Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M
Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa Hospital, and Department of Psychology, Lakehead University, Thunder Bay, Canada.
BJOG. 2007 Feb;114(2):134-42. doi: 10.1111/j.1471-0528.2006.01201.x. Epub 2006 Dec 12.
Intravenous immunoglobulin (IVIG) is a fractionated blood product whose off-label use for treating a variety of conditions, including spontaneous recurrent miscarriage, has continued to grow in recent years. Its high costs and short supply necessitate improved guidance on its appropriate applications.
We conducted a systematic review of randomised controlled trials evaluating IVIG for treatment of spontaneous recurrent miscarriage.
A systematic search strategy was applied to Medline (1966 to June 2005) and the Cochrane Register of Controlled Trials (June 2005).
We included all randomised controlled trials comparing all dosages of IVIG to placebo or an active control.
Two investigators independently extracted data using a standardised data collection form. Measures of effect were derived for each trial independently, and studies were pooled based on clinical and methodologic appropriateness.
We identified eight trials involving 442 women that evaluated IVIG therapy used to treat recurrent miscarriage. Overall, IVIG did not significantly increase the odds ratio (OR) of live birth when compared with placebo for treatment of recurrent miscarriage (OR 1.28, 95% CI 0.78-2.10). There was, however, a significant increase in live births following IVIG use in women with secondary recurrent miscarriage (OR 2.71, 95% CI 1.09-6.73), while those with primary miscarriage did not experience the same benefit (OR 0.66, 95% CI 0.35-1.26).
AUTHOR'S CONCLUSIONS: IVIG increased the rates of live birth in secondary recurrent miscarriage, but there was insufficient evidence for its use in primary recurrent miscarriage.
静脉注射免疫球蛋白(IVIG)是一种血液制品,近年来其在治疗包括自然复发性流产在内的多种病症方面的非适应证使用持续增加。其高昂的成本和供应短缺使得有必要对其合理应用提供更好的指导。
我们对评估IVIG治疗自然复发性流产的随机对照试验进行了系统评价。
采用系统检索策略检索了Medline(1966年至2005年6月)和Cochrane对照试验注册库(2005年6月)。
我们纳入了所有比较不同剂量IVIG与安慰剂或活性对照的随机对照试验。
两名研究者使用标准化数据收集表独立提取数据。每个试验独立得出效应量,并根据临床和方法学适宜性对研究进行汇总。
我们确定了八项涉及442名女性的试验,这些试验评估了用于治疗复发性流产的IVIG疗法。总体而言,与安慰剂相比,IVIG治疗复发性流产时并未显著提高活产的比值比(OR)(OR 1.28,95%CI 0.78 - 2.10)。然而,继发性复发性流产女性使用IVIG后活产率显著增加(OR 2.71,95%CI 1.09 - 6.73),而原发性流产女性未获得同样的益处(OR 0.66,95%CI 0.35 - 1.26)。
IVIG提高了继发性复发性流产的活产率,但在原发性复发性流产中使用的证据不足。