4‐Aminopyridine in Patients with Multiple SclerosisDosage and Serum Level Related to Efficacy and Safety
作者:
H. Van Diemen,
C. Polman,
J. Koetsier,
A. Van Loenen,
J. Nauta,
F. Bertelsmann,
期刊:
Clinical Neuropharmacology
(OVID Available online 1993)
卷期:
Volume 16,
issue 3
页码: 195-204
ISSN:0362-5664
年代: 1993
出版商: OVID
关键词: Multiple sclerosis;4-Aminopyridine;Eye movement registration
数据来源: OVID
摘要:
SummaryIn a recent randomized, double-blind, placebo-controlled crossover trial, we demonstrated efficacy of 4-aminopyridine (4-AP) in improving disability of patients with multiple sclerosis (MS). Here we describe the relationship between dosage, serum level, efficacy, and safety of intravenously and orally administered 4-AP in the same group of 70 MS patients. After both intravenous and oral administration there was a significant relationship between serum levels and 4-AP doses used (p < 0.001 and p < 0.01, respectively). The use of 4-AP in oral doses three times a day showed a large variation and fluctuation in serum levels. After 12 weeks of oral treatment (maximum daily dosage 0.5 mg/kg body weight), a statistically significant improvement was found for the smooth pursuit gain of the eye movements (estimated effect 0.14, 95% confidence interval 0.06–0.23, p < 0.001). The amount of improvement was significantly related to 4-AP serum levels (p = 0.0013). Side effects after intravenous 4-AP occurred frequently and were very troublesome (pain in infusion arm, dizziness). Side effects during oral treatment (dizziness, pares-thesias) were very mild and occurred 30–45 min after intake of the medication and could be related to high serum levels.
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