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亚临床甲状腺功能亢进的新疗法:左旋肉碱和硒有益作用的初步研究。

A novel treatment for subclinical hyperthyroidism: a pilot study on the beneficial effects of l-carnitine and selenium.

机构信息

Department of Experimental Medicine, "Sapienza" University of Rome, Rome, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2017 May;21(9):2268-2273.

PMID:28537653
Abstract

OBJECTIVE

The definition itself of subclinical hyperthyroidism (SHyper) and, therefore, the therapeutic approach to patients with SHyper still remains undefined and controversial. Therefore, the interest of finding a novel and alternative therapy for SHyper has caught the attention. An observational pilot study was performed to assess the effects of l-carnitine and selenium in the management of SHyper symptoms and endocrine profile in patients affected by this disease.

PATIENTS AND METHODS

Patients with TSH levels between 0.1-0.4 mIU/L and positive antibodies were recruited in this study. Subjects received orally one tablet containing 500 mg of l-carnitine and 83 mcg of selenium (L-Carn + Se), daily for 1 month. The primary outcome was the improvement of the quality of life (QoL) with the disappearance of main symptoms (subjective symptomatology) associated to SHyper, evaluated through a 9-items short form survey. Secondary outcomes included TSH, fT3, and fT4, TPOAb, TgAb measurement. Primary and secondary outcomes were evaluated at baseline, after the completion of treatment and after a successive month without treatment.

RESULTS

After 1-month treatment, the subjective symptomatology significantly dropped from 25.61 ± 1.19 to 12.11 ± 1.15 (p < 0.05). On the other hand, during the following 1-month period without treatment, it increased back to 23.33 ± 1.35 (p < 0.05). Thyroid hormones and auto-antibodies remained in their normal range.

CONCLUSIONS

The present pilot study has shown that L-Carn + Se significantly reduced symptoms associated with SHyper, improving QoL of patients, without significant modifications of their endocrine profile. In addition, it is noteworthy that the extension of treatment seems necessary to prevent symptoms reappearance. Prospective randomized controlled trials are needed to address clinicians to define the appropriate treatment-settings for this disorder.

摘要

目的

亚临床甲状腺功能亢进症(SHyper)的定义,以及因此对 SHyper 患者的治疗方法仍然不明确且存在争议。因此,寻找治疗 SHyper 的新方法引起了关注。进行了一项观察性试点研究,以评估左旋肉碱和硒在治疗患有这种疾病的患者的 SHyper 症状和内分泌特征中的作用。

患者和方法

这项研究招募了 TSH 水平在 0.1-0.4 mIU/L 之间且抗体阳性的患者。患者每天口服一片含有 500mg 左旋肉碱和 83μg 硒的药物(L-Carn + Se),持续 1 个月。主要结局是通过 9 项简短形式调查评估 SHyper 相关主要症状(主观症状)消失后的生活质量(QoL)改善。次要结局包括 TSH、fT3、fT4、TPOAb、TgAb 测量。主要和次要结局在基线、治疗完成后和停药后 1 个月进行评估。

结果

治疗 1 个月后,主观症状从 25.61 ± 1.19 显著下降到 12.11 ± 1.15(p < 0.05)。另一方面,在随后的 1 个月停药期间,它又增加到 23.33 ± 1.35(p < 0.05)。甲状腺激素和自身抗体仍在正常范围内。

结论

本试点研究表明,L-Carn + Se 可显著减轻与 SHyper 相关的症状,改善患者的生活质量,而不会对其内分泌特征产生显著影响。此外,值得注意的是,需要延长治疗时间以防止症状再次出现。需要进行前瞻性随机对照试验,以帮助临床医生确定治疗这种疾病的适当治疗方案。

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