Yeh Tsu F, Lin Yuh J, Lin Hung C, Huang Chao C, Hsieh Wu S, Lin Chyi H, Tsai Cheng H
Department of Pediatrics, College of Medicine, China Medical University, Taichung, Taiwan.
N Engl J Med. 2004 Mar 25;350(13):1304-13. doi: 10.1056/NEJMoa032089.
We studied the outcomes at school age in children who had participated in a double-blind, placebo-controlled trial of early postnatal dexamethasone therapy (initiated within 12 hours after birth) for the prevention of chronic lung disease of prematurity.
Of the 262 children included in the initial study, 159 lived to school age. Of these children, 146 (72 in the dexamethasone group and 74 in the control group) were included in our study. All the infants had had severe respiratory distress syndrome requiring mechanical ventilation shortly after birth. In the dexamethasone group, 0.25 mg of dexamethasone per kilogram of body weight was given intravenously every 12 hours for one week, and then the dose was tapered. We evaluated the children's growth, neurologic and motor function, cognition, and school performance.
Children in the dexamethasone group were significantly shorter than the controls (P=0.03 for boys, P=0.01 for girls, and P=0.03 for all children) and had a significantly smaller head circumference (P=0.04). Children in the dexamethasone group had significantly poorer motor skills (P<0.001), motor coordination (P<0.001), and visual-motor integration (P=0.02). As compared with the controls, children in the dexamethasone group also had significantly lower full IQ scores (mean [+/-SD], 78.2+/-15.0 vs. 84.4+/-12.6; P=0.008), verbal IQ scores (84.1+/-13.2 vs. 88.4+/-11.8, P=0.04), and performance IQ scores (76.5+/-14.6 vs. 84.5+/-12.7, P=0.001). The frequency of clinically significant disabilities was higher among children in the dexamethasone group than among controls (28 of 72 [39 percent] vs. 16 of 74 [22 percent], P=0.04).
Early postnatal dexamethasone therapy should not be recommended for the routine prevention or treatment of chronic lung disease, because it leads to substantial adverse effects on neuromotor and cognitive function at school age.
我们研究了参与早期产后地塞米松治疗(出生后12小时内开始)双盲、安慰剂对照试验以预防早产儿慢性肺病的儿童在学龄期的结局。
在初始研究纳入的262名儿童中,159名存活至学龄期。在这些儿童中,146名(地塞米松组72名,对照组74名)纳入我们的研究。所有婴儿出生后不久均患有严重呼吸窘迫综合征,需要机械通气。在地塞米松组,每千克体重0.25毫克地塞米松每12小时静脉注射一次,共一周,然后逐渐减量。我们评估了儿童的生长、神经和运动功能、认知及学业表现。
地塞米松组儿童明显比对照组矮(男孩P = 0.03,女孩P = 0.01,所有儿童P = 0.03),头围明显更小(P = 0.04)。地塞米松组儿童的运动技能(P < 0.001)、运动协调性(P < 0.001)和视动整合能力(P = 0.02)明显更差。与对照组相比,地塞米松组儿童的全智商得分(均值[±标准差],78.2 ± 15.0对84.4 ± 12.6;P = 0.008)、语言智商得分(84.1 ± 13.2对88.4 ± 11.8,P = 0.04)和操作智商得分(76.5 ± 14.6对84.5 ± 12.7,P = 0.001)也明显更低。地塞米松组儿童中具有临床显著残疾的频率高于对照组(72名中的28名[39%]对74名中的16名[22%],P = 0.04)。
不建议将早期产后地塞米松治疗常规用于预防或治疗慢性肺病,因为它会对学龄期儿童的神经运动和认知功能产生重大不良影响。