DOI: 10.1210/clinem/dgad476 ISSN:

A randomized clinical trial of intravenous methylprednisolone with two protocols in patients with Graves’ Orbitopathy

Zhangfang Li, Yaosheng Luo, Quandi Huang, Zhi Chen, Dandan Song, Daoyan Pan, Shidi Hu, Wei Jiang, Qiuyue Cai, Xiaoting Feng, Qing Zhang, Chanyan Weng, Qiang Zhong, Tongfeng Zhao, Chenzhong Li, Tong Zhang, Jie Shen
  • Biochemistry (medical)
  • Clinical Biochemistry
  • Endocrinology
  • Biochemistry
  • Endocrinology, Diabetes and Metabolism
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Abstract

Context

Intravenous glucocorticoids (IVGC) is an accessible and affordable treatment for Graves’ orbitopathy (GO), 4.5-gram protocol is well studied, but many details of treatment protocols need to be clarified.

Objective

To compare the efficacy and safety of weekly and monthly protocol of IVGC in GO.

Design

a prospective, randomized, observer-masked, single-center clinical trial, followed up to week 24.

Setting

The third affiliated hospital of Southern Medical University.

Patients

58 GO Patients aged 18-60 years old with active and moderate-to-severe who have not received relevant treatment.

Interventions

IVGC of the weekly protocol or monthly protocol, both received a cumulative dose of methylprednisolone 4.5g and had a duration of 12 weeks.

Main Outcome Measures

The overall effective rate, improvement of quality of life (QOL) and signal intensity ratio (SIR).

Results

There was no significant difference in the effective rate between the two groups at week 12 and week 24 (86.21% VS 72.41%, P = 0.195; 86.21% VS 82.61%, P = 0.441), there was no significant difference in the improvement of CAS, exophthalmos, soft tissue involvement, diplopia and QOL. At week 24, the mean SIR and maximum SIR of two groups were lower than those before treatment, and there were no statistically significant difference between two groups. There was no significant difference in the incidence of adverse events between the two groups (31.03% VS 27.59%, P = 0.773).

Conclusions

The efficacy and safety of the two protocols are comparable, the monthly protocol could be used as an alternative to the weekly protocol.

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