目的 研究消结安胶囊联合枸橼酸他莫昔芬片治疗乳腺增生症的临床研究。方法 选取2015年12月-2017年12月郑州大学第一附属医院接收的乳腺增生患者100例为研究对象，将所有患者随机分为对照组和治疗组，每组各50例。对照组口服枸橼酸他莫昔芬片，1片/次，2次/d。治疗组在对照组治疗的基础上口服消结安胶囊，2粒/次，3次/d。两组患者均持续治疗2个月。观察两组的临床疗效，比较两组的乳腺超声指标和雌激素水平。结果 治疗后，对照组和治疗组的总有效率分别为82.00%、95.00%，两组比较差异有统计学意义（P<0.05）。治疗后，两组乳腺腺体层厚度、肿块直径、输乳管内径和低回声区直径均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些乳腺超声指标明显低于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组雌二醇、催乳素水平显著降低，孕酮水平显著升高，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些雌激素水平明显优于对照组，两组比较差异具有统计学意义（P<0.05）。结论 消结安胶囊联合枸橼酸他莫昔芬片治疗乳腺增生症具有较好的临床疗效，能够改善患者乳腺超声指标和雌激素水平，安全性较好，具有一定临床推广应用价值。

Objective To study the clinical effect of Xiaojie'an Capsules combined with Tamoxifen Citrate Tablets in treatment of cyclomastopathy. Methods Patients (100 cases) with cyclomastopathy in the First Affiliated Hospital of Zhengzhou University from December 2015 to December 2017 were randomly divided into control and treatment groups, and each group had 50 cases. Patients in the control group were po administered with Tamoxifen Citrate Tablets, 1 tablet/time, twice daily. Patients in the treatment group were po administered with Xiaojie'an Capsules on the basis of the control group, 2 grains/time, three times daily. Patients in two groups were treated for 2 months. After treatment, the clinical efficacies were evaluated, and breast ultrasound indexes and estrogen levels in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 82.00% and 95.00%, respectively, and there was difference between two groups (P<0.05). After treatment, thickness of mammary gland layer, diameter of mass, diameter of feeding duct and diameter of hypoechoic area in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the breast ultrasound indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of estradiol and prolactin in two groups were significantly decreased, but the levels of progesterone in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). And the estrogen levels in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). Conclusion Xiaojie'an Capsules combined with Tamoxifen Citrate Tablets has clinical curative effect in treatment of cyclomastopathy, can improve breast ultrasound indexes and estrogen levels, with good safety, which has a certain clinical application value.