Angelopoulos Nicholas, Paparodis Rodis D, Androulakis Ioannis, Anagnostis Panagiotis, Boniakos Anastasios, Duntas Leonidas, Karras Spyridon N, Livadas Sarantis
Endocrine Unit, Athens Medical Centre, Athens, Greece.
Private Practice, 26G Venizelou St, 65302, Kavala, Greece.
Thyroid Res. 2023 Jul 17;16(1):18. doi: 10.1186/s13044-023-00162-8.
In the last decade, the combination of the widespread use of streptavidin-biotin technology and biotin-containing supplements (BCS) in the daily clinical practice, have led to numerous reports of erroneous hormone immunoassay results. However, there are no studies assessing the clinical and biochemical significance of that phenomenon, when treating patients with hypothyroidism. Therefore, a prospective study was designed to investigate the potential alterations in the measurement of thyroid hormone concentrations and clinical consequences in patients with hypothyroidism using low -dose BCS containing less than 300 μg/day.
Fifty-seven patients on thyroxine supplementation, as a result of hypothyroidism and concurrent use of BCS at a dose <300μg/day for 10 to 60 days were prospectively evaluated. Namely, TSH and free T4 (FT4) concentration measurements were performed, during BC supplementation and 10 days post BCS discontinuation and compared to 31 age-matched patients with supplemented hypothyroidism and without BCS.
A statistically significant increase in TSH and decline in FT4 concentrations was observed after BCS discontinuation. However, on clinical grounds, these modifications were minor and led to medication dose adjustment in only 2/57 patients (3.51%) in whom TSH was notably decreased after supplement discontinuation.
Our study suggests that changes in thyroid hormones profiling, due to supplements containing low dose biotin, are of minimal clinical relevance and in most cases don't occult the need to adjust the thyroxine replacement dose in patients with hypothyroidism. Larger, well-designed trials are required to further evaluate this phenomenon.
在过去十年中，链霉亲和素-生物素技术的广泛应用与日常临床实践中含生物素补充剂（BCS）的联合使用，导致了大量关于激素免疫测定结果错误的报告。然而，在治疗甲状腺功能减退症患者时，尚无研究评估该现象的临床和生化意义。因此，设计了一项前瞻性研究，以调查使用每日剂量低于300μg的低剂量BCS的甲状腺功能减退症患者甲状腺激素浓度测量的潜在变化及临床后果。
前瞻性评估了57例因甲状腺功能减退症而补充甲状腺素且同时使用剂量<300μg/天的BCS达10至60天的患者。具体而言，在补充BCS期间以及停用BCS后10天进行促甲状腺激素（TSH）和游离甲状腺素（FT4）浓度测量，并与31例年龄匹配的补充甲状腺素但未使用BCS的患者进行比较。
停用BCS后，观察到TSH有统计学意义的升高和FT4浓度下降。然而，从临床角度来看，这些变化较小，仅导致2/57例患者（3.51%）的药物剂量调整，这些患者在停用补充剂后TSH显著降低。
我们的研究表明，低剂量生物素补充剂导致的甲状腺激素谱变化临床相关性极小，在大多数情况下并不影响甲状腺功能减退症患者调整甲状腺素替代剂量的必要性。需要更大规模、设计良好的试验来进一步评估这一现象。
