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首页> 外文期刊>The New England journal of medicine >A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus
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A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus

机译：Hyperimune球蛋白的随机试验，以防止先天性细胞病毒

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摘要

BACKGROUND: Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission, from 40% to 16%. METHODS: We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary end point was congenital infection diagnosed at birth or by means of amniocentesis. RESULTS: A total of 123 women could be evaluated in the efficacy analysis (1 woman in the placebo group withdrew). The rate of congenital infection was 30% (18 fetuses or infants of 61 women) in the hyperimmune globulin group and 44% (27 fetuses or infants of 62 women) in the placebo group (a difference of 14 percentage points; 95% confidence interval, -3 to 31; P = 0.13). There was no significant difference between the two groups or, within each group, between the women who transmitted the virus and those who did not, with respect to levels of virus-specific antibodies, T-cell-mediated immune response, or viral DNA in the blood. The clinical outcome of congenital infection at birth was similar in the two groups. The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group (13% vs. 2%). CONCLUSIONS: In this study involving 123 women who could be evaluated, treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy.
机译：背景：对人巨细胞病毒（CMV）的先天性感染是发病率和死亡率的主要原因。在2005年出版的一个不受控制的研究中，将CMV特异性超微母球蛋白的孕妇给予孕妇，患有原发性CMV感染的孕妇显着降低了宫内传播速率，从40％到16％。方法：我们评估了超极化球蛋白在2阶段，随机，安慰剂控制，双盲研究中的疗效。在妊娠预警发生后6周内在6周内随机分配124例妊娠期妊娠期，每4周接收Hyperimmune球蛋白或安慰剂，妊娠36周或直至在羊膜中检测CMV体液。主要终点是在出生时或通过羊膜内肌内诊断的先天性感染。结果：可以在疗效分析中评估123名女性（安慰剂集团退出的1名女子）。在安慰剂组中，先天性感染的率为30％（18名胎儿或61名患者的婴儿），安慰剂组中的44％（62名患有62名婴儿）（差异为14个百分点; 95％的置信区间，-3到31; p = 0.13）。两组或在每组内部，在传播病毒的妇女之间没有显着差异，并且没有关于病毒特异性抗体水平，T细胞介导的免疫应答或病毒DNA血液。在两组中出生时的先天性感染的临床结果在一起。超微征球蛋白组产科不良事件的数量高于安慰剂组（13％对2％）。结论：在这项研究中涉及可以评估的123名妇女，用Hyperimune球蛋白治疗并未显着修改怀孕期间的原发性CMV感染过程。

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  • 来源
    《The New England journal of medicine》 |2014年第14期|共11页
  • 作者

    RevelloM.G.; LazzarottoT.; GuerraB.; SpinilloA.; FerrazziE.; KustermannA.; GuaschinoS.; VerganiP.; TodrosT.; FruscaT.; ArossaA.; FurioneM.; RognoniV.; RizzoN.; GabrielliL.; KlersyC.; GernaG.;

  • 作者单位

    Departments of Obstetrics and Gynecology Fondazione Istituto di Ricovero e Cura a Carattere;

    Department of Specialized Experimental and Diagnostic Medicine St. Orsola-Malpighi General;

    Department of Medical Surgical Sciences St. Orsola-Malpighi General Hospital University of;

    Departments of Obstetrics and Gynecology Fondazione Istituto di Ricovero e Cura a Carattere;

    Department of Woman Mother and Neonate Buzzi Children's Hospital University of Milan Milan;

    Emergency Department of Obstetrics and Gynecology Fondazione IRCCS Ca' Granda Ospedale Maggiore;

    Department of Medical Surgical and Health Sciences University of Trieste Trieste Italy;

    Department of Interdisciplinary Surgical and Medical Sciences University of Milano-Bicocca San;

    Department of Surgical Sciences University of Turin Turin Italy;

    Departments of Obstetrics and Gynecology University of Brescia Brescia Italy;

    Departments of Obstetrics and Gynecology Fondazione Istituto di Ricovero e Cura a Carattere;

    Virology Unit Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico;

    Clinical Microbiology Unit Clinical-Surgical Diagnostic and Pediatric Sciences University of;

    Department of Medical Surgical Sciences St. Orsola-Malpighi General Hospital University of;

    Operative Unit of Microbiology St. Orsola-Malpighi General Hospital University of Bologna;

    Statistics and Biometrics Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS;

    Experimental Research Laboratories Fondazione Istituto di Ricovero e Cura a Carattere Scientifico;

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  • 正文语种 eng
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