Heine O, Mueller-Eckhardt G
Institute for Clinical Immunology and Transfusion Medicine, Justus-Liebig-University, Giessen, Germany.
Clin Exp Immunol. 1994 Jul;97 Suppl 1(Suppl 1):39-42.
A specific effect of intravenous immune globulin (IVIG) on the outcome of pregnancy in patients with a history of habitual abortion has been postulated as an alternative to immunotherapy with allogeneic leucocytes. The results of different pilot studies have been promising, demonstrating a successful outcome of pregnancy in approximately 80% of treated patients. However, the evaluation and interpretation of the study results has to take into account that the probability of a successful pregnancy in women with a history of three spontaneous abortions is about 60% without treatment. Specific pharmacological effects therefore have to be verified in controlled studies in order to rule out psychological (placebo) effects. A specific therapeutic effect could not be verified in a German randomized, double-blind, multicentre trial in comparison to human albumin 5% which was used as a placebo. The result of another controlled study currently underway in the USA is expected.
静脉注射免疫球蛋白(IVIG)对有习惯性流产史患者的妊娠结局具有特定作用,这一观点被认为是同种异体白细胞免疫治疗的替代方法。不同初步研究的结果很有前景,表明约80%接受治疗的患者妊娠成功。然而,在评估和解释研究结果时必须考虑到,有三次自然流产史的女性在未经治疗的情况下成功妊娠的概率约为60%。因此,必须在对照研究中验证特定的药理作用,以排除心理(安慰剂)效应。与用作安慰剂的5%人白蛋白相比,在一项德国随机、双盲、多中心试验中未验证到特定治疗效果。目前美国正在进行的另一项对照研究的结果值得期待。