acute intestinal GVHD acute intestinal GVHD
Conditions
Interventions
Budesonide(9mg/day) added to Prednisolone 1 mg/kg for 100 days, and then after the dose was tapered to 6 mg/day and to 3 mg/day weekly this treatment was finished.The symptom of GVHD is observed, and
Sponsors
Hagihara Maki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 20 years or older and diagnosed with Stage2 or higher acute intestinal GVHD after allogeneic hematopoietic stem cell transplantation Patients who can cooperate with questioning and physical examination Patients with consent to participate in this study
Exclusion criteria
Exclusion criteria: Patients with other known abdominal conditions, such as cytomegalovirus infection or TMA Patients who have difficulty taking stable medications Patients who are currently receiving oral steroid therapy for other medical conditions HBsAg-positive patients Patients with HIV antibody Patients with uncontrolled psychiatric symptoms Patients with uncontrolled active infections Patients with abscesses, intestinal perforations, or active anal fistulas Patients with a history of intestinal surgery within the past 3 months Patients with intestinal obstruction, or corresponding symptoms Patients considered inappropriate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients requiring second-line therapy for progression of intestinal GVHD within 2 weeks after initial treatment with prednisolone 1 mg/kg plus budesonide for intestinal GVHD | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-relapse mortality on day 100 (NRM) Total dose of prednisolone in combination with butesonide Number of diarrhea surveyed by interview on Days 14 and 28, 42, 70,100,142 | — |
Contacts
Public ContactTakuma Ohashi
Department of Hematology and Clinical Immunology, Yokohama City University Hospital
Outcome results
None listed