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巴利昔单抗与有限剂量的达利珠单抗(2毫克/千克)在肾移植中单次或分两次给药的比较。

Basiliximab vs. limited-dose daclizumab (2 mg/kg) administered in single or two separated doses in kidney transplantation.

作者信息

Vega Olynka, Cárdenas Guillermo, Correa-Rotter Ricardo, Alberú Josefina, Morales-Buenrostro Luis E

机构信息

Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City.

出版信息

Rev Invest Clin. 2008 Mar-Apr;60(2):82-6.

PMID:18637565
Abstract

INTRODUCTION

Addition of anti-IL2r monoclonal antibodies (chimeric or humanized) for induction therapy has reduced the frequency of acute rejection (AR). This study compares the impact of type and dosage of induction therapy on frequency of acute rejection and on renal function during the first year post-transplant.

PATIENTS AND METHODS

Comparative retrospective study. Kidney transplant recipients (KTR) were divided in three groups according to induction therapy, as follows: (1) Basiliximab in two 20 mg doses, (2) Daclizumab 2 mg/kg in one dose, and (3) Daclizumab 2 mg/kg divided in two doses (1 mg/kg each). Groups were paired for age, sex, number of shared haplotypes, and previous transplant history. Primary endpoints were AR episodes, time to first AR, graft loss, and death. Secondary endpoints were SCr (at 3, 6, 9 and 12 months), frequency and type of infection, and cost.

RESULTS

There were no baseline differences between groups. Twenty one patients were included in each group. The incidence of AR was similar: 14.2% in group 1, and 9.5% for groups 2 and 3. Two deaths were reported, one in group 1 and another in group 2. Mean SCr was similar between groups. Incidence of infection was 6, 5, and 7 in groups 1 to 3, respectively without a significant difference. The cost was higher in group 1 (p < 0.001).

CONCLUSION

Low dose Daclizumab in one or two doses is equally effective and safe as basiliximab at 12-month follow-up, with inferior cost.

摘要

引言

添加抗IL2r单克隆抗体(嵌合或人源化)进行诱导治疗可降低急性排斥反应(AR)的发生率。本研究比较了诱导治疗的类型和剂量对移植后第一年急性排斥反应发生率及肾功能的影响。

患者与方法

比较性回顾性研究。肾移植受者(KTR)根据诱导治疗分为三组,如下:(1)两次给予20mg巴利昔单抗;(2)一次给予2mg/kg达利珠单抗;(3)将2mg/kg达利珠单抗分为两剂(各1mg/kg)。根据年龄、性别、共享单倍型数量和既往移植史对各组进行配对。主要终点为AR发作、首次AR时间、移植物丢失和死亡。次要终点为血清肌酐(3、6、9和12个月时)、感染频率和类型以及费用。

结果

各组间基线无差异。每组纳入21例患者。AR发生率相似:第1组为14.2%,第2组和第3组为9.5%。报告了2例死亡,1例在第1组,另1例在第2组。各组间平均血清肌酐相似。第1至3组的感染发生率分别为6、5和7,无显著差异。第1组费用更高(p<0.001)。

结论

在12个月的随访中,单剂量或两剂量的低剂量达利珠单抗与巴利昔单抗同样有效且安全,但费用更低。

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Rev Invest Clin. 2008 Mar-Apr;60(2):82-6.
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