神奈川県塩酸ファスジル多施設共同臨床試験結果  [in Japanese] The Results of Multi-institutional Cooperative Clinical Study for Fasudil Hydrochloride in Kanagawa Prefecture  [in Japanese]

Symptomatic vasospasm (SVS) can occur after subarachnoid hemorrhage (SAH) and has been considered as a factor associated with negative prognosis in SAH. However, no standard method for preventing SVS is currently available. Various preventive methods have thus been developed and conducted in each institution. To obtain a standardized preventive method for SVS after SAH, the present multi-institutional cooperative clinical study of fasudil hydrochloride was conducted in 5 institutions in Kanagawa Prefecture. Subjects comprised 112 SAH patients <75-years-old who were admitted to 5 institutions in Kanagawa Prefecture between October 2000 and May 2004, and who underwent clipping of cerebral aneurysms during the acute stage. Subjects were randomly categorized into 3 groups, to receive: fasudil hydrochloride (Fa, n=57); nicardipine hydrochloride (Ni, n=32); or ozagrel sodium (Oz, n=23). Patients were provided with each assigned treatment immediately after the operation. Degree of vasospasm (AVS) observed on cerebral angiography 1 week after onset of SAH, frequency of SVS, and treatment results after 1 and 3 months according to the Glasgow Outcome Scale (GOS) were examined. Frequency of AVS at 1 week after onset of SAH was 56% in all subjects, with 81% for Oz, 55% for Fa and 41% for Ni. A significant difference was observed between Oz and the other treatment groups. Frequency of SVS for all subjects was 22%, with 23% for Fa, 13% for Ni and 35% for Oz. A significant difference was noted between Ni and Oz groups. In the evaluation of Glasgow outcome scale (GOS) after 3 months, good recovery (GR) was achieved by 64% of all subjects, with 70% for Fa, 68% for Ni and 48% for Oz. A significant difference was identified between Fa and Oz groups. Fasudil hydrochloride is recommended for use as a standard therapeutic drug in SAH treatment.