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A Randomized Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus

机译：超免疫球蛋白预防先天性巨细胞病毒的随机试验

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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\udsignificantly 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\udCMV 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\udor by means of amniocentesis. Results: A total of 123 women could be evaluated in the efficacy analysis (1 woman in the\udplacebo 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\udbetween 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\udoutcome 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. (Funded by Agenzia Italiana del Farmaco; CHIP ClinicalTrials.gov number, NCT00881517; EudraCT no. 2008-006560-11.)
机译：人巨细胞病毒（CMV）先天性感染是发病率和死亡率的主要原因。在2005年发表的一项不受控制的研究中，对患有原发性巨细胞病毒感染的孕妇给予巨细胞病毒特异性超免疫球蛋白，子宫内传播率从40％显着降低到16％。方法：我们在第二阶段，随机，安慰剂对照，双盲研究中评估了超免疫球蛋白的疗效。假定感染发生后的6周内，总共124名在妊娠5至26周时患有原发性\ udCMV感染的孕妇被随机分配，每4周接受一次超免疫球蛋白或安慰剂治疗，直到妊娠36周或直到检测到CMV。羊水。主要终点是在出生时/出生时通过羊膜穿刺术诊断出的先天性感染。结果：功效分析中总共评估了123名女性（\ udplacebo组中的1名女性退出了）。高免疫球蛋白组的先天性感染率为30％（18名胎儿或61名妇女的婴儿），安慰剂组为44％（27胎儿或62名妇女的婴儿）（相差14个百分点； 95％置信区间） ，-3至31； P = 0.13）。在病毒特异性抗体，T细胞介导的免疫应答或病毒DNA水平方面，两组之间或两组之间，在传播病毒的女性与未传播病毒的女性之间没有显着差异。在血液中。两组在出生时先天性感染的临床\结果相似。高免疫球蛋白组的产科不良事件数量高于安慰剂组（13％比2％）。结论：在这项涉及123名妇女的研究中，接受超免疫球蛋白治疗并未显着改变妊娠期原发性巨细胞病毒感染的过程。 （由Agenzia Italiana del Farmaco资助; CHIP ClinicalTrials.gov编号，NCT00881517; EudraCT编号2008-006560-11。）

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