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巴利昔单抗与兔抗胸腺细胞球蛋白用于心脏移植术后患者诱导治疗的比较。

Basiliximab versus rabbit anti-thymocyte globulin for induction therapy in patients after heart transplantation.

作者信息

Flaman Flavia, Zieroth Shelley, Rao Vivek, Ross Heather, Delgado Diego H

机构信息

Division of Cardiology and Transplant, Toronto General Hospital, Toronto, Ontario, Canada.

出版信息

J Heart Lung Transplant. 2006 Nov;25(11):1358-62. doi: 10.1016/j.healun.2006.09.002.

Abstract

BACKGROUND

The use of basiliximab or rabbit anti-thymocyte globulin (RATG) for induction therapy has significantly reduced the incidence of acute rejection episodes post-transplantation. The purpose of this study was to compare the safety and efficacy of basiliximab vs RATG in a population of adult heart transplant recipients.

METHODS

We retrospective analyzed the safety and efficacy of basiliximab compared with RATG among 48 adult heart transplant recipients at our center. Twenty-five patients received basiliximab (20 mg on days 0 and 4 after heart transplantation), and 23 patients received RATG (1.5 mg/kg for 3 days). A standard triple-drug immunosuppression regimen was administered to all patients.

RESULTS

The average biopsy score (ABS) at 1 month was 0.79 +/- 0.18 in the Basiliximab Group vs 0.47 +/- 0.2 in the RATG group (p = 0.023) and at 3 months was 0.75 +/- 0.24 in the Basiliximab Group vs 0.46 +/- 0.12 in the RATG Group (p = 0.032). At 6 months after transplantation, the difference between groups was not statistically significant (0.97 +/- 0.23 vs 0.58 +/- 0.17, p = .14). At 12 months the ABS was 0.85 +/- 0.4 in the Basiliximab Group vs 0.63 +/- 0.15 in the RATG Group (p = 0.12), and the number of episodes of infection was similar in both groups (19 vs 26; p = 0.16). There was no correlation between cumulative cyclosporine doses and rejection. Creatinine clearance levels were not statistically different between groups at baseline and up to 12 months after heart transplantation. Three patients died in the Basiliximab Group, and 2 patients died in the RATG Group.

CONCLUSIONS

Rabbit anti-thymocyte globulin is more effective than basiliximab for prevention of rejection episodes after heart transplantation. Both induction agents provide similar safety profile.

摘要

背景

使用巴利昔单抗或兔抗胸腺细胞球蛋白(RATG)进行诱导治疗已显著降低移植后急性排斥反应的发生率。本研究的目的是比较巴利昔单抗与RATG在成年心脏移植受者群体中的安全性和有效性。

方法

我们回顾性分析了本中心48例成年心脏移植受者中巴利昔单抗与RATG的安全性和有效性。25例患者接受巴利昔单抗治疗(心脏移植后第0天和第4天各20 mg),23例患者接受RATG治疗(1.5 mg/kg,共3天)。所有患者均接受标准的三联药物免疫抑制方案。

结果

巴利昔单抗组1个月时的平均活检评分(ABS)为0.79±0.18,而RATG组为0.47±0.2(p = 0.023);3个月时,巴利昔单抗组为0.75±0.24,RATG组为0.46±0.12(p = 0.032)。移植后6个月,两组间差异无统计学意义(0.97±0.23对0.58±0.17,p = 0.14)。12个月时,巴利昔单抗组的ABS为0.85±0.4,RATG组为0.63±0.15(p = 0.12),两组感染发作次数相似(19次对26次;p = 0.16)。环孢素累积剂量与排斥反应之间无相关性。心脏移植后基线及12个月内,两组间肌酐清除率水平无统计学差异。巴利昔单抗组有3例患者死亡,RATG组有2例患者死亡。

结论

兔抗胸腺细胞球蛋白在预防心脏移植后排斥反应发作方面比巴利昔单抗更有效。两种诱导药物的安全性相似。

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