Abstract

Objective: To investigate the effect of ginkgo diterpene lactone meglumine injection on cognitive function in patients with acute ischemic stroke. Methods: This was a randomized, double-blind, placebo parallel-controlled, multicenter clinical trial. Patients with acute ischemic stroke within 48 hours of onset were enrolled. Patients were divided ginkgo diterpene group and placebo control group receive a 14-day treatment, the ginkgo diterpene group was treated with ginkgo diterpene lactone glucamine, and the placebo control group was treated with mimic ginkgo diterpene lactone glucamine injection. The evaluation index was the change of Montreal Cognitive Assessment scale (MoCA) score of at Day 14 and Day 90. Results: A total of 3452 patients from 100 centers were randomized, of which 3163 patients with complete data on MoCA at baseline, day 14, and day 90 were included in analysis set, with 1588 patients received ginkgo diterpene lactone glucamine injection and 1575 patients received mimic ginkgo diterpene lactone glucamine injection. The MoCA scores of the two groups increased after treatment, the average change of MoCA scores at Day 14 and Day 90 in ginkgo diterpene group was 3.93[95% confidence interval (CI), 3.77-4.09] and 5.51 (5.34-5.69), respectively, which was significantly higher than that in the in the placebo control group ( P < 0.05). MoCA subentry analysis showed that the scores of visual space and execution and language in the ginkgo diterpene group were significantly higher than those in the placebo control group at Day 14, and the scores in visual space and execution, attention, language and abstract in the ginkgo diterpene group were significantly higher than those in the placebo control group at Day 90. Conclusions: Ginkgo biloba diterpene lactone meglumine can effectively improve the cognitive function of patients with acute ischemic stroke.

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