2.1 Study design and population
This is a retrospective, single center study. Patients who received lung
transplantation at China-Japan Friendship Hospital from August 2016 to
August 2022 were selectively enrolled according to the criteria for the
study. The inclusion criteria were: (1) lung transplantation for the
first time; (2) received TAC-based immunosuppressive therapy. The
exclusion criteria were: (1) unable to participate in CYP3A5genotyping; (2) switched to cyclosporine or sirolimus; (3) incomplete
baseline data; (4) survived less than three months.
All procedures in this study were in accordance with the 1964 Helsinki
declaration and its amendments, and was approved by the Ethics Committee
of China-Japan Friendship Hospital in June, 2022 (No. 2022-KY-056-1).
2.2 Immunosuppressive
regimens
For induction therapy, patients received methylprednisolone alone or in
combination with basiliximab. Methylprednisolone was given
intraoperatively at a dose of 500–1000 mg. Basiliximab were given both
before transplantation and on post-operative day (POD) 4 at a dose of 20
mg.
The maintenance immunosuppressive regimen consists of immediate-release
capsules of TAC, immediate-release tablets of mycophenolate mofetil, and
prednisone. TAC administration was initiated on POD 1 at a standard
dosage of 2 mg per day, divided into two doses, unless the patient had
an exceptionally high or low body weight. Monitoring of
C0 commenced on POD 3 and continued thrice weekly during
hospitalization, with additional blood draws conducted monthly or during
follow-up visits. Per protocol in our center, the target ranges for TAC
C0 were set at 8–10
ng/mL within the first year (0–12 months) and 6–8 ng/mL within the
second year (12–24 months) after lung transplantation, respectively.
Initially, mycophenolate mofetil was administered in a dose of 1000
mg/day divided into two doses. Prednisone was intravenously administered
at a dosage of 1 mg/kg/day from POD 1 to POD 3, followed by oral
administration at a dosage of 0.5 mg/kg/day which gradually tapered down
to a long-term maintenance dose ranging between 5–10 mg/day.