A NOVEL MANAGEMENT STRATEGY OF STEROID-FREE IMMUNOSUPPRESSION AFTER LIVER TRANSPLANTATION: EFFICACY AND SAFETY OF TACROLIMUS AND MYCOPHENOLATE MOFETIL
A NOVEL MANAGEMENT STRATEGY OF STEROID-FREE IMMUNOSUPPRESSION AFTER LIVER TRANSPLANTATION: EFFICACY AND SAFETY OF TACROLIMUS AND MYCOPHENOLATE MOFETIL
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DOI：
10.1097/00007890-200102270-00005
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发表时间：
2001-02
期刊：
影响因子：
6.2
通讯作者：
B. Ringe;F. Braun;E. Schütz;L. Füzesi;T. Lorf;R. Canelo;M. Oellerich;G. Ramadori
中科院分区：
文献类型：
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作者：
B. Ringe;F. Braun;E. Schütz;L. Füzesi;T. Lorf;R. Canelo;M. Oellerich;G. Ramadori
背景。皮质类固醇传统上用于实体器官移植后的免疫抑制。现代免疫抑制剂的多样性提供了替代风险收益比不利的药物的机会。这项前瞻性试验的目的是研究临床肝移植后新型无类固醇免疫抑制方案。方法。 30 名成年肝移植受者被纳入意向治疗分析。双诱导免疫抑制剂由他克莫司和吗替麦考酚酯组成。未给予预防性类固醇。分析的功效和安全性参数包括患者和移植物的存活率、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。结果。患者和移植物的 2 年存活率分别为 86.7% 和 83.9%。 26.2% 发生急性排斥反应，并与他克莫司血药浓度低于治疗水平和腹泻有关。通过暂时添加类固醇，所有排斥反应都可以完全逆转。 10/30 的患者出现急性肾功能衰竭，这与高他克莫司血药浓度以及原发性肝移植功能障碍有关。 43% 的患者从未接受过任何类固醇治疗，73% 的患者接受无类固醇维持治疗。结论。这些结果证实，肝移植后从一开始就可以完全避免使用皮质类固醇。他克莫司和吗替麦考酚酯双重药物免疫抑制对于患者和移植物的存活以及排斥反应的发生率和严重程度而言是有效且安全的。为了避免吸收或代谢受损可能导致免疫抑制不足或过度，建议密切药物监测。
Background. 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. Methods. 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. Results. 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. Conclusions. 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.