乳癖散结胶囊联合他莫昔芬治疗乳腺增生的效果与安全性

Efficacy and Safety of Rupi Sanjie Capsule combined with Tamoxifen in the Treatment of Mammary Hyperplasia

目的 探讨乳癖散结胶囊联合他莫昔芬治疗乳腺增生的效果与安全性。方法 选取2020年4月至2021年12月临沂市肿瘤医院收治的乳腺增生患者60例作为研究对象,随机分为对照组与试验组,每组30例。对照组单纯给予他莫昔芬治疗,试验组采用他莫昔芬+乳癖散结胶囊治疗,比较两组的治疗效果。结果 试验组治疗有效率93.33%,对照组73.33%,差异有统计学意义(χ^(2)=4.320,P=0.038<0.05)。治疗后试验组视觉模拟评分法(VAS)评分(2.01±0.30)分,低于对照组的(3.44±0.45)分,差异有统计学意义(t=5.274,P=0.017<0.05)。治疗后3个月时,两组血清孕酮、卵泡刺激素水平上升,雌二醇、黄体生成素及催乳素水平降低,且试验组以上性激素指标改善程度均比对照组显著,差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 采用乳癖散结胶囊联合他莫昔芬方案治疗乳腺增生,能提升疾病治疗效果,减轻疼痛,改善性激素水平,并且安全性较高。

Objective To explore the efficacy and safety of Rupi Sanjie capsule combined with tamoxifen in treating mammary hyperplasia.Methods Sixty patients with breast hyperplasia treated in Linyi Cancer Hospital from April 2020 to December 2021were selected as the study objects and randomly divided into control group and experimental group,with 30 cases in each group.The control group was treated with tamoxifen alone,and the experimental group was treated with tamoxifen + Rupi Sanjie capsule.The therapeutic effect of the two groups was compared.Results the effective rate reached 93.33% in the test group and 73.33% in the control group,with significant difference(χ^(2)=4.320,P=0.0380.05).After treatment,the VAS score of the test group(2.01±0.30) was lower than that of the control group(3.44±0.45),which was statistically significant(t=5.274,P=0.0170.05).At 3months after treatment,the serum levels of progesterone and FSH increased,and the levels of estradiol,luteinizing hormone and prolactin decreased in 2 groups,and the improvement degree of above sex hormone indexes in experimental group was significantly higher than that in control group,with statistical significance(P>0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P<0.05).Conclusion Rupi Sanjie capsule combined with tamoxifen in the treatment of breast hyperplasia can improve the therapeutic effect,relieve pain,improve sex hormone levels,and have high safety.