目的 探讨乳疾灵胶囊联合乳腺增生口服液治疗乳腺增生的临床效果。方法 选取2019年1月—2020年3月濮阳市油田总医院收治的100例乳腺增生患者，以随机数字表法分为对照组（n=50）和治疗组（n=50）。对照组口服乳腺增生口服液，20 mL/次，2次/d。治疗组在对照组基础上口服乳疾灵胶囊，3粒/次，3次/d。两组患者均于经期停药，均以1个月经周期为1个疗程，连续治疗3个疗程。观察两组的临床疗效，比较两组治疗前后肿块直径、乳痛视觉模拟量表（VAS）评分、36项健康调查简表（SF-36）评分及血清性激素[雌二醇（E₂）、黄体生成素（LH）、孕酮（P）]、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（bFGF）]水平。结果 治疗后，治疗组总有效率为96.0%，显著高于对照组84.0%（P<0.05）。治疗后，两组肿块直径、乳痛VAS评分均显著降低，但PCS评分、MCS评分显著增高（P<0.05）；治疗后，治疗组肿块直径、乳痛VAS评分低于对照组，但PCS评分、MCS评分高于对照组（P<0.05）。治疗后，两组血清E₂、LH水平均较本组治疗前显著降低，但血清P水平较本组治疗前显著升高（P<0.05）；且治疗组治疗后血清性激素水平改善程度较对照组更显著（P<0.05）。治疗后，两组血清VEGF、bFGF水平较本组治疗前均显著下降（P<0.05）；且治疗组比对照组血清VEGF、bFGF水平的降低更显著（P<0.05）。结论 乳疾灵胶囊联合乳腺增生口服液治疗乳腺增生可取得确切疗效，患者肿块大小及乳痛症状得以有效改善，生活质量明显提高，并可使患者体内异常表达的性激素和促血管生成因子得到纠正，值得临床推广应用。

Objective To investigate the clinical effect of Rujiling Capsules combined with Ruxian Zengsheng Oral Liquid in treatment of mammary gland hyperplasia.Methods A total of 100 patients with breast hyperplasia treated in Puyang Oilfield General Hospital from January 2019 to March 2020 were selected and divided into control group (n=50) and treatment group (n=50) by random number table method. Patients in the control group were po administered with Ruxian Zengsheng Oral Liquid, 20 mL/time, twice daily. Patients in the treatment group were po administered with Rujiling Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in both groups stopped taking medication during menstrual period, and each menstrual cycle was taken as a course of treatment. They were treated for 3 consecutive courses. After treatment, the clinical efficacy was evaluated, and the diameter of the tumor, the visual analog scale for milk pain (VAS) score, the score of 36 health survey short form (SF-36), and the serum sex hormones [estradiol (E₂), luteinizing hormone (LH), Progesterone (P)], pro-angiogenesis factors [vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF)] levels in two groups before and after treatment were compared.Results After treatment, the total effective rate of 96.0% in treatment group was significantly higher than that of control group (84.0%,P<0.05). After treatment, mass diameter and VAS score of breast pain were significantly decreased in both groups, but PCS score and MCS score were significantly increased (P<0.05). After treatment, mass diameter and VAS score in the treatment group were lower than those in the control group, but PCS score and MCS score were higher than those in the control group (P<0.05). After treatment, serum E₂ and LH levels in both groups were significantly lower than those before treatment, but serum P level was significantly higher than that before treatment (P<0.05). The improvement of serum sex hormone level in treatment group was more significant than that in control group (P<0.05). After treatment, the levels of serum VEGF and bFGF in two groups were significantly decreased compared with before treatment (P<0.05). The decrease of serum VEGF and bFGF in treatment group was more significant than that in control group (P<0.05).Conclusion Rujiling Capsules combined with Ruxian Zengsheng Oral Liquid has definite curative effect in treatment of mammary gland hyperplasia, and can effectively improve size of the lump, the symptoms of breast pain, and quality of life, and can correct the abnormal expression of sex hormones and pro-angiogenic factors in patients, which is worthy of clinical promotion and application.

R984

濮阳市科技攻关项目（80614）