Boudhrâa Khaled, Jellouli Mohamed Amine, Amri Mouna, Farhat Monia, Torkhani Fatma, Gara Mohamed Faouzi
Service de Gynécologie obstétrique, CHU Mongi Slim La Marsa, Tunis.
Tunis Med. 2010 May;88(5):335-40.
Polycystic ovarian syndrome (PCOS) is the most common hormonal dysfunction in women. It's a cause of female infertility by oligoanovulation, clinical and biochemical hyperandrogenism and polycystic ovaries. Weight loss, firstly proposed in overweight or obese patient suffering from PCOS, aims to reduce hyperinsulinism and hyperandrogenism. Recently, Metformin, an insulin sensitizer, has been proposed as an alternative first line treatment for polycystic ovarian syndrome by improving hyperinsulinemia and hyperandrogenism in these women.
The aim of our study, and through a literature review, is to demonstrate if Metformin should be used as a first-line drug for infertile women with this syndrome or as an adjunction to Clomifene Citrate, the longest established treatment already used in this syndrome.
A prospective comparative study including 63 patients with PCOS has been done during 2 years. Women were randomly allocated to clomifene + Metformin (Metformin group, Metformin took during 8 weeks, 850 mg twice a day, plus Clomifene 100 mg per day during five days) or Clomifene only (100 mg per day during five days). All patients underwent a two- month's diet.
The middle age was about 30.63 years and the body mass index (BMI) was about 29.88 kg/ m(2). We noticed a 6.2% weight loss in both groups (a non significant difference in p=0.04). The median of infertility period was about 2.49 years. The ovulation rate in the Metformin group was 53.12% (significant difference for inducing ovulation p=0.02) and 32.25% in Clomifene group (non-significant difference 0.07). There was also a significant difference for ongoing pregnancies (p=0.04). In fact, 11 on 32 patients (34%) achieved a full-term pregnancy in Metformin group versus only 4 ones on 31 patients (12.9%) in Clomifene group.
Our conclusion is that Metformin is an effective addition to Clomifene Citrate in term of reestablishment of ovulation and full-term pregnancies achievement, excluding ART cycles.
多囊卵巢综合征（PCOS）是女性中最常见的激素功能障碍。它是女性因排卵稀少、临床和生化高雄激素血症以及多囊卵巢而导致不孕的一个原因。减肥最初是针对患有PCOS的超重或肥胖患者提出的，目的是减少高胰岛素血症和高雄激素血症。最近，二甲双胍作为一种胰岛素增敏剂，通过改善这些女性的高胰岛素血症和高雄激素血症，已被提议作为多囊卵巢综合征的替代一线治疗药物。
我们研究的目的，并通过文献综述，是要证明二甲双胍是否应作为患有该综合征的不孕女性的一线药物，或者作为枸橼酸氯米芬（该综合征中已使用时间最长的既定治疗药物）的辅助药物。
在两年期间进行了一项包括63例PCOS患者的前瞻性对照研究。女性被随机分配到氯米芬 + 二甲双胍组（二甲双胍组，二甲双胍服用8周，850毫克，每日两次，加氯米芬每日100毫克，共五天）或仅氯米芬组（每日100毫克，共五天）。所有患者都接受了为期两个月的饮食控制。
平均年龄约为30.63岁，体重指数（BMI）约为29.88千克/平方米。我们注意到两组体重均减轻了6.2%（p = 0.04，差异无统计学意义）。不孕时间中位数约为2.49年。二甲双胍组的排卵率为53.12%（诱导排卵的差异有统计学意义，p = 0.02），氯米芬组为32.25%（差异无统计学意义，p = 0.07）。持续妊娠方面也有显著差异（p = 0.04）。事实上，二甲双胍组32例患者中有11例（34%）实现了足月妊娠，而氯米芬组31例患者中只有4例（12.9%）。
我们的结论是，就恢复排卵和实现足月妊娠而言，二甲双胍是枸橼酸氯米芬的一种有效辅助药物，不包括辅助生殖周期。
