Ninety-day administration of dl-3-n-butylphthalide for acute ischemic stroke: a randomized, double-blind trial

• DOI: 10.3760/cma.j.issn.0366-6999.20123240
• Publication Date: 2024-01-16T18:19:07Z
• Authors: Li-ying CUI; Yi-cheng ZHU; Shan GAO; Jian-ming WANG; Bing PENG; Jun NI; Li-xin ZHOU; Jia HE; Xiu-qiang MA
• Keywords: Stroke; Regimen; Barthel index

Background Dl-3-n-butylphthalide (NBP), first isolated from the seeds of celery, showed efficacy in animal models stroke. This study was a clinical trial to assess and safety NBP with continuous dose regimen among patients acute ischemic Methods A randomized, double-blind, double-dummy enrolled 573 within 48 hours onset stroke China. Patients were randomly assigned receive 14-day infusion followed by an capsule, 14- day aspirin, or ozagrel aspirin. The measures Barthel index score modified Rankin scale (mRS) at 90. Differences three groups on mRS compared using χ 2 test proportions (with two-sided α=0.05) Logistic regression analysis conducted take baseline National Institutes Health Stroke Scale (NIHSS) into consideration. Results Among 535 subjects included analysis, 90-day treatment associated significantly favorable outcome than as measured ( P <0.001). No significant difference found rate adverse events similar groups. Conclusions could improve outcomes third month after (both intravenous oral) is safe (ChiCTR-TRC-09000483).