2012年12月，美国食品药品管理局（Foodand Drug Administration，FDA）批准在美国使用水痘-带状疱疹免疫球蛋白（A Varicella-Zoster Immunoglobulin，VZIG）（加拿大温伯尼Cangene公司），进行水痘暴露后预防，针对人群为：缺乏水痘...2012年12月，美国食品药品管理局（Foodand Drug Administration，FDA）批准在美国使用水痘-带状疱疹免疫球蛋白（A Varicella-Zoster Immunoglobulin，VZIG）（加拿大温伯尼Cangene公司），进行水痘暴露后预防，针对人群为：缺乏水痘免疫力证据的、展开更多
在美国,对水痘无免疫力、且不能接种水痘减毒活疫苗（Varicella Attenuated Live Vaccine,VarV）的患有严重疾病高风险的人群来说,水痘-带状疱疹免疫球蛋白（Varicella-Zoster Immunoglobulin,VariZIG;加拿大温尼伯Cangene公司）是唯一...在美国,对水痘无免疫力、且不能接种水痘减毒活疫苗（Varicella Attenuated Live Vaccine,VarV）的患有严重疾病高风险的人群来说,水痘-带状疱疹免疫球蛋白（Varicella-Zoster Immunoglobulin,VariZIG;加拿大温尼伯Cangene公司）是唯一可用的VariZIG制剂。在美国通过研究性新药（Investigational New Drug,IND）扩展访问协议即可使用VariZIG。VariZIG是一种纯化制剂,来源于人血浆,含高水平的抗水痘-带状疱疹病毒抗体（Antibody to Varicella-Zoster Virus,Anti-VZV）（IgG）。展开更多
Aims: 1) To assess the safety of intravenous varicella zoster virus hyperimmune globulin G (IV-VZVIG) in neonates; 2) measure varicella zoster virus-specific IgG antibody (VZVIG) changes in newborn IV-VZVIG recipients...Aims: 1) To assess the safety of intravenous varicella zoster virus hyperimmune globulin G (IV-VZVIG) in neonates; 2) measure varicella zoster virus-specific IgG antibody (VZVIG) changes in newborn IV-VZVIG recipients. Methods: Eighteen neonatal intensive care unit (NICU) neonates with varicella exposure were given 1 ml/kg (43 International Units (IU)/kg) Varitect(r) IV-VZVIG. Serum VZVIG titers were assayed in neonatal recipients 0, 1, 7, 14, 21, 28, and 35 d after IV-VZVIG. Also, serum samples for VZV-IgM antibody determinations were obtained at 4 wk post-infusion. Results: No varicella developed in the 18 infants. Infusion of 1 ml/kg (43 IU/kg) IV-VZVIG was generally safe. The IV-VZVIG dose resulted in seroconversion of a non-immune newborn. Five infants had low basal VZVIG titers, and two of them had a 0.6-log10 increase at 24 h post-infusion. Neonatal VZVIG titers (mean ±SEM in log10) before IV-VZVIG and after by 1, 7, 14, 21, 28, and 35 d were 2.22 ±0.15, 2.17 ±0.17, 2.02 ±0.12, 0.87 ±0.2, 1.09 ±0.19, 2.33 ±0.07, and 2.16 ±0.1, respectively. Conclusions: One ml/kg (43 IU/kg) IV-VZVIG was generally safe. Our neonatal mean VZV-immune status did not significantly increase after the 1 ml/kg (43 IU/kg) IVVZVIG dose, although no varicella developed and it caused a VZV-specific seroconversion.展开更多
文摘2012年12月，美国食品药品管理局（Foodand Drug Administration，FDA）批准在美国使用水痘-带状疱疹免疫球蛋白（A Varicella-Zoster Immunoglobulin，VZIG）（加拿大温伯尼Cangene公司），进行水痘暴露后预防，针对人群为：缺乏水痘免疫力证据的、
文摘在美国,对水痘无免疫力、且不能接种水痘减毒活疫苗（Varicella Attenuated Live Vaccine,VarV）的患有严重疾病高风险的人群来说,水痘-带状疱疹免疫球蛋白（Varicella-Zoster Immunoglobulin,VariZIG;加拿大温尼伯Cangene公司）是唯一可用的VariZIG制剂。在美国通过研究性新药（Investigational New Drug,IND）扩展访问协议即可使用VariZIG。VariZIG是一种纯化制剂,来源于人血浆,含高水平的抗水痘-带状疱疹病毒抗体（Antibody to Varicella-Zoster Virus,Anti-VZV）（IgG）。
文摘Aims: 1) To assess the safety of intravenous varicella zoster virus hyperimmune globulin G (IV-VZVIG) in neonates; 2) measure varicella zoster virus-specific IgG antibody (VZVIG) changes in newborn IV-VZVIG recipients. Methods: Eighteen neonatal intensive care unit (NICU) neonates with varicella exposure were given 1 ml/kg (43 International Units (IU)/kg) Varitect(r) IV-VZVIG. Serum VZVIG titers were assayed in neonatal recipients 0, 1, 7, 14, 21, 28, and 35 d after IV-VZVIG. Also, serum samples for VZV-IgM antibody determinations were obtained at 4 wk post-infusion. Results: No varicella developed in the 18 infants. Infusion of 1 ml/kg (43 IU/kg) IV-VZVIG was generally safe. The IV-VZVIG dose resulted in seroconversion of a non-immune newborn. Five infants had low basal VZVIG titers, and two of them had a 0.6-log10 increase at 24 h post-infusion. Neonatal VZVIG titers (mean ±SEM in log10) before IV-VZVIG and after by 1, 7, 14, 21, 28, and 35 d were 2.22 ±0.15, 2.17 ±0.17, 2.02 ±0.12, 0.87 ±0.2, 1.09 ±0.19, 2.33 ±0.07, and 2.16 ±0.1, respectively. Conclusions: One ml/kg (43 IU/kg) IV-VZVIG was generally safe. Our neonatal mean VZV-immune status did not significantly increase after the 1 ml/kg (43 IU/kg) IVVZVIG dose, although no varicella developed and it caused a VZV-specific seroconversion.
