目的 探讨托瑞米芬联合中药治疗重症乳腺增生症的疗效及对激素水平的影响。方法 98例重症乳腺增生症患者随机分为对照组和观察组,各49例。对照组给予平消胶囊,观察组在此基础上加用托瑞米芬,经期停药。观察2组临床疗效、不良反应,及治疗前后乳房疼痛程度、乳腺厚度、肿块大小及硬度评分、子宫内膜厚度及激素水平变化。结果 治疗后,对照组有效率83.67%,显著低于观察组有效率95.92%（P〈0.05）。2组视觉模拟评分（VAS评分）、乳腺厚度、肿块大小及硬度评分均显著下降（P〈0.05或P〈0.01）,子宫内膜厚度无显著变化（P〉0.05）;观察组各项评分及乳腺厚度均显著低于对照组（P〈0.05或P〈0.01）。2组卵泡刺激素（FSH）及孕酮（P）水平均升高,黄体生成素（LH）、雌二醇（E2）及泌乳素（PRL）水平均显著降低（P〈0.01）;组间比较,各激素水平差异均有统计学意义（P〈0.05或P〈0.01）。结论 在中药治疗的基础上加用托瑞米芬,可提高重症乳腺增生症的临床疗效,减轻临床症状,改善激素水平,且不增加不良反应。
Objective To explore the clinical efficacy of torenfifene combined with tradition- al Chinese medicine （TCM） in the treatment of severe cyclomastopathy and its influence on hormonal levels. Methods A total of 98 patients with severe cyclomastopathy were randomly divided into con- trol group and observation group, with 49 cases for each group. Control group was given Pingxiao Capsules, and observation group was added with toremifene （discontinued during menstrual period）. Clinical efficacy and adverse reactions after treatment as well as breast pain severity, the thickness of galactophore, the scores of lump size and rigidity, endometrial thickness and hormonal level changes before and after treatment were observed in both groups. Results After treatment, the response rate was 83.67% in control group, which was evidently lower than 95.92% in observation group （P 〈 0.05 ）. Scores of visual analogue scale （VAS） , the thickness of galactophore, lump size and rigidity decreased markedly （P 〈0.05 or P 〈 0.01 ） , but there was no significant difference in endometrial thickness （P 〉 0.05 ）. Observation group was notably lower than control group in each score and the thickness of galactophore （P 〈 0.05 or P 〈 0.01 ）. Levels of follicle stimulating hormone （FSH） and progesterone （P） increased prominently while the levels of luteinizing hormone （ LH）, estradiol （ E2 ） and prolactin （PRL） decreased obviously after treatment than treatment before （ P 〈 0.01 ）, and there were also significant differences between two groups （ P 〈 0.05 or P 〈 0.01 ）. Conclusion Application of toremifene on the basis of TCM can increase the clinical efficacy , relieve clinical symptoms, and improve hormonal levels without increasing the adverse reactions in the treatment of patients with severe cyclomastopathy.
Journal of Clinical Medicine in Practice