肝移植术后一年，他克莫司和依维莫司从头用药与他克莫司标准剂量减药相比，肾功能相似：一项病例对照配对分析。

Tacrolimus and Everolimus de novo versus minimization of standard dosage of Tacrolimus provides a similar renal function at one year after liver transplantation: a case-control matched-pairs analysis.

作者信息

Mocchegiani Federico, Montalti Roberto, Nicolini Daniele, Svegliati Baroni Gianluca, Benedetti Antonio, Risaliti Andrea, Vivarelli Marco

机构信息

Clinic of Hepatobiliary and Abdominal Transplantation Surgery, Department of Sperimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.

Clinic of Gastroenterology, Department of Clinical and Molecular Science, Polytechnic University of Marche, Ancona, Italy.

出版信息

Ann Transplant. 2014 Oct 27;19:545-50. doi: 10.12659/aot.891091.

DOI:10.12659/aot.891091

PMID:25347718

Abstract

BACKGROUND

The efficacy in renal protection of Everolimus (Evr)-based regimens compared to standard dosages of Tacrolimus (Tac) has recently become known. The purpose of this study was to retrospectively compare the renal function in the first year after LT, with a case-control approach, in patients treated with Tac monotherapy at sub-standard dose vs. an immunosuppressive regimen with Tac and Evr.

MATERIAL/METHODS: Following a 2: 1 case-control approach, 37 patients with an immunosuppression regimen based on Tac only (Tac Group) were retrospectively compared with 74 patients utilizing a combination of Evr and Tac (Evr-Tac Group), based on the following preoperative parameters: sex, age, MELD score (±3), and pre-LT chronic kidney disease (CKD) stage.

RESULTS

After a mean follow-up of 82.8 ± 24 vs. 42.4 ± 16.6 months (p < 0.001), overall survival in 1, 3, and 5 years was 97.3, 91.9, and 86.5% vs. 95.9, 81.1, and 69.5% (p = 0.10) for the Tac Group vs. the Evr-Tac Group, respectively. The trend of the estimated glomerular filtration rate (e-GFR) during the first year post-LT was similar between the 2 study groups (80.1 ± 21 vs. 73.3 ± 16 mL/min/1.73 m^2, for the Tac Group vs. the Evr-Tac Group, respectively, p = 0.23). The incidence of acute rejection histologically proven was 32.4% vs. 20% (p = 0.71) for the Tac Group vs. the Tac-Evr Group, respectively. The rate of CKD was also similar in the 2 study groups.

CONCLUSIONS

The early combination of Evr and Tac is an efficient immunosuppressant regimen and provided similar renal function at 1 year post-LT, compared to a minimization of the monotherapy dose of Tac. The combination therapy of Evr-Tac is subject to a higher rate of drugs discontinuation due to adverse effects of 1 of the 2 drugs.

摘要

背景

与标准剂量的他克莫司（Tac）相比，依维莫司（Evr）为基础的方案在肾脏保护方面的疗效最近已为人所知。本研究的目的是采用病例对照方法，回顾性比较肝移植后第一年接受低于标准剂量的Tac单一疗法与接受Tac和Evr联合免疫抑制方案的患者的肾功能。

材料/方法：采用2:1的病例对照方法，根据以下术前参数，对37例仅采用基于Tac的免疫抑制方案的患者（Tac组）与74例采用Evr和Tac联合方案的患者（Evr-Tac组）进行回顾性比较：性别、年龄、终末期肝病模型（MELD）评分（±3）以及肝移植前慢性肾病（CKD）分期。

结果

平均随访时间分别为82.8±24个月和42.4±16.6个月（p<0.001），Tac组与Evr-Tac组1年、3年和5年的总生存率分别为97.3%、91.9%和86.5%与95.9%、81.1%和69.5%（p = 0.10）。肝移植后第一年估计肾小球滤过率（e-GFR）的变化趋势在两个研究组中相似（Tac组与Evr-Tac组分别为80.1±21与73.3±16 mL/min/1.73 m²，p = 0.23）。经组织学证实的急性排斥反应发生率，Tac组与Tac-Evr组分别为32.4%与20%（p = 0.71）。两个研究组的CKD发生率也相似。