British journal of clinical pharmacology
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Br J Clin Pharmacol · Jun 1989
Comparative Study Clinical Trial Controlled Clinical TrialMetabolic effects of low-dose fluconazole in healthy female users and non-users of oral contraceptives.
1. Azole antifungal agents such as ketoconazole act by inhibiting cytochrome P-450 mediated sterol synthesis in the fungal cell membrane and thus have the potential to interfere with mammalian steroidogenesis. Fluconazole is a novel orally-effective antifungal triazole which has been reported to have more specific effects on the cytochrome P-450 enzymes involved in fungal sterol synthesis. 2. ⋯ Minor biochemical changes associated with fluconazole treatment included increases in serum thyroxine and testosterone concentrations (but not in women taking OC as well as fluconazole) and in insulin and apolipoprotein B levels (but only in women taking OC as well as fluconazole). In general, these changes were small and of no clinical significance with the values remaining within the laboratory normal range. There were no adverse side-effects.(ABSTRACT TRUNCATED AT 250 WORDS)
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Br J Clin Pharmacol · Jan 1989
Clinical Trial Controlled Clinical TrialEfficacy and safety of vigabatrin in the long-term treatment of refractory epilepsy.
1. The long term safety and efficacy of vigabatrin has been studied in 254 patients with refractory epilepsy (82% with partial seizures) in 23 different clinics in eight European countries. 2. This was an open multicentre study in which patients who had experienced a significant benefit from vigabatrin and had continued to take the drug for 1 year or longer were eligible for evaluation. ⋯ There was a very low rate of drop out for adverse events (1.6%). Adverse events, mainly sedation, irritation and weight gain were mostly mild and transient. 75% of patients reported no adverse event at all. 6. Safety evaluation included serial neurological, ophthalmological and general examinations: no new abnormal clinical feature or adverse event emerged with long term therapy.
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Br J Clin Pharmacol · Jan 1989
Multicenter Study Clinical Trial Controlled Clinical TrialA multicentre study of vigabatrin for drug-resistant epilepsy.
1. Vigabatrin (GVG) was given in a single-blind fashion to 89 patients with complex partial seizures (CPS) refractory to conventional drugs. 2. The median number of CPS per month decreased from 11.0 to 5.0 after addition of GVG, and 51% of patients had a 50% or greater decrease in CPS frequency (P less than 0.001). 3. ⋯ Sixty-six patients having a favourable response to GVG during the single-blind study have been followed for 6-54 (median 33) months on GVG. Only 17 patients have dropped out of long-term follow-up due to break through seizures and/or side effects. No serious systemic or neurological toxicity has been detected.
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Br J Clin Pharmacol · Jan 1989
Randomized Controlled Trial Clinical TrialEffect of oral activated charcoal on quinine elimination.
The effect of repeated dose oral activated charcoal on quinine elimination has been studied following a therapeutic (600 mg) dose of quinine bisulphate to seven normal volunteers. Activated charcoal lowered quinine half-life from 8.23 +/- 0.57 s.d. h to 4.55 +/- 0.15 s.d. h (P less than 0.001) and increased its oral clearance by 56%. Activated charcoal may have a role in the management of quinine poisoning.
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1. This study presents the results of the preliminary screening of vigabatrin as add-on therapy in an open, non-controlled multicentre study in children with refractory epilepsy. 2. There were 135 children, with an age range of 2 months-12 years. ⋯ Other adverse events included ataxia (2.2%), nausea (2.2%) and increased appetite (1%). A moderate and transient decrease in haemoglobin was reported in six patients from the same centre; these patients were all receiving very high doses of vigabatrin (250 to 600 mg kg-1 day-1). 6. Vigabatrin thus appears to be a safe antiepileptic drug that may be effective in the treatment of severe epilepsy in children.