使用巴利昔单抗、钙调神经磷酸酶抑制剂和霉酚酸酯的早期停用类固醇方案与由钙调神经磷酸酶抑制剂、霉酚酸酯和类固醇组成的三联方案在肾移植临床结局方面的比较研究

Comparative study of clinical outcome in kidney transplantation between early steroid withdrawal protocol using basiliximab, calcineurin inhibitor, and mycophenolate mofetil and triple regimen consisting of calcineurin inhibitor, mycophenolate mofetil, and steroid.

作者信息

Teraoka S, Sato S, Sekijima M, Iwado K, Urashima Y, Kudo S, Kai K, Koyama I, Tojinbara T, Nakajima I, Fuchinoue S

机构信息

Kidney Center, Department of Surgery, Tokyo Women's Medical University, Tokyo, Japan.

出版信息

Transplant Proc. 2005 Mar;37(2):791-4. doi: 10.1016/j.transproceed.2004.12.185.

DOI:10.1016/j.transproceed.2004.12.185

PMID:15848533

Abstract

AIMS

Effect of early steroid withdrawal protocol using basiliximab in kidney transplantation (KTx) on the clinical outcomes was investigated as compared with triple regimen.

METHODS

Kidney transplant patients in group 1 (n = 62) were treated with 8 mg/kg of cyclosporine (CsA), 2000 mg of MMF, two bolus IV injections of 20 mg of basiliximab and 500 mg of methylprednisolone (MP) rapidly tapered and withdrawn at 14 postoperative days (POD). Group 2 (n = 56) was treated with same dose of CsA and MMF, and 250 mg of MP tapered and continued. Acute rejection (AR) episodes were treated with MP pulse therapy followed by muromonab CD3 (OKT3) in case of steroid-resistant rejection.

RESULTS

In 46 of 62 cases (74.2%) in group 1, steroid was successfully withdrawn at 13.7 +/- 1.7 POD. Graft survival at 3, 6, and 12 months in group 1 was 100%, 100%, and 98.4% (one death with functioning graft), and 100%, 98.2%, and 96.4% in group 2, respectively. The incidence of AR was 12.9% for group 1 and 42.9% for group 2, among which 21 cases in group 2 were treated with ALG or OKT3; no patient needed ALG or OKT3 in group 1. Fifteen cases in group 1 and 13 cases in group 2 developed CMV antigenemia, among which febrile episode was exhibited in 3 cases (4.8%) in group 1 and 5 cases (8.9%) in group 2.

CONCLUSIONS

Early steroid withdrawal protocol using basiliximab is promising for reducing the incidence of AR (especially steroid-resistant rejection), CMV diseases, and steroid-related complications.

摘要

目的

与三联疗法相比，研究在肾移植（KTx）中使用巴利昔单抗的早期激素撤减方案对临床结局的影响。

方法

第1组（n = 62）的肾移植患者接受8mg/kg环孢素（CsA）、2000mg霉酚酸酯（MMF）治疗，静脉注射2次20mg巴利昔单抗，并给予500mg甲泼尼龙（MP），术后14天（POD）迅速减量并停用。第2组（n = 56）接受相同剂量的CsA和MMF治疗，250mg MP逐渐减量并持续使用。急性排斥反应（AR）发作采用MP冲击治疗，对于激素抵抗性排斥反应则采用莫罗单抗CD3（OKT3）治疗。

结果

第1组62例中的46例（74.2%）在13.7±1.7 POD成功停用激素。第1组3个月、6个月和12个月时的移植物存活率分别为100%、100%和98.4%（1例带功能移植物死亡），第2组分别为100%、98.2%和96.4%。第1组AR发生率为12.9%，第2组为42.9%，其中第2组21例接受了抗淋巴细胞球蛋白（ALG）或OKT3治疗；第1组无患者需要ALG或OKT3治疗。第1组15例和第2组13例发生巨细胞病毒（CMV）血症，其中第1组3例（4.8%）和第2组5例（8.9%）出现发热症状。