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银杏二萜内酯葡胺注射液治疗急性缺血性脑卒中的抗血小板作用:一项随机、双盲、安慰剂对照的临床试验。

Antiplatelet effect of ginkgo diterpene lactone meglumine injection in acute ischemic stroke: A randomized, double-blind, placebo-controlled clinical trial.

机构信息

Department of Neurology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Neurology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.

出版信息

Phytother Res. 2023 May;37(5):1986-1996. doi: 10.1002/ptr.7720. Epub 2023 Jan 6.

Abstract

This study was designed to evaluate antiplatelet effect and therapeutic effect of ginkgo diterpene lactone meglumine injection (GDLI) in acute ischemic stroke (AIS) patients. In this randomized, double-blind, placebo-controlled trial, we randomly assigned 70 inpatients within 48 hr after the onset of AIS to combination therapy with GDLI and aspirin (GDLI at a dose of 25 mg/d for 14 days plus aspirin at a dose of 100 mg/d for 90 days) or to placebo plus aspirin in a ratio of 1:1. Platelet function, the National Institute of Health Stroke Scale (NIHSS), and the modified Rankin Scale (mRS) were evaluated. A good outcome was defined as NIHSS scores decrease ≥5 or mRS scores decrease ≥2. Results showed that arachidonic acid induced maximum platelet aggregation rate (AA-MAR) and mean platelet volume (MPV) of the GDLI-aspirin group were much lower than that of the aspirin group (p = 0.013 and p = 0.034, respectively) after the 14-day therapy. The combination of GDLI and aspirin was superior to aspirin alone, and had significant impact on the good outcome at day 90 (ORadj 7.21 [95%CI, 1.03-50.68], p = 0.047). In summary, GDLI has antiplatelet effect and can improve the prognosis of AIS patients.

摘要

本研究旨在评估银杏二萜内酯葡胺注射液(GDLI)对急性缺血性脑卒中(AIS)患者的抗血小板作用和治疗效果。在这项随机、双盲、安慰剂对照试验中,我们将 70 名发病后 48 小时内的住院患者随机分为 GDLI 和阿司匹林联合治疗组(GDLI 剂量为 25mg/d,共 14 天,加用阿司匹林 100mg/d,共 90 天)或安慰剂加阿司匹林组(1:1)。评估血小板功能、国立卫生研究院卒中量表(NIHSS)和改良 Rankin 量表(mRS)。良好结局定义为 NIHSS 评分下降≥5 分或 mRS 评分下降≥2 分。结果显示,在 14 天治疗后,GDLI-阿司匹林组的花生四烯酸诱导的最大血小板聚集率(AA-MAR)和平均血小板体积(MPV)均明显低于阿司匹林组(p=0.013 和 p=0.034)。GDLI 联合阿司匹林与单独使用阿司匹林相比具有优势,并且对 90 天的良好结局有显著影响(ORadj 7.21 [95%CI,1.03-50.68],p=0.047)。总之,GDLI 具有抗血小板作用,可改善 AIS 患者的预后。

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