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桥本甲状腺炎伴持续症状的甲状腺功能正常患者的甲状腺切除术与药物治疗:一项随机试验。

Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial.

机构信息

Telemark Hospital, Skien, Norway (I.G., L.C.R., A.L., C.G., E.C., G.H.).

Stavanger University Hospital, Stavanger, Norway (L.J., J.K.N.).

出版信息

Ann Intern Med. 2019 Apr 2;170(7):453-464. doi: 10.7326/M18-0284. Epub 2019 Mar 12.

DOI:10.7326/M18-0284
PMID:30856652
Abstract

BACKGROUND

Hashimoto disease is a chronic autoimmune thyroiditis. Despite adequate hormone substitution, some patients have persistent symptoms that may be the result of immunologic pathophysiology.

OBJECTIVE

To determine whether thyroidectomy improves symptoms in patients with Hashimoto thyroiditis who still have symptoms despite having normal thyroid gland function while receiving medical therapy.

DESIGN

Randomized trial. (ClinicalTrials.gov: NCT02319538).

SETTING

Secondary care hospital in Norway.

PATIENTS

150 patients aged 18 to 79 years with persistent Hashimoto-related symptoms despite euthyroid status while receiving hormone replacement therapy and with serum antithyroid peroxidase (anti-TPO) antibody titers greater than 1000 IU/mL.

INTERVENTION

Total thyroidectomy or medical management with hormone substitution to secure euthyroid status in both groups.

MEASUREMENTS

The primary outcome was general health score on the Short Form-36 Health Survey (SF-36) at 18 months. Secondary outcomes were adverse effects of surgery, the other 7 SF-36 subscores, fatigue questionnaire scores, and serum anti-TPO antibody titers at 6, 12, and 18 months.

RESULTS

During follow-up, only the surgical group demonstrated improvement: Mean general health score increased from 38 to 64 points, for a between-group difference of 29 points (95% CI, 22 to 35 points) at 18 months. Fatigue score decreased from 23 to 14 points, for a between-group difference of 9.3 points (CI, 7.4 to 11.2 points). Chronic fatigue frequency decreased from 82% to 35%, for a between-group difference of 39 percentage points (CI, 23 to 53 percentage points). Median serum anti-TPO antibody titers decreased from 2232 to 152 IU/mL, for a between-group difference of 1148 IU/mL (CI, 1080 to 1304 IU/mL). In multivariable regression analyses, the adjusted treatment effects remained similar to the unadjusted effects.

LIMITATION

Results are applicable only to a subgroup of patients with Hashimoto disease, and follow-up was limited to 18 months.

CONCLUSION

Total thyroidectomy improved health-related quality of life and fatigue, whereas medical therapy did not. This improvement, along with concomitant elimination of serum anti-TPO antibodies, may elucidate disease mechanisms.

PRIMARY FUNDING SOURCE

Telemark Hospital.

摘要

背景

桥本氏病是一种慢性自身免疫性甲状腺炎。尽管进行了充分的激素替代治疗,但一些患者仍存在持续的症状,这可能是免疫病理生理学的结果。

目的

确定对于桥本氏甲状腺炎患者,在接受药物治疗时甲状腺功能正常但仍有症状的患者,甲状腺切除术是否能改善症状。

设计

随机试验。(ClinicalTrials.gov:NCT02319538)。

地点

挪威的一家二级保健医院。

患者

150 名年龄在 18 至 79 岁之间的患者,尽管接受激素替代治疗且甲状腺功能正常,但仍有与桥本氏病相关的持续性症状,并且血清甲状腺过氧化物酶(anti-TPO)抗体滴度大于 1000IU/ml。

干预措施

甲状腺全切除术或用激素替代治疗以确保两组患者的甲状腺功能正常。

测量

主要结局是在 18 个月时使用健康调查简表 36 项(SF-36)的一般健康评分。次要结局是手术的不良反应、SF-36 的其他 7 个亚量表、疲劳问卷评分以及 6、12 和 18 个月时的血清 anti-TPO 抗体滴度。

结果

在随访期间,只有手术组显示出改善:总体健康评分从 38 分增加到 64 分,两组间差异为 29 分(95%CI,22 至 35 分),在 18 个月时。疲劳评分从 23 分降至 14 分,两组间差异为 9.3 分(CI,7.4 至 11.2 分)。慢性疲劳频率从 82%降至 35%,两组间差异为 39 个百分点(CI,23 至 53 个百分点)。血清 anti-TPO 抗体滴度中位数从 2232IU/ml 降至 152IU/ml,两组间差异为 1148IU/ml(CI,1080 至 1304IU/ml)。在多变量回归分析中,调整后的治疗效果与未调整的效果相似。

局限性

结果仅适用于桥本氏病患者的亚组,随访时间限制为 18 个月。

结论

甲状腺全切除术改善了与健康相关的生活质量和疲劳,但药物治疗没有。这种改善,以及同时消除血清 anti-TPO 抗体,可能阐明了疾病的机制。

主要资金来源

特马克医院。

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