氨己烯酸片治疗癫痫病2021年最新临床进展

Grand Pharmaceuticals (00512.HK) announced that on March 21, 2019, the group's independently developed product for the treatment of refractory partial epilepsy and infantile spasms is planned to be included in the priority review list because it complies with the regulations of the former State Food and Drug Administration's "Opinions of the General Administration on Encouraging Drug Innovation to Implement Priority Review and Approval" (CFDA (2017) No. 126). This time, a total of five domestic drugs have been included in the priority review list, and the company's vigabatrin is the only one selected because it is China's first such rare disease drug. This is also another rare disease drug that the group plans to enter the priority review list after the carboglutamic acid tablets for hyperammonemia.

To evaluate the efficacy and safety of vigabatrin in the treatment of infantile spasms. A total of 46 patients with infantile spasms who were diagnosed and treated at Severance Children's Hospital in South Korea from April 2015 to September 2016 were treated with oral vigabatrin. The starting dose was 50 mg/(kg·d) and was increased to 100 on the second day. mg/(kg·d), if the symptoms are obviously controlled, continue to use it for 3 to 6 months, and review the electroencephalogram regularly; if it is ineffective after 1 week, increase the dose to 150 mg/(kg·d), use it for 3 to 6 months, and follow up for 3 to 10 months. Results: The total effective rate of vigabatrin monotherapy was 67.4% (31/46), the seizure-free rate was 19.6% (9146), and the recurrence rate was 6.5% (3146). The main short-term adverse reactions were lethargy, anorexia, irritability, and hyperactivity. Conclusion: Vigabatrin is effective in treating infantile spasms with low recurrence rate and adverse reactions usually appear early.

The Group independently developed "vigabatrin", which is planned to be included in the priority review list, which will further accelerate the product's marketing approval and registration, and provide an effective treatment drug for Chinese patients suffering from refractory epilepsy and rare infantile spasms.

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