诊断及Graves’病管理泰国：当前实践的调查

Abstract

背景。The data on clinical practice patterns in the evaluation and management of Graves’ disease (GD) are limited in Asia. The aims of this survey were to report the current practices in the management of GD in Thailand and to examine any international differences in the management of GD.方法。泰国的内分泌学会谁在内分泌科进行了认证资格的成员（ñ = 392) were invited to participate in an electronic survey on the management of GD using the same index case and questionnaire as in previous North American and European surveys.Results。从会员一百二十反应（30.6％）都包括在内。TSH受体抗体测定（29.2％），甲状腺彩超（6.7％），以及同位素研究（5.9％）用于不经常确认病因与那些在北美和欧洲的调查比较。用抗甲状腺药物（ATD）治疗是治疗（90.8％）的优选的第一选择。Methimazole at 10–15 mg/day with a beta-blocker was the initial treatment of choice. The preferred ATD in pregnancy was propylthiouracil in the first trimester and methimazole in the second and third trimesters, which was similar to the North American and European surveys.结论。Ultrasound and isotopic studies will be requested only by a small proportion of Thai endocrinologists. Higher physician preference for ATD is similar to Europe, Latin America, and other Asian countries. Geographical differences in the use of ATD, radioactive iodine, and thyroidectomy exist.

1.背景

格雷夫斯病（GD）是甲状腺功能亢进症的最常见的原因在碘充满领域[1]。GD的发展被认为是由于遗传和环境因素之间复杂的相互作用。其自身免疫性起源是众所周知的，并且自身抗体对甲状腺滤泡细胞的TSH受体（TRAb的）的刺激负责一个甲状腺肿的亢进和发展。GD的临床特征是由甲状腺毒症的其他病因共享。然而，GD与不同甲状腺外表现，包括格雷夫斯氏眼病（GO），甲状腺性皮肤病，和杵状指相关联。GD的诊断通常可以临床表现的基础上建立的，凸起的（T4）甲状腺素的水平，并且抑制TSH的水平。如果诊断并不简单，补充测试可以包括TRAb的测定，放射性碘（RAI）摄取试验，或彩色血流甲状腺多普勒超声[2，3]。与GD患者治疗这三种治疗方法是抗甲状腺药物（ATDS），一个RAI治疗和外科甲状腺切除术。所有这三种治疗方案是有效的，但每个治疗方法都有其优点和缺点。患者为中心的通信和共同决策正在成为确定最合适的治疗方案越来越重要。主治医生和患者应该讨论物流，医疗费用，预计恢复时间，好处，缺点和可能出现的副作用为每个治疗方案。该决定也可以通过甲亢的严重程度的影响。

Persistent marked variations in the diagnosis and management of GD exist throughout the world [4]。Burch and colleagues conducted a 2011 questionnaire-based survey of actual clinical practice in the management of GD among international members of the Endocrine Society, the American Association of Clinical Endocrinologists, and the American Thyroid Association (ATA) [五]。此外，类似的调查是在2013年欧洲甲状腺协会（ETA）的成员之间进行6]。在亚洲，在GD的管理临床实践模式的调查结果只能从日本，韩国，中国和印度[7，8]。To this purpose, we used the same questionnaire developed by Burch et al. [五]和分布式它泰国内分泌学会（EST）的成员，调查GD在泰国管理临床实践模式。

2。方法

2.1。调查

调查管理应用程序（谷歌表单，山景，CA，USA）来管理该调查。这项调查包括索引的情况（42岁女子与简单GD）有两种变体，包括GO和病人在未来6-12个月预期妊娠患者，而在以前的调查相同的问题[五]。索引的情况描述为“一个42岁的女性患者，病程2个月中度甲亢症状。她是原本健康的，不带任何药物，不抽烟。她有两个孩子，其中最小的为10岁，并再次怀孕没有计划。这是她的甲亢的首发。她有弥漫性甲状腺肿，大约两到三倍正常大小，每分钟105次脉搏，并具有正常的眼部检查。甲状腺hormone levels are found to be twice the upper limit of normal (free T4 3.6 ng/dL, normal range 1.01–1.79 ng/dL), with an undetectable thyrotropin level (TSH <0.01 mIU/L).” Most questions required a single best response to be selected from multiple choices. Diagnostic preference questions allowed multiple items to be simultaneously selected. To limit bias, questions were carefully constructed to exclude phrasing that could influence the respondents’ answers. The study was approved by the Committee on Human Rights Related to Research Involving Human Subjects of the Faculty of Medicine Ramathibodi Hospital, Mahidol University. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.

EST的成员谁在内分泌学委员会认证（ñ = 392) received e-mails from the EST administrators that included an electronic link to the questionnaire. The authors did not contact potential respondents directly. Survey responses were anonymously collected and stored electronically by the survey application service, accessible in a password-protected manner. Repeat submissions from the same Internet protocol address were automatically blocked by the survey service. Responses were then compared with those of 457 North American specialists extracted from the 2011 American survey [五] and 147 ETA members extracted from the 2013 survey [6]。从受访者的反应，收集从2019 6月26日至2019年8月17日。

2。2。Statistical Analysis

Summary statistics were prepared for responses to each question. Data were analysed using STATA software version 14 (StataCorp LP, TX, USA).

3.结果

3.1。反应率和投诉人口统计学

One hundred and twenty respondents (about 30.6% of the members of the EST who were board certified in endocrinology) participated in the survey, and 100% completed all sections. Due to lacking our own guidelines, respondents mostly followed ATA guidelines. Most respondents graduated from medical school in the 2000s (57%) with 22% graduating in the 2010s and 15% graduating by the 1990s. Forty-seven percent were currently working in a medical school, 28% were working in a private hospital, and 25% were working in a secondary or tertiary healthcare center. Eighty-eight percent of the respondents reported treatment of >10 new cases of GD yearly.

3.2。首发病例的诊断评估

数字图1（a）显示受访者请求对索引的情况下上市的实验室研究的比例。血清TSH和游离T4测定是最常见的有序的测量（分别为95％和81.7％，），而血清游离T3（T3）或总T3被较不频繁地请求（分别为73.3％和20.8％）。在GD的初始评估中，通过受访者（29.2％）的少数请求的血清TRAb的测量，而甲状腺过氧化物酶抗体（TPO ab）和甲状腺球蛋白抗体（TG Ab）的测试命令较不频繁地（分别为10.8％和9.2％，）。

数字图1（b）shows the proportion of respondents who ordered the listed anatomical or functional investigations for the index case. Thyroid ultrasound and RAI uptake were requested by 6.7% and 5.9%, respectively. Baseline assessments of the complete blood count (CBC) and liver function tests were acquired by 41.7% and 36.7% of the respondents, respectively.

3。3。Therapy

3。3.1。Preferred First-Line Treatment in the Index Case

β-阻断剂会首先由绝大多数的受访者（分别为90.8％和7.5％），绝对或可能使用。普萘洛尔是在65％的受访首选药物，随后在阿替洛尔32.5％。目标心脏速率为每分钟90-100次的受访者，每分钟80-90次为34.2％，每分钟70-80次受访者的23.3％，40％。ATD疗法是首选的一线的方法（90.8％），和RAI处理通过仅9.2％选择为最初的治疗，并且没有被任何申请人选择的甲状腺（图2）。按照惯例设置和毕业多年，没有在首选疗法无差异。

3.3.2。ATD治疗

甲巯咪唑（MMI）是为受访100％的优选ATD。应当指出的是，卡比马不可在泰国。The preferred starting dose of MMI was 10–15 mg once daily by 89.2% of the respondents, followed by 20 mg once daily (6.7%) and 30 mg once daily (3.3%). The most frequent starting doses of propylthiouracil (PTU) were 50 mg three times daily by 30% of the respondents, 100 mg three times daily (27.5%), and 150 mg three times daily (19.2%). The titration regimen was selected by 80.8% of the respondents, whereas the block-and-replace regimen was always used by 0.8% of respondents and in selected cases by 18.3%.

After initiating ATD therapy, the next measurement of serum thyroid hormone levels was performed after 4 weeks by 50.8% of respondents and after 6 weeks by 19.2%; after attaining euthyroidism, thyroid function tests would be most frequently performed every 2 (38.3%) or 3 (53.5%) months. Routine monitoring of CBCs and liver function tests during ATD treatment was performed by 19.1% and 5.8% of the respondents, respectively, whereas 80.9% of the respondents did not perform routine monitoring of either of these laboratory parameters.

在的瘙痒黄斑皮疹不响应抗组胺药治疗的情况下，受访77.5％切换到备用ATD，12.5％与用另外的抗组胺剂治疗相同的ATD持续，和10％选择为GD的替代治疗选择，包括RAI或甲状腺手术。由大部分受访者（45％）持续18个月治疗ATD，27.5％持续ATD治疗24个月，和12.5％持续ATD治疗12个月。

3.3.3。辅助治疗ATD在患者接受RAI

在接收RAI治疗的患者，术前用药用ATDS通过受访66.7％常规使用的，由30.8％选择性地使用（通常在患者> 65岁的，具有潜在的心脏疾病或具有多个合并症），并且不使用由2.5％。当使用ATDS术前用药前RAI，64.2％退出ATDS在RAI治疗前7天，30.8％在3-5天RAI治疗前退出ATDS。在早期的治疗后阶段，ATDS被常规使用的受访72.5％，26.7％仅选择性地使用，和从来没有使用过0.8％。

3。3。4。Perioperative Management of Patients Undergoing Thyroidectomy

当选择甲状腺手术，95％的患者呈现与手术前ATDS生化甲状腺机能正常的状态的受访者，而5％不会。术前碘滴，无论是复方碘溶液或碘化钾（SSKI）的饱和溶液，通过的40％的受访使用。手术后，在放电时间预防性剂量的钙和/或维生素d疗法没有使用由69.2％若术后钙水平是正常的。

3。4。Variant 1: Hyperthyroidism with Concurrent GO or Risk Factors for GO

The index case was revised to include current cigarette smoking and the presence of moderately severe and active GO (Clinical Activity Score: 3 of 7 points; pain with eye movement, eyelid swelling, moderate conjunctival injection, and proptosis of 23 mm bilaterally). In this case, the majority of respondents (97.5%) received an ophthalmological consultation, and imaging evaluation of the orbit was requested by about 30% of the respondents (noncontrast computed tomography, 17.5%; magnetic resonance imaging, 12.5%; and ultrasound, 0.8%).

在中度严重和活性GO存在甲状腺机能亢进优选主要治疗方法是ATD治疗（62.5％）。甲状腺（达到与ATDS甲状腺机能正常后）通过受访14.2％选择。无类固醇治疗RAI不使用受访者，而10.2％选择RAI加上低剂量糖皮质激素，和12.5％使用RAI高剂量糖皮质激素（图3和表1）。

在温和的和活性GO的存在下，通过受访76.7％选择的ATDS，RAI单独通过的5％的受访，RAI低剂量的糖皮质激素15％，和RAI高剂量糖皮质激素通过的2.5％受访者。如果患者有对GO（吸烟，高TRAb的滴度和高血清T3水平）的发展不走的迹象，但风险因素，答复没有显着改变，除了事实，没有受访者将给予大剂量糖皮质激素如果RAI治疗是治疗甲状腺功能亢进的所选模态（表1）。有趣的是，患者的威胁视力的GO，轻微的大部分受访者（43.3％）建议甲状腺手术ATDS达到甲状腺功能正常后。

In the great majority of cases (70.8%), high-dose glucocorticoid treatment for active GO was administered by an ophthalmologist, and 26.7% was administered by an endocrinologist.

3.5。变体2：甲亢管理在患者准备怀孕

那么指数的情况下更改为一名年轻女子计划怀孕，在未来6-12个月。ATDS是由受访者，随后RAI，用30％和甲状腺17％53％首选的治疗方法（图3）。在这种情况下，PTU被受访63％优选的，并且剩余的37％的优选的MMI。此外，如果患者有一个正面妊娠试验，而在MMI治疗，绝大多数的受访者（97.5％）转移到PTU，但在第二和第三个三个月期间，受访67.5％切换回MMI。

4。讨论

目前的研究代表了泰国的内分泌科医生在GD管理的观点。据我们所知，这是在东南亚进行了第一次调查。亚洲以前的数据大多来自日本[获得9]。然而，在亚洲大陆国家在地理，种族高度异质性，和经济状况。这凸显了国家特定信息的重要性。

Measurement of TRAbs is a reliable and cost-effective laboratory investigation in the diagnosis of GD hyperthyroidism. Thyroid RAI uptake still offers definitive diagnostic imaging to determining the underlying cause of thyrotoxicosis. If a thyroid nodule is present, a thyroid scan should be added to determine the functional status of the nodule. Compared with North Americans and Europeans, the use of diagnostic tests for GD, such as TRAbs, isotopic studies were ordered less frequently in Thailand. TRAb measurement was used as diagnostic tool by 94.5% of the Korean respondents, 93.9% of the Italian respondents, 85.6% of the European respondents, 54.3% of the North American respondents, and only 29.2% of the Thai respondents [五，6，10，11]。Moreover, thyroid ultrasound and isotopic studies were requested only by a small proportion of respondents in Thailand. Practicing medicine in resource-limited settings, such as Thailand, is challenging. Where laboratory access is limited and there are cost constraints in healthcare systems, most physicians use the clinical recognition of findings to direct decision making. Universal healthcare coverage has improved access to care, but inequality exists between different health plans [12]。

治疗选择甲亢应考虑到伤害，并为每个可用的治疗选择潜在的收益风险的平衡，除了病人的意愿，健康状况，并获得治疗方案。在我们的研究中，ATD治疗是甲亢的首发首选的治疗方案（受访者90.8％）。因此，ATD治疗作为来自韩国（97％），日本（88％），欧洲（77％），澳大利亚（81％），英国（60％），新西兰（59％）的受访者首选的治疗方法，中东和北非（53％）变化[五，6，11，13-16]。RAI一直是北美临床医生的首选一线治疗。然而，近几十年来，偏爱RAI治疗已经下降有利于ATDS [中五]。Fear of radiation is a main reason for the low preference of RAI treatment in Asia [7]。此外，RAI治疗后观察GO发展或恶化的风险增加，以及关于辐射诱发癌症的风险增加的担忧。可通过口服或静脉内的糖皮质激素的施用可以防止RAI诱导GO的风险[3，17]。从一个大的，纵向队列研究的最新数据显示，RAI甲亢会影响，从长远来看，从实体癌症[上升I-131剂量依赖性死亡率18]。然而，有关于前面提到的研究广泛批评，因为缺乏适当的控制和新的未生效分析[19-22]。一些研究报告的癌症和RAI的发展[之间没有相关性23-26]。根据目前的证据，RAI治疗GD被认为是一个安全的程序所推荐的ATA和ETA指南[2，3]。甲状腺切除术is never selected in Thailand for the initial treatment of uncomplicated GD. Preference for initial thyroid surgery has remained low in many regions. Selection of surgery could be related to the fact that inevitable postoperative hypothyroidism requires less monitoring, regarding both follow-up visits and laboratory tests, than that during ATD therapy [27-29]。此外，甲状腺会因为在偏远地区的内分泌学和核医学中心的不足进行选择。

由于大多数泰国内分泌沿袭了ATA的准则，MMI是唯一的ATD推荐的内分泌。2011年的指导方针批准后，MMI应该已经在几乎每一个病人使用时，甲状腺危象的治疗期间除外，在怀孕的头三个月，并在病人有轻微过敏反应MMI [2]。这种变化在临床实践结果的事实，PTU可诱发暴发性肝坏死，这可能是致命的或需要肝移植[三十]。这项研究的结果是相似的其他调查[五，6，10，11]。The preferred initial daily dose of MMI (15 mg/day) was lower than that reported in Caucasians [五，6，10]。A 15 mg dose of MMI not only resulted in a comparable inhibitory effect on thyroid function as those treated with a high dose (30 mg) of MMI in patients with GD but also caused fewer adverse effects [31]。However, the dose of MMI should be adjusted to disease severity because a dose that is too small is insufficient to restore euthyroidism in patients with severe hyperthyroidism [32]。大部分受访者ATD治疗期间没有接受CBC测试中，与ATA和ETA建议[相应2，3]。在日本，在第2个月ATD治疗[建议CBCS的常规监测32]。

从ATA和ETA指导方针，术前复方碘溶液或SSKI应该在大多数GD患者给予甲状腺之前。因为甲状腺手术过程中减少甲状腺血管，出血这种治疗是有益的[33]。However, this protocol is used only by approximately one-third of endocrinologists [五，6，10]。Approximately 30% of the respondents considered prophylactic treatment with oral calcium with or without oral calcitriol. As mentioned in the ATA statement, this approach is cost-effective and can hasten hospital discharge [34，35]。

GO是GD的主要表现甲状腺外，但幸运的是，严重的形式是罕见的。当GD由中度和积极的眼病复杂，多数泰国的内分泌科医生先与眼科医生咨询。这与其他国家的同事[五，6，10]。However, steroids were administered by Thai endocrinologists to only 26.7% of the patients. This study revealed that the majority of respondents would treat patients who have associated GO with ATDs. There was a more than 10-fold increased use of thyroidectomy when the index case was modified for a patient with moderate GO. Patients with moderate-to-severe active GO should receive prompt treatment using high-dose systemic glucocorticoids [36，37]。近三分之一的由任一RAI或甲状腺切除术进行到烧蚀方法的受访者。在用温和的活性GO的患者中，大多数受访相关的机会并发类固醇预防与低剂量口服泼尼松和如果选择RAI治疗中，表示为在GO [推荐由欧洲组37]。

如果一个GD在ATD治疗希望成为女人pregnant in the next 6–12 months, most respondents treated with an ATD, with a preference for PTU over MMI. This approach may minimize prenatal MMI exposure during the sensitive period of organogenesis. Conversely, definitive treatment by surgery was the treatment of choice for a women planning pregnancy by half of the Italian respondents [10]。甲状腺切除术的优点是逐渐remission of circulating TRAbs occurring postsurgery [38]。尽管RAI将暂时提高TRAb的滴度几个月到几年，这可能有助于GO恶化或胎儿的风险[39，40], RAI was the second choice of treatment in the present study and the North American survey [五]。其他部位之间有一个类似的模式ns in the preference for PTU during the first trimester of pregnancy, as well as in the decision to replace the treatment with MMI in the second and third trimesters. The majority of our respondents followed this approach, which is recommended by ATA guidelines [38]。

总之，地域差异在GD的诊断和管理存在。在治疗方案，这些差异可能是由核医学设备和经验丰富的医生甲状腺的可用性造成的。据大幅度变化的做法在泰国的诊断和GD的管理，与其他国家相比，需要调查GD的成本和风险，有效管理的附加详细的研究。

Data Availability

The datasets generated during and/or analysed during the current study are available from the corresponding author upon reasonable request.

Disclosure

在这项研究中所表达的观点仅代表作者本人的不表达EST的意见..

利益冲突

作者宣称，他们没有利益冲突。

Acknowledgments

The authors thank the many endocrinologists who took time to participate in this study. The authors also thank the EST for giving permission to carry out this survey among the members.

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