Pre-emptive therapy of CMVpp65 antigen positive renal transplant recipients with oral ganciclovir: a randomized, comparative study.
Pre-emptive therapy of CMVpp65 antigen positive renal transplant recipients with oral ganciclovir: a randomized, comparative study.
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DOI：
10.1093/ndt/gfg302
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发表时间：
2003-09
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通讯作者：
S. Sagedal;K. Nordal;A. Hartmann;K. Midtvedt;A. Foss;A. Åsberg;M. Degré;P. Fauchald;H. Rollag-
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文献类型：
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作者：
S. Sagedal;K. Nordal;A. Hartmann;K. Midtvedt;A. Foss;A. Åsberg;M. Degré;P. Fauchald;H. Rollag-
背景：如果不采取预防治疗措施，大约四分之一的肾移植患者会出现症状性巨细胞病毒（CMV）病。在这项前瞻性、随机单中心研究中，口服更昔洛韦的先发制人治疗与传统延迟治疗进行了比较。方法在肾移植后的前12周，对18岁以上的肾移植受者（n= 455）每周进行CMV pp65抗原血症筛查。如果移植后8周内白细胞中出现CMV pp65抗原，则将患者随机纳入研究。5例患者在CMV pp65阳性前出现CMV疾病，14例抗原检测阳性患者在随机化前出现CMV疾病，这些都表明结果在整个肾移植人群中的适用性存在局限性。由于各种原因，共有179名患者没有被随机化。80名患者完成了研究，其中42名患者随机接受先发制人的口服更昔洛韦治疗，38名患者接受常规延期治疗（对照组）。结果从移植到更昔洛韦胶囊治疗的中位时间为36（12-60）天，口服更昔洛韦治疗的持续时间为49（27-70）天。先发制人治疗组没有患者在移植后12周内发生巨细胞病毒疾病，而对照组38例患者中有9例（23.7%）发生巨细胞病毒疾病（P= 0.0009）。在移植后3个月至1年期间，每组均有2例患者发生巨细胞病毒疾病。在移植后第一年内，两组患者的急性排斥反应和肾功能无显著差异。结论：肾移植术后12周内口服更昔洛韦可有效预防巨细胞病毒疾病。移植后3个月至1年的晚期巨细胞病毒发病率在两组中相似，表明先发制人的治疗不会导致巨细胞病毒疾病的晚发。
BACKGROUND 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. METHODS 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). RESULTS 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. CONCLUSIONS 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.