Efficiency and safety of fasudil hydrochloride therapy in patients with cerebral vasospasm following subarachnoid hemorrhage——clinical trial in phase IV

Abstract

Objective To investigate the clinical efficiency and safety of fasudil hydrochoride therapy on cerebral vasospasm after aneurysmal subarachoid hemorrhage.Method The open multicenter,large sample clinical study in phase Ⅳ,with a total of 2 092 patients with aneurysmal subarachoid hemorrhage treated by fasudil hydrochoride were included,was conducted in accordance with guidelines laid down by departments of neurosurgery of 74 hospitals in China.Fasudil ( 30 mg ) was prescribed for intravenous administration every 8 hours a day.Fasudil therapy was generally started after aneurysmal surgery or introvascular therapy and continued for 14 consecutive days.The determination of its safty and efficiacy was defined as:the clincal manifestation,general condition graded according to the Hunt and Hess scale as well as Glasgow Coma Scale,routine examinations,biochemical criterion and the average values of blood flow(cm/s) of MCA measured by TCD at the third,seventh and fourteenth days after the begining of treatment.Results The neurological deficits of patients were improved significantly after the treatment for 14 days( the rate of CVS was 94.36％,the mean blood flow of MCA was normal,the total effective rate was 91.21％).The vital signs were not influenced after treatment.The blood examinations were normal.Conclusions The fasudil hydrochloride treatment is not only effective,but also safe for treatment and prevention of cerebral vascular spasm following subarachoid hemorrhage due to ruptured aneurysm.This drug may provide a new therapurtic measure in clinic for treating and suppressing cerebral vasospasm. Key words: Subarachoid hemorrhage; Cerebral vasospasm; Fasudil