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口服缬更昔洛韦与静脉用更昔洛韦预防活体肝移植后巨细胞病毒感染的随机试验

Oral valganciclovir versus intravenous ganciclovir as preemptive treatment for cytomegalovirus infection after living donor liver transplantation: a randomized trial.

机构信息

Artificial Organ and Transplantation Surgery Division, Department of Surgery, The University of Tokyo, Tokyo, Japan.

出版信息

Biosci Trends. 2011;5(5):217-22. doi: 10.5582/bst.2011.v5.5.217.

Abstract

It is unclear whether valganciclovir (VGCV) is effective compared with intravenous ganciclovir (GCV) for preemptive therapy of cytomegalovirus (CMV) infection in living donor liver transplantation (LDLT). A randomized trial was conducted to compare the efficacy of oral VGCV with intravenous GCV for preemptive treatment of CMV infection after LDLT. Patients who developed CMV infection within 6 months after LDLT at Tokyo University Hospital were randomly assigned to the VGCV or GCV group and received either oral VGCV 900 mg/day or intravenous GCV 5 mg/kg twice daily, respectively. The primary endpoint was the treatment success rate. Secondary endpoints were recurrence of CMV infection within 1 year after finishing the treatment, and safety and tolerability of the treatment. Twenty-two patients with CMV infection after LDLT fulfilled the inclusion criteria and were randomly assigned to the oral VGCV group (n = 11) or the intravenous GCV group (n = 11). Treatment success rates were 82% (9 of 11) and 91% (10 of 11) in the VGCV and GCV groups, respectively. One patient in the VGCV group developed recurrence, whereas no patients in the GCV group developed recurrence. All the patients completed the treatment protocol, and no patients in either group dropped out of the study. In conclusion, oral VGCV and intravenous GCV are safe, feasible options for preemptive treatment of CMV infection after LDLT.

摘要

在活体肝移植 (LDLT) 中,更昔洛韦缬酯 (VGCV) 与更昔洛韦静脉注射 (GCV) 用于巨细胞病毒 (CMV) 感染的预防治疗相比是否有效尚不清楚。进行了一项随机试验,比较口服 VGCV 与静脉 GCV 在 LDLT 后预防治疗 CMV 感染的疗效。在东京大学医院接受 LDLT 后 6 个月内发生 CMV 感染的患者被随机分配到 VGCV 或 GCV 组,分别接受口服 VGCV 900mg/天或静脉 GCV 5mg/kg,每日两次。主要终点是治疗成功率。次要终点是治疗结束后 1 年内 CMV 感染的复发率,以及治疗的安全性和耐受性。22 例 LDLT 后发生 CMV 感染的患者符合纳入标准,并被随机分配到口服 VGCV 组(n = 11)或静脉 GCV 组(n = 11)。VGCV 和 GCV 组的治疗成功率分别为 82%(9/11)和 91%(10/11)。VGCV 组 1 例患者复发,GCV 组无患者复发。所有患者均完成了治疗方案,两组均无患者退出研究。总之,口服 VGCV 和静脉 GCV 是 LDLT 后 CMV 感染预防治疗的安全可行选择。

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