目的 探讨坤灵丸联合地屈孕酮片治疗多囊卵巢综合征所致月经不调的临床疗效。方法 选择2018年9月—2019年9月在洛阳市中医院治疗的104例多囊卵巢综合征所致月经不调患者，根据用药的区别分为对照组和治疗组，每组各52例。对照组患者口服地屈孕酮片，从月经周期的第11天开始直到第25天，10 mg/次，2次/d；治疗组在对照组基础上口服坤灵丸，15丸/次，2次/d。所有患者均连续治疗3个月经周期。观察两组患者临床疗效，比较治疗前后两组患者痤疮综合分级系统（GAGS）评分、月经失血图（PBAC）评分、改良F-G多毛评分法（F-G）和基础体温（HPS）评分及临床症状改善时间和性激素水平。结果 治疗后，总有效率方面治疗组显著优于对照组（98.08% vs 82.69%，P<0.05）。治疗后，治疗组GAGS、PBAC、F-G和HPS评分均要优于对照组（P<0.05）。治疗后，治疗组在经期恢复正常时间、经量恢复正常时间、经色恢复正常时间、神疲乏力消失时间、肥胖改善时间上均优于对照组（P<0.05）。经治疗，两组血清促黄体生成激素（LH）、促卵泡生成激素（FSH）、睾酮（T）水平均显著降低（P<0.05），且治疗组降低更明显（P<0.05）。结论 坤灵丸联合地屈孕酮片治疗多囊卵巢综合征所致月经不调不仅可提升临床有效率并改善临床症状，还可促进性激素水平改善，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Kunling Pills combined with dydrogesterone in treatment of irregular menstruation caused by polycystic ovary syndrome. Methods Patients (104 cases) with irregular menstruation caused by polycystic ovary syndrome in Luoyang Hospital of TCM from September 2018 to September 2019 were divided into control and treatment groups based on different treatments, and each group had 52 cases. Patients in the control group were po administered with Dydrogesterone Tablets from the 11th day of the menstrual cycle to the 25th day, 10 mg/time, twice daily. Patients in the treatment group were po administered with Kunling Pills on the basis of the control group, 15 pills/time, twice daily. Patients in two groups were treated for 3 menstrual cycle. After treatment, the clinical efficacy was evaluated, and the scores of GAGS, PBAC, F-G and HPS, the improvement time of clinical symptoms, and the sex hormone levels in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was significantly better than that of the control group (98.08% vs 82.69% P<0.05). After treatment, the scores of GAGS, PBAC, F-G and HPS in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the treatment group was significantly superior to the control group in menstrual recovery time, menstrual volume recovery time, menstrual color recovery time, fatigue disappearance time and obesity improvement time (P<0.05). After treatment, the serum LH, FSH and T levels in both groups were significantly decreased (P<0.05), and the decrease was more significant in the treatment group (P<0.05). Conclusion Kunling Pills combined with Dydrogesterone Tablets in the treatment of irregular menstruation caused by polycystic ovary syndrome can not only improve the clinical effective rate and improve clinical symptoms, but also improve the level of sex hormones, which has a certain clinical application value.

R984

河南省中医药科学研究专项课题（2019ZY3017）