Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.
Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.
HPB (Oxford). 2021 May;23(5):666-674. doi: 10.1016/j.hpb.2020.09.012. Epub 2020 Oct 5.
Corticosteroids are an integral part of immunosuppression following solid organ transplantation, despite their metabolic complications. We conducted a randomized trial to evaluate the efficacy of steroid-free immunosuppression following live donor liver transplantation (LDLT).
We randomized 104 patients stratified based on pre-transplant diabetic status to either a steroid-free arm (SF-arm) (Basiliximab + Tacrolimus and Azathioprine,n = 52) or Steroid arm (S-Arm) (Steroid + Tacrolimus + Azathioprine,n = 52). The primary endpoint was the occurrence of metabolic complications (new-onset diabetes after transplant (NODAT), new-onset systemic hypertension after transplant (NOSHT), post-transplant dyslipidemia) within 6 months after transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR) within six months, patient and graft survival at 6 months.
The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006). Likewise, the incidence of NOSHT (27.8% vs. 4.8%,p-0.01) and hypertriglyceridemia (26.7% vs. 8%,p-0.03) at six months was significantly higher in S-arm. However, there were no differences in BPAR (19.2% vs. 21.2%, p-0.81), time to first rejection (58 vs. 53 days, p-0.78), patient and graft survival (610 vs. 554 days,p- 0.22).
Following LDLT, basiliximab induction with tacrolimus and azathioprine maintenance resulted in significantly lower metabolic complications compared to the triple-drug regimen of steroid, tacrolimus, and azathioprine.
尽管皮质类固醇会引起代谢并发症，但在实体器官移植后，它们仍是免疫抑制治疗的重要组成部分。我们进行了一项随机试验，以评估活体供肝移植（LDLT）后无激素免疫抑制的疗效。
我们根据移植前糖尿病状态将 104 名患者分层，然后将其随机分配至无激素组（SF 组）（巴利昔单抗+他克莫司和硫唑嘌呤，n=52）或激素组（S 组）（激素+他克莫司+硫唑嘌呤，n=52）。主要终点是移植后 6 个月内代谢并发症（移植后新发糖尿病（NODAT）、移植后新发系统性高血压（NOSHT）、移植后血脂异常）的发生情况。次要终点包括 6 个月内活检证实的急性排斥反应（BPAR）、6 个月时的患者和移植物存活率。
S 组在 3 个月（64.5%vs.28.1%，p-0.004）和 6 个月（51.6%vs.15.6%，p-0.006）时 NODAT 的发生率显著更高。同样，S 组在 6 个月时 NOSHT（27.8%vs.4.8%，p-0.01）和高甘油三酯血症（26.7%vs.8%，p-0.03）的发生率也显著更高。然而，BPAR（19.2%vs.21.2%，p-0.81）、首次排斥反应时间（58 天 vs.53 天，p-0.78）、患者和移植物存活率（610 天 vs.554 天，p-0.22）无差异。
与激素、他克莫司和硫唑嘌呤三联药物方案相比，巴利昔单抗诱导加他克莫司和硫唑嘌呤维持治疗在 LDLT 后可显著降低代谢并发症的发生。
