Objective:To observe the effect of compound Kushen injection combined with lapatinib treatment of Her －2 positive ad－vanced breast cancer of and effect on tumor markers.Methods:A total of 65 cases of breast cancer of Her－2 positive stage Ⅳ in our hospital from May 2013 to June 2017 were randomly selected and divided into observation group and control group according to ran －dom numbers.The control group was given lapatinib tablets for oral treatment , and the observation group was given compound Kushen injection vein infusion therapy.The clinical efficacy, quality of life of the two groups , the incidence of adverse reaction , tumor markers, tumor specific markers of breast cancer were analyzed respectively before treatment and after 18 weeks of treat－ment.Results:After 18 weeks, 1) the total effective rate of control group was 69.70%, and the total efficiency of observation group was 87.50%.The observation group was better than the control group (P＜0.05); 2) After treatment, KPS scores of two groups were significantly increased , and ECOG score was significantly lower (P＜0.05).The observation group was better than the control group ( P＜0.05); 3) CEA, CA153 and CA125 of two groups after treatment were lower than before treatment ( P＜0.05).TK1 and IGF－1 expression were down regulated (P＜0.05), and the observation group was better than the control group (P＜0.05); 4) After treatment, the expression of CD3 +, CD4 +, CD4 +/CD8 +and CD69 in the peripheral blood of the observa－tion group was higher than that of the control group , and the CD8 +was lower than that of the control group.The difference was sta－tistically significant (P＜0.05).(5) The results of comparison in the adverse reactions rate of the two groups showed that the ad －verse reaction rate of heart, liver, gallbladder, infection, skin, pain and lung in the observation group was lower than the control group (P＜0.05).Conclusion:Compound Kushen injection combined with lapatinib has better clinical efficacy in patients with Her－2 positive advanced breast cancer , and may reduce the tumor markers of breast cancer and tumor specific markers related to the expression, so as to improve the quality of life of patients.The mechanism of its action may be related to the improvement of cellular immunity.%目的:观察复方苦参注射液联合拉帕替尼治疗Her－2阳性晚期乳腺癌疗效及对肿瘤标志物的影响.方法:选取2013年5月至2017年6月辽宁中医药大学附属第二医院门诊及住院部就诊的Her－2阳性Ⅳ期的乳腺癌患者65例,按随机编号随机分为观察组和对照组,对照组使用拉帕替尼片口服治疗,观察组加以复方苦参注射液静脉滴注治疗,分别在治疗前及治疗18周后,对2组的临床疗效、生命质量、不良反应发生率、广谱肿瘤标志物、乳腺癌特异性肿瘤标志物进行比较分析.结果:在治疗18周后,对照组患者的总有效率为69.70%,观察组患者的总有效率为87.50%,观察组的优于对照组(P＜0.05);治疗后,2组患者的KPS评分均明显升高,ECOG 评分明显降低(P＜0.05),且观察组优于对照组(P＜0.05);2组患者CEA、CA153、CA125治疗后均较治疗前下降(P＜0.05),TK1和IGF－1表达均下调(P＜0.05);其中观察组优于对照组(P＜0.05);治疗后观察组外周血CD3 +、CD4 +、CD4 +/CD8 +、CD69表达高于对照组,CD8 +低于对照组,差异均有统计学意义(P＜0.05).观察组心脏、肝胆、感染、皮肤、疼痛和肺部的不良反应率均较对照组低(P＜0.05).结论:复方苦参注射液联合拉帕替尼对Her－2阳性晚期乳腺癌患者具有较佳的临床疗效,可降低广谱肿瘤标志物及乳腺癌特异性肿瘤标志物的表达,从而提高患者的生命质量,其作用机制可能与改善机体细胞免疫有关.
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