Department of Medicine, University of Alberta, Edmonton, AB, Canada.
Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
Late-onset cytomegalovirus (CMV) disease is a significant problem with a standard 3-month prophylaxis regimen. This multicentre, double-blind, randomized controlled trial compared the efficacy and safety of 200 days' versus 100 days' valganciclovir prophylaxis (900 mg once daily) in 326 high-risk (D+/R-) kidney allograft recipients. Significantly fewer patients in the 200-day group versus the 100-day group developed confirmed CMV disease up to month 12 posttransplant (16.1% vs. 36.8%; p < 0.0001). Confirmed CMV viremia was also significantly lower in the 200-day group (37.4% vs. 50.9%; p = 0.015 at month 12). There was no significant difference in the rate of biopsy-proven acute rejection between the groups (11% vs. 17%, respectively, p = 0.114). Adverse events occurred at similar rates between the groups and the majority were rated mild-to-moderate in intensity and not related to study medication. In conclusion, this study demonstrates that extending valganciclovir prophylaxis (900 mg once daily) to 200 days significantly reduces the incidence of CMV disease and viremia through to 12 months compared with 100 days' prophylaxis, without significant additional safety concerns associated with longer treatment. The number needed to treat to avoid one additional patient with CMV disease up to 12 months posttransplant is approximately 5.
迟发性巨细胞病毒 (CMV) 疾病是标准 3 个月预防方案的一个重大问题。这项多中心、双盲、随机对照试验比较了 326 例高危 (D+/R-) 肾移植受者中 200 天与 100 天缬更昔洛韦预防 (900mg 每日 1 次) 的疗效和安全性。在移植后 12 个月内，200 天组发生确诊 CMV 疾病的患者明显少于 100 天组 (16.1% vs. 36.8%；p<0.0001)。200 天组的确诊 CMV 病毒血症也明显较低 (37.4% vs. 50.9%；p=0.015，在 12 个月时)。两组之间的活检证实的急性排斥反应率没有显著差异 (分别为 11%和 17%，p=0.114)。两组之间不良反应的发生率相似，大多数不良反应的强度为轻度至中度，与研究药物无关。总之，这项研究表明，与 100 天的预防方案相比，将缬更昔洛韦预防 (900mg 每日 1 次) 延长至 200 天可显著降低 CMV 疾病和病毒血症的发生率，直至 12 个月，且与延长治疗相关的安全性问题无显著增加。在移植后 12 个月内，需要治疗的患者数量可减少约 5 人，以避免出现 1 例额外的 CMV 疾病患者。
