Filipponi Franco, Callea Francesco, Salizzoni Mauro, Grazi Gian Luca, Fassati Luigi Rainero, Rossi Massimo, Risaliti Andrea, Burra Patrizia, Agnes Salvatore, De Carlis Luciano, Valente Umberto, Ferrara Roberto, Pisati Roberto
Liver Transplantation Unit, University of Pisa, Hospital of Cisanello, Via Paradisa 2, 56100 Pisa, Italy.
Transplantation. 2004 Nov 27;78(10):1488-95. doi: 10.1097/01.tp.0000140881.07208.4e.
Hepatitis C virus (HCV) recurrence in HCV+ liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab.
A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab + steroids or basiliximab + placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score >or=8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months.
Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab + steroids, 37.5% basiliximab + placebo, P = 0.354). The treatment failure rate was significantly higher in basiliximab + steroids (28.8%) than in basiliximab + placebo (15.6%), P = 0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P = 0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab + steroids, 39.4% basiliximab + placebo, P = 0.04), while the tAR rate was similar (29.7% basiliximab + steroids and 37.9% basiliximab + placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab + placebo).
Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.
丙型肝炎病毒（HCV）阳性肝移植受者中HCV复发几乎不可避免，且免疫抑制可能会促使其复发。我们比较了使用类固醇和巴利昔单抗情况下的肝损伤程度。
总共140名HCV阳性成年肝移植受者被随机分配至巴利昔单抗+类固醇组或巴利昔单抗+安慰剂组（加环孢素和硫唑嘌呤）。主要终点：丙型肝炎组织学复发（12个月时活检的伊沙克分级评分≥8分的肝损伤）；次要终点：治疗失败（死亡、移植物丢失、患者退出）、活检证实的急性排斥反应（BPAR）、治疗的急性排斥反应（tAR）、12个月时的移植物和患者生存率。
在12个月丙型肝炎组织学复发率方面未观察到任何显著差异（巴利昔单抗+类固醇组为41.2%，巴利昔单抗+安慰剂组为37.5%，P = 0.354）。巴利昔单抗+类固醇组的治疗失败率（28.8%）显著高于巴利昔单抗+安慰剂组（15.6%），P = 0.03；联合假设评估的联合检验得出的总体结果接近无显著性差异（P = 0.059）。类固醇治疗组的BPAR率显著更低（巴利昔单抗+类固醇组为24.3%，巴利昔单抗+安慰剂组为39.4%，P = 0.04），而tAR率相似（巴利昔单抗+类固醇组为29.7%，巴利昔单抗+安慰剂组为37.9%）。在1年移植物和患者生存率方面未观察到任何显著差异（巴利昔单抗+类固醇组分别为72.9%和84.8%；巴利昔单抗+安慰剂组分别为81.5%和89.0%）。
结果表明，无类固醇治疗与显著更低的治疗失败率相关，尽管两组丙型肝炎的组织学复发率相似。这种益处并未被需要治疗的移植物排斥率的明显增加所抵消。
