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儿童心脏移植中他克莫司与环孢素免疫抑制的随机临床试验:15个月随访的初步结果

Randomized clinical trial of tacrolimus- vs cyclosporine-based immunosuppression in pediatric heart transplantation: preliminary results at 15-month follow-up.

作者信息

Pollock-Barziv Stacey M, Dipchand Anne I, McCrindle Brian W, Nalli Nadya, West Lori J

机构信息

Division of Cardiology, Department of Pediatrics and Immunology, University of Toronto, The Hospital for Sick Children, Toronto, Ontario, Canada.

出版信息

J Heart Lung Transplant. 2005 Feb;24(2):190-4. doi: 10.1016/j.healun.2004.11.006.

DOI:10.1016/j.healun.2004.11.006
PMID:15701436
Abstract

BACKGROUND

While Tacrolimus (Tac) and Cyclosporine (Cya) immunosuppression are used after cardiac transplantation (tx), few studies have evaluated their use in pediatric patients.

METHODS

We randomized 26 heart transplant recipients (pts) in a prospective, open-label trial to Tac (n = 14) or Cya (n = 12) to compare their efficacy and side-effects. Mean age at tx was 4.2 years for Tac and 5.8 years for Cya. Mean follow-up was 26 months (range: 11-39 months) for Tac and 24 months for Cya (range: 33-13 months).

RESULTS

Our data suggest that both regimens are efficacious in the pediatric population. Conversion from Cya to Tac was useful for dealing with persistent rejection, although this sample did not suggest lower incidence of acute cellular rejection in the Tac group.

CONCLUSIONS

Further studies are required to establish pharmacokinetic parameters to enhance therapeutic monitoring of these patients to minimize side effects and enhance outcomes.

摘要

背景

虽然心脏移植术后使用他克莫司(Tac)和环孢素(Cya)进行免疫抑制治疗,但很少有研究评估它们在儿科患者中的应用情况。

方法

我们在一项前瞻性、开放标签试验中,将26例心脏移植受者随机分为他克莫司组(n = 14)或环孢素组(n = 12),以比较二者的疗效和副作用。他克莫司组移植时的平均年龄为4.2岁,环孢素组为5.8岁。他克莫司组的平均随访时间为26个月(范围:11 - 39个月),环孢素组为24个月(范围:3 - 33个月)。

结果

我们的数据表明,两种治疗方案在儿科人群中均有效。从环孢素转换为他克莫司有助于处理持续性排斥反应,尽管该样本未显示他克莫司组急性细胞排斥反应的发生率更低。

结论

需要进一步研究以确定药代动力学参数,加强对这些患者的治疗监测,从而将副作用降至最低并改善治疗效果。

相似文献

1
Randomized clinical trial of tacrolimus- vs cyclosporine-based immunosuppression in pediatric heart transplantation: preliminary results at 15-month follow-up.儿童心脏移植中他克莫司与环孢素免疫抑制的随机临床试验:15个月随访的初步结果
J Heart Lung Transplant. 2005 Feb;24(2):190-4. doi: 10.1016/j.healun.2004.11.006.
2
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Pediatr Transplant. 2005 Aug;9(4):498-503. doi: 10.1111/j.1399-3046.2005.00334.x.
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引用本文的文献

1
Postoperative care of the transplanted patient.移植患者的术后护理。
Curr Cardiol Rev. 2011 May;7(2):110-22. doi: 10.2174/157340311797484286.
2
Strategies to prevent cellular rejection in pediatric heart transplant recipients.预防儿科心脏移植受者细胞排斥的策略。
Paediatr Drugs. 2010 Dec 1;12(6):391-403. doi: 10.2165/11535990-000000000-00000.
3
Tacrolimus versus cyclosporine as primary immunosuppression after heart transplantation: systematic review with meta-analyses and trial sequential analyses of randomised trials.
他克莫司与环孢素作为心脏移植后主要免疫抑制剂的比较:随机试验的系统评价与荟萃分析和试验序贯分析。
Eur J Clin Pharmacol. 2010 Dec;66(12):1177-87. doi: 10.1007/s00228-010-0902-6. Epub 2010 Sep 30.
4
Tacrolimus: in heart transplant recipients.他克莫司:在心脏移植受者中。
Drugs. 2006;66(17):2269-79; discussion 2280-2. doi: 10.2165/00003495-200666170-00010.