艾愈胶囊联合ET方案治疗三阴乳腺癌的临床研究

Clinical study of Aiyu Capsules combined with ET regimen in treatment of triple negative breast cancer

目的探讨艾愈胶囊联合ET方案(多西他赛注射液和盐酸表柔比星注射液)治疗三阴乳腺癌临床疗效。方法选取2015年7月—2017年8月中国医科大学肿瘤医院收治的96例三阴乳腺癌患者为研究对象,患者根据治疗方式的不同分为对照组(48例)和治疗组(48例)。对照组在第1天静脉滴注多西他赛注射液,75 mg/m2与生理盐水500 mL溶解;同时静脉滴注盐酸表柔比星注射液,80 mg/m2与生理盐水500 mL溶解。治疗组在对照组治疗的基础上口服艾愈胶囊,3粒/次,3次/d。21 d为1个疗程,两组患者均治疗4个疗程。观察两组患者的近期疗效,同时比较两组治疗前后的SF-36评分、血清可溶性Fas(sFas)、雌二醇(E2)、促卵泡生长激素(FSH)水平和毒副作用发生情况。结果治疗后,对照组和治疗组临床总有效率分别为64.58%、81.25%,疾病控制率分别为72.92%、87.50%,两组临床疗效比较差异有统计学意义(P<0.05)。治疗后,两组患者的生理职能、躯体功能、躯体疼痛、生命活力、生理健康、睡眠质量评分均明显上升,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组SF-36评分均明显高于对照组,两组比较差异具有统计学意义(P<0.05)。两组患者血清sFas、E2水平均明显下降,FSH水平明显上升,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组血清sFas水平低于对照组,两组比较差异具有统计学意义(P<0.05),血清E2、FSH水平比较均无差异。治疗后,治疗组白细胞减少发生率显著低于对照组,两组比差异具有统计学意义(P<0.05)。结论艾愈胶囊联合ET方案治疗三阴乳腺癌的临床疗效显著,可有效的提高患者生活质量,抑制血清sFas水平,具有一定的临床应用价值。

Objective To investigate the clinical effect of Aiyu Capsules combined with ET regimen(Docetaxel Injection and Epirubicin Hydrochloride Injection) in treatment of triple negative breast cancer. Methods Women(96 cases) with triple negative breast cancer in Cancer Hospital of China Medical University from July 2015 to August 2017 were randomly divided into control(48 cases) and treatment(48 cases) groups, according to different treatment methods. Women in the control group were iv administered with Docetaxel Injection at the first day, 75 mg/m^2 dissolved with normal saline 500 mL, then were iv administered with Epirubicin Hydrochloride Injection, 80 mg/m^2 dissolved with normal saline 500 m L. Women in the treatment group were po administered with Aiyu Capsules on the basis of the control group, 3 grains/time, three times daily. A course had 21 d, and Women in two groups were treated for 4 courses. After treatment, the short-term efficacy was evaluated, and SF-36 scores, the levels of sFas, E2, and FSH, toxic and side effect in two groups before and after treatment were compared. Results After treatment, the clinical efficacy rates in the control and treatment groups were 64.58% and 81.25%, respectively, and disease control rates in the control and treatment groups were 72.92% and 87.50%, respectively, and there was difference between two groups(P < 0.05). After treatment, the physiological functions, physical function, body pain, life, physical health, sleep quality scores in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05). After treatment, the SF-36 scores in the treatment group were significantly higher than those in the control group, with significant difference between two groups(P < 0.05). After treatment, the levels of sFas and E2 in two groups were significantly decreased, but the levels of FSH in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05). After treatment, s Fas levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups(P < 0.05), but the E2 and FSH levels had no difference between two groups. After treatment, the incidence of leukocyte reduction in the treatment group were significantly lower than those in the control group, there was difference between two groups(P < 0.05).Conclusion Aiyu Capsules combined with ET regimen has clinical curative effect in treatment of triple negative breast cancer, can effectively improve the quality of life of patients, and inhibit the level of serum sFas, which has a certain clinical application value.