目的 观察红花逍遥片联合夏枯草片治疗乳腺囊性增生的临床疗效。方法 选取2023年9月—2025年12月河南省中医院甲状腺乳腺外科诊治的98例乳腺囊性增生患者，按照随机数字法分为对照组和治疗组，每组各49例。对照组口服夏枯草片，6片/次，2次/d。治疗组在对照组的基础上口服红花逍遥片，2～4片/次，3次/d。两组用药3个月经周期。观察两组疗效情况；比较两组的中医症状积分、视觉模拟疼痛评分法（VAS）、症状自评量表（SCL-90）、世界卫生组织生活简易量表（WHOQOL-BREF）、卵泡刺激素（FSH）、催乳素（PRL）、雌二醇（E₂）、黄体生成素（LH）、白细胞介素6（IL-6）、血管内皮生长因子（VEGF）、肿瘤坏死因子-α（TNF-α）。结果 治疗后，治疗组总有效率（95.92%）显著高于对照组（81.63%，P＜0.05）。治疗后，两组乳房胀痛积分、乳房肿块积分、烦躁易怒积分均显著降低（P＜0.05）；治疗后，与对照组对比，治疗组乳房胀痛积分、乳房肿块积分、烦躁易怒积分均降低（P＜0.05）。治疗后，两组患者的SCL-90评分、VAS评分显著降低，而WHOQOL-BREF评分升高（P＜0.05）；治疗后，与对照组对比，治疗组的SCL-90评分、VAS评分均降低，且WHOQOL-BREF评分升高（P＜0.05）。治疗后，两组FSH、PRL、E₂、LH水平较同组治疗前显著降低（P＜0.05）；治疗后，与对照组对比，治疗组FSH、PRL、E₂、LH水平均降低（P＜0.05）。治疗后，两组血清IL-6、VEGF、TNF-α水平均显著下降（P＜0.05）；治疗后，与对照组对比，治疗组的IL-6、VEGF、TNF-α水平均较低（P＜0.05）。结论 红花逍遥片与夏枯草片协同治疗乳腺囊性增生效果显著，可改善乳房疼痛症状及心理状态，调节患者的炎性反应及内分泌水平，生活质量得以提升，值得借鉴与推广。

Objective To observe the clinical efficacy of Honghua Xiaoyao Tablets combined with Xiakucao Tablets in treatment of breast cystic hyperplasia. Methods A total of 98 patients with breast cystic hyperplasia who were treated in Thyroid and Breast Surgery Department of Henan Provincial Hospital from September 2023 to December 2025 were selected. They were randomly divided into control group and treatment group, with 49 cases in each group. Patients in control group were given Xiakucao Tablets orally, 6 tablets/time, twice daily. Patients in treatment group were given Honghua Xiaoyao Tablets on basis of control group, 2— 4 tablets/time, three times daily. Both groups took the medication for 3 menstrual cycles. The therapeutic effects of two groups were observed; the Chinese medicine symptom scores, Visual Analogue Scale (VAS) for pain, Symptom Checklist 90 (SCL-90), World Health Organization Quality of Life-BREF (WHOQOL-BREF), follicle-stimulating hormone (FSH), prolactin (PRL), estradiol (E₂), luteinizing hormone (LH), interleukin 6 (IL-6), vascular endothelial growth factor (VEGF), and tumor necrosis factor-α (TNF-α) were compared between two groups. Results After treatment, the total effective rate of treatment group (95.92%) was significantly higher than that of control group (81.63%, P < 0.05). After treatment, the scores of breast distension pain, breast mass, and irritability in both groups significantly decreased (P< 0.05). After treatment, compared with the control group, the scores of breast distension pain, breast mass, and irritability in the treatment group were all decreased (P < 0.05). After treatment, the SCL-90 scores, VAS scores of the patients in both groups significantly decreased, but WHOQOL-BREF score increased (P < 0.05). After treatment, compared with control group, SCL-90 scores and VAS scores of treatment group were both decreased, and the WHOQOL-BREF score increased (P < 0.05). After treatment, the levels of FSH, PRL, E₂, and LH in both groups were significantly lower than those before treatment in same group (P < 0.05). After treatment, compared with control group, the levels of FSH, PRL, E₂, and LH in treatment group were all decreased (P < 0.05). After treatment, the levels of serum IL-6, VEGF, and TNF-α in both groups significantly decreased (P < 0.05). after treatment, compared with control group, the levels of IL-6, VEGF, and TNF-α in treatment group were lower (P < 0.05). Conclusion The combination of Honghua Xiaoyao Tablets and Xiakucao Tablets has a remarkable therapeutic effect in treatment of breast cystic hyperplasia, and can alleviate breast pain symptoms and improve the psychological state of patients, regulate their inflammatory responses and endocrine levels, and enhance the quality of life. This treatment method is worthy of being adopted and promoted.

R984

河南省中医药科学研究专项课题（2022ZY1080）