Wang Si-Wei, Zhong Song-Yang, Lou Li-Jun, Hu Ze-Fu, Sun Hua-Yu, Zhu Hai-Yan
Department of Pharmacy, The People's Hospital of Quzhou, 2 Zhongloudi Road, Quzhou, Zhejiang 324000, China.
Department of Pharmacy, The People's Hospital of Quzhou, 2 Zhongloudi Road, Quzhou, Zhejiang 324000, China.
Reprod Biomed Online. 2016 Dec;33(6):720-736. doi: 10.1016/j.rbmo.2016.08.025. Epub 2016 Sep 16.
The aim of this study was to investigate the effect of passive immunotherapy using intravenous immunoglobulin (IVIG) on unexplained recurrent spontaneous abortion (RSA). Live birth rates were analysed and binary data were calculated using risk ratio and 95% confidence interval. Meta-analysis of 11 studies showed that the difference in the live birth rate between the IVIG treatment and placebo groups was on the margin of significance (RR = 1.25, 95% CI 1.00 to 1.56, P = 0.05). Both cumulative and trial sequential meta-analyses indicated potential beneficial effect of IVIG but the evidence was inconclusive. Subgroup analysis showed that the live birth rate in primary (RR = 0.88, 95% CI 0.71 to 1.07) and secondary (RR = 1.26, 95% CI 0.99 to 1.61) RSA patients was not significantly different between the IVIG and placebo groups. Live birth rate was significantly different when IVIG was administered before conception (RR = 1.67, 95% CI 1.30 to 2.14, P < 0.0001) but not after implantation (RR = 1.10, 95% CI 0.93 to 1.29). Evidence is insufficient to support the beneficial effects of IVIG on an unexplained RSA. Further high quality studies are needed to elucidate the effectiveness of IVIG.
本研究旨在探讨静脉注射免疫球蛋白（IVIG）进行被动免疫治疗对不明原因复发性自然流产（RSA）的影响。分析活产率，并使用风险比和95%置信区间计算二元数据。对11项研究的荟萃分析表明，IVIG治疗组和安慰剂组之间的活产率差异处于显著边缘（RR = 1.25，95% CI 1.00至1.56，P = 0.05）。累积和序贯试验荟萃分析均表明IVIG可能具有有益作用，但证据尚无定论。亚组分析显示，原发性（RR = 0.88，95% CI 0.71至1.07）和继发性（RR = 1.26，95% CI 0.99至1.61）RSA患者中，IVIG组和安慰剂组的活产率无显著差异。在受孕前给予IVIG时，活产率有显著差异（RR = 1.67，95% CI 1.30至2.14，P < 0.0001），但在着床后给予IVIG时则无显著差异（RR = 1.10，95% CI 0.93至1.29）。证据不足以支持IVIG对不明原因RSA的有益作用。需要进一步的高质量研究来阐明IVIG的有效性。
