Meniere's disease
Conditions
Interventions
Methotrexate:Methotrexate tablets 10mg orally after meals, once a week, 2 weeks later adjusted to 15mg, a total of 6 months
Oral methotrexate followed by oral folate 5mg for 24 hours
Sponsors
Shandong Second Provincial General Hospital(Shandong Provincial ENT Hospital,Shandong ENT Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Confirmed Meniere's disease, according to the 2015 Barany diagnostic criteria. i. Two or more spontaneous dizziness attacks, each lasting 20 minutes to 12 hours. Ii. At least one auditory recording of low to mid frequency sensorineural hearing loss (0.5, 1, 2k Hz) prior to, during, or after the onset of dizziness. Iii. Fluctuating auditory symptoms of the affected ear (hearing, tinnitus, or tinnitus). Iv. Other diagnoses cannot be better explained. 2) Patients with poor control after 6 months of traditional treatment (betamethasone 12 mg t.i.d po, hydrochlorothiazide 25 mg b. i.d, po; systemic and/or tympanic hormone injection during acute phase) (with an average of = 1 episode per month in the first 3 months of enrollment) 3) 18-70 years old.
Exclusion criteria
Exclusion criteria: 1) Cerebellopontine angle tumors or other intracranial space occupying lesions; 2) Age beyond the range of 18-70 years old; 3) There are drug contraindications and a history of adverse/allergic reactions to such drugs. 4) Complicated middle ear diseases that may interfere with treatment and evaluation (such as active middle ear diseases); 5) Pregnant women;Women preparing for pregnancy; women who have not yet given birth 6) Oral corticosteroids, monoclonal antibodies, and immunosuppressive therapy within 6 weeks prior to screening; 7) Subjects who have used any of the following treatment methods within 4 weeks prior to baseline visit or within a period equivalent to 5 times the half-life of the medication, whichever is longer: ? Immunosuppressive/immunomodulatory drugs (such as systemic corticosteroids, cyclosporine, mycophenolate 1) Cerebellopontine angle tumors or other intracranial space occupying lesions; 2) Age beyond the range of 18-70 years old; 3) There are drug contraindications and a history of adverse/allergic reactions to such drugs. 4) Complicated middle ear diseases that may interfere with treatment and evaluation (such as active middle ear diseases); 5) Pregnant women;Women preparing for pregnancy; women who have not yet given birth 6) Oral corticosteroids, monoclonal antibodies, and immunosuppressive therapy within 6 weeks prior to screening; 7) Subjects who have used any of the following treatment methods within 4 weeks prior to baseline visit or within a period equivalent to 5 times the half-life of the medication, whichever is longer: ? Immunosuppressive/immunomodulatory drugs (such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN - ?, Janus kinase inhibitors, azathioprine, etc.), systemic anti-inflammatory drugs ? Other biological agents: within 5 half-lives (if known) or 16 weeks, whichever is longer. 8) Positive for syphilis, HIV, and hepatitis viruses. 9) Severe comorbidities such as cancer, liver disease, or kidney disease 10) Merge autoimmune diseases, including but not limited to rheumatoid arthritis, lupus, thyroid autoimmune diseases, psoriasis, ankylosing spondylitis, polymyositis, and multiple sclerosis. 11)Combined diagnosed mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Number of attack episodes in 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective control rate of vertigo;Pure tone average;Vestibular function;Scale evaluation;Gd-enhanced inner ear MRI;Blood immunological tests: cell subsets, cytokines, IgE; | — |
Countries
China
Contacts
Public ContactHaibo Wang
Shandong Second Provincial General Hospital(Shandong Provincial ENT Hospital,Shandong ENT Institute)
Outcome results
None listed