Yoshida 2005.
| Methods | Randomised clinical trial | |
| Participants | Country: Canada Period of recruitment: not stated Number randomised: 148 Post‐randomisation dropouts: 0 (0.0%) Revised sample size: 148 Average age (years): 53 Females: 48 (32.4%) Primary transplantation: 148 (100.0%) Reason for transplantation Alcohol‐related cirrhosis: 29 (19.6%) Viral‐related cirrhosis: 56 (37.8%) Autoimmune disease‐related cirrhosis: 34 (23.0%) HCC: not stated Others: 29 (19.6%) Maintenance immunosuppression used during induction immunosuppression: tacrolimus plus mycophenolate mofetil Altered immunosuppression after withdrawal: no Other exclusion criteria:
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| Interventions | Group 1: daclizumab + glucocorticosteroids (n = 72) Further details: daclizumab 2 mg/kg i.v. within 4 hours postoperatively and 1 mg/kg i.v. on postoperative day 4 + methylprednisolone 500 mg i.v. intraoperatively, tapering to 20 mg i.v. on postoperative day 5 followed by prednisone 5 mg/day orally. The prednisone was then tapered by 5 mg/month until discontinuation after the month 3 post‐transplant Group 2: glucocorticosteroids (n = 76) Further details: methylprednisolone 500 mg i.v. intraoperatively, tapering to 20 mg i.v. on postoperative day 5 followed by prednisone 5 mg/day PO. The prednisone was then tapered by 5 mg/month until discontinuation after the month 3 post‐transplant | |
| Outcomes | Outcomes reported: mortality at maximal follow‐up, serious adverse events (number of events), liver transplantation at maximal follow‐up, graft rejection (any) Follow‐up (months): 12 | |
| Notes | Source of funding: not stated Trial name/trial registry number: not stated Attempts were made to contact the authors in August 2019. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: this information was not available |
| Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: this information was not available |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were post‐randomisation dropouts. It was not clear whether these could be related to the interventions |
| Selective reporting (reporting bias) | Low risk | Comment: no pre‐published protocol was available, but the authors reported on mortality, graft loss, and adverse events |
| Other bias | High risk | Comment: the regimen for tacrolimus was different between the groups |
Abbreviations:
HCC: hepatocellular carcinoma
HCV: Hepatitis C virus
OLT: orthotopic liver transplantation
RNA: ribonucleic acid