榄香烯注射液联合曲妥珠单抗治疗局部晚期乳腺癌的临床研究

Clinical study on Elemene Injection combined with trastuzumab in treatment of locally advanced breast cancer

目的探讨榄香烯注射液联合曲妥珠单抗治疗局部晚期乳腺癌的临床疗效。方法选取2016年2月—2017年5月在海南医学院第一附属医院治疗的局部晚期乳腺癌患者72例,随机将患者分为对照组(36例)和治疗组(36例)。对照组静脉滴注注射用曲妥珠单抗,首剂量8 mg/kg加入500 m L生理盐水,维持剂量6 mg/kg,1次/21 d。治疗组在对照组基础上经股动脉穿刺注入榄香烯注射液,100 m L/次,1次/7 d。3周为1个疗程,两组均治疗4个疗程。评价两组患者临床疗效,同时比较治疗前后两组患者QLQ-C30评分和血清学指标。结果治疗后,对照组客观缓解率为33.33%,疾病控制率为63.89%均分别显著低于治疗组的55.56%和83.33%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组QLQ-C30评分均明显升高,同组比较差异具有统计学意义(P<0.05);且治疗组QLQ-C30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CA125、CA153、肿瘤特异生长因子(TSGF)水平均显著降低,干扰素-γ(IFN-γ)和IL-2水平显著升高,同组比较差异具有统计学意义(P<0.05);且治疗组上述血清学指标治疗后水平明显优于对照组,两组比较差异具有统计学意义(P<0.05)。结论榄香烯注射液联合曲妥珠单抗治疗局部晚期乳腺癌可有效改善机体细胞因子水平,利于改善患者生活质量,具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Elemene Injection combined with trastuzumab in treatment of locally advanced breast cancer. Methods Patients（72 cases） with locally advanced breast cancer in the First Affiliated Hospital of Hainan Medical University from February 2016 to May 2017 were randomly divided into control（36 cases） and treatment（36 cases） groups. Patients in the control group were iv administered with Trastuzumab Injection, the first dose was 8 mg/kg, and it was added into normal saline 500 m L, and the maintenance dose was 6 mg/kg, once every 21 d. Patients in the treatment group were puncture injection administered with Elemene Injection via femoral artery on the basis of the control group, 100 m L/time, once every 7 d. 3 weeks as a course of treatment, and patients in two groups were treated for 4 courses of treatment. After treatment, the clinical efficacy was evaluated, and the QLQ-C30 scores and the serological indexes in two groups before and after treatment were compared. Results After treatment, the objective remission rate in the control group was 33.33%, and the disease control rate was 63.89%, which were significantly lower than 55.56% and 83.33% in the treatment group, respectively, and there were differences between two groups（P〈0.05）. After treatment, the QLQ-C30 scores in two groups were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. And the QLQ-C30 scores in the treatment group after treatment were significantly higher than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the CA125, CA153 and TSGF levels in two groups were significantly decreased, but IFN-γ and IL-2 levels were significantly increased, and there were differences in the same group（P〈0.05）. And the serological indexes in the treatment group after treatment were significantly better than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Elemene Injection combined with trastuzumab in treatment of locally advanced breast cancer can effectively improve the cytokine level and the quality of life, which has a certain clinical application value.