罕见病药物氨己烯酸片副作用大吗

The main component of the tablet is vigabatrin (vigabatrin), and its mechanism of action is to irreversibly inhibit GABA aminotransferase (GABA-T) and increase the concentration of GABA in the brain. Indications are the treatment of epilepsy, especially partial seizures, in which other antiepileptic drugs are ineffective. It can also treat infantile spasms (West syndrome, West syndrome).

The starting dose of vigabatrin tablets for adults is 2g per day, divided into 2 times or taken as a single dose. If necessary, increase by 0.5 to 1g, with a maximum dose of 4g per day. Children should start taking 40 mg/kg orally per day, 2 times in divided doses, and gradually increase to 80 to 100 mg/kg per day if necessary. Adult doses can be given to those weighing more than 50kg.

Common side effects of vigabatrin tablets include fatigue, drowsiness, headache, dizziness, confusion, and depression, which are usually controllable, but patients need to be alert to the black box warning: vigabatrin tablets can cause permanent vision loss in infants, children, and adults, including progressive and permanent bilateral concentric visual field constriction in >30% of patients, with severity ranging from mild to severe, including tunnel vision to fixed vision within 10 degrees, and can lead to disability.

Onset of vision loss is unpredictable and can occur within weeks of starting treatment, or earlier, or at any time during treatment (even months or years later), and may occur after discontinuation of treatment. Vision evaluation is recommended at baseline (no later than 4 weeks after starting treatment), at least every 3 months of treatment, and approximately 3-6 months after stopping treatment. If vision loss is documented, consider discontinuing the drug, balancing benefits and risks. Patients with other types of irreversible vision loss or those at high risk for them should not be treated unless the benefits of treatment clearly outweigh the risks.

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