Section of Endocrinology and Metabolism, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
BMJ Open. 2021 Feb 23;11(2):e043751. doi: 10.1136/bmjopen-2020-043751.
To evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).
Systematic review and meta-analysis of randomised controlled trials STUDY ELIGIBILITY CRITERIA: Prespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.
Ovid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.
Prespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.
Cochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.
From 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.
Among pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.
CRD42019130459.
评估左甲状腺素治疗对甲状腺过氧化物酶抗体（TPOAb）和/或甲状腺球蛋白抗体（TgAb）阳性且无明显甲状腺功能减退症的孕妇或备孕妇女的妊娠结局的影响，与安慰剂或不治疗相比。
随机对照试验的系统评价和荟萃分析
预先设定的纳入标准为：左甲状腺素与安慰剂或不治疗相比，在 TPOAb 或 TgAb 阳性且妊娠或考虑妊娠的妇女中进行的随机试验。
从 1980 年至 2020 年 11 月 5 日，检索 Ovid MEDLINE、EMBASE、CINAHL、Cochrane 系统评价数据库和 Cochrane 对照试验中心注册库。
提取预先设定的数据要素，并在适当的情况下进行荟萃分析。主要结局包括妊娠成功、流产、早产和活产。
Cochrane 随机对照试验质量评估工具。
从 3023 条引文中共识别出 79 条全文进行审查。其中，6 项试验（共 2263 名妇女）纳入定性和定量分析。仅有一项试验被认为偏倚风险低。左甲状腺素治疗组与对照组相比，妊娠成功率（RR1.03；95%CI0.93 至 1.13）、流产率（RR0.93；95%CI0.76 至 1.14）、早产率（RR0.66；95%CI0.39 至 1.10）或活产率（RR1.01；95%CI0.89 至 1.16）的相对风险无显著差异。早产的敏感性分析确定了研究质量和左甲状腺素起始时间是异质性的来源。
在患有甲状腺自身免疫的孕妇或备孕妇女中，左甲状腺素的使用没有益处的证据（推荐强度为中至高）。在这种情况下使用左甲状腺素的建议需要重新考虑。
PROSPERO 注册号：CRD42019130459。
