2011年ATA妊娠和产后甲状腺疾病诊疗指南(中英文对照版).doc

Guidelines of the American Thyroid Associationfor the Diagnosis and Management of Thyroid DiseaseDuring Pregnancy and Postpartum美国甲状腺协会妊娠期和产后甲状腺疾病的诊断和治疗指南The American Thyroid Association Taskforce on Thyroid Disease During Pregnancy and Postpartum美国甲状腺协会妊娠期和产后甲状腺疾病特别工作组Translated by Wang Xinjun Binzhou peoples hospital,Binzhou Medical College王新军译 滨州医学院附属滨州市人民医院INTRODUCTION前言Pregnancy has a profound impact on the thyroid glandand thyroid function. The gland increases 10% in size during pregnancy in iodine-replete countries and by 20%40% in areas of iodine deficiency. Production of thyroxine(T4) and triiodothyronine (T3) increases by 50%, along with a 50% increase in the daily iodine requirement. These physiological changes may result in hypothyroidism in the later stages of pregnancy in iodine-deficient women who were euthyroid in the first trimester. 妊娠对甲状腺和甲状腺功能具有明显影响。在点充足地区，妊娠期间甲状腺腺体大小增加10，在碘缺乏地区，增加约2040。甲状腺素（T4）和三碘甲状腺原氨酸（T3）增加50，每天碘需求量增加50。这些生理的变化可能导致妊娠前三个月甲状腺功能正常的碘缺乏妇女在妊娠后期发生甲减。The range of thyrotropin (TSH), under the impact of placental human chorionic gonadotropin (hCG), is decreased throughout pregnancy with the lower normal TSH level in the first trimester being poorly defined and an upper limit of 2.5 mIU/L. Ten percent to 20% of all pregnant women in the first trimester of pregnancy are thyroid peroxidase (TPO) or thyroglobulin (Tg) antibody positive and euthyroid. 促甲状腺激素（TSH）的范围在胎盘绒毛膜促性腺激素（hCG）的影响下，在整个妊娠期间均下降，在妊娠前三个月正常低限但尚未充分界定，上限为2.5 MIU/ L。妊娠前三个月大约10%到20的妇女甲状腺过氧化物酶（TPO）或甲状腺球蛋白（Tg）抗体阳性且甲状腺功能正常。Sixteen percent of the women who are euthyroid and positive for TPO or Tg antibody in the first trimester will develop a TSH that exceeds 4.0 mIU/L by the third trimester, and 33%50% of women who are positive for TPO or Tg antibody in the first trimester will develop postpartum thyroiditis. In essence, pregnancy is a stress test for the thyroid, resulting in hypothyroidism in women with limited thyroidal reserve or iodine deficiency, and postpartum thyroiditis in women with underlying Hashimotos disease who were euthyroid prior to conception.妊娠前三个月甲状腺功能正常TPO或TG抗体阳性的妇女中，约16在妊娠后三个月其促甲状腺激素会超过4.0 mIU/ L，妊娠前三个月TPO或Tg抗体阳性的妇女有3350会发生产后甲状腺炎。从本质上讲，妊娠是甲状腺的应激试验，在甲状腺功能储备有限或碘缺乏的妇女会发生甲状腺功能减退，而在怀孕前甲状腺功能正常但有潜在桥本甲状腺疾病的妇女会发生产后甲状腺炎。Knowledge regarding the interaction between the thyroid and pregnancy/the postpartum period is advancing at arapid pace. Only recently has a TSH of 2.5 mIU/L been accepted as the upper limit of normal for TSH in the first trimester. This has important implications in regards to interpretation of the literature as well as a critical impact for the clinical diagnosis of hypothyroidism. 关于甲状腺和妊娠/产后期相互作用的只是进展很快。直到最近，促甲状腺激素 2.5 MIU/ L，为怀孕前三个月TSH的正常上限才被接受。这对于文献的解释及甲状腺功能减退的临床诊断的关键影响具有重要意义。Although it is well accepted that overt hypothyroidism and overt hyperthyroidism have a deleterious impact on pregnancy, studies are now focusing on the potential impact of subclinical hypothyroidism and subclinical hyperthyroidism on maternal and fetal health, the association between miscarriage and preterm delivery in euthyroid women positive for TPO and/or Tg antibody, and the prevalence and long-term impact of postpartum thyroiditis. Recently completed prospective randomized studies have begun to produce critically needed data on the impact of treating thyroid disease on the mother, fetus, and the future intellect of the unborn child.虽然显性甲状腺功能减退和显性甲状腺功能亢进症对妊娠具有不利影响已被广泛接受，目前研究集中在亚临床甲状腺功能减退症和亚临床甲状腺功能亢进症对产妇和胎儿健康的潜在影响、在甲状腺功能正常TPO和/或Tg抗体阳性的妇女流产和早产之间的关系，产后甲状腺炎的流行病学和长期影响方面。最近完成的前瞻性随机研究已经开始给出关于治疗甲状腺疾病对母亲、胎儿的影响，未出生的孩子将来智力的影响方面急需的数据。It is in this context that the American Thyroid Association (ATA) charged a task force with developing clinical guidelines on the diagnosis and treatment of thyroid disease during pregnancy and the postpartum. The task force consisted of international experts in the field of thyroid disease and pregnancy, and included representatives from the ATA, Asia and Oceania Thyroid Association, Latin American Thyroid Society, American College of Obstetricians and Gynecologists, and the Midwives Alliance of North America. Inclusion of thyroidologists, obstetricians, and midwives on the task force was essential to ensuring widespread acceptance and adoption of the developed guidelines.正是在这种背景下，美国甲状腺协会（ATA）成立了一个特别工作组负责制定妊娠和产后甲状腺疾病诊断和治疗的临床指南。特别工作组由甲状腺疾病和妊娠领域的国际专家、ATA的代表、亚洲和大洋洲甲状腺协会的代表、拉丁美洲甲状腺协会的代表、美国妇产科学院的代表和北美助产士联盟的代表组成。工作组包括甲状腺疾病专家、妇产科医生和助产士以确保新指南被广泛的接受和采用。& RECOMMENDATION 1Trimester-specific reference ranges for TSH, as defined in populations with optimal iodine intake, should be applied. Level B-USPSTF1 应该应用最佳的碘摄入量的人群中妊娠早、中、晚期特定的TSH参考值范围。B级证据& RECOMMENDATION 2If trimester-specific reference ranges for TSH are not available in the laboratory, the following reference ranges are recommended: first trimester, 0.12.5 mIU/L; second trimester, 0.23.0 mIU/L; third trimester, 0.33.0 mIU/L. Level I-USPSTF2如果实验室无妊娠早、中、晚期特异的TSH具体参考值范围，建议参考以下参考值范围：妊娠前三月0.12.5 mIU/ L；妊娠中期三个月，0.2-3.0 MIU / L；孕晚期三个月，0.3-3.0 MIU/ L。I级证据& RECOMMENDATION 3The optimal method to assess serum FT4 during pregnancy is measurement of T4 in the dialysate or ultrafiltrate ofserum samples employing on-line extraction/liquid chromatography/tandem mass spectrometry (LC/MS/MS). Level A-USPSTF3在怀孕期间评估血清FT4的最佳方法，是用在线萃取/液相色谱/串联质谱（LC / MS /MS）测量透析或超滤血清样本的T4。A级证据& RECOMMENDATION 4If FT4 measurement by LC/MS/MS is not available, clinicians should use whichever measure or estimate of FT4 is available in their laboratory, being aware of the limitations of each method. Serum TSH is a more accurate indication of thyroid status in pregnancy than any of these alternative methods. Level A-USPSTF4如果没有条件用LC / MS/ MS测定FT4，临床医生应该使用其他方法或用他们实验室中的方法估计FT4的值，但应知道每种方法的局限性。和这些指标相比，血清TSH是妊娠期间甲状腺功能状态更准确的一个指标。 A级证据& RECOMMENDATION 5In view of the wide variation in the results of FT4 assays, method-specific and trimester-specific reference ranges of serum FT4 are required. Level B-USPSTF5鉴于FT4的检测结果差异很大，必需制定方法特异性的和妊娠早、中、晚期特异性的参考值范围。B级证据& RECOMMENDATION 6OH should be treated in pregnancy. This includes women with a TSH concentration above the trimester-specific reference interval with a decreased FT4, and all women with a TSH concentration above 10.0 mIU/L irrespective of the level of FT4. Level A-USPSTF6在怀孕期间明显的甲状腺功能减退症（OH）应该治疗。这包括TSH浓度高于妊娠特异性参考值范围及FT4水平下降的妇女和不论FT4浓度如何但TSH浓度高于10.0 mIU/ L的妇女。A级证据& RECOMMENDATION 7Isolated hypothyroxinemia should not be treated in pregnancy. Level C-USPSTF妊娠期间单纯的低甲状腺素血症不应该治疗。C级证据& RECOMMENDATION 8SCH has been associated with adverse maternal and fetal outcomes. However, due to the lack of randomized controlled trials there is insufficient evidence to recommend for or against universal LT4 treatment in TAb_ pregnant women with SCH. Level I-USPSTF8亚临床甲状腺功能减退症（SCH）与产妇和胎儿结局不利有关。然而，由于缺乏随机对照试验，尚无足够的证据建议对Tab的SCH孕妇用或不用LT4治疗。 I级证据& RECOMMENDATION 9Women who are positive for TPOAb and have SCH should be treated with LT4. Level B-USPSTF9TPOAb阳性的SCH妇女应该用LT4治疗。 B级证据& RECOMMENDATION 10The recommended treatment of maternal hypothyroidism is with administration of oral LT4. It is strongly recommended not to use other thyroid preparations such as T3 or desiccated thyroid. Level A-USPSTF10甲状腺功能减退的孕妇建议口服LT4治疗。强烈建议不用其他甲状腺制剂如T3或干甲状腺治疗。A级证据& RECOMMENDATION 11The goal of LT4 treatment is to normalize maternal serum TSH values within the trimester-specific pregnancy reference range (first trimester, 0.12.5 mIU/L; second trimester, 0.23.0 mIU/L; third trimester, 0.33.0 mIU/L). Level A-USPSTF11LT4治疗的目标是使产妇血清TSH值保持在妊娠特异性的参考值范围正常值以内（头三个月0.1-2.5 mIU/ L；妊娠中三个月，0.2-3.0 mIU/ L；孕晚期三个月，0.3-3.0 mIU/ L）。A级证据& RECOMMENDATION 12Women with SCH in pregnancy who are not initially treated should be monitored for progression to OH with a serum TSH and FT4 approximately every 4 weeks until 1620 weeks gestation and at least once between 26 and 32 weeks gestation. This approach has not been prospectively studied. Level I-USPSTF12没有进行治疗的亚临床甲减孕妇应监测是否进展为明显的甲状腺功能减退症，1620周前应每4周测定TSH和FT4，在孕26到32周之间至少测定一次。这种方法尚无前瞻性研究。 I级证据& RECOMMENDATION 13Treated hypothyroid patients (receiving LT4) who are newly pregnant should independently increase their dose of LT4 by *25%30% upon a missed menstrual cycle or positive home pregnancy test and notify their caregiver promptly. One means of accomplishing this adjustment is to increase LT4 from once daily dosing to a total of nine doses per week (29% increase). Level B-USPSTF13正在接受治疗（LT4）的甲状腺功能低下的新怀孕患者一个月经周期后或妊娠试验阳性后应增加LT4剂量25%30%，并及时通知他们的照护者。一种完成这种调整的方法是由LT4每日1次剂量增加到每周9次（增加29）。 B级证据& RECOMMENDATION 14There exists great interindividual variability regarding the increased amount of T4 (or LT4) necessary to maintain a normal TSH throughout pregnancy, with some women requiring only 10%20% increased dosing, while others may require as much as an 80% increase. The etiology of maternal hypothyroidism, as well as the preconception level of TSH, may provide insight into the magnitude of necessary LT4 increase. Clinicians should seek this information upon assessment of the patient after pregnancy is confirmed. Level A-USPSTF14为保持怀孕期间TSH正常，T4（或LT4）的增加量个体间变异很大，有些妇女仅需增加剂量1020，而其他妇女可能需要增加了80。孕妇甲状腺功能减退的病因，以及孕前TSH水平，可能影响LT4增加的量。临床医师应搜集这些信息以评估怀孕后患者的病情。 A级证据& RECOMMENDATION 15Treated hypothyroid patients (receiving LT4) who are planning pregnancy should have their dose adjusted by their provider in order to optimize serum TSH values to 2.5 mIU/L preconception. Lower preconception TSH values (within the nonpregnant reference range) reduce the risk of TSH elevation during the first trimester. Level B-USPSTF15正在治疗（LT4）的甲状腺功能低下的患者，如果计划怀孕应该在医师指导下调整剂量，使TSH值优化到2.5MIU/ L。较低的TSH值（未孕的参考范围内）会减少妊娠前三个月TSH值升高的风险。B级证据& RECOMMENDATION 16In pregnant patients with treated hypothyroidism, maternal serum TSH should be monitored approximately every 4 weeks during the first half of pregnancy because further LT4 dose adjustments are often required. Level B-USPSTF16正在治疗的甲状腺功能减退症的孕妇，在怀孕的前半个时期应大约每4周检测一次TSH，因为往往需要进一步调整LT4的剂量。B级证据& RECOMMENDATION 17In pregnant patients with treated hypothyroidism, maternal TSH should be checked at least once between 26 and 32 weeks gestation. Level I-USPSTF17正在治疗的甲状腺功能减退症孕妇，在孕26和32周之间应至少检查一次TSH。 I级证据& RECOMMENDATION 18Following delivery, LT4 should be reduced to the patients preconception dose. Additional TSH testing should be performed at approximately 6 weeks postpartum. Level B-USPSTF18分娩后，LT4应减少到孕前剂量。应在产后约6周再次检测TSH值。B级证据& RECOMMENDATION 19In the care of women with adequately treated Hashimotos thyroiditis, no other maternal or fetal thyroid testing is recommended beyond measurement of maternal thyroid function (such as serial fetal ultrasounds, antenatal testing, and/or umbilical blood sampling) unless for other pregnancy circumstances. Level A-USPSTF19在已经适当治疗的桥本甲状腺炎妇女，不建议除检测母体甲状腺功能以外进行其他母体或胎儿甲状腺检测（如串行胎儿超声波检查，产前检测和/或脐带血采样），除非其他怀孕情况。 A级证据& RECOMMENDATION 20Euthyroid women (not receiving LT4) who are TAbt require monitoring for hypothyroidism during pregnancy. Serum TSH should be evaluated every 4 weeks during the first half of pregnancy and at least once between 26 and 32 weeks gestation. Level B-USPSTF20TAb+甲状腺功能正常的妇女（未服用LT4）在怀孕期间需要监测甲状腺功能减退。血清TSH在怀孕前一半时间应每4周评估一次，在26至32周至少评估一次。B级证据& RECOMMENDATION 21A single RCT has demonstrated a reduction in postpartum thyroiditis from selenium therapy. No subsequent trials have confirmed or refuted these findings. At present, selenium supplementation is not recommended for TPOAbt women during pregnancy. Level C-USPSTF21一项随机对照试验显示用硒治疗可减少产后甲状腺炎。没有后续试验证实或推翻这些结论。目前，不建议TPOAb+的妇女在怀孕期间补充硒。 C级证据& RECOMMENDATION 22In the presence of a suppressed serum TSH in the first trimester (TSH 0.1 mIU/L), a history and physical examination are indicated. FT4 measurements should be obtained in all patients. Measurement of TT3 and TRAb may be helpful in establishing a diagnosis of hyperthyroidism. Level B-USPSTF22如果在妊娠前3个月存在血清TSH抑制（TSH0.1 MIU/ L），应该询问病史并进行体格检查。 所有患者应检测FT4。 检测TT3和TRAb或许有助于明确甲状腺功能亢进症的诊断。B级证据& RECOMMENDATION 23There is not enough evidence to recommend for or against the use of thyroid ultrasound in differentiating the cause of hyperthyroidism in pregnancy. Level I-USPSTF23有没有足够的证据支持或反对应用甲状腺超声鉴别孕妇的甲状腺功能亢进症。 I级证据& RECOMMENDATION 24Radioactive iodine (RAI) scanning or radioiodine uptake determination should not be performed in pregnancy. Level D-USPSTF24在怀孕期间不应进行放射性碘（RAI）扫描或放射性碘摄取测定。D级证据& RECOMMENDATION 25The appropriate management of women with gestational hyperthyroidism and hyperemesis gravidarum includes supportive therapy, management of dehydration, and hospitalization if needed. Level A-USPSTF25妊娠妇女甲状腺功能亢进症和妊娠剧吐的合适治疗包括支持治疗、补液，如果需要，可以住院治疗。 A级证据& RECOMMENDATION 26ATDs are not recommended for the management of gestational hyperthyroidism. Level D-USPSTF妊娠甲状腺功能亢进症不建议用抗甲状腺药物治疗。 D级证据& RECOMMENDATION 27Thyrotoxic women should be rendered euthyroid before attempting pregnancy. Level A-USPSTF27甲亢妇女在计划怀孕前应该将甲状腺功能控制到正常。 A级证据& RECOMMENDATION 28PTU is preferred for the treatment of hyperthyroidism in the first trimester. Patients on MMI should be switched to PTU if pregnancy is confirmed in the first trimester. Following the first trimester, consideration should be given to switching to MMI. Level I-USPSTF28在妊娠前三个月，首选丙基硫氧嘧啶治疗甲亢。正在用甲巯咪唑治疗的患者如果确定怀孕，在前三个月应该改用丙基硫氧嘧啶。三个月后，应该考虑改回甲巯咪唑。I级证据& RECOMMENDATION 29A combination regimen of LT4 and an ATD should not be used in pregnancy, except in the rare situation of fetal hyperthyroidism. Level D-USPSTF29在怀孕期间不应该联用LT4和抗甲状腺药物，除非在极少数胎儿甲状腺功能亢进症时。D级证据& RECOMMENDATION 30In women being treated with ATDs in pregnancy, FT4 and TSH should be monitored approximately every 26 weeks. The primary goal is a serum FT4 at or moderately above the normal reference range. Level B-USPSTF30在怀孕期间用抗甲状腺药物进行治疗的妇女，应该每26周检测一次FT4和TSH。主要目标是血清FT4在正常或略高于正常参考值范围。 B级证据& RECOMMENDATION 31Thyroidectomy in pregnancy is rarely indicated. If required, the optimal time for thyroidectomy is in the secondtrimester. Level A-USPSTF31在怀孕期间很少建议甲状腺切除术。如果需要，甲状腺切除术的最佳时间是在妊娠中期。 A级证据& RECOMMENDATION 32If the patient has a past or present history of Graves disease, a maternal serum determination of TRAb should be obtained at 2024 weeks gestation. Level B-USPSTF32如果病人有Graves病或曾患Graves病，应该在妊娠2024周检测孕妇的血清TRAb。 B级证据& RECOMMENDATION 33Fetal surveillance with serial ultrasounds should be performed in women who have uncontrolled hyperthyroidism and/or women with high TRAb levels (greater than three times the upper limit of normal). A consultation with an experienced obstetrician or maternalfetal medicine specialist is optimal. Such monitoring may include ultrasound for heart rate, growth, amniotic fluid volume, and fetal goiter. Level I-USPSTF33如果孕妇的甲亢未控制和/或孕妇的TRAb较高（高于三倍正常值上限），则应该用串行超声进行胎儿监测。最好咨询经验丰富的产科医生或母婴专家。这种超声监测可以包括心率、生长状况、羊水量和胎儿甲状腺肿大。 I级证据& RECOMMENDATION 34Cordocentesis should be used in extremely rare circumstances and performed in an appropriate setting. It may occasionally be of use when fetal goiter is detected in women taking ATDs to help determine whether the fetus is hyperthyroid or hypothyroid. Level I-USPSTF34在极少数情况下，可以在合适的机构进行脐带血采样。这在孕妇服用抗甲状腺药物胎儿甲状腺中大时或许有用，以辅助确定胎儿是否甲状腺功能亢进或甲状腺功能减退。 I级证据& RECOMMENDATION 35MMI in doses up to 2030 mg/d is safe for lactating mothers and their infants. PTU at doses up to 300mg/d is a second-line agent due to concerns about severe hepatotoxicity. ATDs should be administered following a feeding and in divided doses. Level A-USPSTF35MMI的剂量在20-30mg/ d对哺乳期的妇女和婴儿是安全的。因为严重的肝毒性，PTU 300mg/ d是二线药物。抗甲状腺药物应该分次服用，并在喂食后给药。 A级证据& RECOMMENDATION 36All pregnant and lactating women should ingest a minimum of 250 mg iodine daily. Level A-USPSTF36所有孕妇和哺乳期妇女每天最低应摄取250 mg碘。 A级证据& RECOMMENDATION 37To achieve a total of 250 mg iodine ingestion daily in North America all women who are planning to be pregnancy or are pregnant or breastfeeding should supplement their diet with a daily oral supplement that contains 150 mg of iodine. This is optimally delivered in the form of potassium iodide because kelp and other forms of seaweed do not provide a consistent delivery of daily iodide. Level B-USPSTF37在北美，要达到250mg的碘摄入量，所有计划怀孕或已经怀孕或哺乳期的妇女应该在每天饮食中口服补充150mg碘。最好补充碘化钾，因为海带和其他紫菜中的碘含量并不稳定。 B级证据& RECOMMENDATION 38In areas of the world outside of North America, strategies for ensuring adequate iodine intake during preconception, pregnancy, and lactation should vary according to regional dietary patterns and availability of iodized salt. Level A-USPSTF38在北美的世界其他地区，在孕前、怀孕和哺乳期为确保足够的碘摄入量应根据不同区域的饮食习惯和是否有碘盐而制定补碘方案。A级证据& RECOMMENDATION 39Pharmacologic doses of iodine exposure during pregnancy should be avoided, except in preparation for thyroid surgery for Graves disease. Clinicians should carefully weigh the risks and benefits when ordering medications or diagnostic tests that will result in high iodine exposure. Level C-USPSTF39在怀孕期间应该避免服用药理剂量的碘，除非在Graves病甲状腺手术的准备时。临床医师在为患者处方可能高碘的药物或进行诊断试验时应仔细权衡风险和收益。C级证据& RECOMMENDATION 40Sustained iodine intake from diet and dietary supplements exceeding 5001100 mg daily should be avoided due to concerns about the potential for fetal hypothyroidism. Level C-USPSTF40应该避免饮食和膳食补充剂碘摄入量持续每日超过5001100mg，因为这可能导致胎儿潜在的甲状腺功能减退。C级证据& RECOMMENDATION 41There is insufficient evidence to recommend for or against screening all women for anti-thyroid antibodies in the first trimester of pregnancy. Level I-USPSTF41没有足够的证据支持或反对在妊娠前三个月对所有妇女筛选查抗甲状腺抗体。 I级证据& RECOMMENDATION 42There is insufficient evidence to recommend for or against screening for anti-thyroid antibodies,