Inflammatory bowel disease Digestive System Other noninfective gastroenteritis and colitis
Conditions
Interventions
Retrospective self-controlled trial:
Retrospectively assess the impact of genetic variation and concentration of metabolites on efficacy and toxicity of AZA/6-MP in patients with IBD.
Drug dose was s
Sponsors
Sun Yat-sen University (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All consecutive patients with the diagnosis of IBD who received the azathioprine treatment at the Gastroenterology Outpatient Clinic of the First Affiliated Hospital of Sun Yat-sen University 2. Aged from 3 - 74 years, either sex 3. Steroid-dependent disease: unable to reduce corticosteroids below the equivalent of prednisolone 15 mg/day (or budesonide below 3 mg/day) within three months of starting corticosteroids or relapse within three months of stopping corticosteroids 4. Frequent relapses: greater than three relapses in one year or greater than two relapses in six months 5. Remission maintenance 6. Post-operative prophylaxis
Exclusion criteria
Exclusion criteria: 1. Blood transfusion or administration of cyclosporine or methotrexate (MTX) within the last 3 months 2. Treatments potentially interfering with AZA metabolism, including allopurinol and diuretics 3. Insufficient function in heart, liver or kidney 4. Active infection 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Distribution of TPMT, HPRT, GST, XO, ITPA and IMPDH polymorphisms in Chinese IBD patients 2. The impact of genetic variation on efficacy and toxicity of AZA/6-MP in patients with IBD 3. The therapeutic and safe concentration threshold of 6-TGNs in Chinese IBD patients undergoing AZA/6-MP therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparisons between the stable dose therapy group and pharmacogenetic-guided metabolites monitoring therapy group: 1. The efficacy of AZA/6-MP treatment was only assessed when the treatment had been continued for 24 weeks or more. Remission was defined as no need corticosteroids for at least 1 month, and a Pediatric Crohn's Disease Activity Index (PCDAI) less than 10, Crohn's Disease Activity Index (CDAI) less than 150 or according to the criteria for remission defined by Truelove and Witts and without relapse in remaining weeks. Surgery and initiation of biological or other therapies were considered as treatment failure. 2. Haematotoxicity observed as myelosuppression included leukopaenia and neutropaenia. Leukopaenia was defined as a leukocyte count (WBC) less than 3.5 x 10^9/L, and neutropaenia was defined as less than 1.5 x 10^9/L neutrophils. Each decrease of WBC and neutrophils should be continuously observed in two days, and recovered in the next one or two weeks after AZA/6-MP withdrawal. Hepatotoxicity was defined as an increase in transaminases at least two times higher than the normal value. Pancreatitis was diagnosed when compatible symptoms (abdominal pain) were present and serum amylase was increased two times above the upper normal limit. Flu-like symptoms included febris, headache, courbature and arthralgia all over the body while gastrointestinal intolerance was defined as hypogeusia, nausea and vomiting. | — |
Countries
China
Outcome results
None listed