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来自两项前瞻性、随机、开放标签、盲终点研究的格雷夫斯病患者在接受放射性碘和抗甲状腺药物治疗后格雷夫斯眼病的变化。

Changes in graves' ophthalmopathy after radioiodine and anti-thyroid drug treatment of Graves' disease from 2 prospective, randomized, open-label, blinded end point studies.

作者信息

Chen D Y, Schneider P F, Zhang X S, Luo X Y, He Z M, Chen T H

机构信息

Department of Nuclear Medicine of The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.

Clinic for Nuclear Medicine, University Hospital, Würzburg, Germany.

出版信息

Exp Clin Endocrinol Diabetes. 2014 Jan;122(1):1-6. doi: 10.1055/s-0033-1358484. Epub 2013 Nov 7.

DOI:10.1055/s-0033-1358484
PMID:24203649
Abstract

AIMS

A significant association between radioiodine therapy (RIT) and the development or the worsening of pre-existing Graves' ophthalmopathy (GO) has been reported. This post-hoc analysis of 2 studies attempted to describe the changes observed in pre-existing or new-onset GO following RIT with the goal of euthyroidism rather than hypothyroidism and to describe the relationship GO changes and the final outcome.

PATIENTS AND METHODS

In 2 prospective, randomized open-label blinded endpoint trials, patients received radioiodine alone; or, patients received radioiodine or antithyroid drug therapy (ATD). The severity and activity of GO were assessed during a 9-12-year follow-up. The study end points in study 1 were euthyroidism, hyperthyroidism, hypothyroidism, and changes in GO. In study 2, the end points were euthyroidism, hyperthyroidism, hypothyroidism, relapse, and changes in GO.

RESULTS

Both RIT and ATD were associated with worsening GO and new-onset GO. Both RIT and ATD led to similar aggravation of pre-existing GO or the development to new-onset GO. After RIT or ATD, the euthyroid patients (without levothyroxine substitution) demonstrated an improvement in GO, with 78-89% patients with preexisting GO exhibiting improvement, whereas hyperthyroid, hypothyroid and relapsed patients had worsening or new-onset GO.

CONCLUSIONS

Thyroid function is a dominant risk factor. Thyroid function may be the most important determinant in worsening or new-onset GO in both the natural disease course and in treated patients, independent of the kind of treatment. Therefore, we recommend euthyroidism as a goal of treatment.

摘要

目的

已有报道称放射性碘治疗(RIT)与既往存在的格雷夫斯眼病(GO)的发生或恶化之间存在显著关联。这项对两项研究的事后分析试图描述在以甲状腺功能正常而非甲状腺功能减退为目标的RIT治疗后,既往存在或新发GO所观察到的变化,并描述GO变化与最终结局之间的关系。

患者与方法

在两项前瞻性、随机开放标签盲终点试验中,患者单独接受放射性碘治疗;或者,患者接受放射性碘或抗甲状腺药物治疗(ATD)。在9至12年的随访期间评估GO的严重程度和活动度。研究1的研究终点为甲状腺功能正常、甲状腺功能亢进、甲状腺功能减退以及GO的变化。在研究2中,终点为甲状腺功能正常、甲状腺功能亢进、甲状腺功能减退、复发以及GO的变化。

结果

RIT和ATD均与GO恶化和新发GO相关。RIT和ATD均导致既往存在的GO类似程度的加重或发展为新发GO。在接受RIT或ATD治疗后,甲状腺功能正常的患者(未进行左甲状腺素替代)GO有所改善,78%至89%的既往存在GO的患者病情改善,而甲状腺功能亢进、甲状腺功能减退和复发的患者GO病情恶化或出现新发GO。

结论

甲状腺功能是主要危险因素。在自然病程和接受治疗的患者中,甲状腺功能可能是GO恶化或新发的最重要决定因素,与治疗方式无关。因此,我们建议将甲状腺功能正常作为治疗目标。

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