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妊娠期亚临床甲状腺功能减退症或低甲状腺素血症的治疗研究
Treatment of Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy


Brian M. Casey ... 其他 • 2017.03.02
相关阅读
• 治疗妊娠期妇女亚临床甲状腺疾病不太可能改善其子女的认知能力

摘要


背景

妊娠期亚临床甲状腺疾病可能伴发不良结局,包括子女IQ低于正常。诊断为亚临床甲状腺功能减退症或低甲状腺素血症的妊娠期妇女经过左甲状腺素治疗后,是否可改善其儿童的认知功能尚不确定。

 

方法

我们对单胎妊娠20周之内的妇女进行亚临床甲状腺功能减退症筛查,其定义为促甲状腺素水平≥4.00 mU/L,伴正常游离甲状腺素(T4)水平(0.86~1.90 ng/dL [11~24 pmol/ L]);并且进行低甲状腺素血症筛查,其定义为促甲状腺素水平正常(0.08~3.99 mU/L),伴游离T4低水平(<0.86 ng/dL)。在对两种状况分别进行的试验中,妊娠期妇女被随机分配服用左甲状腺素或安慰剂。每月监测甲状腺功能,调整左甲状腺素剂量,使促甲状腺素或游离T4水平(根据具体试验)达到正常值,同时对安慰剂做出假调整。对出生后的儿童每年进行一次发育水平和行为能力的评估,直到5岁。主要结局是儿童5岁时的IQ评分(如果5岁时的数据缺失可用3岁时的IQ评分)或3岁前死亡。

 

结果

总共677名有亚临床甲状腺功能减退症的妇女在平均妊娠16.7周时接受了随机分组,526名有低甲状腺素血症的妇女在平均妊娠17.8周时接受了随机分组。

在亚临床甲状腺功能减退症试验中,儿童的中位IQ评分如下:左甲状腺激素治疗组为97(95%置信区间[CI],94~99),安慰剂组为94(95% CI,92~96)(P=0.71)。在低甲状腺素血症试验中,中位IQ评分如下:左甲状腺激素治疗组为94(95% CI,94~99),安慰剂组为91(95% CI,89~93)(P=0.30)。每项试验中有4%儿童的IQ评分缺失。在任一试验中,在其他神经认知或妊娠结局或者在不良事件发生率方面,无显著的组间差异,两组的不良事件发生率均较低。


结论

在妊娠8~20周开始对亚临床甲状腺功能减退症或低甲状腺素血症进行治疗,并未使儿童截至5岁时的认知结局显著优于没有进行治疗的儿童(由美国尤尼斯-肯尼迪-施莱弗国立儿童健康和人类发展研究所[Eunice Kennedy Shriver National Institute of Child Health and Human Development]及国家神经疾病和卒中研究所[National Institute of Neurological Disorders and Stroke]提供资助;ClinicalTrials.gov注册号为NCT00388297)。





作者信息

Brian M. Casey, M.D., Elizabeth A. Thom, Ph.D., Alan M. Peaceman, M.D., Michael W. Varner, M.D., Yoram Sorokin, M.D., Deborah G. Hirtz, M.D., Uma M. Reddy, M.D., M.P.H., Ronald J. Wapner, M.D., John M. Thorp, Jr, M.D., George Saade, M.D., Alan T.N. Tita, M.D., Ph.D., Dwight J. Rouse, M.D., Baha Sibai, M.D., Jay D. Iams, M.D., Brian M. Mercer, M.D., Jorge Tolosa, M.D., Steve N. Caritis, M.D., and J. Peter VanDorsten, M.D., for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network*
From the University of Texas Southwestern Medical Center, Dallas (B.M.C.), the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Science Center at Houston, McGovern Medical School–Children’s Memorial Hermann Hospital, Houston (B.S.) — all in Texas; George Washington University Biostatistics Center, Washington, DC (E.A.T.); Northwestern University, Chicago (A.M.P.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); Wayne State University, Detroit (Y.S.); the National Institute of Neurological Disorders and Stroke (D.G.H.) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U.M.R.), Bethesda, MD; Columbia University, New York (R.J.W.); the University of North Carolina at Chapel Hill, Chapel Hill (J.M.T.); the University of Alabama at Birmingham, Birmingham (A.T.N.T.); Brown University, Providence, RI (D.J.R.); Ohio State University, Columbus (J.D.I.), and MetroHealth Medical Center–Case Western Reserve University, Cleveland (B.M.M.) — both in Ohio; Oregon Health and Science University, Portland (J.T.); University of Pittsburgh, Pittsburgh (S.N.C.); and the Medical University of South Carolina, Charleston (J.P.V.). Address reprint requests to Dr. Casey at the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75235, or at brian.casey@utsouthwestern.edu. *A complete list of the investigators in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network is provided in the Supplementary Appendix, available at NEJM.org.

 

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