乌苯美司联合XEC化疗方案治疗三阴性乳腺癌的临床研究

Clinical study on ubenimex combined with XEC chemotherapy in treatment of triple negative breast cancer

目的探讨乌苯美司联合XEC化疗方案治疗三阴性乳腺癌患者的临床疗效及其对外周血T淋巴细胞亚群及血清骨桥蛋白(OPN)水平变化的影响。方法选取河南科技大学第一附属医院2015年6月—2017年1月收治的三阴性乳腺癌患者83例,随机分成对照组(41例)和治疗组(42例)。对照组患者给予XEC化疗方案治疗,第1天静脉滴注注射用环磷酰胺500 mg/m^2,同时静脉滴注注射用盐酸表柔比星100 mg/m^2,第1~14天口服卡培他滨片1 g/m^2,疗程为21 d。治疗组在对照组的基础上口服乌苯美司片,30 mg/次,1次/d,疗程为21 d。两组均持续治疗4个疗程。观察两组患者临床疗效,比较治疗前后两组患者SF-36评分、外周血T淋巴细胞亚群表达水平和OPN水平。结果治疗后,对照组和治疗组临床总有效率分别为75.61%、95.24%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组躯体疼痛、躯体功能、睡眠质量、生命活力、生理职能、心理健康等生活质量评分均显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗后治疗组生活质量评分显著高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者CD^(3+)、CD^(4+)、CD^(4+)/CD^(8+)水平均显著升高,CD^(8+)水平显著下降,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组T淋巴细胞亚群水平显著优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组血清OPN水平显著下降,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组血清OPN水平显著低于对照组,两组比较差异具有统计学意义(P<0.05)。结论乌苯美司联合XEC化疗方案治疗三阴性乳腺癌患者效果显著,可有效改善患者外周血T淋巴细胞亚群和血清OPN水平,且安全性较高,具有一定的临床推广应用价值。

Objective To investigate clinical effects of ubenimex combined with XEC chemotherapy in treatment of triple negative breast cancer, and study the influence on peripheral blood T lymphocyte subsets and serum OPN levels. Methods Patients（83 cases） with triple negative breast cancer in the First Affiliated Hospital of Henan University of Science and Technology from June 2015 to January 2017 were randomly divided into control（41 cases） and treatment（42 cases） groups. Patients in the control group were administered with XEC chemotherapy, they were iv administered with Cyclophosphamide for injection 500 mg/m^2 and Epirubicin Hydrochloride for injection 100 mg/m^2 on the first day, and they were po administered with Capecitabine Tablets 1 g/m^2 on 1 — 14 d. A course of treatment was 21 d. Patients in the treatment group were po administered with Ubenimex Capsules on the basis of the control group, 30 mg/time, once daily, and a course of treatment was 21 d. Patients in two groups were treated for 4 courses. After treatment, the clinical efficacy was evaluated, and the SF-36 score, T lymphocytes subset in peripheral blood, and OPN levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 75.61% and 95.24%, respectively, and there were differences between two groups（P〈0.05）. After treatment, the indicators of body pain, physical function, sleep quality, life vitality, role physical, and mental health scores in two groups were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. And these scores in the treatment group were obviously higher than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the CD^（3＋）, CD^（4＋） and CD^（4＋）/CD^（8＋） levels in two groups were significantly increased, but CD^（8＋） level was significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the T lymphocytes subset in peripheral blood levels in the treatment group were more significantly better than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the serum OPN levels in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the serum OPN levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Ubenimex combined with XEC chemotherapy has good effect in treatment of triple negative breast cancer, and can effectively improve the peripheral blood T lymphocyte subsets and serum OPN levels with higher safety, which has a certain clinical application value.