Karmisholt J, Andersen S L, Bulow-Pedersen I, Carlé A, Krejbjerg A, Nygaard B
Dept. of Endocrinology, Aalborg University Hospital, 9000 Aalborg, Denmark.
Dept. of Clinical Institute, Aalborg University, 9100 Aalborg, Denmark.
J Thyroid Res. 2019 Jan 3;2019:5945178. doi: 10.1155/2019/5945178. eCollection 2019.
To study predictors of attaining (part 1) and sustaining (part 2) remission in patients with Graves' hyperthyroidism (GH) treated with antithyroid drugs (ATD). In the prospective first part, the included patients were treated with ATD until a prespecified definition of remission (thyrotropin > 0.4 mU/L and TSH-receptor antibodies (TRAb) ≤ 1. 0 IU/L in a patient receiving a methimazole dose ≤ 5 mg/day, on two occasions two months apart) was met, or for 24 months. In the second part, patients attaining remission in part 1 were randomized to treatment or observation and followed until relapse or for 24 months. 173 patients completed study 1 and 53% attained remission. TRAb and age were the only significant predictors of remission. Patients with baseline TRAb below vs above 10 IU/L attained remission in 63% compared to 39%, and 5 months priorly (p<0.001). In study 2, 96.4% of the patients randomized to treatment (n=33) sustained remission compared to 66% in the observation group (n=33). Treatment arm was the only significant parameter (p<0.001) of sustained remission. Baseline TRAb was prognostic for attaining remission in GH. Consecutive TRAb measurements during treatment were not worthwhile, but a single measurement after 6-8 months in patients with initial TRAb < 10 IU/L could substantially shorten the treatment period in a subgroup of patients. Only 3.6% of the patients in remission experienced relapse during follow-up when treated with a combination of fixed low dose methimazole and L-T4. NCT00796913.
研究接受抗甲状腺药物(ATD)治疗的格雷夫斯甲亢(GH)患者实现缓解(第一部分)和维持缓解(第二部分)的预测因素。在前瞻性研究的第一部分,纳入的患者接受ATD治疗,直至达到预先设定的缓解定义(在接受甲巯咪唑剂量≤5mg/天的患者中,促甲状腺素>0.4mU/L且促甲状腺素受体抗体(TRAb)≤1.0IU/L,两次测量间隔两个月),或治疗24个月。在第二部分,第一部分实现缓解的患者被随机分为治疗组或观察组,并随访至复发或24个月。173例患者完成了研究1,53%实现了缓解。TRAb和年龄是缓解的唯一显著预测因素。基线TRAb低于10IU/L与高于10IU/L的患者,缓解率分别为63%和39%,且前者提前5个月实现缓解(p<0.001)。在研究2中,随机分配至治疗组的患者(n=33)中有96.4%维持缓解,而观察组(n=33)中这一比例为66%。治疗组是维持缓解的唯一显著参数(p<0.001)。基线TRAb对GH患者实现缓解具有预后价值。治疗期间连续测量TRAb并无价值,但对于初始TRAb<10IU/L的患者,在6 - 8个月后进行一次测量可显著缩短部分患者的治疗周期。接受固定低剂量甲巯咪唑和左甲状腺素(L-T4)联合治疗的缓解期患者在随访期间仅有3.6%复发。NCT00796913