Stoynova Mariya Asenova, Shinkov Alexander Dimitrov, Dimitrova Inna Dimitrova, Yankova Inna Angelova, Kovatcheva Roussanka Dimitrova
Department of Endocrinology, Medical University of Sofia, University Hospital of Endocrinology, 2 Zdrave Str., 1431, Sofia, Bulgaria.
Int Ophthalmol. 2023 Dec;43(12):4747-4757. doi: 10.1007/s10792-023-02875-z. Epub 2023 Sep 12.
Intravenous glucocorticoids (GCs) are the mainstay of treatment for severe forms of Graves' orbitopathy (GO). Our aim was to assess the effectiveness and safety of a modified monthly regimen (mMR) and to compare them with those of the established weekly regimen (WR).
This was a prospective non-randomized single-center study involving 62 patients, divided into two therapeutic groups depending on their referral time. Thirty-one subjects, admitted in the period 2017-2018, were treated with mMR, total dose-5.5 g, with intake of oral GCs after completion of intravenous infusions. Thirty subjects, who were referred in the period 2019-2020, were treated with WR, total dose-4.5 g One patient refused to be part of the WR group and was treated with mMR. Eye status and therapeutic response were evaluated on the 1st, 3rd and 6th months, quality of life-at 3rd and 6th month.
At 1st month and 3rd month, there was no significant difference in the therapeutic response between the two groups. At 3rd month, the proportion of patients with improvement in soft tissue manifestations and subjective complaints was significantly higher in mMR group (65.6% vs. 40% and 81.3% vs. 46.7%, respectively) and the same manifestations were of significantly milder degree. At 3rd month, significant improvement in quality of life was found without significant difference between the two groups. At 6th month, worsening of GO occurred in 3 patients from WR group, while in 5 patients from mMR group further improvement was found.
The two GC regimens have comparable efficacy with small differences in the time of onset of the effect and its duration, as well as in the effectiveness on some ocular manifestations. Trial registration number NCT05793359/29.03.2023, retrospectively registered..
静脉注射糖皮质激素（GCs）是重度格雷夫斯眼眶病（GO）治疗的主要手段。我们的目的是评估改良每月方案（mMR）的有效性和安全性，并将其与既定的每周方案（WR）进行比较。
这是一项前瞻性非随机单中心研究，涉及62例患者，根据其转诊时间分为两个治疗组。2017年至2018年期间入院的31名受试者接受了mMR治疗，总剂量为5.5克，静脉输注完成后口服GCs。2019年至2020年期间转诊的30名受试者接受了WR治疗，总剂量为4.5克。一名患者拒绝加入WR组，接受了mMR治疗。在第1、3和6个月评估眼部状况和治疗反应，在第3和6个月评估生活质量。
在第1个月和第3个月，两组的治疗反应无显著差异。在第3个月，mMR组软组织表现和主观症状改善的患者比例显著更高（分别为65.6%对40%和81.3%对46.7%），且相同表现的程度明显较轻。在第3个月，生活质量有显著改善，两组之间无显著差异。在第6个月，WR组有3名患者GO病情恶化，而mMR组有5名患者病情进一步改善。
两种GC方案疗效相当，在起效时间、持续时间以及对某些眼部表现的有效性方面存在细微差异。试验注册号NCT05793359/2023年3月29日，回顾性注册。
