Shuxuening injection for acute ischemic stroke: Efficacy and safety − a randomized, double-blind, placebo controlled, multi-center clinical trial
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摘要:
目的：评价一种来自银杏叶的中药——舒血宁注射液治疗急性缺血性脑卒中（AIS）的疗效和安全性。 方法：2018年11月21日至2022年1月20日，在31个研究中心进行了一项随机、双盲、安慰剂对照的多中心临床试验，涉及446例AIS患者。患者在基础治疗（阿司匹林肠溶片）的基础上，分别给予舒血宁注射液（试验组）或安慰剂（对照组）。主要疗效终点是卒中后90天改良Rankin量表（mRS）评分≤2的患者百分比。次要疗效终点为mRS、美国国立卫生研究院卒中量表（NIHSS）和Barthel指数（BI）评分的变化以及不良事件的发生率。 结果：试验组脑卒中后90 d mRS评分≤2分的患者比例显著高于对照组（P < 0.05）。脑卒中后90 d mRS评分≤1的患者比例试验组高于对照组（P < 0.05）。试验组NIHSS评分变化值在治疗后10天、90天显著高于对照组（P < 0.05）。试验组脑卒中后90天NIHSS评分降低≥50%的比例高于对照组（P < 0.05）。试验组脑卒中后90 d BI评分变化值及≥75的百分比均高于对照组（P < 0.05）。两组之间的安全性没有差异。 结论：舒血宁注射液可有效改善患者功能预后，降低致残率，改善神经功能缺损，增强日常生活活动能力，具有良好的安全性。
Abstract:
Objective: To evaluate the efficacy and safety of Shuxuening injection, a Chinese remedy from Ginkgo biloba, in treating patients with acute ischemic stroke (AIS). Methods: A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted from 21 November 2018 to 20 January 2022 in 31 participating research centers involving 446 patients with AIS. Patients received either a Shuxuening injection (experimental group) or a placebo (control group) alongside basic treatment (aspirin enteric-coated tablets). The primary efficacy endpoint was the percentage of patients with a modified Rankin scale (mRS) score ≤ 2 at 90-day post-stroke. The secondary efficacy endpoints were the changes in mRS, National Institute of Health stroke scale (NIHSS), and Barthel index (BI) scores, and the incidence of adverse events. Results: The percentage of patients with mRS scores ≤ 2 at 90-day post-stroke was significantly higher in the experimental than in the control (P < 0.05) group. The percentage of patients with scores ≤ 1 at 90- day post-stroke was higher in the experimental group (P < 0.05). The change value of NIHSS scores in the experimental group was higher at 10-day post-treatment and 90-day post-stroke (P < 0.05). The percentage of NIHSS score reduction ≥ 50% was higher in the experimental group at 90-day post-stroke (P < 0.05). The change value of BI score and percentage of BI score ≥ 75 were higher in the experimental group at 90-day post-stroke (P < 0.05). Safety profiles did not differ between the groups. Conclusion: Shuxuening injection effectively improves the functional outcome of patients, reduces disability rates, improves neurological deficits, enhances activities of daily living, and demonstrates good safety profiles.
关键词:
急性缺血性脑卒中;功效;随机对照试验;安全性;舒血宁注射液;中药
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Project Supported:
This study was supported by the National Administration of Traditional Chinese Medicine (No. SATCM-2015-BZ402).
Ruihong Ma a, Xiaogang Li b, Xiaolei An c, Juntao Li d, Jianguo Zhu e, Temuqile f, Liping Zhan g, Peiyang Zhou h, Baolong Ren i, Baoai Wang j, Yuanyuan Sun a, Wei Xiao k, Meng Xu l. Shuxuening injection for acute ischemic stroke: Efficacy and safety − a randomized, double-blind, placebo controlled, multi-center clinical trial[J]. Chinese Herbal Medicines (CHM),2026,18(2):461-469
