title: Ninety-day administration of dl-3-n-butylphthalide for acute ischemic stroke: a randomized, double-blind trial.
abstract: BACKGROUND
  Dl-3-n-butylphthalide (NBP), first isolated from the seeds of celery, showed efficacy in animal models of stroke. This study was a clinical trial to assess the efficacy and safety of NBP with a continuous dose regimen among patients with acute ischemic stroke.
  
  
  METHODS
  A randomized, double-blind, double-dummy trial enrolled 573 patients within 48 hours of onset of ischemic stroke in China. Patients were randomly assigned to receive a 14-day infusion of NBP followed by an NBP capsule, a 14-day infusion of NBP followed by aspirin, or a 14-day infusion of ozagrel followed by aspirin. The efficacy measures were Barthel index score and the modified Rankin scale (mRS) at day 90. Differences among the three groups on mRS were compared using χ(2) test of proportions (with two-sided α = 0.05) and Logistic regression analysis was conducted to take the baseline National Institutes of Health Stroke Scale (NIHSS) score into consideration.
  
  
  RESULTS
  Among the 535 subjects included in the efficacy analysis, 90-day treatment with NBP was associated with a significantly favorable outcome than 14-day treatment with ozagrel as measured by mRS (P < 0.001). No significant difference was found among the three groups on Barthel index at day 90. The rate of adverse events was similar among the three groups.
  
  
  CONCLUSIONS
  The 90-day treatment with NBP could improve outcomes at the third month after stroke. The NBP treatment (both intravenous and oral) is safe (ChiCTR-TRC-09000483).
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China (Email: pumchcuily@sina.com).
authors.forename: Li-Ying
authors.initials: LY
authors.lastname: Cui
authors.forename: Yi-Cheng
authors.initials: YC
authors.lastname: Zhu
authors.forename: Shan
authors.initials: S
authors.lastname: Gao
authors.forename: Jian-Ming
authors.initials: JM
authors.lastname: Wang
authors.forename: Bing
authors.initials: B
authors.lastname: Peng
authors.forename: Jun
authors.initials: J
authors.lastname: Ni
authors.forename: Li-Xin
authors.initials: LX
authors.lastname: Zhou
authors.forename: Jia
authors.initials: J
authors.lastname: He
authors.forename: Xiu-Qiang
authors.initials: XQ
authors.lastname: Ma
mesh_terms: D000328:Adult; D000368:Aged; D001572:Benzofurans / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D001572:Benzofurans; C027125:3-n-butylphthalide