Heart Failure and Transplantation Unit, Cardiology Department, Hospital Universitario La Fe, Valencia, Spain.
Clin Transplant. 2011 Jul-Aug;25(4):606-13. doi: 10.1111/j.1399-0012.2010.01309.x. Epub 2010 Jul 28.
Cyclosporine (CsA) and tacrolimus (Tac) in heart transplantation (HTx) have been compared but with certain drawbacks. We compared both drugs in a prospective analysis with medium-term follow-up.
Hundred and six patients were randomized to receive CsA or Tac (53 per group). Target levels of CsA were 200-300 ng/mL in the first six months and 100-200 ng/mL thereafter. Tac levels were 10-15 and 5-10 ng/mL, respectively. We also used daclizumab as induction and mycophenolate mofetil (MMF) and steroids as maintenance therapy.
Baseline characteristics were similar. Survival (CsA 88.7% vs. Tac 81.1%; p = 0.493) was similar. There was a tendency for longer time to first rejection with CsA (93 ± 110 vs. 55 ± 81 d; p = 0.122). There were more rejection-free patients with Tac (39 vs. 28%; p = 0.233). CsA patients suffered more viral infections (0.41 ± 0.58 vs. 0.11 ± 0.31; p = 0.003). CsA patients developed hypertension often (64 vs. 43%; p = 0.032). Tac patients suffered more gastrointestinal complications (16 vs. 6%; p = 0.042). Renal function and the development of diabetes, dyslipidemia, or neurological complications was similar.
Tac patients showed a tendency for longer time to first rejection, and there were more rejection-free patients with Tac and suffered fewer viral infections. Tac patients developed less hypertension and needed less drugs for its control. Renal function was similar in both groups.
环孢素（CsA）和他克莫司（Tac）在心脏移植（HTx）中已经进行了比较，但存在一定的缺点。我们进行了一项前瞻性分析，并进行了中期随访，比较了这两种药物。
106 例患者随机分为 CsA 或 Tac 组（每组 53 例）。CsA 在最初的 6 个月内目标浓度为 200-300ng/mL，此后为 100-200ng/mL。Tac 的目标浓度分别为 10-15ng/mL 和 5-10ng/mL。我们还使用了达利珠单抗作为诱导剂，并用吗替麦考酚酯（MMF）和类固醇作为维持治疗。
基线特征相似。存活率（CsA 88.7% vs. Tac 81.1%；p = 0.493）相似。CsA 组首次排斥反应的时间更长（93 ± 110 vs. 55 ± 81 d；p = 0.122）。Tac 组无排斥反应的患者更多（39 例 vs. 28%；p = 0.233）。CsA 组患者发生病毒感染的频率更高（0.41 ± 0.58 次 vs. 0.11 ± 0.31 次；p = 0.003）。CsA 组患者常发生高血压（64 例 vs. 43%；p = 0.032）。Tac 组患者胃肠道并发症更多（16 例 vs. 6%；p = 0.042）。肾功能以及糖尿病、血脂异常或神经并发症的发生率相似。
Tac 组患者首次排斥反应的时间较长，无排斥反应的患者更多，且病毒感染的发生率更低。Tac 组患者发生高血压的频率较低，控制高血压所需的药物也较少。两组的肾功能相似。
