注射用红花黄色素联合GP方案治疗中晚期乳腺癌的临床观察

Clinical Observation of Safflower Yellow for Injection Combined with GP Regimen for Middle-advanced Breast Cancer

目的:考察红花提取物联合GP(吉西他滨+顺铂)方案对中晚期乳腺癌的临床疗效及安全性。方法:98例中晚期乳腺癌患者按照随机数字表法分成研究组(A组)和对照组(B组),各49例。B组患者仅予以GP方案化疗,3周为1个疗程;A组患者采用GP方案化疗联合注射用红花黄色素100 mg静脉滴注,qd,2周为1个疗程。比较两组患者的临床疗效和治疗前后肿瘤坏死因子α(TNF-α)、血管内皮生长因子(VEGF)、基质金属蛋白酶2(MMP-2)、MMP-9等指标的变化差异,以及不良反应发生情况。结果:A组患者总有效率为83.7%,显著高于B组的63.3%,差异具有统计学意义(P<0.05)。治疗后,两组患者TNF-α、VEGF、MMP-2及MMP-9等指标均较治疗前显著降低,差异具有统计学意义(P<0.05),且A组降幅大于B组,差异具有统计学意义(P<0.05)。两组患者除恶心呕吐发生率比较差异无统计学意义外,A组患者白细胞计数降低、贫血、脱发、食欲下降、肝功能异常、腹泻等不良反应发生率均显著低于B组,差异具有统计学意义(P<0.05)。结论:对中晚期乳腺癌患者予以注射用红花黄色素联合GP化疗方案,可发挥红花提取物抗炎、促进血流灌注、抑制新生血管生成等功效,有效抑制病情发展、减轻化疗毒副反应。

OBJECTIVE：To investigate the clinical efficacy and safety of Safflower yellow for injection combined with GP（gemcitabine＋cisplatin）regimen for middle-advanced breast cancer.METHODS：98 patients with middle-advanced breast cancer were randomly divided into study group（group A）and control group（group B）,with 49 cases in each group.Group B was only treated with GP regimen,and its treatment course lasted for 3 weeks.Group A was treated with GP regimen combined with intravenous dripping of Safflower yellow for injection 100 mg,qd,and the treatment course lasted for 2 weeks.Clinical efficacy,the variance of TNF-α,VEGF,MMP-2,MMP-9 and other indexes were compared between 2 groups before and after treatment,and the occurrence of ADR were compared.RESULTS：The total effective rate of group A was 83.7%,which was significantly higher than63.3% of group B,with statistical significance（P〈0.05）.After treatment,TNF-α,VEGF,MMP-2,MMP-9 and other indexes were significantly lower than before,with statistical significance（P〈0.05）;the decrease of group A was more significant than those of group B,with statistical significance（P〈0.05）.Except that there was no statistically significant difference in the incidence of nausea and vomiting between 2 groups,the incidence of ADR as white blood cell count decreasing,anemia,hair loss,loss of appetite,abnormal liver function and diarrhea in group A were significantly lower than those in group B,with statistical significance（P〈0.05）.CONCLUSIONS：For patients with middle-advanced breast cancer,to adopt Safflower yellow for injection combined with GP regimen can bring the effects of Safflower yellow for injection,such as anti-inflammation,improving blood infusion and inhibiting the generation of new vessel.And it can effectively inhibit the development of disease and alleviate toxic and side effects of chemotherapy.