van Trotsenburg A S Paul, Smit Bert J, Koelman Johannes H T M, Dekker-van der Sloot Marijke, Ridder Jeannette C D, Tijssen Jan G P, de Vijlder Jan J M, Vulsma Thomas
Department of Pediatric Endocrinology, Emma Children's Hospital Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Pediatrics. 2006 Sep;118(3):e825-32. doi: 10.1542/peds.2006-0324. Epub 2006 Aug 21.
The aim of this study was to determine whether thyroxine treatment would improve nerve conduction in infants with Down syndrome.
A single-center, nationwide, randomized, double-blind, clinical trial was performed. Neonates with Down syndrome were assigned randomly to thyroxine (N = 99) or placebo (N = 97) treatment for 2 years. Daily thyroxine doses were adjusted regularly to maintain plasma thyrotropin levels in the normal range and free thyroxine concentrations in the high-normal range. The outcome measures were nerve conduction velocity and central conduction time, determined through median nerve somatosensory evoked potential recording, at the age of 24 months.
At the age of 24 months, somatosensory evoked potential recordings for 81 thyroxine-treated and 84 placebo-treated infants were available for analysis. Nerve conduction velocity and central conduction time did not differ significantly between the 2 treatment groups (nerve conduction velocity: thyroxine: 51.0 m/second; placebo: 50.1 m/second; difference: 0.9 m/second; central conduction time: thyroxine: 8.83 milliseconds; placebo: 8.73 milliseconds; difference: 0.1 milliseconds).
Postnatal thyroxine treatment of infants with Down syndrome did not alter somatosensory evoked potential-measured peripheral or central nerve conduction significantly. The absence of favorable effects suggests that pathologic mechanisms other than mild postnatal hypothyroidism underlie the impaired nerve conduction. The absence of adverse effects suggests that longstanding plasma free thyroxine concentrations in the high-normal range are not harmful to nerve maturation.
本研究旨在确定甲状腺素治疗是否会改善唐氏综合征婴儿的神经传导。
进行了一项单中心、全国性、随机、双盲临床试验。唐氏综合征新生儿被随机分配接受甲状腺素治疗(N = 99)或安慰剂治疗(N = 97),为期2年。定期调整甲状腺素每日剂量,以维持血浆促甲状腺激素水平在正常范围内,游离甲状腺素浓度在高正常范围内。结局指标为24个月龄时通过正中神经体感诱发电位记录测定的神经传导速度和中枢传导时间。
在24个月龄时,有81例接受甲状腺素治疗和84例接受安慰剂治疗的婴儿的体感诱发电位记录可供分析。两个治疗组之间的神经传导速度和中枢传导时间无显著差异(神经传导速度:甲状腺素组:51.0米/秒;安慰剂组:50.1米/秒;差异:0.9米/秒;中枢传导时间:甲状腺素组:8.83毫秒;安慰剂组:8.73毫秒;差异:0.1毫秒)。
唐氏综合征婴儿出生后接受甲状腺素治疗并未显著改变体感诱发电位测量的外周或中枢神经传导。未观察到有益效果表明,除轻度出生后甲状腺功能减退外,还有其他病理机制导致神经传导受损。未观察到不良反应表明,长期维持在高正常范围内的血浆游离甲状腺素浓度对神经成熟无害。