INTRAVENOUS IMMUNE GLOBULIN FOR THE PREVENTION OF BACTERIAL-INFECTIONS IN CHILDREN WITH SYMPTOMATIC HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

被引:118
作者
MOFENSON, LM
机构
[1] National Institute of Child Health and Human Development, Bethesda, Md.
[2] Pediatric, Adolescent and Maternal AIDS Branch, Westat, Inc., Rockville, Md.
[3] Division of Prevention Research, Westat, Inc., Rockville, Md.
[4] Lincoln Hospital Center, Bronx, N.Y.
[5] Cornell Medical Center-New York Hospital, New York
[6] Schneider Children's Hospital—Queens Hospital Center of Long Island Jewish Medical Center, New Hyde Park, N.Y.
[7] Beth Israel Medical Center, New York
[8] Metropolitan Hospital Center, New York
[9] New York Medical College, Valhalla
[10] Harlem Hospital Center, New York
[11] State University of New York Health Science Center, Brooklyn
[12] St. Luke's/Roosevelt Hospital Center, New York
[13] North Shore University Hospital, Manhassett, N.Y.
[14] New York University Medical Center—Bellevue Hospital Center, New York
[15] Babies Hospital, New York
[16] Albert Einstein College of Medicine, Bronx, N.Y.
[17] University of Connecticut Health Center, Hartford
[18] Boston City Hospital, Boston
[19] University of Medicine, Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick
[20] St. Christopher's Hospital, Philadelphia
[21] University of Maryland, Baltimore
[22] Children's Hospital National Medical Center, Washington, D.C.
[23] Emory University School of Medicine, Atlanta
[24] Children's Memorial Hospital, Chicago
[25] University of Illinois College of Medicine, Chicago
[26] Texas Children's Hospital, Houston
[27] Children's Hospital Medical Center, Oakland, Calif.
[28] University of Puerto Rico, San Juan
[29] San Juan City Hospital, San Juan, P.R.
[30] Ramon Ruiz Arnau University Hospital, Bayamon, P.R.
[31] Cutler Biological, Miles, Inc., Berkeley, Calif.
关键词
LACTATE-DEHYDROGENASE LEVELS; B-CELL LYMPHOPROLIFERATION; DEFICIENCY SYNDROME AIDS; GAMMA-GLOBULIN; IMMUNOGLOBULIN THERAPY; POSSIBLE INDICATOR; DISEASE-ACTIVITY; ENZYME LEVELS; COMPLEX; EFFICACY;
D O I
10.1056/NEJM199107113250201
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background. Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the human immunodeficiency virus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection. Methods. In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4+ lymphocyte count at entry into the study and the clinical classification of the Centers for Disease Control. The median length of follow-up was 17 months. Results. For children in either group with CD4+ counts greater-than-or-equal-to 0.2 x 10(9) per liter (greater-than-or-equal-to 200 per cubic millimeter) at entry, treatment with intravenous immune globulin significantly increased the time free from serious infection; estimated infection-free rates after 24 months were 67 percent for children receiving immune globulin as compared with 48 percent for those receiving placebo (P = 0.01). In addition, immune globulin was associated with an overall reduction in the number of both serious and minor bacterial infections (relative risk, 0.68; P = 0.01) and in the number of hospitalizations tor acute care (relative risk, 0.65; P = 0.03). No such benefits were seen for children with CD4+ counts below 0.2 x 10(9) per liter at entry. For group 1 overall, there was a trend toward a difference in serious bacterial infection between immune globulin and placebo (24-month infection-free survival, 31 percent for intravenous immune globulin vs. 25 percent for placebo; P = 0.10). For group 2, the estimates of survival without serious infection were 73 percent with intravenous immune globulin as compared with 53 percent with placebo (P = 0.04). There was no effect of treatment on mortality for any group or CD4+ count at entry. Adverse reactions, noted for less than 1 percent of infusions, were minor. Conclusions. In symptomatic HIV-infected children the prophylactic use of intravenous immune globulin is safe, and it significantly increases the time free from serious bacterial infections for those entering treatment with CD4+ lymphocyte counts greater-than-or-equal-to 0.2 x 10(9) per liter.
引用
收藏
页码:73 / 80
页数:8
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