丹栀逍遥丸联合西药治疗多囊卵巢综合征(PCOS)多中心随机平行对照研究

Danzhi Xiaoyao Pill(丹栀逍遥丸) combined with Western Medicine in the Treatment of Polycystic Ovary Syndrome(PCOS) Multi Center Randomized Controlled Study

[目的]观察丹栀逍遥丸联合西药治疗多囊卵巢综合征(PCOS)疗效。[方法]使用随机平行对照方法,将78例住院患者按病志号抽签方法简单随机分为两组。对照组39例二甲双胍、环丙孕酮、来曲唑口服;复方醋酸环丙孕酮,月经周期第5d开始,1片/d,共21d为1个周期,连服3个月经周期;二甲双胍缓释片,每日晚餐前30min服用,0.5g/次,连续30d;来曲唑2.5mg,1次/d,月经来潮第3d开始,共5d。治疗组39例,丹栀逍遥丸,3g/次,2次/d,西药治疗同对照组。1个治疗周期(3个月经周期)为1疗程。观测临床症状、LH、T、血清胰岛素、优势卵泡、排卵、不良反应。[结果]1hINS、2hINS、T、LH、FINS均明显降低(P<0.05),治疗组优于对照组(P<0.05)。排卵率治疗组86.57%显著高于对照组65.04%(P<0.05);妊娠率治疗组66.67%高于对照组43.59%(P<0.05)。[结论]丹栀逍遥丸联合西医治疗多囊卵巢综合征,疗效满意,提高排卵率及妊娠率,无严重不良反应,值得推广。

[Objective] To observe the clinical effect of Danzhi Xiaoyao pills combined with western medicine on PCOS, analysis the ovulation and pregnancy rates, than compare with western medicine alone. [Methods] Equivalence random parallel control method using multiple center, 78 cases of hospitalized patients by pathography number the draw method is simple and randomly divided into two groups. The control group 39 cases of mefformin letrozole oral, cyproterone,; Compound cyproterone acetate, menstrual cycle 5 d, l/d, a total of 21 d for a cycle, even served three menstrual cycles; mefformin zyban, 30 min before taking the daily dinner, 0.5 g/times, 30 d; letrozole 2.5 mg, l/d, menstrual cramps, 3 d, 5 d. Treatment group （39 cases, Dan Zhi xiaoyao pill, 3 g/time, 2 times/d, western medicine treatment with the control group. One treatment cycle （three menstrual cycles） for 1 course of treatment. Observation of clinical symptoms, LH, T, serum insulin, dominant follicle, ovulation, adverse reactions. [Results] INS lh, 2h, INS, T, LH, FINS were significantly lower （P〈0.05）, treatment group was better than that of control group （P〈0.05）. Ovulation rate is 86.57% in treatment group is significantly higher than the control group 65.04% （P〈0.05）; The pregnancy rate of treatment group was 66.67% higher than the control group 43.59% （P〈0.05）. [Conclusion] Dan Zhi xiaoyao pill combined western medicine treatment of polycystic ovary syndrome, curative effect is satisfied, and increase ovulation rate and pregnancy rate, no serious adverse reactions, worthy of promotion.