CMV infections after two doses of daclizumab versus thymoglobulin in renal transplant patients receiving mycophenolate mofetil, steroids and delayed cyclosporine A
CMV infections after two doses of daclizumab versus thymoglobulin in renal transplant patients receiving mycophenolate mofetil, steroids and delayed cyclosporine A
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DOI：
10.1093/ndt/gfm873
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发表时间：
2008-06-01
影响因子：
6.1
通讯作者：
Touchard, Guy
中科院分区：
文献类型：
--
作者：
Abou-Ayache, Ramzi;Buchler, Mathias;Touchard, Guy
背景。巨细胞病毒（CMV）感染是肾移植后的主要并发症，并与移植物排斥反应有关。抗白细胞介素2受体抗体daclizumab可降低急性排斥反应的发生率，而不增加CMV感染的发生率。方法。这项多中心、随机试验比较了第一例尸体肾移植患者中两种剂量的达珠单抗（54 名患者，D 组）与胸腺球蛋白（55 名患者，T 组）加延迟环孢素 (CsA)、MMF（吗替麦考酚酯）和类固醇的安全性和疗效。主要标准是 CMV 感染/综合征/疾病。 D+/R- 患者接受口服更昔洛韦预防 90 天。结果。两组的 CMV 状态相同。 D 组 CMV 感染/综合征/疾病的发生率为 39%，T 组 (NS) 为 51%。 D 组中 CMV 复制开始时间延迟（P = 0.015），并且 pp65 阳性细胞的平均数量在 4 个月和 6 个月时较低（P < 0.001）。与 T 组相比，整个 D 组中症状性 CMV 发作的发生率并未降低（5.6% 对比 16.4%，NS），但未进行化学预防的 D+/R+ 和 D-/R+ 患者中症状性 CMV 发作的发生率较低（2.8% 对比 21.6%，P = 0.028）。患者和移植物的存活率以及活检证实的急性排斥反应的发生率是相同的。结论。达珠单抗联合 MMF、类固醇和延迟 CsA 给药的有限剂量方案是安全有效的。 CMV 感染的发生率没有显着差异，但无需化学预防，该方案可减少临床表现和病毒复制。
Background. Cytomegalovirus (CMV) infection is a major complication after renal transplantation and is involved in graft rejection. The anti-interleukin-2-receptor antibody daclizumab reduces the incidence of acute rejection without increasing the incidence of CMV infection.Methods. This multicentre, randomized trial compared safety and efficacy, at 1 year, of two doses of daclizumab (54 patients, group D) with thymoglobulin (55 patients, group T) plus delayed cyclosporine (CsA), MMF (mycophenolate mofetil) and steroids in first cadaver kidney transplant patients. Primary criterion was CMV infection/syndrome/disease. D+/R- patients received oral ganciclovir prophylaxis for 90 days.Results. Status for CMV was identical in the both groups. The incidence of CMV infection/syndrome/disease was 39% in group D versus 51% in group T (NS). Time to onset of CMV replication was delayed in group D (P = 0.015) and mean number of pp65-positive cells was lower at 4 and 6 months (P < 0.001). Incidence of symptomatic CMV episodes was not reduced in whole group D (5.6% versus 16.4%, NS), but lower in D+/R+ and D-/R+ patients without chemoprophylaxis, compared to group T (2.8% versus 21.6%, P = 0.028). Patient and graft survivals and incidence of biopsy-proven acute rejection were identical.Conclusions. Limited dosing regimen of daclizumab with MMF, steroids and delayed CsA introduction was safe and effective. The incidence of CMV infection was not significantly different, but without chemoprophylaxis, clinical manifestations and viral replication were reduced with this regimen.