Calcium antagonists acting directly on the vascular smooth muscle have recently been reported to be effective for prevention and treatment of cerebral vasospasm. These agents, however, generally induce reduction of systemic blood pressure when administered intravenously, and this hypotensive action of calicium blockers, even that of diltiazem, cannot be ignored especially in the presence of intensive hypertension.
We attempted to combine topical high-concentration administration of a vasodilator with cisternal drainage by attaching a polymer of diltiazem and silicone to the tip of the drainage tube. Results of in vitro and animal experiments were reported previously. In this report, results of clinical trials are presented. Subjects consisted of 14 patients with ruptured cerebral aneurysm aged 35-67 years who underwent surgery 0-4 days after the rupture. The patients were classified according the scale of Hunt and Hess as Grade I (5 patients), II (3), III (4), or IV (2), and SAH scale of Fisher as Grade I (1 patient), II (3), III (8), or IV (2).
In general, the concentration of diltiazem in the cerebrospinal fluid (CSF) reaches a peak (5ng/ml/mg), 15 minutes after a bolus intravenous injection, and that during continuous intravenous infusion of 2-3μg/min/kg of body weight is 150-200 ng/ml in serum and 10-20ng/ml in CSF. The concentration in the cisternal drainage fluid attained by our method 1, 5, and 10 days after the surgery was 2-10, 0.4-6, and 0.25-1.2ng/ml/mg, respectively. The concentration tended to be high in patients with lesions of higher grades or showing CT images of massive subarachnoid hemorrhage, but was unaffected by the daily amount of the drained fluid.
One grade III patient died, but the remaining 13 patients all showed favorable outcome. Prognosis appeared to be unrelated to the grading or the amount of hemorrhage, but the number of cases was too small for valid statistical analysis.
The present method is considered to be of additional value for examining serial changes in the condition of the CSF or direct monitoring the intracranial pressure.
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