Karmisholt J, Andersen S L, Bulow-Pedersen I, Krejbjerg A, Nygaard B, Carlé A
Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.
Department of Clinical Institute, Aalborg University, Aalborg, Denmark.
Eur Thyroid J. 2022 May 24;11(3):e220031. doi: 10.1530/ETJ-22-0031.
In this prospective multicenter study with patients newly diagnosed with Graves' hyperthyroidism (GH), we studied the timing and characteristics of adverse drug reactions in patients treated with anti-thyroid drugs (ATD) for up to 48 months.
Patients with GH were treated with ATD until remission and hereafter with a low-dose regime to keep the patients in remission. The patients were followed with blood samples and recording of adverse events approximately every second month for the first 2 years and every third month for the following 2 years.
We included 208 patients and the patients were treated for a median of 22 (range: 0.5-49) months. Ten percent of the patients experienced adverse drug reactions and 75% of the cases occurred during the first 6 months. After 24 months, the methimazole dose was lowered to 5 mg/day, and after this time point, no further adverse drug reactions were recorded. Skin reactions were the most prominent reaction, comprising 68% of the registered reactions, and no hepatic and bonemarrow affection was recorded.
With this study, we report the frequency, timing of occurrence, and characteristics of adverse drug reactions when treating GH with the ATD drug methimazole for up to 48 months. Long-term low-dose methimazole treatment can be a cost-effective and straightforward treatment option if adverse drug reactions such as severe hepatic and bone marrow affection are kept in mind.
在这项针对新诊断为格雷夫斯甲亢(GH)患者的前瞻性多中心研究中,我们研究了接受抗甲状腺药物(ATD)治疗长达48个月的患者药物不良反应的发生时间和特征。
GH患者接受ATD治疗直至缓解,此后采用低剂量方案维持患者缓解状态。在最初2年,大约每两个月对患者进行一次血样检测并记录不良事件,接下来2年每三个月进行一次。
我们纳入了208例患者,患者的中位治疗时间为22个月(范围:0.5 - 49个月)。10%的患者出现药物不良反应,其中75%的病例发生在最初6个月内。24个月后,甲巯咪唑剂量降至5毫克/天,自此之后未再记录到药物不良反应。皮肤反应是最突出的反应,占已记录反应的68%,未记录到肝脏和骨髓受累情况。
通过本研究,我们报告了使用ATD药物甲巯咪唑治疗GH长达48个月时药物不良反应的发生频率、时间及特征。如果考虑到严重肝脏和骨髓受累等药物不良反应,长期低剂量甲巯咪唑治疗可能是一种经济有效且简便的治疗选择。