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The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups,including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose interleukin-2 | Active Comparator | One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks. |
|
| Rapamycin | Active Comparator | Rapamycin 0.5ml once per day for 12 weeks. |
|
| Low-dose interleukin-2 and rapamycin | Experimental | One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose interleukin-2 | Drug | low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once twice a week, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Treg cells in peripheral blood | Proportion of Treg cells in peripheral blood will be detected by flowcytometry | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| ESSDAI [potential score 0 - 123] | ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome. | week 12 |
| Physician's Global Disease Activity VAS, (potential score 0 - 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li | Peking university peoples hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university people's hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| rapamycin | Drug | Rapamycin 0.5ml was taken orally once per day |
|
|
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
| week 12 |
| Patient's Global Disease Activity VAS, (potential score 0 - 80) | Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome. | week 12 |
| Rate of Participants with adverse effects associated with experimental drugs | Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy. | week 12 |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |