Moll E, Korevaar J C, Bossuyt P M M, van der Veen F
Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1109 AZ Amsterdam, The Netherlands.
Hum Reprod. 2008 Aug;23(8):1830-4. doi: 10.1093/humrep/den182. Epub 2008 May 17.
An RCT among newly diagnosed, therapy naive women with polycystic ovary syndrome (PCOS) showed no significant differences in ovulation rate, ongoing pregnancy rate or spontaneous abortion rate in favour of clomifene citrate plus metformin compared with clomifene citrate. We wanted to assess whether there are specific subgroups of women with PCOS in whom clomifene citrate plus metformin leads to higher pregnancy rates.
Subgroup analysis based on clinical and biochemical parameters of 111 women randomized to clomifene citrate plus metformin compared with 114 women randomized to clomifene citrate plus placebo. The data for age, BMI, waist-hip ratio (WHR) and plasma testosterone were available in all women, 2 h glucose in 80% of women and homeostatic model assessment for assessing insulin sensitivity (HOMA) in 50% of women.
Of the women who were allocated to the metformin group, 44 women (40%) reached an ongoing pregnancy. In the placebo group, 52 women (46%) reached an ongoing pregnancy. There was a significantly different chance of an ongoing pregnancy for metformin versus placebo between subgroups based on age and WHR (P = 0.014). There was a positive effect of metformin versus placebo on pregnancy rate in older women (>or=28 years) with a high WHR, a negative effect of metformin versus placebo in young women (<28 years) regardless of their WHR and no effect in older, not viscerally obese women. No significant differences in effect of treatment were found for groups based on BMI, 2 h glucose, HOMA or plasma testosterone.
Metformin may be an effective addition to clomifene citrate in infertile women with PCOS, especially in older and viscerally obese patients.
一项针对新诊断的、未接受过治疗的多囊卵巢综合征（PCOS）女性的随机对照试验（RCT）显示，与枸橼酸氯米芬相比，枸橼酸氯米芬联合二甲双胍在排卵率、持续妊娠率或自然流产率方面无显著差异。我们想评估是否存在PCOS女性的特定亚组，在这些亚组中枸橼酸氯米芬联合二甲双胍可导致更高的妊娠率。
基于111名随机分配至枸橼酸氯米芬联合二甲双胍组的女性与114名随机分配至枸橼酸氯米芬联合安慰剂组的女性的临床和生化参数进行亚组分析。所有女性均有年龄、体重指数（BMI）、腰臀比（WHR）和血浆睾酮数据，80%的女性有2小时血糖数据，50%的女性有用于评估胰岛素敏感性的稳态模型评估（HOMA）数据。
在分配至二甲双胍组的女性中，44名女性（40%）实现了持续妊娠。在安慰剂组中，52名女性（46%）实现了持续妊娠。基于年龄和WHR的亚组中，二甲双胍组与安慰剂组在持续妊娠机会上存在显著差异（P = 0.014）。对于WHR高的老年女性（≥28岁），二甲双胍相对于安慰剂对妊娠率有积极影响；对于年轻女性（<28岁），无论其WHR如何，二甲双胍相对于安慰剂有负面影响；对于老年、非内脏肥胖女性则无影响。基于BMI、2小时血糖、HOMA或血浆睾酮的组间治疗效果无显著差异。
对于患有PCOS的不孕女性，尤其是老年和内脏肥胖患者，二甲双胍可能是枸橼酸氯米芬的有效辅助药物。
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