Abstract

Objective: To explore the effect of ginkgo diterpene lactone meglumine on the quality of life 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 received ginkgo diterpene lactone meglumined injection or placebo for 14 days. The ginkgo diterpene lactone meglumine group was treated with ginkgo diterpene lactone glucamine, and the placebo control group was treated with mimic ginkgo diterpene lactone glucamine injection. The outcomes were the change of EuroQol-visual analogue scales (EQ-VAS) total score at day 14 and day 90 after randomization and the different dimension score of EuroQol-5 Dimensions. Results: A total of 3452 patients from 100 centers were randomized, of which 3219 patients with complete data on EQ-5D at baseline, day 14, and day 90 were included in the analysis, with 1615 patients received ginkgo diterpene lactone meglumine injection and 1604 patients received placebo.The EQ-VAS scores of the two groups increased after treatment, the average change of EQ-VAS scores at Day 14 and Day 90 in ginkgo diterpene lactone meglumine group was 18.16 [95% confidence interval (CI), 17.51-18.81] and 26.30 (95% CI, 25.64-26.95), respectively, which was significantly higher than that in the placebo control group ( P <0.05). EQ-5D subentry analysis showed that the scores of each dimension were significantly higher than those in the placebo control group ( P <0.05). Conclusions: Ginkgo diterpene lactone meglumine can effectively improve the quality of life for patients with acute ischemic stroke.

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