妊娠亚临床甲状腺功能减退症及甲状腺素血症进展为产后显性甲状腺功能减退症：两项随机对照试验的汇总分析数据。
Progression of Gestational Subclinical Hypothyroidism and Hypothyroxinemia to Overt Hypothyroidism After Pregnancy: Pooled Analysis of Data from Two Randomized Controlled Trials.
机构信息
Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.
Departments of Obstetrics and Gynecology, The George Washington University Biostatistics Center, Washington, District of Columbia, USA.
出版信息
Thyroid. 2024 Sep;34(9):1171-1176. doi: 10.1089/thy.2023.0616. Epub 2024 Jul 31.
To examine the incidence of overt hypothyroidism 1 and 5 years after pregnancies where screening before 21 weeks identified subclinical hypothyroidism (SH) or hypothyroxinemia (HT). Secondary analysis of two multicenter treatment trials for either SH or HT diagnosed between 8 and 20 weeks gestation. Current analyses focus only on individuals randomized to the placebo groups in the two parallel studies. SH was diagnosed with thyrotropin (TSH) ≥4.0 mU/L and normal free T4 (fT4) (0.86-1.9 ng/dL). HT was diagnosed with normal TSH (0.08-3.99 mU/L) but fT4 <0.86 ng/dL. Serum from initial testing was stored for later thyroid peroxidase (TPO) antibody assay; results were not returned for clinical management. At 1 and 5 years after delivery, participants were asked whether they had either been diagnosed with or were being treated for a thyroid condition. Maternal serum was collected at these visits and thyroid function measured. Subsequent overt hypothyroidism was defined as TSH ≥4.0 mU/L with fT4 <0.86 ng/dL. Data for 1- and 5-year follow-up were available in 307 of the 338 participants with SH and 229 of the 261 with HT. Subsequent hypothyroidism was more common both at year 1 (13.4% vs. 3.1%, < 0.001) and year 5 (15.6% vs. 2.6%, < 0.001) for participants with SH compared with those with HT. This progression was more common in individuals with TSH values >10 mIU/mL. Baseline TPO level >50 IU/mL in participants with SH was associated with higher rates of hypothyroidism at year 1 (26.7% vs. 6.5%, odds ratio [OR] = 5.3 [confidence interval (CI) 2.6-10.7]) and year 5 (30.5% vs. 7.5%, OR = 5.4 [CI: 2.8-10.6]) compared with those with TPO levels ≤50 IU/mL. For participants with HT, no differences in overt hypothyroidism were seen at 1 year related to baseline TPO level >50 IU/mL (1/10 (10%) vs. 6/218 (2.8%), OR = 3.9 [CI: 0.43-36.1]), but more participants with TPO levels >50 IU/mL developed hypothyroidism by year 5 (2/10 (20%) vs. 4/218 (1.8%), OR = 13.4 [CI: 2.1-84.1]). SH is associated with higher rates of overt hypothyroidism or thyroid replacement therapy within 5 years of delivery than is HT when these conditions are diagnosed in the first half of pregnancy.
为了检查在怀孕 21 周之前进行筛查发现亚临床甲状腺功能减退症（SH）或甲状腺素血症（HT）后 1 年和 5 年时显性甲状腺功能减退症的发生率。对两项分别针对 SH 或 HT 进行的多中心治疗试验进行二次分析，这些试验均在妊娠 8 至 20 周时确诊。目前的分析仅关注两项平行研究中被随机分配到安慰剂组的个体。SH 的诊断标准为促甲状腺激素（TSH）≥4.0 mU/L 且游离甲状腺素（fT4）正常（0.86-1.9 ng/dL）。HT 的诊断标准为 TSH 正常（0.08-3.99 mU/L）但 fT4＜0.86 ng/dL。初始检测的血清被储存起来以备进行甲状腺过氧化物酶（TPO）抗体检测；结果未反馈用于临床管理。在分娩后 1 年和 5 年时，参与者被问及是否曾被诊断出患有甲状腺疾病或正在接受甲状腺疾病治疗。在这些就诊时采集了母亲的血清并测量了甲状腺功能。随后的显性甲状腺功能减退症定义为 TSH≥4.0 mU/L 且 fT4＜0.86 ng/dL。在 338 名患有 SH 的参与者中，有 307 名和 261 名患有 HT 的参与者分别有 1 年和 5 年的随访数据。与 HT 相比，患有 SH 的参与者在第 1 年（13.4%比 3.1%，<0.001）和第 5 年（15.6%比 2.6%，<0.001）时发生后续甲状腺功能减退症的情况更为常见。在 TSH 值＞10 mIU/mL 的个体中，这种进展更为常见。患有 SH 的参与者基线 TPO 水平＞50 IU/mL 与第 1 年（26.7%比 6.5%，比值比 [OR] = 5.3 [95%置信区间（CI）2.6-10.7]）和第 5 年（30.5%比 7.5%，OR = 5.4 [95%CI 2.8-10.6]）发生甲状腺功能减退症的几率更高，而 TPO 水平≤50 IU/mL 的参与者中发生甲状腺功能减退症的几率则较低。对于 HT 患者，基线 TPO 水平＞50 IU/mL 与第 1 年显性甲状腺功能减退症无关（1/10（10%）比 6/218（2.8%），OR = 3.9 [95%CI 0.43-36.1]），但更多 TPO 水平＞50 IU/mL 的参与者在第 5 年时发生了甲状腺功能减退症（2/10（20%）比 4/218（1.8%），OR = 13.4 [95%CI 2.1-84.1]）。在妊娠前半段确诊 SH 或 HT 时，与 HT 相比，SH 与产后 5 年内发生显性甲状腺功能减退症或甲状腺替代治疗的几率更高。
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