Palomba Stefano, Falbo Angela, Russo Tiziana, Manguso Francesco, Tolino Achille, Zullo Fulvio, De Feo Pierpaolo, Orio Francesco
Department of Gynecology and Obstetrics, University Magna Graecia of Catanzaro, Via Pio X, 88100 Catanzaro, Italy.
J Clin Endocrinol Metab. 2007 Aug;92(8):3128-35. doi: 10.1210/jc.2007-0441. Epub 2007 May 22.
To date, the metabolic effects of the long-term metformin administration in anovulatory patients with polycystic ovary syndrome (PCOS) are known, whereas few data are available on the effects of its suspension.
The objective of the study was to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.
This was a prospective, randomized, placebo-controlled study.
The study was conducted at the University "Magna Graecia" of Catanzaro, Italy.
Patients included 30 normal-weight anovulatory PCOS women and 10 age- and body mass index-matched healthy controls.
PCOS patients were randomized to receive 1700 mg daily metformin (metformin group) or placebo tables (placebo group) for 12 months, whereas no treatment was administered in healthy women (control group).
Clinical, endocrine, and metabolic profile and clamp insulin sensitivity index were evaluated at study entry and after 6, 12, 18, and 24 months.
At baseline, the clamp insulin sensitivity index resulted significantly different (P < 0.05) in PCOS patients in comparison with healthy controls, without difference between metformin and placebo groups. During treatment, the clamp insulin sensitivity index was significantly improved (P < 0.05) in the metformin group in comparison with baseline and placebo group, without significant differences between the 6- and 12-month assessments. At 6 and 12 months after treatment suspension, in the metformin group, insulin sensitivity index significantly (P < 0.05) worsened in comparison with that observed at baseline and during treatment and with that observed in the placebo and control groups.
In normal-weight anovulatory PCOS patients, long-term metformin administration exerts beneficial effects on peripheral insulin sensitivity. Furthermore, this effect disappears at treatment suspension.
迄今为止，长期服用二甲双胍对多囊卵巢综合征（PCOS）无排卵患者的代谢影响已为人所知，但其停药后的影响数据较少。
本研究旨在评估二甲双胍停药对PCOS患者胰岛素敏感性的影响。
这是一项前瞻性、随机、安慰剂对照研究。
该研究在意大利卡坦扎罗的“大希腊”大学进行。
患者包括30名体重正常的无排卵PCOS女性和10名年龄及体重指数匹配的健康对照者。
PCOS患者被随机分为两组，一组每天服用1700毫克二甲双胍（二甲双胍组），另一组服用安慰剂片（安慰剂组），为期12个月，而健康女性不接受任何治疗（对照组）。
在研究开始时以及6、12、18和24个月后，评估临床、内分泌和代谢状况以及钳夹胰岛素敏感性指数。
在基线时，与健康对照相比，PCOS患者的钳夹胰岛素敏感性指数有显著差异（P<0.05），二甲双胍组和安慰剂组之间无差异。在治疗期间，与基线和安慰剂组相比，二甲双胍组的钳夹胰岛素敏感性指数显著改善（P<0.05），6个月和12个月评估之间无显著差异。在停药后6个月和12个月时，二甲双胍组的胰岛素敏感性指数与基线和治疗期间观察到的指数以及安慰剂组和对照组观察到的指数相比，显著恶化（P<0.05）。
在体重正常的无排卵PCOS患者中，长期服用二甲双胍对外周胰岛素敏感性有有益影响。此外，这种影响在停药时消失。
