Sagedal Solbjørg, Nordal Knut P, Hartmann Anders, Midtvedt Karsten, Foss Aksel, Asberg Anders, Degré Miklos, Fauchald Per, Rollag Halvor
Department of Internal Medicine, Rikshospitalet University Hospital, Oslo, Norway.
Nephrol Dial Transplant. 2003 Sep;18(9):1899-908. doi: 10.1093/ndt/gfg302.
About one-quarter of renal transplant patients will suffer from symptomatic cytomegalovirus (CMV) disease if no preventive therapeutic measures are taken. In this prospective, randomized single-centre study pre-emptive therapy with oral ganciclovir is compared with conventional deferred treatment.
Renal transplant recipients (n= 455) over 18 years of age were screened weekly for CMV pp65 antigenaemia during the first 12 weeks post-transplantation. If CMV pp65 antigen in leukocytes appeared within 8 weeks post-transplantation patients were randomized and included in the study. Five patients developed CMV disease before positive CMV pp65, and 14 patients with a positive antigen test developed CMV disease before randomization could take place, all these representing a limitation of the applicability of the results in the overall renal transplant population. Altogether 179 patients were not randomized for various reasons. Eighty patients completed the study, 42 were randomized to receive pre-emptive oral ganciclovir therapy and 38 to conventional deferred treatment (control group).
Time from transplantation to start of ganciclovir capsules was 36 (12-60) days and duration of oral ganciclovir therapy was 49 (27-70) days, median (range). No patient in the pre-emptive treatment group, but nine of 38 patients (23.7%) in the control group, developed CMV disease during the first 12 weeks post-transplantation (P= 0.0009). In the period from 3 months to 1 year post-transplantation, two patients in each group developed CMV disease. There were no significant differences in acute rejection or renal function between treatment groups during the first post-transplant year.
Pre-emptive oral ganciclovir therapy in renal transplant recipients during the first 12 weeks post-transplantation effectively prevents CMV disease during this time period. The incidence of late CMV disease (3 months to 1 year after transplantation) was similar in the two groups, indicating that pre-emptive therapy does not result in late onset of CMV disease.
如果不采取预防性治疗措施，约四分之一的肾移植患者将患上有症状的巨细胞病毒（CMV）疾病。在这项前瞻性、随机单中心研究中，将口服更昔洛韦的抢先治疗与传统的延迟治疗进行了比较。
对年龄超过18岁的肾移植受者（n = 455）在移植后的前12周每周进行CMV pp65抗原血症筛查。如果在移植后8周内白细胞中出现CMV pp65抗原，则将患者随机分组并纳入研究。5例患者在CMV pp65呈阳性之前发生了CMV疾病，14例抗原检测呈阳性的患者在随机分组前发生了CMV疾病，所有这些都表明该结果在整个肾移植人群中的适用性存在局限性。共有179例患者因各种原因未被随机分组。80例患者完成了研究，42例被随机分配接受口服更昔洛韦抢先治疗，38例接受传统的延迟治疗（对照组）。
从移植到开始服用更昔洛韦胶囊的时间为36（12 - 60）天，口服更昔洛韦治疗的持续时间为49（27 - 70）天，中位数（范围）。抢先治疗组在移植后的前12周内无患者发生CMV疾病，但对照组的38例患者中有9例（23.7%）发生了CMV疾病（P = 0.0009）。在移植后3个月至1年期间，每组各有2例患者发生CMV疾病。移植后第一年，治疗组之间在急性排斥反应或肾功能方面无显著差异。
肾移植受者在移植后的前12周内进行口服更昔洛韦抢先治疗可有效预防该时间段内的CMV疾病。两组中晚期CMV疾病（移植后3个月至1年）的发生率相似，这表明抢先治疗不会导致CMV疾病的延迟发作。
