Ringe B, Braun F, Schütz E, Füzesi L, Lorf T, Canelo R, Oellerich M, Ramadori G
Klinik für Transplantationschirurgie, Abteilung Klinische Chemie, Georg-August-Universität Göttingen, Germany.
Transplantation. 2001 Feb 27;71(4):508-15. doi: 10.1097/00007890-200102270-00005.
Corticosteroids have been used traditionally for immunosuppression after solid organ transplantation. The variety of modern immunosuppressive agents offers the chance to replace drugs with an unfavorable risk-benefit ratio. The objective of this prospective pilot study was to investigate a novel steroid-free immunosuppressive regimen after clinical liver transplantation.
30 adult liver graft recipients were included in an intent-to-treat analysis. Dual induction immunosuppression consisted of tacrolimus and mycophenolate mofetil. Prophylactic steroids were not given. Efficacy and safety parameters analyzed were patient and graft survival, incidence and severity of rejection, and adverse events in correlation to immunosuppressive drug levels.
Patient and graft survival at 2 years was 86.7 and 83.9%, respectively. Acute rejection occurred in 26.2%, and was associated with subtherapeutic tacrolimus blood levels and diarrhea. All rejections were completely reversible by temporary addition of steroids. Acute renal failure was seen in 10/30 patients, and was related to high tacrolimus blood levels together with primary liver graft dysfunction. 43% of all patients never received any steroids, and 73% were on a steroid-free maintenance regimen.
These results confirm that corticosteroids can be completely avoided from the beginning after liver transplantation. Double drug immunosuppression with tacrolimus and mycophenolate mofetil is effective and safe in terms of patient and graft survival as well as incidence and severity of rejection. In order to avoid under- or over-immunosuppression, which may be caused by impaired absorption or metabolism, close drug monitoring is advised.
传统上，皮质类固醇用于实体器官移植后的免疫抑制。多种现代免疫抑制剂为替换风险效益比不佳的药物提供了机会。这项前瞻性试点研究的目的是调查临床肝移植后一种新型无类固醇免疫抑制方案。
30名成年肝移植受者纳入意向性分析。双重诱导免疫抑制由他克莫司和霉酚酸酯组成。未给予预防性类固醇。分析的疗效和安全性参数包括患者和移植物存活率、排斥反应的发生率和严重程度，以及与免疫抑制药物水平相关的不良事件。
2年时患者和移植物存活率分别为86.7%和83.9%。26.2%发生急性排斥反应，且与他克莫司血药浓度低于治疗水平及腹泻有关。所有排斥反应通过临时加用类固醇均可完全逆转。10/30例患者出现急性肾衰竭，与他克莫司血药浓度高及原发性肝移植物功能障碍有关。43%的患者从未接受过任何类固醇治疗，73%的患者采用无类固醇维持方案。
这些结果证实肝移植后可从一开始就完全避免使用皮质类固醇。他克莫司和霉酚酸酯双重药物免疫抑制在患者和移植物存活率以及排斥反应的发生率和严重程度方面是有效且安全的。为避免可能由吸收或代谢受损引起的免疫抑制不足或过度，建议密切监测药物。
