Elfayoumy Khaled Nagy, Elgazzar Usama Bahgat, Aboalabbas Mohamed, Al-Adl Ahmed Salama
Internal Medicine Department, Faculty of Medicine, Al-Azhar University, New Damietta, Damietta, Egypt.
Biochemistry Department, Faculty of Medicine, Al-Azhar University, New Damietta, Damietta, Egypt.
Electron Physician. 2017 Feb 25;9(2):3706-3713. doi: 10.19082/3706. eCollection 2017 Feb.
Many hypothyroid patients are not tolerant and not satisfied with levothyroxine (LT4). Older studies used large doses of both carbimazole and LT4 for Hashimoto's thyroiditis (HT), because Graves' disease (GD) and HT were considered as very closely related syndromes produced by thyroid autoimmunity.
The aim of the study was to determine the outcome after adding small doses of carbimazole to reduced doses of LT4 for patients with primary hypothyroidism, who are unable to tolerate LT4.
The study is a non-randomized, single arm, interventional study. It included 19 female patients diagnosed with primary hypothyroidism who could not tolerate LT4. Subjects were recruited from the outpatient clinic of AL-Azhar University Hospital in Damietta, Egypt from January to March 2015. They were divided into two groups; group 1 included 10 patients with HT and 2 patients with non-specified primary hypothyroidism, and group 2 included 7 patients with subtotal thyroidectomy for GD. All patients received carbimazole (10 mg/day) beside LT4 (25 μg thrice/week) for 10 weeks. Statistical analysis of the data was done by SPSS version 20, using paired-sample t-test, ANOVA, Chi square, and Pearson coefficient test.
There was significant increase in free triiodothyronine (FT3) in addition to significant improvement in depression and LT4 tolerance in the whole population. There was non-significant improvement in TSH in group 1 (p=0.053). Surprisingly, in group 2, in spite of significant increase in TSH (p=0.007) and non-significant decrease in free thyroxine (FT4), there was non-significant increase in FT3. Whether carbimazole improves the pathology of the hypothyroid gland or the peripheral deiodination of T4 to T3 (where the serum and tissue levels of the latter may be responsible for improvement of symptoms) is in need of investigation.
Adding carbimazole to LT4 improves FT3, LT4 tolerance, and depression in primary hypothyroid female patients. Further studies are required to determine the appropriate doses of this regimen in different cases.
This study was registered at Thai Clinical Trials Registration center (http://www.clinicaltrials.in.th) with registration ID: TCTR20170123003.
The study received no fund or grant.
许多甲状腺功能减退患者对左甲状腺素(LT4)不耐受且不满意。早期研究对桥本甲状腺炎(HT)患者同时使用大剂量的卡比马唑和LT4,因为格雷夫斯病(GD)和HT被认为是由甲状腺自身免疫产生的密切相关综合征。
本研究的目的是确定对于无法耐受LT4的原发性甲状腺功能减退患者,在减少LT4剂量的基础上添加小剂量卡比马唑后的效果。
本研究为非随机、单臂干预性研究。纳入19例诊断为原发性甲状腺功能减退且无法耐受LT4的女性患者。研究对象于2015年1月至3月从埃及达米埃塔的爱资哈尔大学医院门诊招募。她们被分为两组;第1组包括10例HT患者和2例未明确病因的原发性甲状腺功能减退患者,第2组包括7例因GD行甲状腺次全切除术的患者。所有患者在服用LT4(25μg,每周三次)的基础上,加用卡比马唑(10mg/天),持续10周。使用SPSS 20版软件对数据进行统计分析,采用配对样本t检验、方差分析、卡方检验和皮尔逊相关系数检验。
全体患者的游离三碘甲状腺原氨酸(FT3)显著升高,抑郁症状和LT4耐受性也有显著改善。第1组促甲状腺激素(TSH)改善不显著(p = 0.053)。令人惊讶的是,在第2组中,尽管TSH显著升高(p = 0.007),游离甲状腺素(FT4)无显著下降,但FT3却有不显著的升高。卡比马唑是改善甲状腺功能减退腺体的病理状态还是改善T4向T3的外周脱碘作用(后者的血清和组织水平可能是症状改善的原因),尚需进一步研究。
在LT4基础上加用卡比马唑可改善原发性甲状腺功能减退女性患者的FT3、LT4耐受性和抑郁症状。需要进一步研究以确定该方案在不同病例中的合适剂量。
本研究在泰国临床试验注册中心(http://www.clinicaltrials.in.th)注册,注册号:TCTR20170123003。
本研究未获得任何资金或资助。