Koren Gideon, Money Deborah, Boucher Marc, Aoki Fred, Petric Martin, Innocencion Gilda, Wolosk Michael, Remple Valencia, Pelland Francine, Geist Ruth, Ho Tommy, Bar-Oz Benny, Loebstein Ronen
Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, Toronto, Ontario.
J Clin Pharmacol. 2002 Mar;42(3):267-74. doi: 10.1177/00912700222011283.
Chickenpox is teratogenic in humans, and varicella zoster immune globulin (VZIG) is given to pregnant women believed to be susceptible to the virus after contact with chickenpox. Available VZIG is given as intramuscular injections. The objective of this study was to evaluate the efficacy, safety, and serum concentrations of a new VZIG that can be given intravenously. The new VZIG (Cangene Pharm., Inc.) was compared to the standard VZIG (Massachusetts Public Health Biologic Laboratories) in a randomized protocol in 57 pregnant women seronegative to varicella zoster virus (VZV). Pregnant women received 125 units per 10 kg body weight to a maximal dose of 625 units. Women were evaluated on days 2, 7, 14, and 28 and at other times if symptoms developed into clinical varicella, which was scored by the Constitutional Illness Score. The new VZIG was comparable to the standard VZIG on all parameters of efficacy and safety. Levels of VZV antibodies at day 2 postinjection were significantly higher among those receiving the new preparation intravenously. The authors concluded that the new intravenous form of VZIG confers higher initial levels of VZV antibodies and is comparable in terms of its maternal efficacy and safety to the standard form of VZIG.
水痘对人类具有致畸性，对于接触水痘后被认为易感染该病毒的孕妇，会给予水痘带状疱疹免疫球蛋白（VZIG）。现有的VZIG通过肌肉注射给药。本研究的目的是评估一种可静脉注射的新型VZIG的疗效、安全性和血清浓度。在一项随机试验方案中，将新型VZIG（Cangene制药公司）与标准VZIG（马萨诸塞州公共卫生生物实验室）在57名水痘带状疱疹病毒（VZV）血清阴性的孕妇中进行比较。孕妇按每10千克体重125单位给药，最大剂量为625单位。在第2、7、14和28天对孕妇进行评估，若症状发展为临床水痘，则在其他时间进行评估，临床水痘通过体质疾病评分进行打分。新型VZIG在所有疗效和安全性参数方面与标准VZIG相当。静脉注射新型制剂的患者在注射后第2天的VZV抗体水平显著更高。作者得出结论，新型静脉注射形式的VZIG能使VZV抗体达到更高的初始水平，在母体疗效和安全性方面与标准形式的VZIG相当。
