综合管理下达英-35与达英-35联合二甲双胍治疗多囊卵巢综合征的疗效研究

Efficacy of Diane 35 vs Diane 35 plus metformin on polycystic ovarian syndrome women under comprehensive management

目的在个体化营养和运动指导的前提下,比较达英-35和达英-35联合二甲双胍治疗多囊卵巢综合征（polycystic ovarian syndrome,PCOS）的疗效,为PCOS患者的规范化管理和治疗提供理论依据。方法将确诊为PCOS的患者60例采用数字随机表法随机分为达英-35治疗组和达英-35联合二甲双胍治疗组,每组各30例。在入组时根据静息能量消耗测定及体成分运动功能测定等,给予患者个体化营养运动指导。两组患者均服用达英-35 3个周期,联合用药组加服二甲双胍片3个月,1日2次,1次500 mg。分别在治疗前后测量身高、体质量、腰围、臀围、全身脂肪含量;进行痤疮评分、多毛评分;于月经2-5 d空腹测定卵泡刺激素、黄体生成素、睾酮、血糖、血脂、胰岛素等。结果 1治疗3个月后,达英-35治疗组和达英-35联合二甲双胍治疗组的体质量指数、痤疮评分、黄体生成素、睾酮,高密度脂蛋白胆固醇升高,差异具有统计学意义;多毛评分稍有下降,差异无统计学意义;总胆固醇、三酰甘油升高,差异无统计学意义。2治疗3个月后,联合用药组全身脂肪含量、空腹血糖、胰岛素抵抗指数下降,差异有统计学意义。3治疗3个月后,达英-35治疗组空腹血糖升高,空腹胰岛素降低,差异无统计学意义。4体质量指数、空腹血糖的变化在两组之间差异有统计学意义,其余各指标在两组间的差异均无统计学意义。结论在个体化营养和运动指导的前提下应用达英-35或达英-35联合二甲双胍干预3个周期均能有效降低血清睾酮质量浓度,改善痤疮症状,但尚不足以改善多毛症状。达英-35联合二甲双胍能降低PCOS患者脂肪含量,改善血糖血脂代谢,单用达英-35并不恶化PCOS患者的糖脂代谢状态。

Objective To provide theoretical basis of standardized management and treatment for polycystic ovarian syndrome （ PCOS） patients through the study of Diane 35 vs Diane 35 plus metformin on PCOS women under comprehensive management .Methods Sixty patients with PCOS were randomly divided into two groups , Diane-35-only group and Diane-35 plus metformin（the combination） group, each with 30 cases.Their resting-energy-consumption and body-composition-measurement on movement functionality were analyzed to offer individualized nutrition and exercise guidance .Three Diane-35 cycles were administered;metformin was added in one group .We selected the data of patients＇height, weight, waist circumference, hip circumference, body fat percentage, acne score, hirsutism score; serumhormone level were tested between 2nd and 5th days of menstrual cycle, such as follicle-stimulating hormone, luteinizing hormone, testosterone, blood glucose, blood lipids, insulin, etc.Results ① After three months＇treatment, body mass index, acne score, LH levels and T levels dropped in both groups, while HDL-C concentration elevated, the difference was statistically significant（P〈0.05）;the hairy score decreased slightly（P〉0.05）; total cholesterol and triglycerides concentration elevated （P〉0.05）.② After three months＇treatment, the body fat content , fasting glucose and insulin resistance index in combined treatment group decreased , the difference was statistically significant（P〈0.05）.③ After three months＇treatment, fasting blood sugar was elevated and fasting insulin concentration dropped in Diane-35 treatment group（P〉0.05）.④The body mass index, fasting blood glucose changes were significant different between two groups（P〈0.05）, while the rest indicators were not significantly different （P〉0.05）.Conclusion Under the individualized nutrition and exercise guidance , Diane-35 only group or Diane-35 plus metformin group could both effectively reduce serum testosterone levels, improve acne symptoms, but not hirsutism.The combination group can reduce the fat content in patients with PCOS , improve glucose and lipid metabolism , and Diane-35 alone does not worsen glucose and lipid metabolism in patients with PCOS .