目的 探讨西黄胶囊联合他莫昔芬治疗乳腺增生症的临床效果。方法 选取选取2017年1月-2019年8月濮阳市中医医院收治的乳腺增生症患者102例，随机分为对照组和治疗组，每组各51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西黄胶囊，4~8粒/次，2次/d。连续治疗2个月为1疗程。观察两组的临床疗效，比较两组治疗前后乳房超声检查指标和相关性激素指标的变化情况。结果 治疗后，对照组和治疗组的总有效率分别是82.4%、96.1%，两组比较差异有统计学意义（P<0.05）。治疗后，治疗组乳房输乳管内径、肿块直径及腺体层厚度均较治疗前显著降低（P<0.05）；治疗后，治疗组患者输乳管内径、肿块直径及腺体层厚度均显著小于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，两组雌二醇（E₂）、促卵泡成熟激素（FSH）、黄体生成激素（LH）、催乳激素（PRL）及睾酮（T）水平均较治疗前显著降低（P<0.05）；治疗后，治疗组性激素指标显著低于对照组，两组比较差异有统计学意义（P<0.05）。结论 西黄胶囊联合他莫昔芬治疗乳房增生症具有较好的临床疗效，可明显改善患者的临床症状，降低性激素水平，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of xihuang capsule combined with tamoxifen in the treatment of breast hyperplasia. Methods 102 Patients with mammary hyperplasia admitted to Puyang Hospital of Traditional Chinese Medicine from January 2017 to August 2019 were randomly divided into two groups. The control group was po administered with Tamoxifen Citrate Tablets, 1 tablet/time, twice daily. The treatment group was po administered with Xihuang Capsules on the basis of the control group, 4-8 grains/time, twice daily. Continuous treatment for 2 months is a course of treatment. The clinical efficacy of the two groups was observed, and the changes of breast ultrasound examination indexes and related sex hormone indexes before and after treatment were compared. Results After treatment, the total effective rate in the control group and the treatment group was 82.4% and 96.1%, respectively, and there were differences between two groups (P<0.05). After treatment, the inner diameter of the lactiferous duct, the diameter of the mass and the thickness of the glandular layer in the treatment group were significantly lower than before treatment (P<0.05). After treatment, the inner diameter of lactiferous duct, mass diameter and glandular thickness of patients in the treatment group were significantly smaller than those in the control group, and the differences between the two groups were statistically significant (P<0.05). After treatment, levels of estradiol (E₂), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and testosterone (T) in both groups were significantly lower than before treatment (P<0.05). After treatment, the sex hormone indexes of the treatment group were significantly lower than those of the control group, and the difference between the two groups was statistically significant (P<0.05). Conclusion Xihuang Capsules combined with tamoxifen has better clinical efficacy in treatment of mammary hyperplasia, and can significantly improve the patient's clinical symptoms, and also can reduce the level of sex hormones, which has a certain clinical application value.

R984

河南省医学科技攻关项目（201602169）