偏倚工具对文章进行评价。采用 RevMan 5.3 和 Stata 15.0 软件进行汇总分析。
共纳入 12 项 RCT，涉及 1769 例缺血性脑卒中患者，联合使用 XST 和 WM 治疗。此外，漏斗图显示纳入研究无明显发表偏倚。Meta 分析显示，XST 联合 WM 组总有效率高于 WM 组[比值比（OR）=4.04，95%置信区间（CI）：2.86 至 5.73，P<0.001]。XST 联合 WM 组美国国立卫生研究院卒中量表（NIHSS）评分明显低于 WM 组[加权均数差（WMD）=-3.17，95%CI：-4.14 至-2.20，P<0.001]。此外，XST 联合 WM 可显著降低缺血性脑卒中患者的血浆黏度、纤维蛋白原水平、全血高切黏度和全血低切黏度（P<0.01）。比较不良反应，结果显示 XST 联合 WM 组与 WM 组缺血性脑卒中患者不良反应发生率无显著差异。
与单独 WM 药物治疗相比，XST 联合 WM 可提高总临床有效率，促进患者神经功能恢复，且不良反应少，安全性高，临床应用价值高。
