Chauhan Anahita R, Nandanwar Yogeshwar S, Ramaiah Aruna, Yelikar Kanan A, Rashmi M D, Sachan Rekha, Mayekar Rahul V, Trivedi Yamini N, Paradkar Gopalkrishna V, Patole Kiran P
1Department of Obstetrics and Gynaecology, Seth GS Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra 400012 India.
2Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra 400022 India.
J Obstet Gynaecol India. 2019 Oct;69(5):420-425. doi: 10.1007/s13224-019-01234-2. Epub 2019 Jun 3.
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.
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.
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.
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. Clinical Trial Registration Number: CTRI/2015/09/006172.
比较单克隆抗恒河猴（抗-D）免疫球蛋白（IgG）与多克隆抗-D IgG在预防母体Rh血型免疫反应中的疗效和安全性。
这是一项在印度九家三级护理医院产科住院部进行的随机、多中心、开放标签的比较性临床试验。206名恒河猴（D）阴性、未对Rh抗原致敏且分娩Rh阳性婴儿的妇女，在产后接受了单克隆或多克隆抗-D IgG的肌肉注射。主要结局指标为抗-D IgG给药后180天时通过间接抗人球蛋白试验（ICT）结果判定的未发生Rh血型免疫反应的受试者比例，以及不良事件的发生率。
105名受试者被随机分配至单克隆组，101名被分配至多克隆组。单克隆组94名受试者在180天时ICT结果为阴性，无阳性结果；而多克隆组87名受试者ICT结果为阴性，1名阳性；其余受试者（单克隆组和多克隆组分别为11名和13名）失访。共报告了5例不良事件（单克隆组3例，多克隆组2例）；其中仅1例为严重不良事件。所有不良事件均被判定与干预药物无关。单克隆组中无受试者对单克隆抗-D产生免疫原性反应。
在预防母体Rh血型免疫反应方面，单克隆抗-D制剂的疗效和安全性与多克隆抗-D制剂相当。临床试验注册号：CTRI/2015/09/006172。
