A Multicenter, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Monoclonal Anti-Rh (D) Immunoglobulin with Polyclonal Anti-Rh (D) Immunoglobulin for the Prevention of Maternal Rh-Isoimmunization
A Multicenter, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Monoclonal Anti-Rh (D) Immunoglobulin with Polyclonal Anti-Rh (D) Immunoglobulin for the Prevention of Maternal Rh-Isoimmunization
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DOI：
10.1007/s13224-019-01234-2
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发表时间：
2019-10-01
影响因子：
0.7
通讯作者：
Patole, Kiran P.
中科院分区：
文献类型：
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作者：
Chauhan, Anahita R.;Nandanwar, Yogeshwar S.;Patole, Kiran P.
目的比较单克隆抗恒河猴（抗D）免疫球蛋白（IgG）和多克隆抗D IgG预防母源性Rh同种免疫的有效性和安全性。方法这是一项随机、多中心、开放标签、比较性临床试验，在印度9家三级医院的产科住院部进行。206例Rh（D）阴性、Rh抗原未致敏且分娩Rh阳性婴儿的妇女接受产后肌内注射单克隆或多克隆抗D IgG。主要结局指标为抗D IgG给药后第180天通过间接Coombs试验（ICT）阴性结果确定的受试者免于Rh同种免疫的比例和不良事件的发生率。结果105例受试者随机分为单克隆组和多克隆组。第180天时，单克隆组94例ICT结果为阴性，无一例ICT结果为阳性，而多克隆组87例ICT结果为阴性，1例ICT结果为阳性;其余（分别为11例和13例受试者）失访。共报告了5起不良事件（单克隆组3起，多克隆组2起）;其中仅1起为严重事件。所有不良事件均被判定为与干预药物无关。单克隆组中没有受试者对单克隆抗D产生免疫原性反应。结论抗D单克隆抗体预防母源Rh同种免疫的有效性和安全性与抗D多克隆抗体相当。临床试验注册号：CTRI/2015/09/006172。
Objectives To compare the efficacy and safety of monoclonal anti-Rhesus (anti-D) immunoglobulin (IgG) with polyclonal anti-D IgG in the prevention of maternal Rh-isoimmunization. Methods This was a randomized, multicenter, open-label, comparative clinical trial conducted in the obstetric in-patient departments of nine tertiary care hospitals in India. 206 Rhesus (D)-negative women, not sensitized to Rh antigen, and delivering Rh positive babies, received postpartum intramuscular administration of monoclonal or polyclonal anti-D IgG. The main outcome measures were the proportion of subjects protected from Rh-isoimmunization, identified by a negative indirect Coombs test (ICT) result, at day 180 after anti-D IgG administration, and incidence of adverse events. Results 105 subjects were randomized to the monoclonal group and 101 to the polyclonal group. 94 from the monoclonal group had a negative ICT result and none had a positive ICT result at day 180, whereas 87 from the polyclonal group had a negative ICT result and one had a positive ICT result; the rest (11 and 13 subjects respectively) were lost to follow-up. A total of 5 adverse events were reported (3 in the monoclonal group and 2 in the polyclonal group); only one of these was serious. All the adverse events were judged to be unrelated to the interventional drug. None of the subjects in the monoclonal group developed immunogenic reaction to the monoclonal anti-D. Conclusion The efficacy and safety of the monoclonal preparation of anti-D was comparable to the polyclonal preparation of anti-D when used in the prevention of maternal Rh-isoimmunization. Trial registration Clinical Trial Registration Number: CTRI/2015/09/006172.