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与高纯度人绝经期促性腺激素相比,使用重组卵泡刺激素进行体外受精需要更少的 IU 用量:来自欧洲回顾性观察性图表回顾的结果。

In vitro fertilisation with recombinant follicle stimulating hormone requires less IU usage compared with highly purified human menopausal gonadotrophin: results from a European retrospective observational chart review.

机构信息

Merck Serono, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.

出版信息

Reprod Biol Endocrinol. 2010 Nov 8;8:137. doi: 10.1186/1477-7827-8-137.

Abstract

BACKGROUND

Previous studies have reported conflicting results for the comparative doses of recombinant follicle stimulating hormone (rFSH) and highly purified human menopausal gonadotrophin (hMG-HP) required per cycle of in vitro fertilisation (IVF); the aim of this study was to determine the average total usage of rFSH versus hMG-HP in a 'real-world' setting using routine clinical practice.

METHODS

This retrospective chart review of databases from four European countries investigated gonadotrophin usage, oocyte and embryo yield, and pregnancy outcomes in IVF cycles (± intra-cytoplasmic sperm injection) using rFSH or hMG-HP alone. Included patients met the National Institute for Health and Clinical Excellence (NICE) guideline criteria for IVF and received either rFSH or hMG-HP. Statistical tests were conducted at 5% significance using Chi-square or t-tests.

RESULTS

Of 30,630 IVF cycles included in this review, 74% used rFSH and 26% used hMG-HP. A significantly lower drug usage per cycle for rFSH than hMG-HP (2072.53 +/- 76.73 IU vs. 2540.14 +/- 883.08 IU, 22.6% higher for hMG-HP; p < 0.01) was demonstrated. The median starting dose was also significantly lower for rFSH than for hMG-HP (150 IU vs. 225 IU, 50% higher for hMG-HP, p < 0.01). The average oocyte yield per IVF cycle in patients treated with rFSH was significantly greater than with hMG-HP (10.80 +/- 6.02 vs. 9.77 +/- 5.53; p < 0.01), as was the average mature oocyte yield (8.58 +/- 5.27 vs. 7.72 +/- 4.59; p < 0.01). No significant differences were observed in pregnancy outcomes including spontaneous abortion between the two treatments. There was a significantly higher rate of OHSS (all grades) with rFSH (18.92% vs. 14.09%; p < 0.0001). The hospitalisation rate due to OHSS was low but significantly higher in the rFSH group (1.07% of cycles started vs. 0.67% of cycles started with rFSH and hMG-HP, respectively; p = 0.002).

CONCLUSIONS

Based on these results, IVF treatment cycles with rFSH yield statistically more oocytes (and more mature oocytes), using significantly less IU per cycle, versus hMG-HP. The incidence of all OHSS and hospitalisations due to OHSS was significantly higher in the rFSH cycles compared to the hMG-HP cycles. However, the absolute incidence of hospitalisations due to OHSS was similar to that reported previously. These results suggest that the perceived required dosage with rFSH is currently over-estimated, and the higher unit cost of rFSH may be offset by a lower required dosage compared with hMG-HP.

摘要

背景

之前的研究对于体外受精(IVF)周期中所需的重组卵泡刺激素(rFSH)和高纯度人绝经期促性腺激素(hMG-HP)的比较剂量得出了相互矛盾的结果;本研究旨在使用常规临床实践确定 rFSH 与 hMG-HP 的平均总用量。

方法

这项来自四个欧洲国家的数据库回顾性图表研究调查了使用 rFSH 或 hMG-HP 单独进行的 IVF 周期(±胞浆内精子注射)中的促性腺激素使用、卵母细胞和胚胎产量以及妊娠结局。符合国家卫生与临床优化研究所(NICE)IVF 指南标准的纳入患者接受了 rFSH 或 hMG-HP 治疗。使用卡方检验或 t 检验在 5%的显著性水平上进行了统计检验。

结果

在本综述中,30630 个 IVF 周期中,74%使用 rFSH,26%使用 hMG-HP。与 hMG-HP 相比,rFSH 的每周期药物用量明显较低(2072.53 +/- 76.73 IU 与 2540.14 +/- 883.08 IU,hMG-HP 高 22.6%;p < 0.01)。rFSH 的起始剂量中位数也明显低于 hMG-HP(150 IU 与 225 IU,hMG-HP 高 50%,p < 0.01)。rFSH 治疗的患者每个 IVF 周期的平均卵母细胞产量明显大于 hMG-HP(10.80 +/- 6.02 与 9.77 +/- 5.53;p < 0.01),平均成熟卵母细胞产量也是如此(8.58 +/- 5.27 与 7.72 +/- 4.59;p < 0.01)。两种治疗方法之间的妊娠结局(包括自然流产)没有观察到显著差异。rFSH 组(18.92%)的卵巢过度刺激综合征(OHSS)(所有等级)发生率明显高于 hMG-HP 组(14.09%;p < 0.0001)。OHSS 的住院率较低,但 rFSH 组明显较高(开始的周期中分别为 1.07%和 0.67%;p = 0.002)。

结论

根据这些结果,与 hMG-HP 相比,rFSH 治疗的 IVF 周期每周期使用的 IU 明显较少,但统计上产生的卵母细胞(和更多成熟卵母细胞)更多。rFSH 周期中所有 OHSS 和因 OHSS 导致的住院的发生率明显高于 hMG-HP 周期。然而,因 OHSS 导致的住院的绝对发生率与之前报道的相似。这些结果表明,目前 rFSH 的预期所需剂量被高估了,与 hMG-HP 相比,rFSH 的单位成本较高可能被较低的所需剂量所抵消。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dfe9/2993713/2d6fff83d0fd/1477-7827-8-137-1.jpg

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