散结消癖汤联合枸橼酸他莫昔芬片治疗肝郁痰凝型乳腺增生病临床研究

Clinical Study on Sanjie Xiaopi Decoction Combined with Tamoxifen Citrate Tablets for Mammary Gland Hyperplasia of Liver Constraint and Phlegm Coagulation Type

目的:观察散结消癖汤联合枸橼酸他莫昔芬片治疗肝郁痰凝型乳腺增生病患者的临床疗效。方法:按随机数字表法将80例女性肝郁痰凝型乳腺增生病患者分为联合组与对照组各40例,对照组给予枸橼酸他莫昔芬片治疗,联合组予散结消癖汤联合枸橼酸他莫昔芬片治疗。2组均连续治疗2个疗程。治疗前后评定中医证候评分、乳房肿块评分(包含肿块大小、肿块范围和肿块质地3项评分指标)、乳房疼痛评分[视觉模拟评分法(VAS)评分],检测内分泌激素指标[雌二醇(E_(2))、黄体生成素(LH)、孕酮(P)、催乳素(PRL)]。比较2组临床疗效。观察并记录治疗过程中不良反应的发生情况。结果:治疗后,联合组总有效率高于对照组(P<0.05)。2组乳房胀痛、善郁易怒、胸闷胁胀、心烦、口苦、失眠多梦评分均较治疗前降低(P<0.05),联合组上述6项评分均低于对照组(P<0.05)。2组乳房肿块大小、肿块范围、肿块质地评分及乳房疼痛VAS评分均较治疗前降低(P<0.05),联合组4项评分均低于对照组(P<0.05)。2组血清E_(2)、LH、PRL水平均较治疗前降低(P<0.05),血清P水平均较治疗前升高(P<0.05);联合组血清E_(2)、LH、PRL水平均低于对照组(P<0.05),血清P水平高于对照组(P<0.05)。2组患者在治疗期间均未见明显不良反应。结论:散结消癖汤联合枸橼酸他莫昔芬片治疗肝郁痰凝型乳腺增生病患者疗效更佳,能有效软化、消散乳房肿块,减轻乳房疼痛与相关症状,调节内分泌激素水平,且安全性较高。

Objective:To observe the clinical effect of Sanjie Xiaopi Decoction combined with Tamoxifen Citrate Tablets on patients with mammary gland hyperplasia of liver constraint and phlegm coagulation type.Methods:A total of 80 cases of female patients with mammary gland hyperplasia of liver constraint and phlegm coagulation type were divided into the combination group and the control group according to the random number table method,with 40 cases in each group.The control group was treated with Tamoxifen Citrate Tablets,and the combination group was treated with Sanjie Xiaopi Decoction combined with Tamoxifen Citrate Tablets.Both groups were continuously treated for two courses.Traditional Chinese medicine(TCM)syndrome scores,breast lump scores(including three scoring indicators:the size,range,and texture of lumps),and breast pain scores[Visual Analogue Scale(VAS)score]were evaluated before and after treatment.Endocrine hormone indicators[estradiol(E_(2)),luteinizing hormone(LH),progesterone(P),and prolactin(PRL)]were detected.Clinical effects were compared between the two groups.Adverse reactions during treatment were observed and recorded.Results:After treatment,the total effective rate in the combination group was higher than that in the control group(P<0.05).The scores of breast tenderness,the tendency to depression and irascibility,chest oppression and rib-side distension,vexation,bitter taste,and insomnia and profuse dreaming in the two groups were decreased when compared with those before treatment(P<0.05),and the above six scores in the combination group were lower than those in the control group(P<0.05).The scores of size,range,and texture of breast lumps,as well as VAS scores of breast pain in the two groups were decreased when compared with those before treatment(P<0.05),and the above four scores in the combination group were lower than those in the control group(P<0.05).The levels of E_(2),LH,and PRL in serum in the two groups were declined when compared with those before treatment(P<0.05),and serum P levels were increased when compared with those before treatment(P<0.05);the levels of E_(2),LH,and PRL in serum in the combination group were lower than those in the control group(P<0.05),and serum P level in the combination group was higher than that in the control group(P<0.05).No obvious adverse reaction occurred in the two groups during treatment.Conclusion:Sanjie Xiaopi Decoction combined with Tamoxifen Citrate Tablets has better curative effects in the treatment of patients with mammary gland hyperplasia of liver constraint and phlegm coagulation type,which can effectively soften and dissipate breast lumps,alleviate breast pain and related symptoms,and regulate hormone levels,with high safety.