目的 探讨乳癖散结颗粒联合枸橼酸托瑞米芬片治疗乳腺增生症的临床疗效。方法 将湖南中医药大学第一附属医院在2022年2月—2024年5月收治的92例乳腺增生症患者作为研究对象，按随机数字表法将患者分为对照组和治疗组，每组46例。对照组患者口服枸橼酸托瑞米芬片，1片/次，1次/d。治疗组在对照组基础上开水冲服乳癖散结颗粒，1袋/次，3次/d。两组患者持续治疗45 d。比较两组患者的治疗效果、肿块大小、主观疼痛程度、血清指标。结果 治疗组的总有效率为93.48%，对照组的总有效率为78.26%，组间差异显著（P＜0.05）。治疗后，两组的肿块显著缩小（P＜0.05），且治疗组缩小程度比对照组高（P＜0.05）。治疗后，两组患者静息、按压VAS评分均显著减小（P＜0.05）；治疗组的静息、按压VAS评分均小于对照组（P＜0.05）。治疗后，两组患者的血清血管内皮生长因子（VEGF）、转化生长因子-β1（TGF-β1）水平低于治疗前，血清B细胞淋巴瘤因子3（Bcl-3）水平高于治疗前（P＜0.05）；治疗组的血清VEGF、TGF-β1水平低于对照组，血清Bcl-3水平高于对照组（P＜0.05）。结论 乳癖散结颗粒联合枸橼酸托瑞米芬片可提高乳腺增生症的疗效，进一步缩小肿块大小，减轻疼痛程度，抑制异常组织生长。

Objective To explore the clinical efficacy of Rupi Sanjie Granules combined with Toremifene Citrate Tablets in treatment of breast hyperplasia. Methods 92 Patients with breast hyperplasia from The First Hospital of Hunan University of Chinese Medicine from February 2022 to May 2024 were selected, and were divided into control group and treatment group using a random number table method, with 46 patients in each group. Patients in the control group were po administered with Toremifen Citrate tablets, 1 tablets/time, once daily. On the basis of the control group, patients in the treatment group were took Rupi Sanjie Granules with boiled water, 1 bag/time, 3 times daily. Two groups of patients were continuously treated for 45 d. The treatment efficacy, tumor size, subjective pain level, and serum indicators between two groups of patients were compared. Results The total effective rate of patients in the treatment group was 93.48%, that of the control group was 78.26%, and the difference between the groups was significant (P < 0.05). After treatment, tumor sizes in both groups were significantly decreased (P < 0.05), and the degree of tumor sizes reduction in the treatment group was higher than that in the control group (P < 0.05). After treatment, the VAS scores of two groups of patients at rest and under pressure were significantly reduced (P < 0.05). The VAS scores at rest and under pressure in the treatment group were lower than those in the control group after treatment (P < 0.05). After treatment, the serum levels of vascular endothelial growth factor (VEGF) and transforming growth factor-β1 (TGF-β1) in both groups of patients were lower than these before treatment , but the serum level of B-cell lymphoma factor 3 (Bcl-3) was higher than these before treatment (P < 0.05). The serum levels of VEGF and TGF-β1 in the treatment group were lower than those in the control group, while the serum levels of Bcl-3 were higher than that in the control group (P < 0.05). Conclusion The combination of Rupi Sanjie Granules and Toremifene Citrate Tablets can improve the efficacy of breast hyperplasia, further reduce tumor size, alleviate pain, and inhibit abnormal tissue growth.

R984

湖南省卫生健康委科研计划项目(202203075671)