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一项关于OKT3单克隆抗体治疗尸体肾移植急性排斥反应的随机临床试验。

A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants.

出版信息

N Engl J Med. 1985 Aug 8;313(6):337-42. doi: 10.1056/NEJM198508083130601.

DOI:10.1056/NEJM198508083130601
PMID:2861567
Abstract

Since the murine monoclonal antibody OKT3 reacts with human T cells and blocks their function, we explored its effectiveness in treating T-cell-mediated rejection of renal allografts. In a prospective randomized multicenter trial, 123 patients undergoing acute rejection of cadaveric renal transplants were treated either with OKT3 daily for a mean of 14 days, with concomitant lowering of the dosage of other immunosuppressive drugs (63 patients), or with conventional high-dose steroids (60 patients). OKT3 reversed 94 per cent of the rejections--a figure that was significantly better (P = 0.009) than the 75 per cent reversal rate obtained with conventional steroid treatment. This superior reversal rate with OKT3 was reflected in an improved one-year graft survival of 62 per cent for the OKT3-treated group, as compared with 45 per cent for the steroid-treated group (P = 0.029), in patients who were all selected by virtue of having had acute rejection. We conclude that treatment with OKT3 (with concomitant lowering of the dosage of other immunosuppressive drugs) is an effective approach for acute renal-allograft rejection.

摘要

由于鼠单克隆抗体OKT3可与人T细胞发生反应并阻断其功能,我们探讨了其在治疗T细胞介导的同种异体肾移植排斥反应中的有效性。在一项前瞻性随机多中心试验中,123例接受尸体肾移植急性排斥反应治疗的患者,其中63例患者平均14天每日使用OKT3治疗,并同时降低其他免疫抑制药物的剂量,另外60例患者接受传统大剂量类固醇治疗。OKT3使94%的排斥反应得到逆转,这一数字显著优于(P = 0.009)传统类固醇治疗75%的逆转率。在均因发生急性排斥反应而入选的患者中,OKT3治疗组1年移植肾存活率提高至62%,而类固醇治疗组为45%(P = 0.029),这反映出OKT3具有更高的逆转率。我们得出结论,使用OKT3治疗(同时降低其他免疫抑制药物的剂量)是治疗急性同种异体肾移植排斥反应的有效方法。

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1
A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants.一项关于OKT3单克隆抗体治疗尸体肾移植急性排斥反应的随机临床试验。
N Engl J Med. 1985 Aug 8;313(6):337-42. doi: 10.1056/NEJM198508083130601.
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OKT3 prophylaxis versus conventional drug therapy: single-center perspective, part of a multicenter trial.OKT3预防与传统药物治疗:单中心视角,多中心试验的一部分
Am J Kidney Dis. 1989 Nov;14(5 Suppl 2):5-9.
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The use of OKT3 in cadaveric renal transplantation for rejection that is unresponsive to conventional anti-rejection therapy.在尸体肾移植中,使用OKT3治疗对传统抗排斥疗法无反应的排斥反应。
Am J Kidney Dis. 1988 Feb;11(2):90-3. doi: 10.1016/s0272-6386(88)80186-0.
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A randomized clinical trial of induction therapy with OKT3 in kidney transplantation.一项关于肾移植中使用OKT3进行诱导治疗的随机临床试验。
Transplantation. 1993 Jan;55(1):44-50. doi: 10.1097/00007890-199301000-00009.
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OKT3 treatment of steroid-resistant renal allograft rejection.用OKT3治疗类固醇抵抗性肾移植排斥反应。
Transplantation. 1987 Feb;43(2):176-84. doi: 10.1097/00007890-198702000-00003.
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Monoclonal antibody OKT3 therapy in pediatric kidney transplant recipients.单克隆抗体OKT3疗法在小儿肾移植受者中的应用
J Pediatr. 1990 May;116(5):S86-91. doi: 10.1016/s0022-3476(05)82708-8.
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Anti-rejection therapy in renal transplantation: Use of the monoclonal antibody OKT3.肾移植中的抗排斥治疗:单克隆抗体OKT3的应用。
Nephrol Dial Transplant. 1991;6(4):275-9. doi: 10.1093/ndt/6.4.275.
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OKT3: First-dose safety and success.OKT3:首剂安全性与疗效。
Nephron. 1987;46 Suppl 1:12-8. doi: 10.1159/000184430.
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Delayed response to orthoclone OKT3 treatment for renal allograft rejection resistant to steroid and antilymphocyte globulin.对Orthoclone OKT3治疗抵抗类固醇和抗淋巴细胞球蛋白的肾移植排斥反应的延迟反应。
Transplantation. 1988 Jan;45(1):65-7. doi: 10.1097/00007890-198801000-00015.
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Early use of OKT3 monoclonal antibody in renal transplantation to prevent rejection.肾移植中早期使用OKT3单克隆抗体预防排斥反应。
Am J Kidney Dis. 1988 Feb;11(2):107-10. doi: 10.1016/s0272-6386(88)80190-2.

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