Pulmonary effects of triiodothyronine (T3) and hydrocortisone (HC) supplementation in preterm infants less than 30 weeks gestation:: Results of the THORN trial -: Thyroid hormone replacement in neonates

Pulmonary effects of triiodothyronine (T3) and hydrocortisone (HC) supplementation in preterm infants less than 30 weeks gestation:: Results of the THORN trial -: Thyroid hormone replacement in neonates
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DOI:
10.1203/01.pdr.0000041512.36915.d4
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发表时间:
2003-01-01
期刊:
影响因子:
3.6
通讯作者:
Walters, D
Walters, D
中科院分区:
医学3区
文献类型:
--
作者:
Biswas, S;Buffery, J;Walters, D

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THRON试验是一项多中心、随机、双盲、安慰剂对照的临床试验,以检验给予三碘甲腺原氨酸(T-3)和氢化可的松将降低妊娠小于30周的早产儿死亡率和呼吸道发病率的假设。253名婴儿随机接受6 mg·kg(-1)·d(-1)的T-3和1 mg·kg(-1)·d(-1)的氢化可的松或5%葡萄糖(安慰剂)作为连续静脉注射。输液7d。剂量在第5天减半。我们的第一个主要结果是1周时死亡或呼吸机依赖,第二个结果是2周时死亡或氧气依赖。两组的总死亡率均为11.4%。与安慰剂组相比,1周时死亡或呼吸机依赖的相对风险为0.87,p=0.2;2周时死亡或氧气依赖的相对风险为1.00,p=0.9。我们研究了253名婴儿出生后前7天的游离T-3(FT3)和游离甲状腺素(FT4)水平与1周时主要结局死亡或呼吸机依赖的关系。我们发现FT3和FT4之间存在显著的正相关关系,p=0.002。因此,FT3和FT4水平越高,结果越好。未发现T-3和氢化可的松的有益作用。在这项研究中,尽管FT3水平通过治疗输注增加了一倍,但FT4水平显著受到抑制。在我们的研究中,T-3没有任何有益的作用,这可能是因为治疗组抑制了FT4。
The THORN trial was a multicenter, randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that administration of triiodothyronine (T-3) and hydrocortisone would decrease mortality and respiratory morbidity in preterm infants of less than 30 wk gestation. Two hundred fifty-three infants were randomized to receive either 6 mug.kg(-1).d(-1) of T-3 with 1 mg.kg(-1).d(-1) of hydrocortisone or 5% dextrose (placebo) as a continuous i.v. infusion for 7 d. The dose was halved on d 5. Our first primary outcome was death or ventilator dependence at 1 wk, and the second was death or oxygen dependence at 2 wk. The overall mortality rate for both groups was 11.4%. Relative risk of death or ventilator dependence at 1 wk, treated versus placebo, was 0.87, p = 0.2, and death or oxygen dependence at 2 wk, 1.00, p = 0.9. We examined the relationship between free T-3 (FT3) and free thyroxine (FT4) levels in the first 7 d and the primary outcome death or ventilator dependence at 1 wk in all 253 babies. We found significant positive correlations of p = 0.05 for FT3 and p = 0.002 for FT4. Thus the higher the FT3 and FT4 levels, the better the outcome. No beneficial effects of T-3 and hydrocortisone were shown. In this study, although FT3 levels were doubled by the treatment infusion, FT4 levels were significantly suppressed. The lack of any beneficial effect of T-3 in our study may be explained by suppression of FT4 in the treatment group.