Clinical trial of nicardipine prolonged-release implants for preventing cerebral vasospasm: multicenter cooperative study in Tokyo.
BACKGROUND
since October 1999, nicardipine pellets (NP) have been used to prevent vasospasm in patients with subarachnoid hemorrhage (SAH). We started a multicenter cooperative study on Jan 1, 2007, and 136 patients in six hospitals were enrolled to this trial in 2 years. The incidence of cerebral vasospasm and outcome were examined in these patients.


METHODS
the patients with SAH were treated with NP during surgery after clipping of their aneurysms.


RESULTS
the study included 87 female patients, 38 over 70 years old, 34 in grades 4 and 5, and 46 of Fisher group 2 or 4. Aneurysms were located on anterior circulation in 133, posterior in 3. All patients were treated with Fasudil hydrochloride except for 3. Two to twelve pellets were implanted in the cistern where thick clots existed and vasospasm was highly likely. Delayed ischemic neurological deficits (DIND), angiographical vasospasm and cerebral infarctions were seen in 11 of 134 (8.2%), 32 of 130 patients (24.6%), and 16 of 129 (12.4%), respectively. No complications were experienced. Independent rate at 3 months was 78%.


CONCLUSIONS
the incidence of cerebral vasospasm in this multicenter trial is similar to that of our first trial performed in a single center.
Department of Neurosurgery, Medical Center East, Tokyo Women's Medical University, 2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567, Japan, kasuyane@dnh.twmu.ac.jp.
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Kasuya
D019307:1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D003299:Cooperative Behavior; D016503:Drug Delivery Systems / Q000379:methods; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009529:Nicardipine / Q000008:administration & dosage*; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000188:drug therapy; D016896:Treatment Outcome; D020301:Vasospasm, Intracranial / Q000209:etiology / Q000517:prevention & control*
D002121:Calcium Channel Blockers; D019307:1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; D009529:Nicardipine; C049347:fasudil