Reid Sally M, Middleton Philippa, Cossich Mary C, Crowther Caroline A, Bain Emily
ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, Discipline of Obstetrics and Gynaecology,The University of Adelaide, Adelaide, Australia.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007752. doi: 10.1002/14651858.CD007752.pub3.
Over the last decade there has been enhanced awareness of the appreciable morbidity of thyroid dysfunction, particularly thyroid deficiency. Since treating clinical and subclinical hypothyroidism may reduce adverse obstetric outcomes, it is crucial to identify which interventions are safe and effective.
To identify interventions used in the management of hypothyroidism and subclinical hypothyroidism pre-pregnancy or during pregnancy and to ascertain the impact of these interventions on important maternal, fetal, neonatal and childhood outcomes.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2013).
Randomised controlled trials (RCTs) and quasi-randomised controlled trials that compared a pharmacological intervention for hypothyroidism and subclinical hypothyroidism pre-pregnancy or during pregnancy with another intervention or placebo.
Two review authors assessed trial eligibility and quality and extracted the data.
We included four RCTs of moderate risk of bias involving 362 women. In one trial of 115 women, levothyroxine therapy to treat pregnant euthyroid (normal thyroid function) women with thyroid peroxidase antibodies was not shown to reduce pre-eclampsia significantly (risk ratio (RR) 0.61; 95% confidence interval (CI) 0.11 to 3.48) but did significantly reduce preterm birth by 72% (RR 0.28; 95% CI 0.10 to 0.80). Two trials of 30 and 48 hypothyroid women respectively compared levothyroxine doses, but both trials reported only biochemical outcomes. A trial of 169 women compared the trace element selenomethionine (selenium) with placebo and no significant differences were seen for either pre-eclampsia (RR 1.44; 95% CI 0.25 to 8.38) or preterm birth (RR 0.96; 95% CI 0.20 to 4.61). None of the four trials reported on childhood neurodevelopmental delay.There was a non-significant trend towards fewer miscarriages with levothyroxine, and selenium showed some favourable impact on postpartum thyroid function and a decreased incidence of moderate to advanced postpartum thyroiditis.
AUTHORS' CONCLUSIONS: This review found no difference between levothyroxine therapy and a control for treating pregnant euthyroid women with thyroid peroxidase antibodies for the outcome of pre-eclampsia, however a reduction in preterm birth and a trend towards reduced miscarriage with levothyroxine was shown. This review also showed no difference for pre-eclampsia or preterm birth when selenium was compared with placebo, however a promising reduction in postpartum thyroiditis was shown. Childhood neurodevelopmental delay was not assessed by any trial included in the review.Given that this review is based on four trials of moderate risk of bias, with only two trials contributing data (n = 284), there is insufficient evidence to recommend the use of one intervention for clinical or subclinical hypothyroidism pre-pregnancy or during pregnancy over another, for improving maternal, fetal, neonatal and childhood outcomes.
在过去十年中，人们对甲状腺功能障碍，尤其是甲状腺功能减退的明显发病率有了更高的认识。由于治疗临床和亚临床甲状腺功能减退可能会降低不良产科结局，因此确定哪些干预措施安全有效至关重要。
确定在孕前或孕期管理甲状腺功能减退和亚临床甲状腺功能减退时使用的干预措施，并确定这些干预措施对重要的母体、胎儿、新生儿和儿童结局的影响。
我们检索了Cochrane妊娠与分娩组试验注册库（2013年3月31日）。
随机对照试验（RCT）和半随机对照试验，这些试验比较了孕前或孕期甲状腺功能减退和亚临床甲状腺功能减退的药物干预与另一种干预或安慰剂。
两位综述作者评估了试验的合格性和质量，并提取了数据。
我们纳入了四项偏倚风险为中度的RCT，涉及362名女性。在一项有115名女性参与的试验中，对患有甲状腺过氧化物酶抗体的甲状腺功能正常的孕妇进行左甲状腺素治疗，未显示出能显著降低先兆子痫的发生率（风险比（RR）0.61；95%置信区间（CI）0.11至3.48），但确实显著降低了72%的早产率（RR 0.28；95%CI 0.10至0.80）。两项分别有30名和48名甲状腺功能减退女性参与的试验比较了左甲状腺素剂量，但两项试验均仅报告了生化指标结果。一项有169名女性参与的试验将微量元素硒代蛋氨酸（硒）与安慰剂进行了比较，先兆子痫（RR 1.44；95%CI 0.25至8.38）或早产（RR 0.96；95%CI 0.20至4.61）方面均未发现显著差异。四项试验均未报告儿童神经发育迟缓情况。左甲状腺素治疗组流产次数有减少的趋势但不显著，硒对产后甲状腺功能有一些有利影响，并降低了中度至重度产后甲状腺炎的发生率。
本综述发现，对于患有甲状腺过氧化物酶抗体的甲状腺功能正常的孕妇，在先兆子痫结局方面，左甲状腺素治疗与对照治疗无差异，但左甲状腺素治疗显示出早产率降低以及流产有减少趋势。本综述还表明，与安慰剂相比，硒在先兆子痫或早产方面无差异，但在产后甲状腺炎方面显示出有希望的降低。本综述纳入的任何试验均未评估儿童神经发育迟缓情况。鉴于本综述基于四项偏倚风险为中度的试验，仅有两项试验提供了数据（n = 284），因此没有足够的证据推荐在孕前或孕期使用一种干预措施而非另一种来治疗临床或亚临床甲状腺功能减退，以改善母体、胎儿、新生儿和儿童结局。
