Infectious Diseases Division, University of Nebraska Medical Center, Omaha, Nebraska 68198-5400, USA.
Clin Infect Dis. 2011 Feb 1;52(3):313-21. doi: 10.1093/cid/ciq143. Epub 2010 Dec 28.
valganciclovir (VGC) 900 mg is approved for CMV prophylaxis, but it has been associated with 10%-40% leucopenia rate. We hypothesize that VGC 450 mg daily may be as effective as and safer than 900 mg daily.
studies evaluating valganciclovir 900 mg and 450 mg daily against controls were evaluated. Direct comparisons were performed by random-effects models and indirect comparisons by the Bucher method.
twelve trials with VGC 900 mg (1543 patients) and 8 trials with VGC 450 mg (1531 patients) were included. The risk of CMV disease with VGC 900 mg versus controls was 1.06 (95% confidence interval [CI], .64-1.76; P = .81; I2=29%) and with VGC 450 mg vs controls .77 (95%CI, .49-1.18; P = .23; I2=24%). The risk of leucopenia was 5.24 (2.09-13.15; P = .0004; I2=44%) for VGC 900 mg versus controls and 1.58 (.96-2.61; P = .07; I2=36%) for VGC 450 mg versus controls; the risk for acute allograft rejection was 1.71 (.45, -6.50; P = .43) for VGC 900 mg and .80 (.50-1.28; P = .34) for VGC 450 mg. Adjusted indirect comparison between VGC 900 mg and VGC 450mg: the risk for CMV disease was not significantly different: odds ratio (OR), 1.38 (.84-2.25); P = .19; the risk of leucopenia was significantly increased with VGC 900 mg: 3.32 (1.76-6.26); P = .0002; and the risk of rejection was significantly increased with VGC 900 mg: 2.56 (1.50-4.53); P = .0005. Results remained consistent after adjustments by allograft, CMV control strategy, and immunosuppression.
valganciclovir 900 mg showed no superiority efficacy compared to controls (ganciclovir or preemptive) and equivalent efficacy to VGC 450 mg (statistical power: 94% and 97%, respectively) for CMV universal prophylaxis.VGC 900 mg was significantly associated with 3 times increase in the risk of leucopenia and 2 times increase in the risk of rejection compared with VGC 450 mg.
缬更昔洛韦（VGC）900mg 已被批准用于 CMV 预防，但与 10%-40%的白细胞减少症发生率相关。我们假设 VGC 每天 450mg 可能与每天 900mg 一样有效且更安全。
评估了缬更昔洛韦 900mg 和 450mg 每日与对照组的研究。直接比较采用随机效应模型进行，间接比较采用 Bucher 法。
纳入了 12 项 VGC 900mg（1543 例患者）和 8 项 VGC 450mg（1531 例患者）的试验。VGC 900mg 与对照组相比，CMV 疾病的风险为 1.06（95%置信区间[CI]，0.64-1.76；P=0.81；I2=29%），VGC 450mg 与对照组相比为 0.77（95%CI，0.49-1.18；P=0.23；I2=24%）。VGC 900mg 与对照组相比，白细胞减少症的风险为 5.24（2.09-13.15；P=0.0004；I2=44%），VGC 450mg 与对照组相比为 1.58（0.96-2.61；P=0.07；I2=36%）；VGC 900mg 与对照组相比，急性移植物排斥反应的风险为 1.71（0.45，-6.50；P=0.43），VGC 450mg 与对照组相比为 0.80（0.50-1.28；P=0.34）。VGC 900mg 与 VGC 450mg 之间的调整间接比较：CMV 疾病的风险无显著差异：比值比（OR），1.38（0.84-2.25）；P=0.19；白细胞减少症的风险显著增加，VGC 900mg 为 3.32（1.76-6.26）；P=0.0002；排斥反应的风险显著增加，VGC 900mg 为 2.56（1.50-4.53）；P=0.0005。在调整移植物、CMV 控制策略和免疫抑制后，结果仍然一致。
与对照组（更昔洛韦或预防性）相比，缬更昔洛韦 900mg 显示出没有优越性的疗效，且与 VGC 450mg（统计效能：94%和 97%）等效，用于 CMV 通用预防。与 VGC 450mg 相比，VGC 900mg 与白细胞减少症风险增加 3 倍和排斥反应风险增加 2 倍相关。
