德生丹治疗排卵障碍性不孕症肾虚肝郁证患者临床研究

目的?观察中原门氏验方德生丹对排卵障碍性不孕症肾虚肝郁证患者的临床疗效。方法?将120例排卵障碍性不孕症肾虚肝郁证患者随机分为中药组（采用中药德生丹）、联合组（采用中药德生丹+克罗米芬）、西药组（单纯使用克罗米芬）。治疗12周后观察3组患者优势卵泡直径、子宫内膜厚度、宫颈黏液（Insler）评分及排卵率、妊娠率及血清雌二醇（E₂）、孕酮（P）水平的变化等。结果?治疗后3组优势卵泡直径与治疗前比较均显著增长（P<0.05~0.01），联合组与西药组优于中药组（P<0.01）；3组中医证候积分均显著下降（P<0.01），联合组与中药组优于西药组（P<0.01）；中药组、联合组子宫内膜厚度、Insle评分均有所增加（P<0.01），优于西药组（P<0.05~0.01）；排卵日3组血清E₂水平均有所增长（P<0.01），联合组与中药组优于西药组（P<0.05）；中药组、联合组黄体期血清P水平增长明显（P<0.01），优于西药组（P<0.05~0.01）；3组排卵率比较，联合组与西药组均优于纯中药组（P<0.05~0.01）；3组妊娠率比较，联合组优于中药组、西药组（P<0.05~0.01），中药组优于西药组（P<0.05）。结论?德生丹能改善排卵障碍性不孕症肾虚肝郁证患者临床症状，减少单纯克罗米芬抑制子宫内膜的不良作用，提高临床排卵及妊娠率。 

Clinical Research on the Desheng Elixir Treating Sterility of Ovulation Disturbance Patients with Kidney Deficiency and Liver Depression Syndrome

OBJECTIVE?To observe the clinical effect of Zhongyuan Men's proved recipe Desheng elixir on sterility of ovulation disturbance patients with kidney deficiency and liver stagnation syndrome. METHODS?120 cases of sterility of ovulation disturbance with kidney deficiency and liver depression syndrome were randomly divided into three groups: traditional Chinese medicine group (using Desheng elixir)， combination group (using Desheng elixir + clomiphene)， western medicine group (using clomiphene only). After 12 weeks of treatment， the leading follicle diameter， endometrial thickness， cervical mucus (Insler) score， ovulation rate， pregnancy rate， serum estradiol (E₂) and progesterone (P) levels in the three groups were observed. RESULTS?After treatment， the leading follicle diameter in the three groups increased significantly compared with that before treatment (P<0.05，P<0.01)， among which the combination group and the western medicine group increased more significantly (P<0.01). The TCM syndrome scores of the three groups decreased significantly (P<0.01)， among which the combination group and the Chinese medicine group decreased more significantly (P<0.01). The endometrial thickness and Insle score in the Chinese medicine group and the combination group increased (P<0.01)， more significantly than those in the western medicine group (P<0.05，P<0.01). Serum E₂ level increased in the three groups on the day of ovulation (P<0.01)， among which the combination group and the Chinese medicine group increased more significantly (P<0.05).Serum P level in the luteal phase increased significantly in the Chinese medicine group and the combination group (P<0.01)， better than that in the western medicine group (P<0.05，P<0.01). From the perspective of ovulatory rate， the combination group and the western medicine group increased more than that in the Chinese medicine group (P<0.05，P<0.01). As to the pregnancy rate， the combination group was higher than the other two (P<0.05， P<0.01) and the Chinese medicine group was higher than the western medicine group (P<0.05). CONCLUSION?Desheng elixir can improve the clinical symptoms of sterility of ovulation disturbance patients with kidney deficiency and liver depression syndrome， reduce the adverse effect of clomiphene alone on inhibiting endometrium， and improve the clinical ovulation and pregnancy rate.