Hasenbein W, Albani J, Englert C, Spehr A, Grabhorn E, Kemper MJ, Burdelski M, Ganschow R.
儿科，小儿肝脏病学，德国Hamburg-Eppendorf大学医学院，汉堡，德国
钙调素抑制剂（CNIs）、环孢素和他克莫司都被广泛应用于小儿肝移植受体，关于单一用药或低剂量的其他药的长期结果，目前尚缺乏足够的数据。为评估小儿肝移植至少5年后两种药物的利弊，129名儿童参与了本次研究。其中38名儿童因各种原因单独使用他克莫司治疗[激素型排斥反应(15例)、慢性排斥反应（5例）、严重急性排斥反应（4例）、急性重复排斥反应（5例）、移植肝失功能（ 3例）、环孢素代谢不足（3例）、多毛症（2例）、环孢素毒性（1例）]，4例患者使用他克莫司治疗，87例使用环孢素。原位肝移植术后至少五年，两种药物的平均谷浓度分别为5.3 +/- 2.3 ng/mL (他克莫司) 和 73.6 +/- 44.5 micro/L (环孢素)。环孢素的肾小球滤过率为142.7 + 39.5 mL/min/1.73 m(2)，他克莫司为151.1 +/- 44.1 mL/min/1.73 m(2)，二者并无显著差别；发生动脉性高血压的概率分别为7.1%和9.2%，发生肝中毒的概率则分别为0%和 2.3%。使用环孢素的患者超过三分之一的人出现了面容变化，使用他克莫司的患者出现面容变化的概率则为4.8%。两组患者的生活质量都很好（自我评估）。此次研究不能评估钙调素抑制剂对慢性移植物失功能的影响。根据研究结果我们得出结论，环孢素和他克莫司在小儿肝移植术后维持免疫抑制方面的疗效很理想。但是，在使用环孢素的儿童和使用他克莫司的患者之间存在的偏见限制了这种回溯性分析。为评估何种钙调素抑制剂对原位肝移植的儿童最有帮助，有必要再进行一项前瞻性随机对照组实验。
PMID: 17096762 [PubMed - indexed for MEDLINE]
Pediatr Transplant. 2006 Dec;10(8):938-42
Long-term evaluation of cyclosporine and tacrolimus based immunosuppression in pediatric liver transplantation
Hasenbein W, Albani J, Englert C, Spehr A, Grabhorn E, Kemper MJ, Burdelski M, Ganschow R.
Department of Pediatrics, Pediatric Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Both calcineurin inhibitors (CNIs), cyclosporine and tacrolimus, are widely used in pediatric liver transplant recipients and currently data are limited with regards to long-term results using the one drug or the other in comparable low doses. We conducted the present study to assess the advantages and disadvantages of both drugs in children at least five yr post-liver transplantation. A total of 129 children were enrolled in the study. Thirty-eight of the children were switched to tacrolimus monotherapy for different reasons [steroid resistant graft rejection (n = 15), chronic rejection (n = 5), severe acute rejection (n = 4), repetitive acute graft rejection (n = 5), dysfunction of the transplant (n = 3), insufficient CsA metabolism (n = 3), hypertrichosis (n = 2), and CsA toxicity (n = 1)], four patients had primary tacrolimus therapy, and 87 patients are receiving cyclosporine. Mean trough levels were 5.3 +/- 2.3 ng/mL (tacrolimus) and 73.6 +/- 44.5 micro/L (cyclosporine), respectively at least five yr post-orthotopic liver transplantation (OLT). There was no significant difference in the calculated glomerular filtration rate between children on cyclosporine and tacrolimus (142.7 + 39.5 mL/min/1.73 m(2) vs. 151.1 +/- 44.1 mL/min/1.73 m(2)). The incidence of arterial hypertension was 7.1% vs. 9.2%, that of hepatotoxicity was 0% vs. 2.3%. Cosmetic changes were found in more than one-third of the patients on cyclosporine and in 4.8% of the patients receiving tacrolimus. Quality of life was excellent in both groups (self assessment). The impact of CNIs on chronic graft dysfunction cannot be assessed by our present study. We conclude from the results that cyclosporine and tacrolimus are both excellent drugs for maintenance immunosuppression in the long-term course following pediatric liver transplantation. However, this retrospective analysis is limited by the bias between children on CsA as compared with patients receiving tacrolimus. A prospective randomized controlled trial is needed in order to assess which CNI is the best for children following OLT.
PMID: 17096762 [PubMed - indexed for MEDLINE]
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