Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, McGill University, Montreal, Quebec, Canada.
Fertil Steril. 2011 Mar 1;95(3):1080-5.e1-2. doi: 10.1016/j.fertnstert.2010.12.021. Epub 2011 Jan 12.
To estimate whether intravenous immunoglobulin (IVIG) improves the probability of a live birth in women with unexplained recurrent miscarriage (RM).
A computerized search in Medline, Embase, Central, Ovid Medline In-Process, and Other Non-Indexed Citations Databases and randomized controlled trial (RCT) registries was performed. Abstracts of the American Society of Reproductive Medicine and European Society of Human Reproduction and Embryology annual meetings and reference lists of identified reports were searched.
None.
PATIENT(S): Women with unexplained primary (without a prior live birth) or secondary (subsequent to a live birth) RM.
INTERVENTION(S): IVIG or placebo control intervention.
MAIN OUTCOME MEASURE(S): Live birth rate per randomized woman.
RESULT(S): Six relevant RCTs were identified including 272 women with unexplained RM. The overall odds ratio for live birth is 0.92, with a 95% confidence interval of 0.55-1.54, indicating a lack of a treatment effect with IVIG. Similarly, IVIG was not found to be beneficial when women with primary and secondary RM were analyzed separately.
CONCLUSION(S): A beneficial effect of IVIG in treatment of RM was not observed. Given the absence of a proven mechanism of action, and the lack of a diagnostic algorithm to identify patients who are likely to benefit from such treatment, IVIG administration for treatment of recurrent miscarriage is not justified outside the context of properly designed RCTs.
评估静脉注射免疫球蛋白(IVIG)是否能提高不明原因复发性流产(RM)女性的活产概率。
在 Medline、Embase、CENTRAL、ovid Medline In-Process 和其他非索引引文数据库以及随机对照试验(RCT)登记处进行计算机检索。还检索了美国生殖医学学会和欧洲人类生殖与胚胎学学会年会的摘要以及已确定报告的参考文献列表。
无。
不明原因原发性(无既往活产)或继发性(继发于活产后)RM 的女性。
IVIG 或安慰剂对照干预。
每位随机女性的活产率。
确定了 6 项相关 RCT,共纳入 272 例不明原因 RM 女性。活产的总体优势比为 0.92,95%置信区间为 0.55-1.54,表明 IVIG 治疗无效果。同样,当分别分析原发性和继发性 RM 女性时,也未发现 IVIG 有益。
未观察到 IVIG 对 RM 治疗有有益作用。鉴于缺乏已证实的作用机制,也缺乏识别可能从这种治疗中获益的患者的诊断算法,因此,在未进行精心设计的 RCT 的情况下,IVIG 治疗复发性流产并无正当理由。