短期联合应用艾塞那肽和二甲双胍治疗超重/肥胖多囊卵巢综合征女性。
Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome.
机构信息
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
出版信息
Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712.
BACKGROUND
Obesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS.
METHODS
Fifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein.
RESULTS
Forty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P < 0.050). Mild and moderate gastrointestinal reactions were the most common adverse events in both groups.
CONCLUSIONS
COM therapy was more effective than MET alone in reducing body weight, BMI, and waist circumference, and improving insulin sensitivity in overweight/obese women with PCOS, with acceptable short-term side effects.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04029272. https://clinicaltrials.gov/ct2/show/NCT04029272.
背景
肥胖和胰岛素抵抗（IR）是多囊卵巢综合征（PCOS）的常见特征。二甲双胍（MET）可增加胰岛素敏感性，但与不理想的体重减轻有关。胰高血糖素样肽-1 受体激动剂艾塞那肽已被证明可降低糖尿病患者的体重和 IR。本研究旨在探讨每周一次（QW）给予 exenatide 联合 MET 对超重/肥胖的 PCOS 妇女体重以及代谢和内分泌参数的治疗作用。
方法
根据鹿特丹标准诊断为 PCOS 的 50 名超重/肥胖女性被随机分配至两组治疗之一：MET（500mg，每日三次[TID]）或联合治疗（COM）（MET 500mg TID，exenatide 2mg QW），疗程为 12 周。主要结局为与肥胖相关的人体测量学变化，次要结局包括生殖激素水平、葡萄糖和脂质代谢以及 C 反应蛋白的变化。
结果
40 名（80%）患者完成了研究。COM 治疗在减轻体重（P=0.045）、体重指数（BMI）（P=0.041）和腰围（P=0.023）方面优于 MET 单药治疗。COM 组平均减重 3.8±2.4kg，而 MET 组为 2.1±3.0kg。在 COM 组中，BMI 和腰围分别降低了 1.4±0.87kg/m2和 4.63±4.42cm，而 MET 组分别降低了 0.77±1.17kg/m2和 1.72±3.07cm。此外，COM 治疗后空腹血糖、口服葡萄糖耐量试验（OGTT）2 小时血糖和 OGTT 2 小时胰岛素水平明显低于 MET（P<0.050）。两组最常见的不良反应均为轻度和中度胃肠道反应。
结论
COM 治疗在减轻超重/肥胖的 PCOS 妇女体重、BMI 和腰围以及改善胰岛素敏感性方面优于 MET 单药治疗，且短期不良反应可接受。
试验注册
ClinicalTrials.gov，NCT04029272。https://clinicaltrials.gov/ct2/show/NCT04029272。
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