益气复脉冻干注射剂治疗急性缺血性卒中（FAST）的疗效和安全性：一项随机、双盲、安慰剂对照试验的原理与设计

Efficacy and safety of YQFM (YiQiFuMai lyophilized injection) on acute ischemic stroke (FAST): rationale and design for a randomized, double-blind, placebo-controlled trial.

作者信息

Xu Yingzhi, Sun Li, Meng Zhaoyou, Lai Xinxing, Ma Dayong, An Yuqiu, Du Boxuan, Ren Qiaosheng, Gao Ying, Cao Kegang

机构信息

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.

出版信息

BMC Complement Med Ther. 2025 Jul 22;25(1):284. doi: 10.1186/s12906-025-05036-0.

DOI:10.1186/s12906-025-05036-0

PMID:40696376

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12285189/

Abstract

BACKGROUND

Low blood pressure at acute ischemic stroke onset is associated with both short- and long-term adverse outcomes. Studies have shown that YQFM (YiQiFuMai lyophilized injection) can ameliorate neurological deficits in ischemic stroke.However, all of these studies are all small-sample clinical observations lacking rigorous study design for AIS with inappropriate blood pressure.

AIMS

To describe the design of the YQFM aimed at reducing the disability rate in AIS patients with inappropriate blood pressure.

METHODS

This trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial aimed at evaluating the efficacy and safety of YQFM in reducing the disability rate in patients with acute hypoperfusion stroke within 90 days. We will recruit 480 patients with AIS within 48 h of symptom onset from 24 hospitals, who have large atherosclerosis, systolic pressure ≤ 155 mmHg, and an NIHSS score of 4-18. Eligible patients will be randomly assigned to receive either YQFM or 0.9% NaCl injection once daily for 10 days and will be followed up until the 90th day after stroke onset.The primary outcome will be the proportion of patients with mRS ≤ 2 at 90 days after patient recruitment. Secondary outcomes will include the proportion of early neurological deterioration at 7 days, patient self-reported outcomes and the syndrome score at 10 days, MMSE scale and BI scale at 90 days.During the trial, adverse events will be recorded. These data will be analyzed according to the predetermined statistical analysis plan.

CONCLUSION

This study is the first randomized controlled double-blind trial to evaluate the efficacy and safety of YQFM in patients with AIS. This trial will provide evidence-based data for YQFM application in AIS with inappropriate blood pressure.

CLINICAL TRIAL REGISTRATION

ChiCTR2300074125 was registered on 31 July, 2023. For more information, please visit Clinical Trials.gov at https://www.chictr.org.cn/showproj.html?Proj=200686 .

摘要

背景

急性缺血性卒中发病时的低血压与短期和长期不良结局均相关。研究表明，益气复脉冻干注射剂（YQFM）可改善缺血性卒中的神经功能缺损。然而，所有这些研究均为小样本临床观察，缺乏针对血压异常的急性缺血性卒中（AIS）的严谨研究设计。

目的

描述旨在降低血压异常的AIS患者致残率的YQFM研究设计。

方法

本试验是一项前瞻性、多中心、随机、双盲、安慰剂对照的优效性试验，旨在评估YQFM在降低急性低灌注性卒中患者90天内致残率方面的疗效和安全性。我们将从24家医院招募症状发作48小时内的480例AIS患者，这些患者患有严重动脉粥样硬化，收缩压≤155 mmHg，美国国立卫生研究院卒中量表（NIHSS）评分4 - 18分。符合条件的患者将被随机分配，每天接受一次YQFM或0.9%氯化钠注射液治疗，持续10天，并随访至卒中发病后第90天。主要结局将是入组后90天改良Rankin量表（mRS）≤2分的患者比例。次要结局将包括7天时早期神经功能恶化的比例、患者自我报告结局以及10天时的证候评分、90天时的简易精神状态检查表（MMSE）量表和巴氏指数（BI）量表。试验期间，将记录不良事件。这些数据将根据预定的统计分析计划进行分析。