Primary Sjögren's syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who meet the 2016 United States College of Rheumatology/European League Against Rheumatism classification criteria for PSS. Specifically: (1) labial focal lymphocytic infiltration with a focal index >= 1 lesion/4 mm^2 (should be scored by a pathologist who specializes in focal lymphocyte infiltration and focal index counting), 3 points; (2) Positive anti-SSA/Ro antibody, 3 points; (3) At least 1 point for monocular OSS staining score >=5 or van Bijsterveld score >=4); (4) At least monocular Schirmer test =4 was diagnosed as pSS. 2. Be between the ages of 18-70; 3.Without other well-diagnosed diseases, such as diabetes, cardiovascular disease, autoimmune disease, or viral infection; 4.No recent history of vaccination, surgery, organ transplantation, and chemoradiotherapy; 5.Subjects in the control group should meet the following criteria: 1) have dry mouth symptoms; 2) Pre-healthy, no benign and malignant tumors, endocrine diseases, cardiovascular diseases and autoimmune diseases; 3) No recent history of infection, vaccination, radiation exposure and drug use;4)Be between the ages of 18-70.
Exclusion criteria
Exclusion criteria: 1.Age70; 2.Pregnant or lactating; 3.Comorbid with the following conditions: history of head and neck radiotherapy, active hepatitis C virus infection (confirmed by PCR), AIDS, sarcoidosis, amyloidosis, graft-versus-host disease, autoimmune diseases such as IgG4-related disease, and systemic lupus erythematosus; 4.Recent vaccination, surgery, organ transplant, or receiving medication or chemoradiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sjogren's syndrome disease activity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| total saliva flow rate;Schirmer test;break-up time; | — |
Countries
China
Contacts
The Third Affiliated Hospital Sun Yat-sen University