González-Pinto I M, Rimola A, Margarit C, Cuervas-Mons V, Abradelo M, Alvarez-Laso C, Londoño M C, Bilbao I, Sánchez-Turrión V
Liver Transplantation Unit, Hospital 12 de Octubre, Madrid, Spain.
Transplant Proc. 2005 May;37(4):1713-5. doi: 10.1016/j.transproceed.2005.03.128.
We evaluate 5-year results of a prospective randomized trial that compared cyclosporine microemulsion (CsA-me) and Tacrolimus (Tac) for primary immunosuppression. One hundred one adult patients undergoing liver transplantation were randomized to receive Tac (n = 50) or CsA-me (n = 51). The most frequent indication for the procedure was cirrhosis due to virus C followed by alcoholism. Survival rates at 1, 3, and 5 years were 86%, 75%, and 72%, respectively; there was no significant difference between CsA-me versus Tac arms. Acute rejection occurred in 30 cases (30%), independent of the type of primary immunosuppression. Serious adverse events were reported significantly more among patients under CsA-me (48 episodes) than under Tac (32 episodes). Nineteen patients were switched to the other calcineurin inhibitor. The switch was much more frequent from CsA-me to Tac (n = 15; 29.4%), mainly because of lack of efficacy (n = 10; 19.6%). There were no cases of chronic rejections in the Tac arm. Four patients were switched from Tac to CsA-me for side effects; only 1 remains alive, after treatment was changed from CsA-me to an antimetabolite. There were no statistical differences in renal dysfunction, diabetes, hypertension, neurologic disorders, new-onset malignancies, or infections. There were no differences in survival or rejection among the intention-to-treat groups. Serious adverse events, total patients with switch of calcineurin inhibitor, as well as switches due to lack of efficacy, were statistically more frequent under CsA-me. Tacrolimus seems to be a more appropriate drug to be used for primary immunosuppression in liver transplantation.
我们评估了一项前瞻性随机试验的5年结果，该试验比较了环孢素微乳剂（CsA-me）和他克莫司（Tac）用于初始免疫抑制的效果。101例接受肝移植的成年患者被随机分为接受Tac组（n = 50）或CsA-me组（n = 51）。该手术最常见的指征是丙型病毒性肝炎所致肝硬化，其次是酒精性肝硬化。1年、3年和5年的生存率分别为86%、75%和72%；CsA-me组和Tac组之间无显著差异。30例（30%）发生了急性排斥反应，与初始免疫抑制的类型无关。报告显示，接受CsA-me治疗的患者（48例次）出现严重不良事件的情况明显多于接受Tac治疗的患者（32例次）。19例患者换用了另一种钙调神经磷酸酶抑制剂。从CsA-me换用Tac的情况更为频繁（n = 15；29.4%），主要原因是疗效不佳（n = 10；19.6%）。Tac组未出现慢性排斥反应病例。4例患者因副作用从Tac换用CsA-me；在治疗从CsA-me改为抗代谢药物后，仅1例存活。在肾功能不全、糖尿病、高血压、神经疾病、新发恶性肿瘤或感染方面无统计学差异。意向性治疗组在生存率或排斥反应方面无差异。在CsA-me治疗下，严重不良事件、钙调神经磷酸酶抑制剂换药的患者总数以及因疗效不佳而换药的情况在统计学上更为常见。他克莫司似乎是肝移植初始免疫抑制更合适的药物。
