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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Serum concentrations, efficacy, and safety of a new, intravenously administered varicella zoster immune globulin in pregnant women.
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Serum concentrations, efficacy, and safety of a new, intravenously administered varicella zoster immune globulin in pregnant women.

机译：孕妇静脉注射新的水痘带状疱疹免疫球蛋白的血清浓度，功效和安全性。

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摘要

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.
机译：水痘在人类中具有致畸性，水痘带状疱疹免疫球蛋白（VZIG）用于被认为与水痘接触后容易感染该病毒的孕妇。可用的VZIG以肌肉注射的形式给予。这项研究的目的是评估可以静脉注射的新型VZIG的疗效，安全性和血清浓度。在随机选择的57例水痘带状疱疹病毒（VZV）阴性孕妇中，将新的VZIG（Cangene Pharm。，Inc.）与标准VZIG（马萨诸塞州公共卫生生物学实验室）进行了比较。孕妇每10公斤体重获得125个单位，最大剂量为625个单位。在第2、7、14和28天以及其他时间，如果症状发展为临床水痘，则对女性进行评估，并通过体质疾病评分对妇女进行评估。新的VZIG在功效和安全性的所有参数上均与标准VZIG相当。在静脉内接受新制剂的患者中，注射后第2天的VZV抗体水平显着较高。作者得出的结论是，新的静脉注射形式的VZIG可赋予较高的VZV抗体初始水平，并且在母体效力和安全性方面可与标准形式的VZIG相媲美。

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