Bowman J M, Friesen A D, Pollock J M, Taylor W E
Can Med Assoc J. 1980 Dec 6;123(11):1121-7.
An Rh immune globulin [Rh IgG] for intravenous use, WinRho, has been prepared by the Winnipeg Rh Institute by a modification of the ion-exchange column method of Hoppe and colleagues. When administered to Rh-negative male and nonpregnant female volunteers WinRho was found to be nonpyrogenic, nontoxic, safe and protective against Rh alloimmunization. In a clinical trial with 240 microgram given at about 28 weeks' gestation and 120 microgram given after delivery to Rh-negative women at risk of Rh immunization WinRho was effective in preventing Rh immunization. Of the 870 women carrying Rh-positive fetuses who were treated with WinRho during pregnancy and were not tested several months after delivery 14 would have shown evidence of Rh immunization by the time of delivery if WinRho had been ineffective; none showed such evidence. Of the 1122 women carrying Rh-positive fetuses who were retested 4 to 6 months after delivery 83 would have shown evidence of Rh immunization at that time if WinRho had been ineffective; only 1 showed such evidence. The efficiency of yield of anti-D with the modified method of production, the fct that it can be given intravenously (a route that causes the patient less discomfort and immediately results in high anti-D levels) and the lower levels of contaminating IgA and IgM make WinRho the preparation of choice for preventing Rh immunization.
一种静脉注射用的Rh免疫球蛋白[Rh IgG],即WinRho,由温尼伯Rh研究所通过对霍普等人的离子交换柱法进行改进而制备。当给Rh阴性男性和未怀孕女性志愿者使用时,发现WinRho无致热原性、无毒、安全且能预防Rh同种免疫。在一项临床试验中,给妊娠约28周的Rh阴性有Rh免疫风险的女性注射240微克,产后注射120微克,WinRho在预防Rh免疫方面有效。在870名孕期接受WinRho治疗且产后未进行检测的怀有Rh阳性胎儿的女性中,如果WinRho无效,14名女性在分娩时会出现Rh免疫的证据;但无人出现此类证据。在1122名产后4至6个月接受重新检测的怀有Rh阳性胎儿的女性中,如果WinRho无效,83名女性在那时会出现Rh免疫的证据;只有1名女性出现此类证据。改进生产方法后抗-D的产率、可静脉注射(该途径给患者带来的不适较少且能立即产生高抗-D水平)以及较低的污染性IgA和IgM水平,使得WinRho成为预防Rh免疫的首选制剂。