Background: Stroke can cause physical and mental problems. This study examined how the sequential therapy of N-butylphthalide (NBP) could effectively improve physical movement, life activities, and psychological disorders in stroke patients.
Methods: This double-blind, randomized controlled trial included middle-aged or elderly patients with acute ischemic stroke that had commenced within 48 hours before enrolment in the study. The experimental group was administered 100 mL NBP injections twice a day in the first 14 days, and a sequential 200 mg NBP soft capsule 3 times a day for the next 76 days. The control group was administered 100 mL NBP placebo injections twice a day in the first 14 days and 200 mg sequential NBP placebo soft capsule 3 times a day for the next 76 days. Primary outcomes were the National Institutes of Health Stroke Scale, the Barthel Index of activities of daily living, and Modified Rankin Scale which were evaluated at day 0, day 14, and month 1 or at day 14, month 3, and month 6. Secondary outcomes included the Hamilton Anxiety Scale and the Hamilton Depression Scale, all were evaluated on day 0, month 3, and month 6. Moreover, the adverse reaction of NBP or other serious adverse events were evaluated at each time.
Results: Our therapy significantly increased the Barthel Index of activities of daily living scores, decreased the National Institutes of Health Stroke Scale and Modified Rankin Scale scores, and the incidence of the Hamilton Anxiety Scale and the Hamilton Depression Scale of ischemic stroke patients (P < .05).
Conclusion: Our results indicated that 90 days' sequential therapy with NBP as an additional therapy in the treatment of ischemic stroke can better improve patients' psychological and behavioral functions without significant side effects.
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.