目的 观察消乳散结胶囊联合他莫昔芬治疗乳腺增生症的临床效果。方法 选择2017年2月—2019年4月在郑州大学第三附属医院治疗的乳腺增生症患者77例，随机分为对照组（38例）和治疗组（39例）。对照组口服枸橼酸他莫昔芬片，1片/次，2次/d。治疗组在对照组基础上口服消乳散结胶囊，3粒/次，3次/d。两组患者连续治疗3个月。观察两组患者临床疗效，同时比较治疗前后两组患者性激素水平和临床症状改善情况。结果 治疗后，对照组和治疗组临床有效率分别为71.05%、92.31%，两组比较差异有统计学意义（P<0.05）。治疗后，两组患者孕酮（P）和卵泡刺激素（FSH）水平均明显升高（P<0.05），而黄体生成激素（LH）和雌二醇（E2）水平均显著降低（P<0.05），且治疗组P、FSH、LH和E2水平明显比对照组好（P<0.05）。治疗后，两组肿块最大径和疼痛程度均明显降低（P<0.05），且治疗组明显比对照组小（P<0.05）。结论 消乳散结胶囊联合他莫昔芬治疗乳腺增生症，可明显缓解乳房胀痛，缩小乳腺肿块，改善性激素水平，临床效果较好。

Objective To observe the clinical effect of Xiaoru Sanjie Capsules combined with tamoxifen in treatment of mammary hyperplasia. Methods Patients (77 cases) with mammary hyperplasia in the Third Affiliated Hospital of Zhengzhou University from February 2017 to April 2019 were randomly divided into control (38 cases) and treatment (39 cases) groups. 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 Xiaoru Sanjie Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the sex hormone levels and the improvement of clinical symptoms in two groups before and after treatment were compared. Results After treatment, the clinical efficacy and in the control and treatment groups was 71.05% and 92.31%, respectively, and there were differences between two groups (P<0.05). After treatment, the levels of P and FSH in two groups were significantly increased (P<0.05), but the levels of LH and E2 were significantly decreased (P<0.05), and the sex hormone levels in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the maximum diameter of the mass and VAS score in two groups were significantly decreased (P<0.05), and these indexes in the treatment group were significantly lower than those in the control group (P<0.05). Conclusion Xiaoru Sanjie Capsules combined with tamoxifen in treatment of mammary hyperplasia can obviously relieve breast tenderness, reduce breast lumps, improve sex hormone levels, which has a good clinical effect.

R984

河南省医学科技攻关计划普通项目（201503111）