Shinwell E S, Karplus M, Reich D, Weintraub Z, Blazer S, Bader D, Yurman S, Dolfin T, Kogan A, Dollberg S, Arbel E, Goldberg M, Gur I, Naor N, Sirota L, Mogilner S, Zaritsky A, Barak M, Gottfried E
Kaplan Medical Center, Rechovot, Israel.
Arch Dis Child Fetal Neonatal Ed. 2000 Nov;83(3):F177-81. doi: 10.1136/fn.83.3.f177.
To study the long term neurodevelopmental outcome of children who participated in a randomised, double blind, placebo controlled study of early postnatal dexamethasone treatment for prevention of chronic lung disease.
The original study compared a three day course of dexamethasone (n = 132) with a saline placebo (n = 116) administered from before 12 hours of age in preterm infants, who were ventilated for respiratory distress syndrome and had received surfactant treatment. Dexamethasone treatment was associated with an increased incidence of hypertension, hyperglycaemia, and gastrointestinal haemorrhage and no reduction in either the incidence or severity of chronic lung disease or mortality. A total of 195 infants survived to discharge and five died later. Follow up data were obtained on 159 of 190 survivors at a mean (SD) age of 53 (18) months.
No differences were found between the groups in terms of perinatal or neonatal course, antenatal steroid administration, severity of initial disease, or major neonatal morbidity. Dexamethasone treated children had a significantly higher incidence of cerebral palsy than those receiving placebo (39/80 (49%) v. 12/79 (15%) respectively; odds ratio (OR) 4.62, 95% confidence interval (95% CI) 2.38 to 8.98). The most common form of cerebral palsy was spastic diplegia (incidence 22/80 (28%) v. 5/79 (6%) in dexamethasone and placebo treated infants respectively; OR 4.45, 95% CI 1.95 to 10.15). Developmental delay was significantly more common in the dexamethasone treated group (44/80 (55%)) than in the placebo treated group (23/79 (29%); OR 2. 87, 95% CI 1.53 to 5.38). Dexamethasone treated infants had more periventricular leucomalacia and less intraventricular haemorrhage in the neonatal period than those in the placebo group, although these differences were not statistically significant. Eleven children with cerebral palsy had normal ultrasound scans in the neonatal period; all 11 had received dexamethasone. Logistic regression analysis showed both periventricular leucomalacia and drug assignment to dexamethasone to be highly significant predictors of abnormal neurological outcome.
A three day course of dexamethasone administered shortly after birth in preterm infants with respiratory distress syndrome is associated with a significantly increased incidence of cerebral palsy and developmental delay.
研究参与一项随机、双盲、安慰剂对照试验的儿童的长期神经发育结局，该试验旨在探讨出生后早期使用地塞米松预防慢性肺病的效果。
原研究比较了地塞米松三日疗程（n = 132）与生理盐水安慰剂（n = 116）在早产婴儿中的应用，这些早产婴儿因呼吸窘迫综合征接受机械通气并已接受表面活性剂治疗，给药时间在出生后12小时内。地塞米松治疗与高血压、高血糖和胃肠道出血的发生率增加相关，且慢性肺病的发生率或严重程度以及死亡率均未降低。共有195名婴儿存活至出院，5名婴儿随后死亡。在190名存活婴儿中，对159名进行了随访，随访时的平均（标准差）年龄为53（18）个月。
两组在围产期或新生儿病程、产前使用类固醇、初始疾病严重程度或主要新生儿疾病方面均无差异。接受地塞米松治疗的儿童脑瘫发生率显著高于接受安慰剂治疗的儿童（分别为39/80（49%）和12/79（15%）；优势比（OR）4.62，95%置信区间（95%CI）2.38至8.98）。脑瘫最常见的类型是痉挛性双瘫（地塞米松治疗组和安慰剂治疗组的发生率分别为22/80（28%）和5/79（6%）；OR 4.45，95%CI 1.95至10.15）。地塞米松治疗组发育迟缓的发生率显著高于安慰剂治疗组（44/80（55%）对23/79（29%）；OR 2.87，95%CI 1.53至5.38）。与安慰剂组相比，地塞米松治疗的婴儿在新生儿期脑室周围白质软化更多，脑室内出血更少，尽管这些差异无统计学意义。11名患有脑瘫的儿童在新生儿期超声扫描正常；这11名儿童均接受了地塞米松治疗。逻辑回归分析显示，脑室周围白质软化和使用地塞米松均是神经发育异常结局的高度显著预测因素。
呼吸窘迫综合征早产婴儿出生后不久给予三日疗程的地塞米松与脑瘫和发育迟缓的发生率显著增加相关。
