The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial
The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial
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DOI：
10.1016/s1474-4422(05)70199-x
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发表时间：
2005-11-01
期刊：
影响因子：
48
通讯作者：
Osborne, JP
中科院分区：
文献类型：
--
作者：
Lux, AL;Edwards, SW;Osborne, JP
研究背景婴儿痉挛症是一种严重的婴儿癫痫病，发病率高，治疗困难。随机分组后第13天和第14天无痉挛在接受激素治疗的婴儿中比接受氨己烯酸治疗的婴儿更常见。我们试图评估痉挛的早期控制是否与改善发育或癫痫outcomes.Methods婴儿参加了英国婴儿痉挛研究（UKISS）随机分配激素治疗（n=55）或氨己烯酸（n=52），并随访至临床评估在12-14个月的年龄。我们评估了神经发育与葡萄园适应行为量表（VABS）在14个月大的意向治疗basis.Findings的107名婴儿参加，5人死亡，101名幸存者达到两个后续评估。最终临床评估时，各治疗组无痉挛（激素41/55 [75%] vs氨己烯酸39/51 [76%]）相似（差异1（.）9%，95% CI -18（.）3%至14（.）4%;卡方检验（2）=0（.）05; p=0（.）82）。平均VABS评分无显著差异（激素78（.）6 [SD 16（.）8]与氨己烯酸77（.）5 [SD 12（.）7];差异1（.）0，95% CI -4（.）9至7（.）0; t（99）=0（.）35，p=0（.）第73段）。在没有确定潜在病因的婴儿中，激素治疗组的平均VABS评分高于氨己烯酸治疗组（88（.）2 [17（.）3]vs 78（.）9 [14（.）3];差异9（.）3，95% CI 1（.）2至17.3; t（95）=2（.）28，p=0（.）025).解释激素治疗控制痉挛比氨己烯酸更好地开始，但不是在12-14个月大。在那些没有确定潜在病因的患者中，通过激素治疗更好地控制痉挛可能会改善发育结果。
Background Infantile spasms is a severe infantile seizure disorder that is difficult to treat and has a high morbidity. Absence of spasms on days 13 and 14 after randomisation is more common in infants allocated hormone treatments than in those allocated vigabatrin. We sought to assess whether early control of spasms is associated with improved developmental or epilepsy outcomes.Methods Infants enrolled in the United Kingdom Infantile Spasms Study (UKISS) were randomly assigned hormone treatment (n=55) or vigabatrin (n=52) and were followed up until clinical assessment at 12-14 months of age. We assessed neurodevelopment with the Vineland adaptive behaviour scales (VABS) at 14 months of age on an intention to treat basis.Findings Of 107 infants enrolled, five died and 101 survivors reached both follow-up assessments. Absence of spasms at final clinical assessment (hormone 41/55 [75%] vs vigabatrin 39/51 [76%]) was similar in each treatment group (difference 1(.)9%, 95% CI -18(.)3% to 14(.)4%; chi(2)=0(.)05; p=0(.)82). Mean VABS score did not differ significantly (hormone 78(.)6 [SD 16(.)8] vs vigabatrin 77(.)5 [SD 12(.)7]; difference 1(.)0, 95% CI -4(.)9 to 7(.)0; t(99)=0(.)35, p=0(.)73). In infants with no identified underlying aetiology, the mean VABS score was higher in those allocated hormone treatment than in those allocated vigabatrin (88(.)2 [17(.)3] vs 78(.)9 [14(.)3]; difference 9(.)3, 95% CI 1(.)2 to 17.3; t(95)=2(.)28, p=0(.)025).Interpretation Hormone treatment controls spasms better than does vigabatrin initially, but not at 12-14 months of age. Better initial control of spasms by hormone treatment in those with no identified underlying aetiology may lead to improved developmental outcome.