贞芪扶正胶囊联合他莫昔芬治疗雌激素受体阳性乳腺癌的临床研究

目的探讨贞芪扶正胶囊联合枸橼酸他莫昔芬片治疗雌激素受体阳性乳腺癌的临床疗效。方法选取2016年1月—2017年7月河南科技大学第一附属医院收治的雌激素受体阳性乳腺癌患者86例为研究对象,按照随机数字表法将所有患者分为对照组和治疗组,每组各43例。对照组口服枸橼酸他莫昔芬片,10 mg/次,2次/d。治疗组在对照组基础上口服贞芪扶正胶囊,6粒/次,2次/d。两组患者均连续治疗12周。观察两组的临床疗效,比较两组的淋巴细胞、NK细胞和不良反应。结果治疗后,对照组和治疗组的有效率分别为32.56%、48.84%,两组有效率比较无明显差异。治疗后,对照组和治疗组的控制率分别为51.16%、72.09%,两组控制率比较差异具有统计学意义(P0.05)。治疗后,两组CD~(3+)、CD~(4+)、CD~(4+)/CD~(8+)、NK细胞水平均显著升高(P0.05),同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显高于对照组,两组比较差异具有统计学意义(P0.05)。治疗组不良反应中恶心、头痛和潮热例数较对照组少,两组比较差异有统计学意义(P0.05)。结论贞芪扶正胶囊联合枸橼酸他莫昔芬片治疗雌激素受体阳性乳腺癌具有较好的临床疗效,能改善免疫系统功能,安全性较好,具有一定的临床推广应用价值。

Clinical study on Zhenqi Fuzheng Capsules combined with tamoxifen in treatment of estrogen receptor positive breast cancer

Objective To investigate the clinical effect of Zhenqi Fuzheng Capsules combined with Tamoxifen Citrate Tablet in treatment of estrogen receptor positive breast cancer. Methods Patients (86 cases) with estrogen receptor positive breast cancer in the First Affiliated Hospital of Henan University of Science and Technology from January 2016 to February 2017 were randomly divided into control and treatment groups, and each group had 43 cases. Patients in the control group were po administered with Tamoxifen Citrate Tablets, 10 mg/time, twice daily. Patients in the treatment group were po administered with Zhenqi Fuzheng Capsules on the basis of the control group, 6 grains/time, twice daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical efficacies were evaluated, and lymphocytes, NK cells, and adverse reaction in two groups were compared. Results After treatment, the clinical efficacies rates in the control and treatment groups were 32.56% and 48.84%, respectively, and there was no difference between two groups. After treatment, the control rates in the control and treatment groups were 51.16% and 72.09%, respectively, and there was difference between two groups (P < 0.05). After treatment, the levels of CD³⁺, CD⁴⁺, CD⁴⁺/CD⁸⁺, and NK cells in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). And the observational indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P < 0.05). The incidence of nausea, headache, and hot flashes in two groups were difference between two groups (P < 0.05). Conclusion Zhenqi Fuzheng Capsules combined with Tamoxifen Citrate Tablets has clinical curative effect in treatment of estrogen receptor positive breast cancer, can improve immune system function, with good safety, which has a certain clinical application value.