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达利珠单抗在预防同种肾移植急性排斥反应中的临床应用(英文)
引用本文:冯新顺,薛武军,田普训.达利珠单抗在预防同种肾移植急性排斥反应中的临床应用(英文)[J].中国新药与临床杂志,2002,21(10):577-580.
作者姓名:冯新顺  薛武军  田普训
作者单位:西安交通大学第一医院肾移植科,陕西,西安,710061
摘    要:目的 :探讨达利珠单抗在预防同种肾异体移植术后急性排斥反应的作用。方法 :回顾分析了已随访 1a的 2 8例 (男性 2 4例 ,女性 4例 ,年龄 32a±s 5a)应用 2剂达利珠单抗的病人的临床效果 ,并以同期肾移植 80例 (男性 6 8例 ,女性 12例 ,年龄34a± 11a)作为对照组。所有病人均给予以麦考酚酸酯 (mycophenolatemofetil,MMF) ,环孢素 (ci closporin ,CsA) ,甲基强的松龙 (methylprednisolone ,MPD)和泼尼松 (prednisone ,Pred)为基础的免疫抑制方案 ;达利珠单抗在基础治疗方案上 ,分别于手术前 2 4h内和手术后d 14按照剂量为 1mg·kg- 1通过静脉注射给药。观察急性排斥反应发生率、药物不良反应、感染发生率、病人和移植物的 1a存活率。所有病人均随访 1a以上。结果 :达利珠单抗组在 3mo内急性排斥反应发生率 (4% )显著低于对照组 (2 5 % ) ,差异有显著意义 (P <0 .0 5 ) ;达利珠单抗具有良好的耐受性 ,无细胞因子释放综合征的发生 ;在感染及不良反应方面与对照组比较无显著性差异 ;2组比较病人 1a的存活率 (达利珠单抗组为 89% ,对照组为 96 % )和移植肾存活率 (达利珠单抗组 89% ,对照组 94 % )无显著性差异 (P >0 .0 5 )。结论 :2剂达利珠单抗加上MMF ,CsA ,MPD ,Pred联合应用的免疫抑制方案对预防同种异

关 键 词:肾移植  达利珠单抗  免疫抑制剂

Clinical application of daclizumab for prevention of acute renal allograft rejection
Abstract.Clinical application of daclizumab for prevention of acute renal allograft rejection[J].Chinese Journal of New Drugs and Clinical Remedies,2002,21(10):577-580.
Authors:Abstract
Abstract:AIM: To investigate clinical application of daclizumab for prevention of acute rejection in renal transplant recipients. METHODS: This was a non-randomized and retrospective study. A total of twenty-eight renal transplant recipients(M 24,F 4; age 32 a±s 5 a) were studied and followed. A simultaneous cohort of eighty renal transplant recipients(M 68,F 12; age 34 a±11 a) served as control group. All of patients were addition of baseline regimen of mycophenolate mofetil(MMF), ciclosporin(CsA), methylprednisolone(MPD), and prednisone(Pred). The treatment of daclizumab was based on baseline regimen. The first dosage of daclizumab, 1 mg*kg-1 was administered by intraverous infusion over 15 min within 24 h prior to operation. The second same dosage was administered in the d 14 after operation. The rate of acute rejection, adverse reactions, infection episode, and patient and graft survival were observed. All of patients received a follow-up of 12 mo at least. RESULTS: Acute rejection during the first 3 mo was significantly lower for daclizumb treated patients(4%) compared with control group(25%)(P<0.05). Daclizumab was well tolerated. There was no cytokine release syndrome related to daclizumab. No difference in infection episodes and adverse events between daclizumab group and control group. One year patient survival was 89% in daclizumab group, compared 96% in control group (P>0.05), with graft survival of 89% and 94% for daclizumab and control group, respectively(P>0.05). CONCLUSION:  The treatment consisting of daclizumab, MMF, CsA, MPD and Pred was effective in the prevention of acute rejection in renal transplant recipients.
Keywords:kidney transplantation  daclizumab  immunosuppressive agents
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