英文药名: Sabril(vigabatrin powder) 中文药名: 氨己烯酸片 生产厂家: Sanofi Aventis 给药说明 FDA批准Sabril喜保宁(氨己烯酸片)治疗婴儿痉挛症。 近日，美国食品药品管理局（FDA）批准Sabril（氨己烯酸）口服溶液治疗1个月至2岁儿童的婴儿痉挛症（IS）；Sabril片剂与其它药物联合用药，治疗成人复杂局部性癫痫发作（CPS）。 婴儿痉挛症属于难治性的癫痫综合症，多数是因脑部器质性病变或遗传性代谢疾病所引起。Sabril是FDA批准的第一个婴儿痉挛症的治疗药物，被认定为罕见病治疗药物。 Sabril存在的重要安全性问题是视觉损伤。Sabril药品说明书[黑框警告]中警示医生，使用Sabril存在发生进行性周边视觉丧失的风险，可能导致视力衰退。视觉损伤风险与Sabril使用剂量和时间增加有关，但即使最低剂量的Sabril也可能引起视觉损伤。因此服用Sabril病人必须进行定期视力检查。 药品英文名 Vigabatrin 药品别名 喜保宁、Sabril 药物剂型 片剂：500mg。 药理作用 本品为γ-氨基丁酸(GABA)的类似物，能特异性地与GABA氨基转移酶结合，且不可逆转，导致脑内GABA浓度增高，从而发挥抗癫痫作用。本品作为辅助治疗，用于治疗对其他抗癫痫药无效的患者，特别是部分性发作(主要用于控制复杂的部分性发作)患者。本品可加重失神发作或肌阵挛性发作。本品还可用于韦斯特(West)综合征(婴儿痉挛症)的婴儿，此症对常规抗癫痫药通常无效。作为辅助治疗药物，本品可获得较好疗效。单独应用时，对新诊断出的患者治疗有效。 药动学 口服吸收迅速，服后2h可达血药峰值。t1/2为5～7h。主要随尿排出，给药量的65%左右在头24h内以原药随尿排出。血浆蛋白结合不明显。 适应证 1.治疗其他抗癫痫药无效的癫痫，特别是部分性发作。 2.还可治疗婴儿痉挛症(韦斯特综合征、West综合征)。 禁忌证 对本品过敏者、孕妇、哺乳者禁用。 注意事项 老年和肾损害患者慎用。 不良反应 1.常见的有疲劳、嗜睡、头痛、头晕、精神错乱和抑郁。 2.偶有攻击行为和精神病(多见于有精神病史和行为问题的患者)、记忆减退、复视、体重增加、胃肠障碍、水肿和脱发。 3.还可能发生眼球震颤、神经过敏、易激动、共济失调、感觉异常和震颤。 4.有些患者发生不可逆的视野缺损、视网膜病变如视网膜周围萎缩，更少见者有视神经炎和萎缩。 5.精神方面可能发生激动、攻击性行为、妄想狂，有或无精神病史者均可出现。 6.还极少发生躁狂症或精神失常。 7.血红蛋白和转氨酶值可能降低。 用法用量 1.成人开始剂量为每天2g，分2次或单次服。必要时增加0.5～1g，最大剂量每天4g。 2.儿童开始口服每天40mg/kg，2次分服，必要时逐渐增加到每天80～100mg/kg。体重大于50kg者可给予成人剂量。 药物相应作用 抗癫痫药物之间有着复杂的相互作用，毒性可能增加，而抗癫痫的作用却并非相应的增加。这类相互作用变化很多，不可预测，在合用中必须严密监测血药浓度，谨防中毒。 专家点评 临床上该药主要用于治疗部分性发作，也可用于婴儿痉挛或作为继发性全身发作的加用药。但对于失神发作，肌阵挛性发作无效。 Sabril (vigabatrin) is an antiepileptic drug indicated for the treatment of refractory complex partial seizures (CPS) and infantile spasms (IS). It was developed by Ovation Pharmaceuticals, which was later acquired by Lundbeck in February 2009. The Peripheral and Central Nervous System Drugs Advisory Committee appointed by the US Food and Drug Administration (FDA), recommended sabril as an adjunctive treatment for adults with CPS, in January 2009. In August 2009, sabril was approved by the FDA for the treatment of IS in paediatric patients aged one month to two years, and also as add-on therapy for adult patients with refractory CPS. Details of CPS and IS conditions A complex partial seizure is an epileptic seizure, which starts focally within the lobe of the brain and results in loss of consciousness. It is estimated that about three million people in the US are affected by epilepsy and 35% of them have CPS. Infantile spasms, also known as West Syndrome, is a rare epileptic disorder found in infants. Every year 2,500 new cases of IS are registered across the US. Sabril mechanism of action Sabril is an anti-epileptic drug that contains vigabatrin. The exact mechanism of action of the drug is not known, but it is assumed that the drug works by restraining the enzyme responsible for metabolising gamma-aminobuytric acid transaminase (GABA-T). The drug reduces the risk of seizures by increasing the level of GABA in the brain. The drug is available in the form of 500mg tablets and powder for oral solution. Clinical trials of Lundbeck's antiepileptic drug The FDA approval for sabril for treating CPS and IS indications was based on two Phase III clinical trials for each indication. The first Phase III clinical trial for CPS was a randomised, double-blind and placebo-controlled and doseresponse study. It enrolled 174 subjects with CPS. The study was for an eight-week baseline period followed by an 18-week treatment period. The patients were administered with placebo or 1, 3, or 6g/day sabril twice daily. Study results showed that the patients treated with 3g/day and 6g/day dose of sabril were statistically superior when compared to placebo. It also demonstrated that 6g/day dose was not superior to the 3g/day dose. The second clinical trial was a randomised, double-blind, placebo-controlled, parallel study. The study enrolled 183 patients with CPS. The study consisted of an eight-week baseline period followed by a 16-week treatment period. The dose of sabril was titrated upward during the trial. The results of the study demonstrated that the patients treated with sabril 3g/day were statistically superior when compared to the placebo group. The FDA approval for IS indication was also based on two Phase III clinical trials. The first trial was a multicentre, randomised, parallel group, and a partially-blind study. It enrolled 221 patients with IS. Patients were randomised to receive sabril in either low dose consisting 18-36mg/kg/day or high dose consisting 100-148mg/kg/day. The endpoint of the study was finding spasm-free patients for seven consecutive days beginning within the first 14 days of sabril therapy. The results of the study showed that 17 patients treated with high doses of sabril achieved spasm freedom compared with eight patients in the low dose group. The second clinical trial on sabril for treating patients with IS enrolled 40 subjects. The study consisted of a pre-treatment period of two-three days, followed by a five-day double-blind treatment phase. Patients were administered with sabril 50mg/kg/day or placebo. The study results showed that sabril was statistically significant in overall reduction in spasms by 68.9% when compared to 17% in the placebo group. Lundbeck initiated Phase IV clinical trials on Sabril in December 2010. It is an open label single group assignment which enrolled 80 patients with CPS. The study is initiated across many centres in the US. The primary outcome measure of the study is to find the change in visual fields and measure the change in the retinal structure. The study is expected to be completed by July 2013. Marketing commentary for sabril (vigabatrin) Sabril was launched into the US market in the third quarter of 2009. It is the first therapy approved by the FDA for treatment of IS. Sabril, however, can cause permanent vision loss in infants, children and adults. Central vision and visual acuity are unaffected. ----------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买以咨询为准！ ----------------------------------------------------------------- 产地国家: 德国 原产地英文商品名: Sabril 500mg/Tab 100 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 100片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ----------------------------------------------------------------- 产地国家: 德国 原产地英文商品名: Sabril 500mg/Tab 50 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 50片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ----------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: Sabril 500mg 50bags 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克 50袋 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ----------------------------------------------------------------- 产地国家: 希腊 原产地英文商品名: Sabril 500mg/Tab 30 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 30片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE 该药品相关信息网址1: http://www.sabril.net 该药品相关信息网址2: http://www.drugs.com/sabril.html