JAMA Network Open | 584万中国育龄期女性孕前TSH水平与妊娠结局的关联——基于人群的队列研究

2021-04-15 JACKZHAO MedSci原创

既往已有多项研究证实妊娠早期母体的甲状腺功能异常与流产、早产、围产期并发症、胎儿神经智力发育损伤等多项不良妊娠结局有关。考虑到备孕期女性随时可能进入妊娠期,有学者建议将对妊娠期甲状腺疾病的预防和干预窗

既往已有多项研究证实妊娠早期母体的甲状腺功能异常与流产、早产、围产期并发症、胎儿神经智力发育损伤等多项不良妊娠结局有关。考虑到备孕期女性随时可能进入妊娠期,有学者建议将对妊娠期甲状腺疾病的预防和干预窗口由孕期移至孕前。然而,女性孕前的甲状腺功能是否与不良母儿结局有关,此阶段反映甲状腺功能的重要指标——血清促甲状腺激素(TSH)的参考范围是否需要特殊设定?对于以上问题尚未有明确答案。

2021年4月13日,我国国家卫生健康委科学技术研究所的杨英教授、马旭教授和广东省人民医院的关海霞教授合作在JAMA Network Open发表了题为Preconception Thyroid-Stimulating Hormone Levels and Risk of Adverse Pregnancy Outcomes in Chinese Women Aged 20 to 49 Years的研究论文,探讨了女性孕前6个月内的血清TSH水平与四种不良妊娠结局的关联。

研究基于我国国家免费孕前优生健康检查项目(NFPCP),该项目分为孕前检查、妊娠早期随访和妊娠结局随访三个阶段。共计5 840 894名20-49岁的女性(平均年龄26岁)纳入本研究队列,她们均在TSH测定后6个月内成功妊娠。本研究中评估的不良妊娠结局包括早产(PTB)、小于胎龄儿(SGA)、出生缺陷和围产儿死亡。

研究首先根据目前公认的(美国临床生化研究院)TSH参考范围制定方法,计算得到孕前女性人群TSH参考范围为0.37-4.87 mIU/L。研究对象的中位TSH水平为1.60 mIU/L,其中TSH<0.37 mIU/L和≥4.88 mIU/L的比例分别为3.82%和2.52%。PTB、SGA、出生缺陷和围产儿死亡的发生率分别为6.56%、7.21%、0.02%和0.33%。

随后,研究者根据对象孕前6个月内的血清TSH水平,将其分为TSH<0.10 mIU/L、0.10-0.36 mIU/L、0.37-2.49 mIU/L、2.50-4.87 mIU/L、4.88-9.99 mIU/L和≥10.00 mIU/L六组。调整对象的教育程度、吸烟饮酒史、孕前体质量指数(BMI)、甲状腺疾病病史、高血压病史和糖尿病病史等多项混杂因素的Logistic回归分析

结果显示,孕前TSH 0.37-2.49 mIU/L组女性其四种不良妊娠结局的发生率均为最低。以TSH 0.37-2.49 mIU/L的对象为参照,TSH高于正常范围(≥4.88 mIU/L)或TSH低于正常范围(<0.37 mIU/L)均与PTB、SGA和围产儿死亡风险显著增加有关。

图1  不同孕前血清TSH组别人群中不良妊娠结局的发生率比较(调整后比值比)

进一步通过绘制限制性立方条图进行剂量反应关系分析得出,孕前6个月内的TSH水平与PTB、SGA和围产儿死亡的风险呈“J”形关系,即TSH水平过高或过低均增加不良妊娠结局风险。此外,研究者计算了TSH的中位数倍数(TSH MoM),以排除不同TSH检测方法、检测试剂盒以及仪器差异造成的检测值偏倚,结果显示TSH MoM与PTB、SGA和围产儿死亡风险仍呈现“J”形关联,而TSH MoM水平与出生缺陷的风险呈线性相关。

图2  孕前6个月内的血清TSH水平与不良妊娠结局的剂量反应关系

本研究是迄今为止首项探讨孕前甲状腺功能与妊娠结局的大规模人群队列研究,为育龄期女性孕前的甲状腺功能管理策略的制订提供了重要循证证据。研究有下述重要的临床指导意义:

- 提供了基于我国人群、大样本备孕期女性数据的血清TSH参考范围,即0.37-4.87 mIU/L。这一范围与我国非妊娠期普通成人的TSH参考范围(通常在0.35-5.0 mIU/L区间)很接近。

- 孕前6个月内的血清TSH低于或高于正常范围均于不良妊娠结局的发生风险增加相关,均应当给予重视和有效管理。

- 孕前6个月内的血清TSH在0.37-2.49 mIU/L区间者,妊娠不良结局的发生率最低,可被认定为TSH最适区间。这个结果为目前中外指南中推荐的“已患临床甲减的妇女需先调整LT4 剂量将血清TSH控制在正常参考范围下限~2.5mIU/L水平后再计划妊娠”提供了有力证据。

- 对于孕前无甲减病史、孕前6个月内的TSH处于2.50-4.87 mIU/L者,其不良妊娠结局的发生风险较最优TSH范围(0.37-2.49mIU/L)者并没有临床意义的显著增加。因此,无需对这部分备孕女性进行干预并将其TSH水平控制在2.5mIU/L以下。

这项基于大规模国家队列的研究为保障我国备孕期女性健康、制定合理的孕前甲状腺功能异常评判标准,以及指导孕前女性甲状腺功能异常的临床干预提供了高质量依据。研究也充分说明了我国推行免费孕前优生健康检查项目的重要意义和巨大价值。期待未来有更多关于孕前女性甲状腺功能及其相关干预措施(如纠正甲状腺功能异常、进行孕期监测等)与母胎健康关系的大规模前瞻性队列研究,以进一步明确具体的干预阈值和管理策略。

国家卫生健康委科学技术研究所杨英教授、河北医科大学研究生郭同磊和中国医科大学研究生付金蓉为本文的共同第一作者,国家卫生健康委科学技术研究所的马旭教授和广东省人民医院的关海霞教授为本文的共同通讯作者。其他主要贡献者包括来自广东省人民医院的邝建教授和来自国家卫生健康委科学技术研究所的王媛媛博士等。

原文链接:JAMA Network Open. 2021;4(4):e215723. doi:10.1001/jamanetworkopen.2021.5723

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    2021-06-04 canlab
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    2021-05-08 szhvet
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    2021-07-10 feather89
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    2021-04-15 七安

    #梅斯医学科研互助群# 欢迎您的加入,添加【梅斯医学科研助手WeChat:medsci_2021】邀您进群! 【社群简介】👉 梅斯医学目前已建立覆盖肿瘤、心血管、神经、消化、内分泌、呼吸等30个科室的学习交流社群。 【入群福利】👉 群内可实时交流病例,提问同行,跨群讨论,每天更新前沿医学资讯和指南共识,每周推出至少1场专业直播,不时共享科研干货,入群即可获得100份SCI写作攻略!

    0

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    2021-04-17 xinxin088
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    2021-04-15 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

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