Recurrent Pregnancy Loss Clinic, Department of Obstetrics and Gynaecology, Aalborg University Hospital, Aalborg, Denmark.
Recurrent Pregnancy Loss Unit, Fertility Clinic 4071, Rigshospitalet, Copenhagen University Hospital, Denmark.
J Reprod Immunol. 2019 Jun;133:37-42. doi: 10.1016/j.jri.2019.06.001. Epub 2019 Jun 18.
Intravenous immunoglobulin (IVIg) has a documented clinical effect in many autoimmune diseases and has so far been tested in >10 randomised controlled trials (RCTs) in women with recurrent pregnancy loss (RPL). The results of the RCTs have, however, been very divergent. In meta-analyses of all trials, no significant impact on live birth rate has been reported. In contrast, in sensitivity analyses, IVIg significantly increased live birth rates when initiated prior to conception and it had a borderline significant therapeutic effect in women with secondary RPL. Higher dosages of IVIg and serological signs of autoimmunity in the treated patients tended to increase the success rate after treatment. A follow-up study of patients from our recent RCT also supports a significant therapeutic effect in patients who had received IVIg before conception. The lessons learned from the published trials and meta-analyses should be incorporated in the design of future RCTs of IVIg in the treatment of RPL.
静脉注射免疫球蛋白（IVIg）在许多自身免疫性疾病中具有明确的临床疗效，迄今为止已在 >10 项针对复发性妊娠丢失（RPL）女性的随机对照试验（RCT）中进行了测试。然而，这些 RCT 的结果却大相径庭。在所有试验的荟萃分析中，并未报告活产率有显著影响。相比之下，在敏感性分析中，在受孕前开始使用 IVIg 时，活产率显著增加，并且在继发性 RPL 女性中具有边缘显著的治疗效果。更高剂量的 IVIg 和治疗患者的血清学自身免疫迹象往往会增加治疗后的成功率。我们最近的 RCT 中对患者的随访研究也支持在受孕前接受 IVIg 治疗的患者有显著的治疗效果。从已发表的试验和荟萃分析中吸取的经验教训应纳入未来 RCT 中 IVIg 治疗 RPL 的设计中。
