紫龙金联合埃克替尼治疗表皮生长因子受体突变阳性晚期肺腺癌的疗效分析

Zilongjin combined with Icotinib in treatment of epidermal growth factor receptor mutation advanced lung adenocarcinoma:A curative effect analysis

目的观察紫龙金联合埃克替尼治疗表皮生长因子受体(epidermal growth factor receptor,EGFR)突变阳性晚期肺腺癌患者的疗效。方法采用随机、对照的前瞻性研究方法。选取2017年12月—2020年7月在河北省人民医院就诊的EGFR突变阳性晚期肺腺癌患者80例,按随机数字表法分为对照组和观察组,每组40例。对照组给予盐酸埃克替尼片,服药至疾病进展或无法耐受;观察组在对照组基础上加用紫龙金片,共服用16周。2组均以2个月为1个周期。治疗2个周期后评价生活质量、近期疗效,比较癌灶面积、免疫功能、肿瘤标志物变化情况,观察不良反应,随访2组无进展生存期(progression free survival,PFS)。结果观察组卡氏表现状态评分总改善率为87.5%,明显高于对照组的65.0%(P<0.05)。对照组客观缓解率和疾病控制率分别为27.5%、57.5%,观察组分别为50.0%、80.0%,观察组均明显高于对照组(P<0.05)。观察组癌灶减小面积明显大于对照组(P<0.05)。观察组的CD3+、CD4+以及CD4+/CD8+均高于对照组,差异有统计学意义(P<0.05)。2组患者癌胚抗原(carcino-embryonic antigen,CEA)、糖类抗原-125(carbohydrate antigen-125,CA125)、细胞角蛋白19片段(cytokeratin-19-fragment,Cyfra21-1)水平均较治疗前有所下降,并且治疗后观察组明显低于对照组(P<0.05)。观察组腹泻、皮疹、肝损伤发生率均低于对照组(P<0.05)。对照组与观察组的中位PFS分别为8个月和10个月,二者比较差异有统计学意义(P<0.05)。结论紫龙金与埃克替尼联合用于EGFR突变阳性晚期肺腺癌有延长PFS的趋势,可显著改善患者症状,提高免疫力及生活质量,同时可减少不良反应的发生。

Objective To evaluate the clinical efficacy of Zilongjin(紫龙金)combined with Icotinib in treatment of epidermal growth factor receptor(EGFR)mutation advanced lung adenocarcinoma.Methods By randomized,controlled,prospective clinical research methods,80 patients with EGFR mutation advanced NSCLC in Hebei General Hospital from December 2017 to July 2020 were randomly assigned to the control group and the observation group,40 patients in each group.Patients in the control group took Icotinib.Patients were treated with Zilongjin in the observation group based on the control group,a total of 16 weeks.Each group took two months as a cycle.After treated for two cycles,the quality of life,the short-term efficacy,the area of cancer focal area,immune function,tumor markers and toxicity were evaluated.Followed up progression free survival(PFS)in two groups were evaluated.Results Total improvement rate of KPS score in the control and observation group were 65.0%and 87.5%,respectively,and there was statistical significance between the two groups(P<0.05).Objective response rate in the control and observation group were 27.5%and 50.0%,respectively,disease control rate in the control and observation group were 57.5%and 80.0%,respectively,and there were statistical significance between the two groups(P<0.05).The reduction area of cancer focus of the observation group was significantly larger than that in the control group(P<0.05).CD3+,CD4+and CD4+/CD8+in the observation group were higher than those in the control group(P<0.05).CEA,CA125 and Cyfra21-1 in the two groups decreased compared with before treatment,and the observation group was significantly lower than the control group,with statistical significance(P<0.05).The incidences of diarrhea,skin rash and liver injury in the observation group were lower than the control group,with a statistically significant difference(P<0.05).The median PFS in the in the control and observation group were eight months and 10 months,respectively,with a statistically significant difference(P<0.05).Conclusion Zilongjin combined with Icotinib has the tendency to prolong the PFS in treatment of EGFR mutation advanced lung adenocarcinoma,which can significantly improve the symptoms,immunity and the quality of life,and reduce serious adverse events.