Santaguida Maria Giulia, Virili Camilla, Del Duca Susanna Carlotta, Cellini Miriam, Gatto Ilenia, Brusca Nunzia, De Vito Corrado, Gargano Lucilla, Centanni Marco
Department of Medico-surgical Sciences and Biotechnologies, "Sapienza" University of Rome, Latina, Italy.
Endocrine. 2015 May;49(1):51-7. doi: 10.1007/s12020-014-0476-7. Epub 2015 Jan 17.
The key role of an intact gastric acid secretion for subsequent intestinal T4 absorption is supported by an increased requirement of thyroxine in patients with gastric disorders. A better pH-related dissolution profile has been described in vitro for softgel T4 preparation than for T4 tablets. Our study was aimed at comparing softgel and tablet T4 requirements in patients with gastric disorders. A total of 37 patients with gastric-related T4 malabsorption were enrolled, but only 31 (28F/3M; median age = 50 years; median T4 dose = 2.04 μg/kg/day) completed the study. All patients were in long-lasting treatment (>2 years) with the same dose of T4 tablets when treatment was switched to a lower dose of softgel T4 capsules (-17 %; p = 0.0002). Assessment of serum FT4 and TSH was carried out at baseline and after 3, 6, 12, and 18 months after the treatment switch. In more than 2/3 of patients (good-responders n = 21), despite the reduced dose of T4, median TSH values were similar at each time point (p = 0.3934) with no change in FT4 levels. In the remaining patients (poor-responders n = 10), TSH levels were significantly higher at each time point than at baseline (p < 0.0001). To note, in five of them intestinal comorbidity was subsequently detected. Comorbidity associated with poor-responders status was the only significant predictor in multivariate analysis (OR = 11.333). Doses of softgel T4 capsules lower than T4 tablet preparation are required to maintain the therapeutic goal in 2/3 of patients with impaired gastric acid secretion.
胃酸分泌完整对后续肠道甲状腺素(T4)吸收的关键作用,得到了胃部疾病患者对甲状腺素需求增加的支持。体外研究表明,软胶囊T4制剂的pH相关溶出曲线比T4片剂更好。我们的研究旨在比较胃部疾病患者对软胶囊和片剂T4的需求。共纳入37例与胃部相关的T4吸收不良患者,但只有31例(28例女性/3例男性;中位年龄 = 50岁;中位T4剂量 = 2.04μg/kg/天)完成了研究。所有患者在改用较低剂量的软胶囊T4胶囊治疗前(-17%;p = 0.0002),均长期(>2年)使用相同剂量的T4片剂进行治疗。在治疗转换前及转换后3、6、12和18个月时,对血清游离甲状腺素(FT4)和促甲状腺激素(TSH)进行了评估。在超过2/3的患者(反应良好者n = 21)中,尽管T4剂量降低,但各时间点的中位TSH值相似(p = 0.3934),FT4水平无变化。在其余患者(反应不良者n = 10)中,各时间点的TSH水平均显著高于基线水平(p < 0.0001)。需要注意的是,其中5例随后被检测出肠道合并症。多因素分析显示,与反应不良者状态相关的合并症是唯一的显著预测因素(比值比 = 11.333)。对于2/3胃酸分泌受损的患者,需要低于T4片剂制剂剂量的软胶囊T4胶囊来维持治疗目标。