Sjogren Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients fulfilled the 2002 American-European Consensus Group classification criteria or 2016 ACR/EULAR Consensus Group classification criteria; 2. All patients still showed oral dryness and xerophthalmia after a 6-mouths treatment of hydroxychloroquine sulfate.
Exclusion criteria
Exclusion criteria: 1. Patients with the existence of other connective tissue diseases; 2. Acute sialadenitis, or existence of a relevant, active infection, hepatitis B or C, tuberculosis, HIV or other immunodeficiency, malignancies within 5 years prior, recent organ transplant; 3. Serious cardiovascular diseases, kidney, liver, and other important organ damage, Serious diseases of the blood system and endocrine system; 4. Severe intercurring neurological or psychiatric disease; 5. Pregnancy/lactation and unwillingness to use contraception throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unstimulated whole saliva flow;Stimulated whole saliva flow;Schirmer test;Corneal fluorescence staining;Tear break-up time;EULAR Sjogren's Syndrome Patient Reported Index (ESSPI) Score;EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| XI Score;COD Score;Chinese version of the symptom assessment in dry eye (SANDE) score;Blood routine examination;Erythrocyte sedimentation rate;Immunologic function; | — |
Countries
China
Contacts
Ningbo Medical Center Lihuili Hospital