目的 探讨岩鹿乳康胶囊联合芦笋菠萝蛋白酶胶囊治疗乳腺增生的安全性与有效性。方法 选取2019年1月—2020年1月在河南省中医院治疗的乳腺增生患者131例，随机分成对照组（65例）和治疗组（66例）。对照组患者饭后口服芦笋菠萝蛋白酶胶囊，5粒/次，3次/d；治疗组患者在对照组的基础上饭后口服岩鹿乳康胶囊，4粒/次，3次/d，于月经前连续服用15 d，来月经时停用15 d。30 d为1个疗程。两组均连续治疗1个疗程。观察两组患者临床疗效，同时比较治疗前后两组患者肿块直径，输乳管内径和疼痛视觉模拟（VAS）评分，及雌二醇（E₂）、血管内皮生长因子（VEGF）、丙二醛（MDA）水平。结果 治疗后，对照组临床有效率为87.69%，显著低于治疗组的96.97%，两组比较差异具有统计学意义（P<0.05）。治疗后，两组患者肿块直径、输乳管内径，VAS评分，及血清E₂、VEGF、MDA水平均显著降低（P<0.05），且治疗组降低更显著（P<0.05）。结论 岩鹿乳康胶囊联合芦笋菠萝蛋白酶治疗乳腺增生安全性高、疗效显著，且能够显著缩小患者乳腺肿块和输乳管内径，具有一定的临床推广应用价值。

Objective To explore the safety and efficacy of Yanlu Rukang Capsules combined with Asparagus and Bromelains Capsules in treatment of mammary hyperplasia. Methods Patients (131 cases) with mammary hyperplasia in Henan Province Hospital of TCM from January 2019 to January 2020 were randomly divided into control (65 cases) and treatment (66 cases) groups. Patients in the control group were po administered with Yanlu Rukang Capsules after meal, 5 grains/time, three times daily. Patients in the treatment group were po administered with Asparagus and Bromelains Capsules on the basis of the control group after meal, 4 grains/time, three times daily. The treatment lasted for 15 days before menstruation, and stopped taking medicine during menstruation for 15 d. 30 Days was one course of treatment. Both groups received 1 course of treatment continuously. After treatment, the clinical efficacy was evaluated, and the tumor mass diameter, lactiferous tube diameter, VAS scores, and the serum levels of E₂, VEGF, and MDA in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 87.69%, which was significantly lower than 96.97% in the treatment group, and there were differences between two groups (P<0.05). After treatment, the tumor mass diameter, lactiferous tube diameter, VAS scores, and the serum levels of E₂, VEGF, and MDA in two groups were significantly decreased (P<0.05), and these indexes in the treatment group were significantly lower than those in the control group (P<0.05). Conclusion Yanlu Rukang Capsules combined with Asparagus and Bromelains Capsules is safe and effective in treatment of mammary hyperplasia, can significantly reduce the tumor mass diameter and lactiferous tube diameter, which has a certain clinical application value.

R984