Perianal Fistulizing Crohn's disease
Conditions
Interventions
Ustekinumab dual initial intravenous dose group:Remission was induced by two intravenous injections of ustekinumab at standard doses at weeks 0 and 8, followed by maintenance treatment with subcutaneo
Ustekinumab standard induction group:Remission was induced by two intravenous injections of ustekinumab at standard doses at week 0, followed by maintenance treatment with subcutaneous ustekinumab at
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: a. Patients diagnosed with Perianal Fistulizing Crohn's disease, confirmed with Perianal Fistulising by physical examination or MRI, and treated with UST (including those who have used other biological agents in the past). Crohn's disease lacks a gold standard for diagnosis, mainly combining clinical, laboratory examination, imaging, endoscopy and histopathological manifestations for comprehensive analysis, and making a diagnosis based on the exclusion of infectious and other non-infectious colitis. Its diagnostic criteria are referred to in detail:Consensus opinion on the diagnosis and treatment of inflammatory bowel disease (2018-Beijing)[J]. Chinese Journal of Practical Internal Medicine,2018,38(9):796-813.Perianal Fistulizing Crohn's disease is different from ordinary anal fistula, and the fistula situation is usually more complicated. Its diagnosis is referred to in detail:Expert consensus opinion on the diagnosis and treatment of Perianal Fistulizing Crohn's disease[J]. Chinese Journal of Inflammatory Bowel Disease,2019(02):105-110; b. Meet the indications for the use of UST monoclonal antibody; c. Age between 18-65 years old and gender; d. Consciousness, no psychiatric system diseases, and normal cognitive personality; e. Those who are informed about the content of this study and participate voluntarily, all signing the informed consent form.
Exclusion criteria
Exclusion criteria: a. Patients who refused to participate in the study of the subject, patients who voluntarily withdrew from the study of the subject in the middle of the study, and those whose poor co-operation made it impossible to obtain important information; b. Patients with previous intestinal tuberculosis, leucosis, primary intestinal malignant lymphoma, colorectal cancer and other gastrointestinal diseases other than Crohn's disease; c. Serious diseases of the heart, liver, kidneys and other important organs, tumours, infectious diseases, immunological diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula clinical remission rate;Fistula radiological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein, CRP;Fecal calprotectin, FC;Crohn's disease activity index, CDAI;Perianal disease activity index, PDAI;Erythrocyte sedimentation rate, ESR; | — |
Countries
China
Contacts
Public ContactYang Bolin
Affiliated Hospital of Nanjing University of Chinese Medicine
Outcome results
None listed