Role of steroid minimization in the tacrolimus-based immunosuppressive regimen for liver transplant recipients: a systematic review and meta-analysis of prospective randomized controlled trials.
To evaluate the efficacy and safety of early steroid withdrawal or steroid avoidance in the tacrolimus (Tac)-based immunosuppressive regimen for liver transplant recipients. According to the requirements of the Cochrane systematic review, a thorough literature search was performed in the PubMed/MEDLINE and Cochrane electronic databases between 1995 and 2011 using the key words "liver transplantation," "Tac," and "steroid free" or "steroid withdrawal," restricting articles to the English language. Data were processed for a meta-analysis by Stata 12 software. Altogether 17 prospective randomized controlled trials containing 1,980 transplanted patients were included in this study. The overall pooled RR estimates of 1-, 2-, 3-, and 5-year patient and graft survival rates were 0.985, 0.998, 0.995, and 1.100 (95 % CI 0.925-1.048, 0.934-1.067, 0.894-1.107, and 0.968-1.250, respectively), as well as 0.998, 0.993, 0.945, and 1.053, respectively (95 % CI 0.928-1.072, 0.902-1.092, 0.833-1.072, and 0.849-1.307, respectively). The other pooled RR estimates of acute rejection and chronic rejection rates for all enrolled studies were 1.077 and 0.311 (95 % CI 0.864-1.343 and 0.003-37.207). As for secondary predictors, the pooled RR estimates such as HCV recurrence, HCC recurrence, diabetes, hypertension, kidney dysfunction, bacterial infection, and CMV were 1.101, 1.403, 1.836, 1.607, 0.842, 1.096, and 2.280, respectively (95 % CI 0.964-1.257, 0.422-4.688, 1.294-2.606, 0.926-1.228, 0.693-1.022, 0.783-1.533, and 1.500-3.465, respectively). There were no differences between the steroid group and steroid-free group for all clinical observational indices except for the incidence of diabetes (p = 0.001) and CMV infection (p < 0.001). In summary, our study indicate that rapid discontinuation of steroid in the Tac-based immunosuppressive regimen may not lead to an increased risk of morbidity and rejection rate.
Department of Hepatobiliary Surgery, Affiliated DrumTower Hospital of Nanjing University Medical School, Nanjing, China ; Jiangsu Province's Key Medical Center for Hepatobiliary Disease, Nanjing, China ; Institute of Hepatobiliary Surgery, Nanjing University, Nanjing, China.
Jinyang
J
Gu
Department of Hepatobiliary Surgery, Affiliated DrumTower Hospital of Nanjing University Medical School, Nanjing, China ; Jiangsu Province's Key Medical Center for Hepatobiliary Disease, Nanjing, China ; Institute of Hepatobiliary Surgery, Nanjing University, Nanjing, China.
Xingyu
X
Wu
Department of Surgical Oncology, The 81st Hospital of PLA, Nanjing, China.
Lei
L
Lu
Department of Gastroenterology, Affiliated DrumTower Hospital of Nanjing University Medical School, Nanjing, China.
Shu
S
Zhang
Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.
Jianling
J
Bai
Department of Hepatobiliary Surgery, DrumTower Clinical Medical College of Nanjing Medical University, Nanjing, China.
Jun
J
Wang
Department of Ultrasonography, Wuxi Hospital for Infectious Diseases, Wuxi, China.
Jun
J
Li
Department of Hepatobiliary Surgery, Affiliated DrumTower Hospital of Nanjing University Medical School, Nanjing, China ; Jiangsu Province's Key Medical Center for Hepatobiliary Disease, Nanjing, China ; Institute of Hepatobiliary Surgery, Nanjing University, Nanjing, China.
Yitao
Y
Ding
Liver transplantation; Meta-analysis; Randomized controlled trial; Steroid minimization; Systematic review; Tacrolimus