Prophylaxis of cytomegalovirus infection in liver transplantation: a randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir. NIDDK Liver Transplantation Database.
Prophylaxis of cytomegalovirus infection in liver transplantation: a randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir. NIDDK Liver Transplantation Database.
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肝移植中巨细胞病毒感染的预防：一项比较更昔洛韦和阿昔洛韦组合与阿昔洛韦的随机试验。
DOI：
10.1097/00007890-199707150-00013
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发表时间：
1997
期刊：
影响因子：
6.2
通讯作者：
Paya,CV
中科院分区：
文献类型：
--
作者：
Badley,AD;Seaberg,EC;Porayko,MK;Wiesner,RH;Keating,MR;Wilhelm,MP;Walker,RC;Patel,R;Marshall,WF;DeBernardi,M;Zetterman,R;Steers,JL;Paya,CV
背景。预防原位肝移植患者巨细胞病毒（CMV）感染和疾病的最佳预防方案仍有待确定。我们测试是否结合静脉注射更昔洛韦(GCV)其次是高剂量口服阿昔洛韦(ACV) 4个月提供更高程度的保护比口服巨细胞病毒无环鸟苷alone.Methods.One几百六十七肝移植接受者被随机分配接受120天开始抗病毒治疗的移植的时候要么无环鸟苷组成的800毫克口服每天四次(n = 84)静脉注射或14天的GCV 5毫克/公斤每12 hr 800毫克口服无环鸟苷紧随其后每天4次（n= 83）。进行前瞻性实验室和临床监测，以确定主要终点（巨细胞病毒感染和巨细胞病毒疾病的发病）和次要终点（真菌和细菌感染率、同种异体移植排斥反应和移植后存活率）。结果：移植后的第一年，57%接受ACV治疗的患者发生巨细胞病毒感染，37%接受GCV+ ACV治疗的患者发生巨细胞病毒感染（P= 0.001）。23%的ACV治疗患者和11%的GCV+ ACV治疗患者发生巨细胞病毒疾病（P= 0.03）。在CMV血清阳性供者（D+/R-）的同种异体移植物的血清阴性受体中，58%的ACV治疗患者和25%的GCV+ ACV治疗患者发生CMV疾病（P= 0.04）。在D+/ r组中，54%的ACV组患者和17%的GCV+ ACV组患者发生白色念珠菌感染（P= 0.05）。预防肝移植患者的巨细胞病毒感染，静脉注射GCV 14天，然后服用大剂量口服ACV，在减少巨细胞病毒感染和疾病方面比单独服用大剂量口服ACV更有效，即使对D+/R-CMV血清学组患者也是如此。
Background.The optimal prophylactic regimen to prevent cytomegalovirus (CMV) infection and disease in orthotopic liver-transplant patients remains to be established. We tested whether a combination of intravenous ganciclovir (GCV) followed by high dosages of oral acyclovir (ACV) for 4 months provided a higher degree of protection from CMV than oral ACV alone.Methods.One hundred sixty-seven liver-transplant recipients were randomized to receive 120 days of antiviral treatment starting at the time of transplantation consisting of either ACV 800 mg orally four times daily (n= 84) or 14 days of GCV 5 mg/kg intravenously every 12 hr followed by oral ACV 800 mg four times daily (n= 83). Prospective laboratory and clinical surveillance was performed to determine primary endpoints (onset of CMV infection and CMV disease) and secondary endpoints (rates of fungal and bacterial infection, allograft rejection, and survival after transplantation). One-year event rates are presented as cumulative percentages.Results.During the first year after transplantation, CMV infection developed in 57% of patients treated with ACV and in 37% of patients treated with GCV+ ACV (P= 0.001). CMV disease developed in 23% of patients treated with ACV and in 11% of patients treated with GCV+ ACV (P= 0.03). In seronegative recipients of allografts from CMV-seropositive donors (D+/R-), CMV disease developed in 58% of patients treated with ACV and in 25% of patients treated with GCV+ ACV (P= 0.04). In the D+/R-group, 54% of patients treated with ACV and 17% of patients treated with GCV+ ACV developed infection with Candida albicans (P= 0.05).Conclusions.Prophylaxis of CMV infection in liver-transplant patients with 14 days of intravenous GCV followed by high-dosage oral ACV is more effective than high-dosage oral ACV alone at reducing CMV infection and disease, even for patients in the D+/R-CMV serological group.