Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system:: A randomized, controlled trial
Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system:: A randomized, controlled trial
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DOI：
10.1016/s0022-3476(03)00192-6
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发表时间：
2003-07-01
影响因子：
5.1
通讯作者：
Whitley, RJ
中科院分区：
文献类型：
--
作者：
Kimberlin, DW;Lin, CY;Whitley, RJ
目的评价更昔洛韦治疗新生儿先天性巨细胞病毒（CMV）感染的有效性和安全性。研究设计将有症状的CMV感染累及中枢神经系统的新生儿随机分为两组，分别静脉注射更昔洛韦和不治疗6周。主要终点是基线和6个月随访之间脑干诱发反应（BSER）的改善（或者，对于基线听力正常的患者，两个时间点的BSER均正常）。其中，42例患者进行了基线和6个月随访BSER听力检查，因此可用于主要终点评价。25名接受更昔洛韦的患者中有21名（84%）在基线和6个月之间听力改善或保持正常听力，而17名对照患者中有10名（59%）（P = 0.06）。25名接受更昔洛韦治疗的患者中，从基线到6个月，听力没有恶化（0%），而17名对照患者中有7名（41%）听力恶化（P <0.01）。共有43例患者在基线和第1年或以后均具有BSER。24例接受更昔洛韦治疗的患者中有5例（21%）在基线至≥ 1年之间听力恶化，而19例对照患者中有13例（68%）听力恶化（P
Objective To evaluate the efficacy and safety of gancielovir therapy in neonates with congenital cytomegalovirus (CMV) disease.Study design Neonates with symptomatic CMV disease involving the central nervous system were randomly assigned to receive 6 weeks of intravenous gancielovir versus no treatment. The primary end point was improved brainstem-evoked response (BSER) between baseline and 6-month follow-up (or, for patients with normal baseline hearing, normal BSER at both time points).Results From 1991 to 1999, 100 patients were enrolled. Of these, 42 patients had both a baseline and 6-month follow-up BSER audiometric examination and thus were evaluable for the primary end point. Twenty-one (84%) of 25 gancielovir recipients had improved hearing or maintained normal hearing between baseline and 6 months versus 10 (59%) of 17 control patients (P = .06). None (0%) of 25 gancielovir recipients bad worsening in hearing between baseline and 6 months versus 7 (41%) of 17 control patients (P < .01). A total of 43 patients had a BSER at both baseline and at I year or beyond. Five (21%) of 24 gancielovir recipients had worsening of hearing between baseline and greater than or equal to 1 year versus 13 (68%) of 19 control patients (P