目的 探讨乳康片联合达那唑治疗乳腺增生症的临床效果。方法 选取2019年2月—2020年2月天津中医药大学第一附属医院收治的96例乳腺增生症患者，采取随机数字表法分成对照组（n=48）和治疗组（n=48）。对照组口服达那唑胶囊，1粒/次，2次/d，于行经当天开始服药。治疗组在对照组基础上口服乳康片，3片/次，3次/d，饭后服用，经期停服。两组均连续治疗3个月。观察两组的临床疗效，比较两组治疗前后乳腺疼痛视觉模拟量表（VAS）评分、肿块最大径、36项健康调查简表（SF-36）总分、乳腺供血动脉血流动力学参数[收缩期峰值流速（V_max）、阻力指数（RI）]及血清性激素[雌二醇（E₂）、孕酮（P）、P/E₂比值]水平变化情况。结果 治疗后，治疗组患者总有效率为95.8%，显著高于对照组的83.3%（P<0.05）。治疗后，两组患者乳腺疼痛VAS评分、肿块最大径均显著低于本组治疗前，但SF-36总分均显著高于本组治疗前（P<0.05）；治疗后，治疗组乳腺疼痛VAS评分、肿块最大径低于对照组，但SF-36总分高于对照组（P<0.05）。治疗后，两组乳腺供血动脉V_max、RI均较本组治疗前显著降低（P<0.05）；且治疗后，治疗组乳腺供血动脉血流动力学参数改善优于对照组（P<0.05）。治疗后，两组血清E₂水平均显著下降，但血清P水平、P/E₂比值显著升高（P<0.05）；治疗后，治疗组血清性激素水平改善优于对照组（P<0.05）。结论 乳康片联合达那唑治疗乳腺增生症的总体疗效确切，能安全有效地缓解患者症状和体征，改善其生活质量，并对患者乳腺供血动脉血流动力学及内分泌功能均有显著改善作用，值得临床推广应用。

Objective To investigate the clinical effect of Rukang Tablets combined with danazol in treatment of hyperplasia of mammary glands. Methods A total of 96 patients with breast hyperplasia admitted to the First Affiliated Hospital of Tianjin University of Chinese Medicine from February 2019 to February 2020 were selected and divided into control group (n=48) and treatment group (n=48) by random number table method. Patients in the control group were po administered with Danazole Capsules, 1 tablet/time, twice daily, and the medication began on the day of menstruation. Patients in the treatment group were po administered with Rukang Tablets after meals on the basis of the control group, 3 tablets/time, 3 times daily, and stopped taking during menstruation. Both groups were treated continuously for 3 months. The clinical efficacy of the two groups was observed, and the visual analogue scale (VAS) scores of breast pain, the maximum diameter of the mass, the total score of 36 health survey summary (SF-36), and the hemodynamic parameters of the mammary artery [peak systolic flow rate (V_max)], resistance index (RI)] and serum sex hormones [estradiol (E₂), progesterone (P), P/E₂ ratio] in two groups before and after treatment were compared. Results After treatment, the total effective rate (95.8%) in the treatment group was significantly higher than that in the control group (83.3%) (P<0.05). After treatment, VAS score and maximum diameter of breast pain in two groups were significantly lower than before treatment, but total SF-36 score was significantly higher than before treatment (P<0.05). After treatment, the VAS score and the maximum diameter of breast pain in the treatment group were lower than those in the control group, but the total score of SF-36 in the treatment group was higher than that in the control group (P<0.05). After treatment, V_max and RI of breast supplying artery in two groups were significantly decreased compared with before treatment (P<0.05). After treatment, the improvement of the mechanical parameters of the mammary artery in the treatment group was better than that in the control group (P<0.05). After treatment, serum E₂ level in both groups was significantly decreased, but serum P level and P/E₂ ratio were significantly increased (P<0.05). After treatment, the improvement of serum sex hormone level in treatment group was better than that in control group (P<0.05). Conclusion Rukang Tablets combined with danazol has definite curative effect in treatment of hyperplasia of mammary glands, can safely and effectively relieve the symptoms and signs of patients, improve their life quality, and significantly improve the hemodynamics and endocrine function of the mammary gland blood supply artery, which is worthy of clinical application.

R984

天津市卫生和计划生育委员会科研基金项目（2017KZ091）