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Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tarcolimus | refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission | ||
| methotrexate | refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission |
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| Measure | Description | Time Frame |
|---|---|---|
| disease activity assessment after one year treatment | Disease activity is assessed through blood test, radiology and clinical for both Crohn's disease and ulverative colitis. We evaluate clinical response based on Crohn's disease activity index (CDAI) for CD and Mayo score for UC at the end of one year observation. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events. | The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | one year |
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Inclusion Criteria:
Exclusion Criteria:
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Inflammatory bowel disease patients who are refractory or intolerance to conventional therapy (including mesalazine, steroid, azathioprine and biological agents). Tarcolimus or methotrexate was used in these patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Shen, MD | Contact | 8613651829887 | shenjun@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhihua Ran, MD | Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health;Shanghai Inflammatory Bowel Disease Research Center;Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health;Shanghai Inflammatory Bowel Disease Research Center;Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200000 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| China |
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