目的 探讨乳块消颗粒联合乳腺增生口服液治疗乳腺增生症的临床效果。方法 选取2017年1月-2018年12月天津中医药大学第一附属医院收治的120例乳腺增生症，随机分成对照组（n=60）和治疗组（n=60）。对照组口服乳腺增生口服液，20 mL/次，2次/d，服时摇匀，经期停服。治疗组在对照组基础上口服乳块消颗粒，1袋/次，3次/d，开水冲服，经期停服。两组均连续治疗2个月。比较两组临床疗效，治疗前后主要症状及体征评分、乳腺超声参数值及血清性激素指标[雌二醇（E₂）、孕酮（P）、催乳激素（PRL）]、促血管新生因子[血管内皮生长因子（VEGF）、碱性成纤维细胞生长因子（βFGF）]水平变化情况。结果 治疗组总有效率为95.0%，较对照组（83.3%）显著升高（P<0.05）。两组治疗后主要症状、体征（乳痛及肿块硬度、范围、大小）评分均显著低于治疗前（P<0.05），且治疗组治疗后以上主要症状、体征评分均较对照组同期显著更低（P<0.05）。与治疗前对比，两组治疗后乳腺超声相关参数（肿块直径、腺体层厚度、输乳管内径、低回声区直径）值均显著缩小（P<0.05）；但治疗后，治疗组上述乳腺超声相关参数值均显著小于对照组同期（P<0.05）。两组治疗后血清E₂、PRL、VEGF及βFGF水平均显著低于治疗前（P<0.05），血清P含量则均显著升高（P<0.05）；且治疗后，治疗组血清E₂、P、PRL、VEGF、βFGF水平的改善效果均显著优于对照组同期（P<0.05）。结论 乳块消颗粒联合乳腺增生口服液治疗乳腺增生症的整体疗效显著，可有效缓解患者的症状和体征，改善局部乳腺结构和形态，正性调控内分泌，抑制促血管生长因子过度表达，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Rukuaixiao Granules combined with Mammary Hyperplasia Oral Liquid in treatment mammary of hyperplasia. Methods 120 Patients with mammary hyperplasia admitted to First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2017 to December 2018 were randomly divided into control group (n=60) and treatment group (n=60). The control group was po administered with Mammary Hyperplasia Oral Liquid, 20 mL/time, twice daily, shake well when taking, stop taking during menstruation. The treatment group was po administered with Rukuaixiao Granules on the basis of the control group, 1 bag/time, three times daily. All patients were treated for 2 months. The clinical effects of the two groups were compared. The main symptom and sign scores, breast ultrasound parameter values, serum sex hormone indexes[estradiol (E₂), progesterone (P), prolactin (PRL)], and angiogenesis promoting factors[vascular endothelial growth factor (VEGF), basic fibroblast growth factor (βFGF)] levels before and after treatment were compared. Results The total effective rate of the treatment group was 95.0%, significantly higher than that of the control group (83.3%) (P<0.05). After treatment, the scores of main symptoms and signs (breast pain and mass hardness, range and size) in the two groups were significantly lower than those before treatment (P<0.05), and the scores of main symptoms and signs in the treatment group were significantly lower than those in the control group at the same time (P<0.05). Compared with before treatment, the breast ultrasound-related parameters (tumor diameter, gland layer thickness, inner diameter of breast duct and diameter of hypoechoic region) of the two groups decreased significantly after treatment (P<0.05). However, after treatment, the above-mentioned breast ultrasound-related parameters in the treatment group were significantly lower than those in the control group at the same time (P<0.05). After treatment, the levels of serum E₂, PRL, VEGF and βFGF in the two groups were significantly lower than before treatment (P<0.05), while the levels of serum P were significantly increased (P<0.05). After treatment, the improvement effect of serum E₂, P, PRL, VEGF, βFGF concentration in the treatment group was significantly better than that in the control group at the same time (P<0.05). Conclusion Rukuaixiao Granules combined with Mammary Hyperplasia Oral Liquid has a significant overall curative effect in treatment of mammary hyperplasia, can effectively relieve the symptoms and signs of patients, improve the structure and morphology of local mammary glands, and can positively regulate endocrine, inhibit the overexpression of vascular growth factor, which has a certain clinical application value.

R984