moderate to severe active systemic lupus erythematosus
Conditions
Interventions
Immunomodulation combined with traditional DMARDS treatment group:Immunomodulation combined with traditional DMARDS group: On the basis of glucocorticoid and traditional DMARDS treatment, metformin hy
atorvastatin tablets 10mg, 1 times / day
in the first 4 weeks , 12 weeks and 24 weeks to assess the SELSNA-SLEDAI score table,
traditional DMARDS treatment group:Traditional DMARDS treatment group: the use of glucocorticoid and traditional DMARDS treatment. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index scor
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) SLE patients who met the 1997 American College of Rheumatology (ACR) systemic lupus erythematosus classification criteria; (3) the definition of moderate to severe systemic lupus erythematosus: SLEDAI score to = 10 points; (4) Screening subjects with body mass index (BMI) = 20; (5) Th17 / Treg imbalance or Th17 higher than normal range or Treg below normal range; (6) Pregnancy test for women of childbearing age was negative and agreed to take effective contraceptive measures during the trial period and within 6 months after the end of the trial; (7) subjects can be scheduled for referral; (8) signed informed consent.
Exclusion criteria
Exclusion criteria: (1) known prednisone acetate tablets, methylprednisolone tablets, metformin hydrochloride tablets, atorvastatin tablets, hydroxychloroquine tablets and traditional DMARDS drug 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) active bleeding and gastrointestinal ulcers; (10) to merge other autoimmune diseases; (11) such as lymphoma and other lymphoproliferative diseases; (12) multiple sclerosis or other central nervous demyelomy disease; (13) 4 weeks participated in other drug observers or recently applied other biological agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Th17, Treg and Th17 / Treg ratio;SELENA -SLEDAI scorecard;BILAG worksheet;SLE damage index score;Complement C3;Complement C4;ds-DNA quantification;ESR;CRP;Renal function;blood routine;urine routine;Peripheral blood cell count;liver 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