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巴利昔单抗(舒莱)用于急性肾小管坏死高危肾移植患者。

Basiliximab (Simulect) in acute tubular necrosis high-risk kidney transplantation.

作者信息

Rivera C Fernández, Hernández A Alonso, Verdejo P Villaverde, García J Oliver, Rego S Cillero, Cañedo F Valdés

机构信息

Nephrology Department, Hospital Juan Canalejo, La Coruña, Spain.

出版信息

Transplant Proc. 2005 Nov;37(9):3733-5. doi: 10.1016/j.transproceed.2005.09.179.

Abstract

BACKGROUND

Basiliximab (Simulect) therapy reduces acute rejection episodes in renal transplantation. Posttransplant acute tubular necrosis (ATN) is a predisposing factor for acute rejection and reduced graft survival. Anti-lymphocyte antibodies have been used to delay the use of calcineurin antagonists in patients receiving cadaveric renal transplants and to prevent acute rejection episodes. The aim of our study was to learn about the effects of Simulect on ATN in high-risk cadaveric renal transplantation recipients.

MATERIALS AND METHODS

We studied 93 patients including, 45 who received Simulect (20 mg before transplantation and 20 mg at day 4 posttransplant and 48 patients who did not receive Simulect. All patients received mycophenolate mofetil, steroids, and cyclosporine (46%) or tacrolimus (54%). We defined ATN as the need for dialysis during the first week after transplantation. Risk factors for ATN were: cold ischemia time, donor and recipient age, donor cause of death as stroke, HLA matching, and panel-reactive antibodies.

RESULTS

Among 54 patients who experienced ATN, 44% were in the Simulect group and 71% in the other group (P = .01). In the regression analysis, Simulect was shown to be a protective factor: 0.19 (0.05 to 0.62). Presence of de novo diabetes was more frequent in the group that did not receive Simulect (16 [33%] vs 6 [13%]; P = .02). Acute rejection episodes were similar in both groups: 2.5% in the Simulect group versus 4% in the other group (P = .34). CMV infections occurred in 15 patients (33%) from the Simulect group and in 20 patients (42%) in the other group. Seven patients died in the Simulect group, and five patients died in the other group. In general, Simulect was well tolerated and the degree of complications was similar in both groups.

CONCLUSION

Simulect reduced the incidence of ATN among patients receiving a high-risk renal graft. It was well tolerated and no adverse effects were observed. The use of Simulect should be considered for patients receiving renal grafts at high risk for ATN.

摘要

背景

巴利昔单抗(舒莱)治疗可减少肾移植中的急性排斥反应。移植后急性肾小管坏死(ATN)是急性排斥反应和移植肾存活率降低的一个易感因素。抗淋巴细胞抗体已被用于延迟尸体肾移植受者中钙调神经磷酸酶抑制剂的使用,并预防急性排斥反应。我们研究的目的是了解舒莱对高危尸体肾移植受者ATN的影响。

材料与方法

我们研究了93例患者,其中45例接受舒莱治疗(移植前20mg,移植后第4天20mg),48例未接受舒莱治疗。所有患者均接受霉酚酸酯、类固醇和环孢素(46%)或他克莫司(54%)。我们将ATN定义为移植后第一周内需要透析。ATN的危险因素包括:冷缺血时间、供体和受体年龄、供体死因(中风)、HLA配型和群体反应性抗体。

结果

在54例发生ATN的患者中,舒莱组占44%,另一组占71%(P = 0.01)。在回归分析中,舒莱被证明是一个保护因素:0.19(0.05至0.62)。未接受舒莱治疗的组中,新发糖尿病更为常见(16例[33%]对6例[13%];P = 0.02)。两组的急性排斥反应相似:舒莱组为2.5%,另一组为4%(P = 0.34)。舒莱组15例患者(33%)发生巨细胞病毒感染,另一组20例患者(42%)发生感染。舒莱组7例患者死亡,另一组5例患者死亡。总体而言,舒莱耐受性良好,两组并发症程度相似。

结论

舒莱降低了接受高危肾移植患者的ATN发生率。它耐受性良好,未观察到不良反应。对于发生ATN高危的肾移植患者,应考虑使用舒莱。

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