Asberg A, Humar A, Rollag H, Jardine A G, Mouas H, Pescovitz M D, Sgarabotto D, Tuncer M, Noronha I L, Hartmann A
Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
Am J Transplant. 2007 Sep;7(9):2106-13. doi: 10.1111/j.1600-6143.2007.01910.x. Epub 2007 Jul 19.
Intravenous ganciclovir is the standard treatment for cytomegalovirus disease in solid organ transplant recipients. Oral valganciclovir is a more convenient alternative. In a randomized, international trial, recipients with cytomegalovirus disease were treated with either 900 mg oral valganciclovir or 5 mg/kg i.v. ganciclovir twice daily for 21 days, followed by 900 mg daily valganciclovir for 28 days. A total of 321 patients were evaluated (valganciclovir [n = 164]; i.v. ganciclovir [n = 157]). The success rate of viremia eradication at Day 21 was 45.1% for valganciclovir and 48.4% for ganciclovir (95% CI -14.0% to +8.0%), and at Day 49; 67.1% and 70.1%, respectively (p = NS). Treatment success, as assessed by investigators, was 77.4% versus 80.3% at Day 21 and 85.4% versus 84.1% at Day 49 (p = NS). Baseline viral loads were not different between groups and decreased exponentially with similar half-lives and median time to eradication (21 vs. 19 days, p = 0.076). Side-effects and discontinuations of assigned treatment (18 of 321 patients) were comparable. Oral valganciclovir shows comparable safety and is not inferior to i.v. ganciclovir for treatment of cytomegalovirus disease in organ transplant recipients and provides a simpler treatment strategy, but care should be taken in extrapolating to organ transplant recipients not properly represented in the present study.
静脉注射更昔洛韦是实体器官移植受者巨细胞病毒病的标准治疗方法。口服缬更昔洛韦是一种更方便的替代方法。在一项随机国际试验中，患有巨细胞病毒病的受者接受900毫克口服缬更昔洛韦或5毫克/千克静脉注射更昔洛韦治疗，每日两次，共21天，随后每日服用900毫克缬更昔洛韦28天。总共评估了321名患者（缬更昔洛韦组[n = 164]；静脉注射更昔洛韦组[n = 157]）。在第21天时，缬更昔洛韦组病毒血症根除成功率为45.1%，更昔洛韦组为48.4%（95%置信区间为-14.0%至+8.0%）；在第49天时，分别为67.1%和70.1%（p = 无统计学意义）。根据研究者评估，治疗成功率在第21天时分别为77.4%和80.3%，在第49天时分别为85.4%和84.1%（p = 无统计学意义）。两组的基线病毒载量无差异，且均呈指数下降，半衰期和根除中位时间相似（21天对19天，p = 0.076）。副作用和指定治疗的停药情况（321名患者中有18名）相当。口服缬更昔洛韦显示出相当的安全性，在治疗器官移植受者的巨细胞病毒病方面并不逊于静脉注射更昔洛韦，并且提供了更简单的治疗策略，但在将结果外推至本研究中未充分代表的器官移植受者时应谨慎。
