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.
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.
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。
Zotero 插件