Ballard R A, Ballard P L, Cnaan A, Pinto-Martin J, Davis D J, Padbury J F, Phibbs R H, Parer J T, Hart M C, Mannino F L, Sawai S K
Department of Pediatrics, University of Pennsylvania School of Medicine and Children's Hospital of Philadelphia, 19104, USA.
N Engl J Med. 1998 Feb 19;338(8):493-8. doi: 10.1056/NEJM199802193380802.
Pulmonary disease is common in preterm infants, despite antenatal glucocorticoid therapy. The addition of antenatal thyrotropin-releasing hormone therapy has been reported to decrease pulmonary morbidity in these infants.
We enrolled 996 women at 13 North American centers who were in preterm labor at <30 weeks' gestation in a double-blind, placebo-controlled, randomized trial of antenatal thyrotropin-releasing hormone, given intravenously in four doses of 400 microg each at eight-hour intervals. The primary outcome was chronic lung disease or death of the infant on or before the 28th day after delivery, and secondary outcomes were respiratory distress syndrome and chronic lung disease or death at 36 weeks' postmenstrual age. Complete data were available for 981 women and their 1134 live-born infants. The 769 infants born at < or = 32 weeks' gestation were defined as the group at risk.
There were no significant differences between the at-risk treatment and placebo groups in mean (+/-SD) birth weight (1109+/-354 vs. 1097+/-355 g), gestational age (27.9+/-2.1 vs. 27.9+/-2.1 weeks), sex, or race. The frequencies of respiratory distress syndrome (66 percent vs. 65 percent), death at 28 days (11 percent vs. 11 percent), chronic lung disease or death at 28 days (45 percent vs. 42 percent) and at 36 weeks (32 percent vs. 34 percent), and other neonatal complications as well as the severity of lung disease were not significantly different in the at-risk treatment and placebo groups. Similarly, there were no differences in outcome between the treatment and placebo groups for the infants born at >32 weeks' gestation.
In preterm infants at risk for lung disease, antenatal administration of thyrotropin-releasing hormone and glucocorticoid is no more beneficial than glucocorticoid alone.
尽管进行了产前糖皮质激素治疗，但肺部疾病在早产儿中仍很常见。据报道，添加产前促甲状腺激素释放激素治疗可降低这些婴儿的肺部发病率。
我们在北美13个中心招募了996名妊娠小于30周的早产妇女，进行一项双盲、安慰剂对照、随机试验，静脉注射产前促甲状腺激素释放激素，每8小时注射400微克，共4剂。主要结局是婴儿在出生后第28天或之前出现慢性肺部疾病或死亡，次要结局是呼吸窘迫综合征以及在月经龄36周时出现慢性肺部疾病或死亡。981名妇女及其1134名活产婴儿有完整数据。将769名妊娠小于或等于32周出生的婴儿定义为风险组。
风险组治疗组和安慰剂组在平均（±标准差）出生体重（1109±354 vs. 1097±355克）、胎龄（27.9±2.1 vs. 27.9±2.1周）、性别或种族方面无显著差异。风险组治疗组和安慰剂组在呼吸窘迫综合征发生率（66% vs. 65%）、28天死亡率（11% vs. 11%）、28天慢性肺部疾病或死亡率（45% vs. 42%）以及36周时慢性肺部疾病或死亡率（32% vs. 34%）、其他新生儿并发症以及肺部疾病严重程度方面无显著差异。同样，妊娠大于32周出生的婴儿治疗组和安慰剂组在结局方面也无差异。
在有肺部疾病风险的早产儿中，产前给予促甲状腺激素释放激素和糖皮质激素并不比单独使用糖皮质激素更有益。
