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所有来源于人的卵泡刺激素产品都一样吗?一项直接和调整后的间接分析的系统评价和荟萃分析,以确定 Fostimon®是否比 Metrodin-HP®更有效。

Are all human-derived follicle-stimulating hormone products the same? A systematic review and meta-analysis using direct and adjusted indirect analyses, to determine whether Fostimon® is more efficient than Metrodin-HP®.

机构信息

Department of Obstetrics and Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt.

出版信息

Gynecol Endocrinol. 2012 Feb;28(2):94-101. doi: 10.3109/09513590.2011.569612. Epub 2011 May 19.

DOI:10.3109/09513590.2011.569612
PMID:21591977
Abstract

BACKGROUND

Randomized trials (RCTs) and systematic reviews have challenged the claim for superiority of recombinant follicle-stimulating hormone (recFSH) compared with human-derived FSH (hFSH). Even so, much of the evidence comes from unavailable products. If the efficacy of the currently available Fostimon(®) is superior, the off-market Metrodin-HP(®), then data from the latter should not be used, gauge of the former.

METHODS

Electronic/hand searches were performed to identify RCTs comparing Fostimon(®) vs. Metrodin-HP(®) or either product with recFSH. Primary outcomes were live-birth rate (LBR), ongoing pregnancy rate (OPR), and OPR/LBR. Secondary outcomes were clinical pregnancy rate (CPR), multiple pregnancy rate (MPR), ovarian hyperstimulation syndrome (OHSS), abortion rates, and cycle demographics. Data were extracted, allowed for an intention-to-treat analysis, and meta-analyzed using combined direct/adjusted indirect methods.

RESULTS

Twenty-two RCTs met the inclusion criteria: Fostimon(®) vs. Metrodin-HP(®) (n = 2); Fostimon(®) vs. recFSH (n = 8); and Metrodin-HP(®) vs. recFSH (n = 12). LBR (odds ratio = 1.72; 95% confidence interval = 1.05-2.80), OPR/LBR, and CPR were all significantly higher favoring Fostimon(®). OPR, MPR, OHSS, and miscarriage rates were not significantly different. Pooled results for cycle demographics were not reported due to high heterogeneity. Conclusions. Fostimon(®) is superior to Metrodin-HP(®) regarding clinical outcomes. Therefore, care should be taken not to assume that all hFSH products have the same efficacy.

摘要

背景

随机对照试验(RCT)和系统评价对重组促卵泡激素(recFSH)优于人源性 FSH(hFSH)的说法提出了质疑。即便如此,大部分证据都来自无法获得的产品。如果目前可用的 Fostimon(®)的疗效更好,那么就不应该使用已退市的 Metrodin-HP(®)的数据来衡量前者。

方法

进行电子/手工检索,以确定比较 Fostimon(®)与 Metrodin-HP(®)或任何一种产品与 recFSH 的 RCT。主要结局指标是活产率(LBR)、持续妊娠率(OPR)和 OPR/LBR。次要结局指标是临床妊娠率(CPR)、多胎妊娠率(MPR)、卵巢过度刺激综合征(OHSS)、流产率和周期人口统计学。提取数据,允许进行意向治疗分析,并使用联合直接/间接调整方法进行荟萃分析。

结果

22 项 RCT 符合纳入标准:Fostimon(®)与 Metrodin-HP(®)(n=2);Fostimon(®)与 recFSH(n=8);Metrodin-HP(®)与 recFSH(n=12)。LBR(优势比=1.72;95%置信区间=1.05-2.80)、OPR/LBR 和 CPR 均显著更高,有利于 Fostimon(®)。OPR、MPR、OHSS 和流产率无显著差异。由于高度异质性,未报告周期人口统计学的汇总结果。结论。Fostimon(®)在临床结局方面优于 Metrodin-HP(®)。因此,不应假设所有 hFSH 产品都具有相同的疗效。

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