AlexGold
29.09.2005, 15:00
Исследование посвящено выяснению эффективности пассивной иммунизации беременных с первичной цитомегаловирусной инфекцией (ЦМВИ) гипериммунным ЦМВИ-иммуноглобулином для предотвращения врожденной цитомегаловирусной инфекции у рожденных от них детей.
N Engl J Med 353:1350-1362, 2005
Passive Immunization during Pregnancy for Congenital Cytomegalovirus Infection
Giovanni Nigro, M.D., Stuart P. Adler, M.D., Renato La Torre, M.D., Al M. Best, Ph.D., for the Congenital Cytomegalovirus Collaborating Group
Background. Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy.
Methods. We studied pregnant women with a primary CMV infection. The therapy group comprised women whose amniotic fluid contained either CMV or CMV DNA and who were offered intravenous CMV hyperimmune globulin at a dose of 200 U per kilogram of maternal weight. A prevention group, consisting of women with a recent primary infection before 21 weeks' gestation or who declined amniocentesis, was offered monthly hyperimmune globulin (100 U per kilogram intravenously).
Results. In the therapy group, 31 women received hyperimmune globulin, only 1 (3 percent) of whom gave birth to an infant with CMV disease (symptomatic at birth and handicapped at two or more years of age), as compared with 7 of 14 women who did not receive hyperimmune globulin (50 percent). Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV disease (adjusted odds ratio, 0.02; 95 percent confidence interval, –infinity to 0.15; P<0.001). In the prevention group, 37 women received hyperimmune globulin, 6 (16 percent) of whom had infants with congenital CMV infection, as compared with 19 of 47 women (40 percent) who did not receive hyperimmune globulin. Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV infection (adjusted odds ratio, 0.32; 95 percent confidence interval, 0.10 to 0.94; P=0.04). Hyperimmune globulin therapy significantly (P<0.001) increased CMV-specific IgG concentrations and avidity and decreased natural killer cells and HLA-DR+ cells and had no adverse effects.
Conclusions. Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.
Source Information:
From the Departments of Pediatrics (G.N.) and Gynecological Sciences, Perinatology, and Child Health (G.N., R.L.), La Sapienza University, Rome; and the Department of Pediatrics and Biostatistics, Medical College of Virginia Campus, Virginia Commonwealth University, Richmond (S.P.A., A.M.B.).
Address reprint requests to Dr. Nigro at Via dei Villini 35, 00161 Rome, Italy, or at [Ссылки могут видеть только зарегистрированные и активированные пользователи].
N Engl J Med 353:1350-1362, 2005
Passive Immunization during Pregnancy for Congenital Cytomegalovirus Infection
Giovanni Nigro, M.D., Stuart P. Adler, M.D., Renato La Torre, M.D., Al M. Best, Ph.D., for the Congenital Cytomegalovirus Collaborating Group
Background. Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy.
Methods. We studied pregnant women with a primary CMV infection. The therapy group comprised women whose amniotic fluid contained either CMV or CMV DNA and who were offered intravenous CMV hyperimmune globulin at a dose of 200 U per kilogram of maternal weight. A prevention group, consisting of women with a recent primary infection before 21 weeks' gestation or who declined amniocentesis, was offered monthly hyperimmune globulin (100 U per kilogram intravenously).
Results. In the therapy group, 31 women received hyperimmune globulin, only 1 (3 percent) of whom gave birth to an infant with CMV disease (symptomatic at birth and handicapped at two or more years of age), as compared with 7 of 14 women who did not receive hyperimmune globulin (50 percent). Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV disease (adjusted odds ratio, 0.02; 95 percent confidence interval, –infinity to 0.15; P<0.001). In the prevention group, 37 women received hyperimmune globulin, 6 (16 percent) of whom had infants with congenital CMV infection, as compared with 19 of 47 women (40 percent) who did not receive hyperimmune globulin. Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV infection (adjusted odds ratio, 0.32; 95 percent confidence interval, 0.10 to 0.94; P=0.04). Hyperimmune globulin therapy significantly (P<0.001) increased CMV-specific IgG concentrations and avidity and decreased natural killer cells and HLA-DR+ cells and had no adverse effects.
Conclusions. Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.
Source Information:
From the Departments of Pediatrics (G.N.) and Gynecological Sciences, Perinatology, and Child Health (G.N., R.L.), La Sapienza University, Rome; and the Department of Pediatrics and Biostatistics, Medical College of Virginia Campus, Virginia Commonwealth University, Richmond (S.P.A., A.M.B.).
Address reprint requests to Dr. Nigro at Via dei Villini 35, 00161 Rome, Italy, or at [Ссылки могут видеть только зарегистрированные и активированные пользователи].