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【NEJM】肾移植前脱敏新方法
ABSTRACT
Background Few options for transplantation currently exist for patients highly sensitized to HLA. This exploratory, open-label, phase 1–2, single-center study examined whether intravenous immune globulin plus rituximab could reduce anti-HLA antibody levels and improve transplantation rates.
Methods Between September 2005 and May 2007, a total of 20 highly sensitized patients (with a mean [±SD] T-cell panel-reactive antibody level, determined by use of the complement-dependent cytotoxicity assay, of 77±19% or with donor-specific antibodies) were enrolled and received treatment with intravenous immune globulin and rituximab. We recorded rates of transplantation, panel-reactive antibody levels, cross-matching results at the time of transplantation, survival of patients and grafts, acute rejection episodes, serum creatinine values, adverse events and serious adverse events, and immunologic factors.
Results The mean panel-reactive antibody level was 44±30% after the second infusion of intravenous immune globulin (P<0.001 for the comparison with the pretreatment level). At study entry, the mean time on dialysis among recipients of a transplant from a deceased donor was 144±89 months (range, 60 to 324). However, the time to transplantation after desensitization was 5±6 months (range, 2 to 18). Sixteen of the 20 patients (80%) received a transplant. At 12 months, the mean serum creatinine level was 1.5±1.1 mg per deciliter (133±97 µmol per liter), and the mean survival rates of patients and grafts were 100% and 94%, respectively. There were no infusion-related adverse events or serious adverse events during the study. Long-term monitoring for infectious complications and neurologic problems revealed no unanticipated events.
Conclusions These findings suggest that the combination of intravenous immune globulin and rituximab may prove effective as a desensitization regimen for patients awaiting a transplant from either a living donor or a deceased donor. Larger and longer trials are needed to evaluate the clinical efficacy and safety of this approach. Rituximab and Intravenous Immune Globulin for Desensitization during Renal Transplantation
利妥昔单抗和静脉用免疫球蛋白脱敏疗法在肾移植中运用
ABSTRACT
摘要
Background Few options for transplantation currently exist for patients highly sensitized to HLA. This exploratory, open-label, phase 1–2, single-center study examined whether intravenous immune globulin plus rituximab could reduce anti-HLA antibody levels and improve transplantation rates.
背景：目前关于肾移植有些观点认为移植的患者对HLA有高的致敏性。本项前瞻性、开放性、前1、2阶段、单中心的研究验证静注免疫球蛋白联用利妥昔单抗是否能够减少抗HLA抗体的水平和提高移植成功率。
Methods Between September 2005 and May 2007, a total of 20 highly sensitized patients (with a mean [±SD] T-cell panel-reactive antibody level, determined by use of the
complement-dependent cytotoxicity assay, of 77±19% or with donor-specific antibodies) were enrolled and received treatment with intravenous immune globulin and rituximab. We recorded rates of transplantation, panel-reactive antibody levels, cross-matching
results at the time of transplantation, survival of patients and grafts, acute rejection
episodes, serum creatinine values, adverse events and serious adverse events, and
immunologic factors.
方法：在2005年9月到2007年5月，总共20个高致敏性的患者（均数±标准差来表示用补体依赖性细胞毒性反应测定法来测定的T细胞群体反应性抗体水平，为77±19%或者捐献者特异性抗体）入组运用静注免疫球蛋白联合利妥昔单抗。记录了移植成功率、群体反应性抗体水平、移植时交叉配血结果、患者和移植器官的存活率、急性排斥反应发生率、血清肌酐水平、不良事件和严重不良事件的发生率和免疫因子的水平。
Results The mean panel-reactive antibody level was 44±30% after the second infusion of intravenous immune globulin (P<0.001 for the comparison with the pretreatment level).At study entry, the mean time on dialysis among recipients of a transplant from a
deceased donor was 144±89 months (range, 60 to 324). However, the time to transplantation after desensitization was 5±6 months (range, 2 to 18). Sixteen of the 20 patients (80%) received a transplant. At 12 months, the mean serum creatinine level was 1.5±1.1 mg per deciliter (133±97 µmol per liter), and the mean survival rates of patients and grafts were 100% and 94%, respectively. There were no infusion-related adverse events or serious adverse events during the study. Long-term monitoring for infectious
complications and neurologic problems revealed no unanticipated events.
结果：在第二次静注免疫球蛋白后平均群反应性抗体水平是44±30% （与使用前水平相比较p<0.001）研究提示，从死亡捐献者接受移植前透析时间平均为144±89 月 (范围为 60到324)。然而，脱敏后移植时间为5±6月 (范围, 2到18)。20人之中有16人接受了移植占总数的（80%）。在12个月期间，平均血清肌酐水平为1.5±1.1 mg/dl(133±97 µmol/L)，患者平均生存率和器官存活率分别为100%和94%。研究中没有输注药物相关的不良事件和严重不良事件发生。长期的随访没有发现不可预料的感染性疾病和神经系统病变事件。
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作者:admin@医学,生命科学 2010-10-06 05:11
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