Mueller-Eckhardt G
Klinikum, Justus-Liebig-Universitat Giessen, Germany.
Am J Reprod Immunol. 1994 Dec;32(4):281-5. doi: 10.1111/j.1600-0897.1994.tb01126.x.
Due to its strong "immunomodulating" effect in several well established disorders, high-dose intravenous immunoglobulins (IVIG) has been proposed as an alternative for immunotherapy with allogeneic leucocytes in patients with unexplained recurrent spontaneous abortion. This paper is intended to provide an overview on the European experience in this field.
Five European pilot studies with a total of 172 patients as well as one controlled double-blind multicenter study including 64 patients were considered. In the latter, 5% human albumin was used as placebo.
Success rates of the pilot studies varied from 68 to 87%. In the German controlled study, a significant specific effect of IVIG could not be verified. However, success rates for both IVIG and albumin were in the same range as for allogeneic leucocytes.
At present, it is not sufficiently proven that IVIG is an appropriate tool for immunotherapy of recurrent spontaneous abortions. It is suggested that success rates of both IVIG and albumin are due to a placebo effect. However, we cannot exclude that albumin itself provides immunomodulating capacity.
由于高剂量静脉注射免疫球蛋白(IVIG)在几种已明确的疾病中具有强大的“免疫调节”作用,因此有人提出将其作为不明原因复发性自然流产患者同种异体白细胞免疫治疗的替代方法。本文旨在概述欧洲在该领域的经验。
纳入了五项欧洲试点研究,共172例患者,以及一项包括64例患者的对照双盲多中心研究。在后者中,使用5%人白蛋白作为安慰剂。
试点研究的成功率从68%到87%不等。在德国的对照研究中,无法证实IVIG有显著的特定效果。然而,IVIG和白蛋白的成功率与同种异体白细胞的成功率处于同一范围。
目前,尚无充分证据证明IVIG是复发性自然流产免疫治疗的合适工具。有人认为IVIG和白蛋白的成功率均归因于安慰剂效应。然而,我们不能排除白蛋白本身具有免疫调节能力。