Primary mild to moderate systemic systemic lupus erythematosus
Conditions
Interventions
Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 w
Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and ser
Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets)
Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally
and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.
Sponsors
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 65 years old, male or female; (2) Newly diagnosed SLE patients who met the 1997 American College of Rheumatology (ACR) systemic lupus erythematosus classification criteria; (3) mild to moderate systemic lupus erythematosus definition: SLEDAI score to = 5 points and <15 points; (4) Screening subjects with body mass index (BMI) = 20; (5) Pregnancy test for women of childbearing age is negative and agreed to take effective contraceptive measures during the trial period and within 6 months after the end of the trial; (6) subjects can be scheduled for referral; (7) Sign informed consent.
Exclusion criteria
Exclusion criteria: (1) known prednisone acetate tablets, methylprednisolone tablets, metformin hydrochloride tablets, atorvastatin tablets, leflunomide tablets, hydroxychloroquine allergy; (2) active neuropsychiatric lupus; (3) abnormal liver function (valley or aspartate aminotransferase higher than the upper limit of normal 2 times); (4) pregnant or lactating women; (5) history of malignant tumors and does not meet the following conditions (suffering from basal cell carcinoma and have been properly treated; suffering from other malignancies but have been successfully treated for more than 5 years before screening and no evidence of recurrence); (6) subjects with severe acute, chronic or recurrent infections (eg pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.); (7) Hepatitis B virus carrying or chronic active hepatitis B, hepatitis C, HIV infection; (8) compensatory disorders of cardiac insufficiency or severe hypertension or diabetes, that is, systolic blood pressure higher than 160mmHg, or diastolic blood pressure higher than 100mmHg; (9) blood if abnormal, WBC 1.0g; (11) active bleeding and gastrointestinal ulcers; (12) combined with other autoimmune diseases; (13) such as lymphoma and other lymphoproliferative diseases; (14) with multiple sclerosis or other central nervous demyelomy disease; (15) 4 weeks participated in other drug observers or recently used other biological agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Urine routine;ANA;ENA;ds-DNA;Complement C3;Complement C4;ESR;CRP;Peripheral blood Th17, Treg cell absolute count and proportion;SELENA -SLEDAI score;BILAG score;SLE damage index score;Peripheral blood cell count;liver function;Renal function;blood sugar;blood lipids;Myocardial enzymes; | — |
Countries
China
Contacts
Public ContactWang Yongfu
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Outcome results
None listed