None
Conditions
Interventions
Observation group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, any gender; 2. Diagnosed with end-stage organ disease and has undergone allogeneic organ transplantation (including kidney transplantation, liver transplantation, etc.); 3. Postoperative treatment includes sirolimus as part of the basic immunosuppressive regimen, with a medication duration of >= 7 days; 4. Complete documented sirolimus blood concentration monitoring during the study period (including blood sampling time, drug concentration values, and testing methods); 5. Complete baseline information traceable in the electronic medical record system (such as age, gender, weight, type of transplant, pre-transplant comorbidity history, etc.), medication history (including initial sirolimus dose, adjustments, types and doses of concomitant medications, etc.), and records of adverse reactions (such as symptoms, time of occurrence, diagnostic basis, management, and outcomes).
Exclusion criteria
Exclusion criteria: 1. Patients who experienced transplant failure or died within a short period after surgery (<30 days) due to serious complications; 2. Patients with irregular use of sirolimus (such as frequent missed doses or self-adjustment of dosage) or incomplete blood concentration monitoring data (missing key sampling time points or concentration values); 3. Patients with severe immune system diseases (such as AIDS, active systemic lupus erythematosus) or malignant tumors (except for low-risk tumors such as newly developed skin cancer after transplantation); 4. Patients whose treatment plans were significantly adjusted due to other severe diseases (such as serious infections, acute myocardial infarction) during the study period, making it impossible to accurately determine the association of adverse reactions with sirolimus; 5. Patients with severe liver and kidney dysfunction (such as decompensated cirrhosis, uremia without dialysis treatment) and who were clearly deemed unsuitable for sirolimus before surgery; 6. Patients who withdrew from the study midway for personal reasons or medical disputes, making it impossible to obtain complete follow-up data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sirolimus blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sirolimus-related infection events;Sirolimus-related liver and kidney toxicity;Everolimus-related cardiovascular events; | — |
Countries
China
Contacts
Public ContactPan Hui
Shanghai General Hospital
Outcome results
None listed