Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial
Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial
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DOI：
10.5468/ogs.2020.63.3.315
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发表时间：
2020-05-01
影响因子：
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通讯作者：
Divekar, Ganesh Harishchandra
中科院分区：
文献类型：
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作者：
Mayekar, Rahul Vishwanath;Paradkar, Gopalkrishna Vinayak;Divekar, Ganesh Harishchandra
目的比较重组抗D抗体的疗效和安全性（R-抗D）与常规多克隆抗D目的探讨多聚抗D（Poly anti-D）在预防母胎恒河猴D（RhD）同种免疫中的作用及R-抗D的免疫原性。在未接受产前抗D且分娩RhD的RhD阴性孕妇中进行的多中心临床试验-阳性婴儿，并在基线时显示阴性间接库姆斯试验（ICT）。这些妇女以2：1的比例随机分配到R-抗D或聚抗D组，并在分娩后72小时内给予300 mcg（IM）相应的药物。在抗D注射后72小时、90天和180天进行ICT。在第90天和第180天采集血清样本，使用桥接酶联免疫吸附试验检查抗R-抗D抗体的产生。在第90天和第180天ICT结果呈阳性的受试者的比例进行了比较，使用Fisher精确test.Results组间共有144名妇女被随机分配到R-抗-D组和71聚抗-D组。在第90天，R-抗-D组中有3名女性的ICT结果为阳性，而多聚抗-D组中无女性。在第180天，两组中均无女性出现阳性ICT结果。两种药物均耐受良好，每组仅报告4例不良事件-均为轻度、非严重且消退无后遗症。结论研究的R-抗-D抗体与传统的Poly抗-D抗体疗效相当，且安全、无免疫原性。
Objective To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.Methods This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.Results A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D.Conclusion The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.