老年人跟儿童能使用喜保宁(氨己烯酸片)吗？

Vigabatrin (SABRIL) is available in pediatric patients 2 to 16 years of age, but clinical studies of Vigabatrin (vigabatrin) did not include a sufficient number of patients 65 years and older to determine whether they responded differently than younger patients.

About Vigabatrin (vigabatrin tablets)

Since the 1970s, Vigabatrin (vigabatrin tablets) has entered the clinical research and development stage for the purpose of registration, and was first approved for marketing in the UK in 1989 It is used for the treatment of refractory partial-onset epilepsy. In 2009, the US FDA approved it as a single drug for the treatment of infantile spasms and as an add-on drug to other anti-epileptic drugs for the treatment of refractory complex partial-onset epilepsy. In my country, Vibatrin was included in the "Second Batch of Clinically Urgent Overseas New Drugs List" jointly issued by the National Health Commission, the Ministry of Industry and Information Technology, and the State Food and Drug Administration in 2019. Its indications are monotherapy for infantile spasms and auxiliary treatment for refractory partial-onset epilepsy.

Children's Vigabatrin (vigabatrin tablets)

The safety and efficacy of SABRIL as an adjunctive treatment for refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and are supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, an adequate and well-controlled study in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age. Dosing recommendations for this population vary by age group and are based on body weight. Adverse reactions in this pediatric population are similar to those observed in the adult population.

The safety and effectiveness of Vigabatrin as a monotherapy in children with infantile spasms (1 month to 2 years old) have been established.

The safety and efficacy as adjunctive treatment for refractory complex partial seizures in children younger than 2 years of age and as monotherapy for infantile spasms in children younger than 1 month of age have not been established.

In a post hoc analysis of the Canadian Pediatric Epilepsy Network (CPEN) study of developmental outcomes in patients with infantile spasms, the duration of treatment for infantile spasms was assessed. This analysis suggests that a total duration of methotrexate treatment of 6 months is sufficient to treat infantile spasms. However, the prescriber must use his or her own clinical judgment to determine the most appropriate period of use.

Vigabatrin (vigabatrin) in the elderly

Clinical studies of vigabatrin (vigabatrin) did not include a sufficient number of patients aged 65 and older to determine whether they responded differently than younger patients.

Vigabatrin is known to be primarily excreted through the kidneys, and patients with impaired renal function may be at greater risk for toxic reactions to this drug. Because elderly patients are more likely to have decreased renal function, caution should be used in dose selection, and monitoring of renal function may be useful.

In elderly (≥65 years) patients with reduced creatinine clearance (< 50 mL/min), 4 of 5 patients experienced moderate to severe sedation and disturbance of consciousness lasting up to 5 days after a single oral dose of 1.5 g of vegrebatin. Elderly subjects (≥65 years old) with healthy kidneys cleared coumarin 36% lower than young healthy men. Adjustment of dose or frequency of administration should be considered. Such patients may respond to lower maintenance doses.

Other reported clinical experience has not found a difference in response between older and younger patients.

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