银杏二萜内酯葡胺注射液对有无大动脉粥样硬化型急性缺血性脑卒中患者的有效性研究

doi:10.3969/j.issn.1006-7795.2025.02.008

首都医科大学学报 ›› 2025, Vol. 46 ›› Issue (2): 228-233.doi: 10.3969/j.issn.1006-7795.2025.02.008

• 临床研究与方法学应用进展 • 上一篇下一篇

银杏二萜内酯葡胺注射液对有无大动脉粥样硬化型急性缺血性脑卒中患者的有效性研究

景娇，张思瑶，刘艳伶，王芬，肖伟，王振中^*

中药制药过程控制与智能制造技术全国重点实验室，江苏连云港 222001

收稿日期:2024-11-20 出版日期:2025-04-21 发布日期:2025-04-14
通讯作者: 王振中 E-mail:WZZ9301@kanion.com
基金资助:
江苏省院士工作站支撑项目（BM2023118）。

Effect of large artery atherosclerosis subtype on the efficacy of Ginkgo Diterpene Lactone Meglumine in acute ischemic stroke

Jing Jiao, Zhang Siyao, Liu Yanling, Wang Fen, Xiao Wei, Wang Zhenzhong^*

National Key Laboratory of Process Control and Intelligent Manufacturing Technology for Traditional Chinese Medicine, Lianyungang 222001, Jiangsu Province, China

Received:2024-11-20 Online:2025-04-21 Published:2025-04-14
Supported by:
This study was supported by the Jiangsu Provincial Academician Workstation (BM2023118).

摘要/Abstract

摘要： 目的探讨银杏二萜内酯葡胺注射液对大动脉粥样硬化型（large artery atherosclerosis,LAA）和非LAA的急性缺血性卒中患者的疗效差异。方法本研究是一项随机、双盲、安慰剂平行对照、多中心临床研究的事后分析。共纳入3 448例发病48 h内的急性缺血性卒中患者，按照1∶1随机接受银杏二萜内酯葡胺注射液和安慰剂治疗14 d。研究对象按照LAA型和非LAA型卒中分为2组。主要疗效指标为随机化后(90±7)d发生改良Rankin量表(modified Rankin Scale,mRS)评分完全生活自理（mRS达到0~1分）的比例。结果共纳入3 448例缺血性卒中患者，其中non-LAA型患者1 604例（46.52%），LAA型患者1 844例（53.48%）。non-LAA患者（OR=1.24,95% CI:1.02~1.51；P=0.03）和LAA患者（OR=1.37；95% CI:1.14~1.65；P<0.001），银杏二萜内酯葡胺注射液相比于安慰剂均可显著提高90 d mRS评分0~1分患者的比例。LAA分型与不同治疗方式无显著交互作用（交互P=0.48）。结论在不同LAA分型患者中，银杏二萜内酯葡胺注射液可能有效提高急性缺血性卒中患者90 d的功能预后，但研究结果仍需进一步验证。

关键词: 大动脉粥样硬化分型, 银杏二萜内酯葡胺注射液, 缺血性卒中, 功能预后, 随机对照研究

Abstract: Objective To investigate the effect of large artery atherosclerosis (LAA) and non-LAA subtypes on the efficacy of Ginkgo Diterpene Lactone Meglumine (GDLM) in patients with acute ischemic stroke. Methods This was a post-hoc analysis of multicenter, randomized, double-blind, placebo-controlled, and parallel-group trial. A total of 3 448 patients who had acute ischemic stroke were randomly assigned in a 1∶1 ratio to receive the injection of GDLM or the placebo once day within 48 h after symptoms and continued for 14 d. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) of 0 or 1 on day 90 after randomization. Results A total of 3 448 patients were enrolled, with 1 604 (46.52%) patients with non-LAA and 1 844 (53.48%) with LAA. Compared to the placebo treatment. GDLM injection effectively improve the functional prognosis, with a higher proportion of mRS score of 0-1 in both non-LAA (OR=1.24, 95% CI: 1.02-1.51; P=0.03) and LAA (OR=1.37, 95% CI:1.14-1.65; P<0.001) group. There was no significant interaction between LAA subtypes with treatment (P=0.48 for interaction). Conclusion Among patients with acute ischemic stroke in this randomized clinical trial, GDLM might improve the favorable clinical outcomes at 90 d compared with placebo, regardless of LAA subtypes. Nevertheless, it is necessary to confirm the findings in the future.

Key words: large artery atherosclerosis subtypes, Ginkgo Diterpene Lactone Meglumine injection, ischemic stroke, functional outcome, randomized clinical trial

中图分类号:

R742

景娇, 张思瑶, 刘艳伶, 王芬, 肖伟, 王振中. 银杏二萜内酯葡胺注射液对有无大动脉粥样硬化型急性缺血性脑卒中患者的有效性研究[J]. 首都医科大学学报, 2025, 46(2): 228-233.

Jing Jiao, Zhang Siyao, Liu Yanling, Wang Fen, Xiao Wei, Wang Zhenzhong. Effect of large artery atherosclerosis subtype on the efficacy of Ginkgo Diterpene Lactone Meglumine in acute ischemic stroke[J]. Journal of Capital Medical University, 2025, 46(2): 228-233.

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银杏二萜内酯葡胺注射液对有无大动脉粥样硬化型急性缺血性脑卒中患者的有效性研究

Effect of large artery atherosclerosis subtype on the efficacy of Ginkgo Diterpene Lactone Meglumine in acute ischemic stroke

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