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缬更昔洛韦治疗有症状的先天性巨细胞病毒疾病
Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease


David W. Kimberlin ... 围产医学和儿科 • 2015.03.05

摘要


背景

已有研究显示,更昔洛韦静脉用药6周治疗有症状的先天性巨细胞病毒(CMV)疾病,可改善6个月时的听力结局,但随着时间推移,获益逐渐减弱。

 

方法

我们在有症状的先天性CMV疾病新生儿中,开展了一项缬更昔洛韦治疗疾病的随机、安慰剂对照试验,对治疗6个月和治疗6周进行了比较。主要终点是从基线至6个月,听力较好的耳朵的听力(“最佳耳朵”的听力)变化。次要终点包括从基线至12和24个月随访时的听力变化以及神经发育结局,使用基线中枢神经系统受累情况对各终点进行了校正。

 

结果

共有96名新生儿被随机分组,其中86名有6个月时的随访数据可供评估。6个月组和6周组中最佳耳朵的听力相似(分别2名和3名参与者出现改善;36名和37名无变化;5名和3名恶化;P=0.41)。与6周组相比,在6个月组中,全部耳朵听力(可评估的1只或2只耳朵的听力)改善或保持正常的可能性较大(73% vs. 57%,P=0.01)。24个月时,全部耳朵听力的获益得到了保持(77% vs. 64%,P=0.04)。贝利婴幼儿发展量表(第三版)语言综合部分(P=0.004)和理解沟通量表(P=0.003)的评估结果显示,在24个月时,与6周组相比,6个月组的神经发育评分较好。前6周期间,19%的参与者发生了3级或4级中性粒细胞减少。在研究的随后4.5个月期间,6个月组21%的参与者和6周组27%的参与者发生了3级或4级中性粒细胞减少(P=0.64)。

 

结论

与治疗6周相比,使用缬更昔洛韦治疗有症状的先天性CMV疾病6个月未改善近期听力结局,但似乎小幅度地改善了较远期的听力和发育结局(由美国国立过敏和传染病研究所[National Institute of Allergy and Infectious Diseases]资助;在ClinicalTrials.gov注册号为NCT00466817)。





作者信息

David W. Kimberlin, M.D., Penelope M. Jester, B.S.N., M.P.H., Pablo J. Sánchez, M.D., Amina Ahmed, M.D., Ravit Arav-Boger, M.D., Marian G. Michaels, M.D., M.P.H., Negar Ashouri, M.D., Janet A. Englund, M.D., Benjamin Estrada, M.D., Richard F. Jacobs, M.D., José R. Romero, M.D., Sunil K. Sood, M.D., M. Suzanne Whitworth, M.D., Mark J. Abzug, M.D., Mary T. Caserta, M.D., Sandra Fowler, M.D., Jorge Lujan-Zilbermann, M.D., Gregory A. Storch, M.D., Roberta L. DeBiasi, M.D., Jin-Young Han, M.D., Ph.D., April Palmer, M.D., Leonard B. Weiner, M.D., Joseph A. Bocchini, M.D., Penelope H. Dennehy, M.D., Adam Finn, M.D., Paul D. Griffiths, M.D., Suzanne Luck, M.B., Ch.B., Kathleen Gutierrez, M.D., Natasha Halasa, M.D., James Homans, M.D., M.P.H., Andi L. Shane, M.D., M.P.H., Michael Sharland, M.D., Kari Simonsen, M.D., John A. Vanchiere, M.D., Ph.D., Charles R. Woods, M.D., Diane L. Sabo, Ph.D., Inmaculada Aban, Ph.D., Huichien Kuo, M.S., Scott H. James, M.D., Mark N. Prichard, Ph.D., Jill Griffin, R.N., Dusty Giles, R.N., Edward P. Acosta, Pharm.D., and Richard J. Whitley, M.D. for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Kimberlin at the Division of Pediatric Infectious Diseases, University of Alabama at Birmingham, 1600 Seventh Ave. S., Children's Harbor Bldg., Rm. 303, Birmingham, AL 35233, or at dkimberlin@peds.uab.edu.

 

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