目的 探讨小金丸联合乳安片治疗乳腺增生症的临床效果。方法 选取2019年5月-2021年5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,使用随机数字表法将所有患者分成对照组和治疗组,每组各48例。对照组口服乳安片,5片/次,2次/d。治疗组在对照组基础上口服小金丸,1.2 g/次,2次/d。所有患者均于月经来潮第7天开始用药,连用21 d后停药7 d,此为1个疗程,连续治疗2个疗程后评价两组疗效。比较治疗前后两组乳腺疼痛视觉模拟量表(VAS)评分、肿块最大径、肿块评分、乳腺增生区血流动力学指标及血清雌二醇(E₂)、催乳激素(PRL)、孕酮(P)和血管内皮生长因子(VEGF)水平。结果 治疗后,治疗组总有效率是93.75%,较对照组79.17%显著增高(P<0.05)。治疗后,两组乳腺疼痛VAS评分、肿块最大径及肿块大小、硬度、范围评分均较本组治疗前显著降低(P<0.05);且均以治疗组的改善更显著(P<0.05)。治疗后,两组乳腺增生区血流信号分级均显著优于同组治疗前,RI均显著降低(P<0.05);但乳腺增生区血流动力学指标均以治疗组改善更显著(P<0.05)。治疗后两组血清E₂、PRL和VEGF水平均显著下降,而血清P水平均显著增高(P<0.05);且治疗后,治疗组血清E₂、PRL、VEGF、P水平改善优于对照组(P<0.05)。结论 小金丸联合乳安片对乳腺增生症患者具有确切的临床疗效,可安全有效地缓解患者乳腺疼痛,软化并缩小乳腺肿块,减少增生区内部血供,纠正内分泌功能紊乱,抑制体内促血管生成因子的异常表达。

Objective To investigate the clinical effect of Xiaojin Pills combined with Ru’an Tablets in treatment of mammary hyperplasia. Methods A total of 96 patients with mammary hyperplasia admitted to the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from May 2019 to May 2021 were selected. All patients were divided into control group and treatment group by random number table method, with 48 cases in each group. Patients in the control group were po administered with Ru’an Tablets, 5 tablets/time, twice daily. Patients in the treatment group were po administered with Xiaojin Pills on the basis of the control group, 1.2 g/time, twice daily. All patients started medication on the 7th day of menstrual cramps, and stopped the medication for 7 d after 21 d of continuous use. This was one course of treatment. The curative effects of the two groups were observed after 2 consecutive courses of treatment. The visual analog scale (VAS) score, the maximum diameter of the tumor, the tumor score, the hemodynamic index of the breast hyperplasia area and the serum estradiol (E₂), prolactin (PRL), progesterone (P), and vascular endothelial growth factor (VEGF) were compared between the two groups before and after treatment. Results After treatment, the total effective rate of 93.75% in the treatment group was significantly higher than 79.17% in the control group (P < 0.05). After treatment, VAS score, maximum diameter, mass size, hardness and range score of breast pain in two groups was significantly decreased compared with before treatment (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, blood flow signal grade in breast hyperplasia area in both groups was significantly better than before treatment, but RI was significantly decreased (P < 0.05).However, the hemodynamic indexes in the hyperplasia area were improved more significantly than those in the treatment group (P < 0.05). After treatment, serum E₂, PRL, and VEGF levels were significantly decreased, while serum P level was significantly increased in both groups (P < 0.05). After treatment, the levels of E₂, PRL, VEGF, and P in the treatment group were better than those in the control group (P < 0.05). Conclusion Xiaojin Pills combined with Ru’an Tablets has a definite clinical effect on patients with breast hyperplasia, and can safely and effectively relieve breast pain, soften and reduce breast masses, reduce blood supply in the hyperplasia area, correct endocrine dysfunction, and also can inhibit angiogenesis factors in the body abnormal expression.

R984

天津市卫生和计划生育委员会科研基金资助项目（2017KZ091）