Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study
Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study
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DOI：
10.1086/516445
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发表时间：
1997-05-01
影响因子：
6.4
通讯作者：
Sommadossi, JP
中科院分区：
文献类型：
--
作者：
Whitley, RJ;Cloud, G;Sommadossi, JP
先天性巨细胞病毒（CMV）感染发生在大约1%的美国新生儿中。更昔洛韦治疗先天性巨细胞病毒感染的II期评估。每日剂量为8或12mg /kg，每隔12小时分次给药，持续6周。临床和实验室评估寻求毒性、尿中定量病毒学反应、血浆药物浓度和临床结果的证据。共有14名和28名婴儿分别接受了8毫克/公斤/天和12毫克/公斤/天的治疗，另外5名婴儿在同情请求的基础上接受了更昔洛韦。显著的实验室异常包括37例婴儿血小板减少（小于或等于50,000/mm(3)）和29例婴儿绝对中性粒细胞减少（小于或等于500 mm(3)）。尿中巨细胞病毒的定量排泄减少；然而，停止治疗后，病毒数量恢复到接近治疗前的水平。在30名6个月或更晚的婴儿中，有5名（16%）出现听力改善或稳定，表明有效。
Congenital cytomegalovirus (CMV) infection occurs in similar to 1% of newborns in the United Stales. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively, Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (less than or equal to 50,000/mm(3)) in 37 babies and absolute neutropenia (less than or equal to 500 mm(3)) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.