N Engl J Med. 1991 Jul 11;325(2):73-80. doi: 10.1056/NEJM199107113250201.
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.
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.
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 for 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.
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.
严重复发性细菌感染是感染人类免疫缺陷病毒（HIV）儿童发病和死亡的主要原因。由于静脉注射免疫球蛋白已被证明可预防原发性免疫缺陷患者的细菌感染，并且在对HIV感染儿童的非对照研究中也有此效果，我们开展了一项多中心研究，以评估其在有症状HIV感染儿童中的安全性和疗效。
在一项双盲试验中，372名有HIV疾病临床或免疫学证据的HIV感染儿童（平均年龄40个月）被随机分配，每28天接受一次静脉注射免疫球蛋白（每公斤体重400毫克）或安慰剂（0.1%白蛋白）。根据入组时的CD4+淋巴细胞计数和疾病控制中心的临床分类，将儿童分为两组。随访的中位时间为17个月。
对于入组时CD4+计数大于或等于0.2×10⁹/L（大于或等于200/立方毫米）的两组儿童，静脉注射免疫球蛋白治疗显著延长了无严重感染的时间；接受免疫球蛋白治疗的儿童24个月时的估计无感染率为67%，而接受安慰剂治疗的儿童为48%（P = 0.01）。此外，免疫球蛋白与严重和轻度细菌感染的总数减少（相对危险度，0.68；P = 0.01）以及急性护理住院次数减少（相对危险度，0.65；P = 0.03）相关。对于入组时CD4+计数低于0.2×10⁹/L的儿童，未观察到此类益处。对于总体1组，免疫球蛋白和安慰剂在严重细菌感染方面存在差异趋势（24个月无感染生存率，静脉注射免疫球蛋白组为31%，安慰剂组为25%；P = 0.10）。对于2组，静脉注射免疫球蛋白时无严重感染的生存率估计为73%，而安慰剂组为53%（P = 0.04）。治疗对任何组或入组时的CD4+计数的死亡率均无影响。不良反应发生率低于1%的输液，且症状轻微。
在有症状的HIV感染儿童中，预防性使用静脉注射免疫球蛋白是安全的，对于入组时CD4+淋巴细胞计数大于或等于0.2×10⁹/L的儿童，它可显著延长无严重细菌感染的时间。
