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静脉注射免疫球蛋白(IVIG)制剂用于婴儿麻疹暴露后预防(PEP)的有效性和安全性。

Effectiveness and Safety of an Intravenous Immune Globulin (IVIG) Preparation in Post-exposure Prophylaxis (PEP) Against Measles in Infants.

作者信息

Kohlmaier Benno, Holzmann Heidemarie, Stiasny Karin, Leitner Manuel, Zurl Christoph, Strenger Volker, Kundi Michael, Zenz Werner

机构信息

Department of General Pediatrics, Medical University of Graz, Graz, Austria.

Center for Virology, Medical University of Vienna, Vienna, Austria.

出版信息

Front Pediatr. 2021 Dec 2;9:762793. doi: 10.3389/fped.2021.762793. eCollection 2021.

DOI:10.3389/fped.2021.762793
PMID:34926346
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8675579/
Abstract

Administration of measles virus (MV)-specific IgG as post-exposure prophylaxis (PEP) is known to effectively prevent measles. Since the introduction of active immunization against measles, the levels of MV-specific IgG antibodies in the population have dropped. Therefore, the concentration of MV-specific antibodies in immunoglobulin products derived from human plasma donors has declined as the proportion of vaccinated donors has increased. Literature on the effectiveness of PEP with current available immunoglobulins is limited. Here we examine the effectiveness of 400 mg/kg intravenous immunoglobulin (IVIG) (IgVena®, Kendrion) as PEP in infants during a measles outbreak in Austria, 2019. After exposure to a highly contagious measles patient, identified infants were evaluated for eligibility for IVIG PEP. Infants were tested for measles maternal antibodies, if the result was expected to be available within 72 h after exposure. IVIG was administered to eligible infants with negative maternal IgG antibody levels ( = 11), infants with protective levels but result beyond 72 h ( = 2) and infants not tested for maternal IgG antibodies ( = 52). Telephone enquiries were made asking for measles infection. Effectiveness was calculated using exact logistic regression. Samples of four out of seven used IVIG batches were tested for MV-neutralizing antibody capacity. In 63 (96.9%) of 65 infants PEP with IVIG was administered. The parents of two infants declined IVIG PEP. None of the infants with IVIG PEP got measles or symptoms suggestive for measles, but both infants who did not receive PEP were infected. Effectiveness of IVIG PEP was calculated to be 99.3% (CI 95%: 88.7-100%). No serious adverse event of IVIG treatment was observed. The investigation on MV-neutralizing antibody capacity showed a geometric mean titer ranging from 10.0 to 12.7 IU/ml, resulting in a 1.57-2.26-fold higher concentration than postulated as minimum level for immunity. Our findings suggest that the used IVIG preparation provided an at least non-inferior protection rate compared to IVIG preparations derived from donors before the global introduction of standard active immunization against measles.

摘要

已知给予麻疹病毒(MV)特异性IgG作为暴露后预防(PEP)可有效预防麻疹。自引入麻疹主动免疫以来,人群中MV特异性IgG抗体水平有所下降。因此,随着接种疫苗的献血者比例增加,源自人类血浆捐献者的免疫球蛋白产品中MV特异性抗体的浓度也有所下降。关于使用现有免疫球蛋白进行PEP有效性的文献有限。在此,我们研究了400mg/kg静脉注射免疫球蛋白(IVIG)(IgVena®,Kendrion)在2019年奥地利麻疹疫情期间作为婴儿PEP的有效性。在接触具有高度传染性的麻疹患者后,对确定的婴儿进行评估以确定其是否符合IVIG PEP的条件。如果预计在接触后72小时内可获得结果,则对婴儿进行麻疹母体抗体检测。对母体IgG抗体水平为阴性的符合条件的婴儿(n = 11)、具有保护性水平但结果超过72小时的婴儿(n = 2)以及未检测母体IgG抗体的婴儿(n = 52)给予IVIG。通过电话询问是否感染麻疹。使用精确逻辑回归计算有效性。对所使用的7批IVIG中的4批样本进行了MV中和抗体能力检测。65名婴儿中有63名(96.9%)接受了IVIG PEP。两名婴儿的父母拒绝了IVIG PEP。接受IVIG PEP的婴儿中无一感染麻疹或出现疑似麻疹的症状,但未接受PEP的两名婴儿均被感染。IVIG PEP的有效性经计算为99.3%(95%CI:88.7 - 100%)。未观察到IVIG治疗的严重不良事件。对MV中和抗体能力的研究表明,几何平均滴度范围为10.0至12.7IU/ml,其浓度比假定的最低免疫水平高1.57至2.26倍。我们的研究结果表明,与全球引入标准麻疹主动免疫之前来自献血者的IVIG制剂相比,所使用的IVIG制剂提供了至少非劣效的保护率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/912b/8675579/48a3ff26f853/fped-09-762793-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/912b/8675579/48a3ff26f853/fped-09-762793-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/912b/8675579/48a3ff26f853/fped-09-762793-g0001.jpg

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