Overview
This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
Description
Graves' orbitopathy (GO) is one of the common manifestations of Graves' disease (GD), which results in proptosis, eyelid retraction, soft tissue swelling, diplopia or even visual acuity impairment. In addition, mental health and quality of life are often affected. In current guidelines, limited treatment options are suggested for patients with mild GO.
Recently, cell study revealed that there are multiple effects of hydroxychloroquine (HCQ) on orbital fibroblasts in patients with mild GO, including suppression of cell proliferation, adipogenesis and production of hyaluronic acid, which poses a great potential in the treatment of mild GO clinically. This randomized controlled trial is aimed to investigate the effects of HCQ in patients with mild GO on the effects of ophthalmic outcomes, quality of life, orbital volumetry on orbital computed tomography, serum inflammatory and fibrosis markers.
Eligibility
Inclusion Criteria:
- Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist.
- No previous treatment of GO except for eyedrops
- Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months.
Exclusion Criteria:
- Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist.
- Pregnancy
- Drug or alcohol abuse
- Unable to comply with the study protocol
- Unable to obtain informed consent
- Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment
- History of side effects of hydroxychloroquine
- History of retinopathy
- Renal dysfunction (estimated glomerular filtration rate (eGFR) < 60ml/min)
- Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit)
- Anemia (hemoglobin (Hb) < 10g/dl)
- Neutropenia (absolute neutrophil count < 100/uL)
- Thrombocytopenia (platelet (PLT) < 150000/uL)
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Porphyria cutaneous tarda
- Allergy to 4-aminoquinoline