Efficacy and safety of nicardipine prolonged-release implants for preventing vasospasm in humans.
OBJECTIVE
Despite extensive investigative efforts, there are few treatments that can prevent vasospasm after subarachnoid hemorrhage. This study was conducted to examine the efficacy and safety of nicardipine prolonged-release implants (NPRI) for humans, which have already been proven in dogs.


METHODS
Twenty consecutive subarachnoid hemorrhage patients with thick subarachnoid clot were treated with NPRI (a pellet of diameter 2 mm, length 10 mm, containing 4 mg of nicardipine) during surgery after clipping of their aneurysm. The number and location of pellets depended on the amount and site of subarachnoid clot on preoperative CT and on craniotomy.


RESULTS
Two to 10 pellets were implanted in the cistern of the internal carotid, middle cerebral, and/or anterior cerebral artery, where thick clots existed and therefore vasospasm related to delayed ischemic neurological deficits was highly likely. Delayed ischemic neurological deficits and cerebral infarctions were seen in 1 patient. Angiography performed on days 7 to 12 revealed no vasospasm in any arteries near which NPRI were placed. No complications were experienced.


CONCLUSIONS
Vasospasm was completely prevented for the arteries in thick clot cisterns, when NPRI were placed adjacent to the arteries during surgery. This drug-delivery system offers a promising approach for preventing vasospasm.
Kasuya
Hidetoshi
H
Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan. hkasuya@nij.twmu.ac.jp
Onda
Hideaki
H
Takeshita
Mikihiko
M
Okada
Yoshikazu
Y
Hori
Tomokastu
T
D000368:Aged; D020771:Anterior Cerebral Artery / Q000000981:diagnostic imaging / Q000187:drug effects / Q000601:surgery; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging / Q000187:drug effects / Q000601:surgery; D002533:Cerebral Angiography; D003399:Craniotomy; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004341:Drug Evaluation; D004343:Drug Implants / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020768:Middle Cerebral Artery / Q000000981:diagnostic imaging / Q000187:drug effects / Q000601:surgery; D009529:Nicardipine / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000517:prevention & control; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures; D020301:Vasospasm, Intracranial / Q000209:etiology / Q000517:prevention & control*
D003692:Delayed-Action Preparations; D004343:Drug Implants; D009529:Nicardipine