益坤丸治疗多囊卵巢综合征机理的临床研究

Clinical study on treating the mechanisms of polycystic ovary syndrome with Yikun pill

目的:观察我院自制药品益坤丸治疗多囊卵巢综合征患者的疗效,初步探讨其作用机理。方法:将120位肾虚痰浊型多囊卵巢综合征患者随机分为单纯生活方式改变、生活方式改变+药物(益坤丸、二甲双胍及益坤丸合二甲双胍)四组,每组各30例。单纯生活方式改变组指导饮食及锻炼计划,不予以药物治疗。其他三组在改变生活方式的基础上予以药物治疗。观察4组患者治疗前、后排卵情况,比较BMI、腰围、腰围与臀围比值WHR、LH/FSH、睾酮水平、空腹胰岛素水平、胰岛素抵抗指数、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白.胆固醇(HDL-c)、低密度脂蛋白-胆固醇(LDL-c),脂蛋白α(LPα)。结果:治疗前4组患者年龄、BMI、腰围、WHR、睾酮水平、空腹真胰岛素水平、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白,胆固醇(HDL-c)、低密度脂蛋白-胆固醇(LDL-c)比较,差异均无统计学意义(P>0.05)。单纯生活方式调整组的30例患者中27例完成治疗,22%(6/27)恢复排卵;生活方式调整+二甲双胍组的30例患者中22例完成治疗,36%(8/22)恢复排卵;生活方式调整+益坤丸组的30例患者中28例完成治疗,57%(16/28)恢复排卵;生活方式调整+二甲双胍+益坤丸组30例患者23例完成治疗,60%(14/23)恢复排卵。结论:益坤丸可以使多囊卵巢综合征患者的排卵率明显升高,并且使BMI、LH、T、LH/FSH、FINS、HOMA-IR下降,具统计学意义(P<0.05);TC、TG等具下降趋势,但治疗前后比较,差异无统计学意义(P>0.05)。益坤丸组与益坤丸+二甲双胍组结果比较,单独使用益坤丸即有较高及较快的恢复排卵及受孕的作用。如与二甲双胍合用在治疗有较重胰岛素抵抗的患者有更好的治疗作用。四组血脂治疗前后均无统计学意义。

Objective： To observe the effect on treating the mechanisms of polycystic ovary syndrome with Yikun pill in our hospital, explore its mechanism preliminarily. Methods： 120 patients with polycystic ovary syndrome of type kidney phlegm were randomly divided into four groups of lifestyle changes, lifestyle changes ＋ Drugs （Yikun pill, metformin and metformin plus Yiktm Pill）, 30 cases in each group. The lifestyle changes only group was guided the diet and exercise program, without drug treatment. The other three groups were treated with drug treatment on the basis of lifestyle changes. Observe the ovulation of the 4 groups before and after the treatment, compare the BMI, waist circumference, waist-hip ratio WHR, LH/FSH, testosterone level, fasting insulin, insulin resistance index, total cholesterol （TC）, triglyceride （TG）, high density lipoprotein. Cholesterol （HDL-c）, low density lipoprotein-cholesterol （LDL-c）, lipoprotein α（LPα）. Results： Compared the BMI, waist circumference, WHR, testosterone levels, so fasting insulin levels, total cholesterol （TC）, triglyceride （TG）, high density lipoprotein cholesterol （HDL-c）, low density Lipoprotein-cholesterol （LDL-c）of the four groups before the treatment, the difference was not statistically significant （P〉0.05）. In the lifestyle changes only group, 27 patients completed the treatment in 30 patients, 22% （6/27） restored ovulation; In the lifestyle changes ＋ metformin group, 22 patients completed the treatment in 30 patients, 36% （8/22） restored ovulation; In the lifestyle changes ＋ Yikun pill group, 28 patients completed the treatment in 30 patients, 57% （16/28） restored ovulation; In the lifestyle changes ＋ Yikun pill ＋ metformin group, 23 patients completed the treatment in 30 patients, 60% （14/23） restored ovulation. Conclusion： Yikun pill can improve the ovulation rate of polycystic ovary syndrome obviously, and decrease the BMI, LH, T, LH/FSH, FINS, HOMA-IR, has statistical significance （P〈0.05）; TC, TG. etc have decreased trend, but compared before and after treatment, the difference was not statistically significant （P〉0.05）. Compared the Yikun group and Yikun pill ＋ metformin group, Yikun pill only group has a higher and faster recovery of ovulation and pregnancy effect. If combined with metformin in the treatment of patients with severe insulin resistance, the effect was better. The lipids were all not statistically significant in the four groups before and after the treatment.