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Lessons learnt from many years of experience using anti-D in humans for prevention of RhD immunization and haemolytic disease of the fetus and newborn

机译:多年在人类中使用抗D预防胎儿和新生儿RhD免疫和溶血性疾病的经验教训

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摘要

For 40 years prophylactic anti-D has been given to D-negative women after parturition to prevent haemolytic disease of the fetus and newborn. Monoclonal or recombinant anti-D may provide alternatives to the current plasma-derived polyclonal IgG anti-D, although none of them have yet proved as effective in phase 1 clinical trials. The variation in efficacy of the antibodies may have been influenced by heterogeneity in glycosylation of anti-D produced from different cell lines. Some aspects of the conduct of the human studies, most notably the use of low doses of anti-D and target D positive red cells in vivo, may aid the design of the clinical development of other immunomodulatory drugs in order to minimize adverse effects.
机译:在分娩后对D阴性的妇女进行预防性D预防已有40年,以预防胎儿和新生儿的溶血性疾病。单克隆或重组抗D可能会提供目前血浆衍生的多克隆IgG抗D的替代品,尽管在1期临床试验中尚未证明它们有效。抗体功效的变化可能已受到由不同细胞系产生的抗D的糖基化异质性的影响。人体研究的某些方面,尤其是体内低剂量抗D和靶D阳性红细胞的使用,可能有助于其他免疫调节药物的临床开发设计,以最大程度地减少不良反应。

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