参一胶囊联合吉非替尼治疗晚期非小细胞肺癌50例临床研究

目的 观察参一胶囊联合吉非替尼治疗晚期非小细胞肺癌的临床疗效.方法 将经化疗失败的Ⅲb-Ⅳ期非小细胞肺癌患者100例随机分为治疗组和对照组各50例,对照组口服吉非替尼每次250mg,每日1次；治疗组在此基础上口服参一胶囊每次20mg,每日2次.治疗60天后评价近期疗效、生活质量和不良反应,观察疾病无进展生存期(PFS).结果 治疗组肿瘤治疗有效率为26.53％,控制率为59.18％;对照组分别为22.92％和50.0％,两组比较差异无统计学意义(P＞0.05)；治疗组中位疾病PFS为(132.00±6.22)天,对照组(112.00±9.39)天,治疗组优于对照组(P=0.037);治疗组生活质量改善率为91.84％,对照组为66.67％,治疗组优于对照组(P＜0.05);治疗组腹泻发生率低于对照组(P＜0.01).治疗组Ⅲ-Ⅳ级皮疹、恶心呕吐、肝功能异常发生率低于对照组,但两组比较差异无统计学意义(P＞0.05).结论 吉非替尼联合参-胶囊治疗晚期非小细胞肺癌疗效优于单药吉非替尼,可延长治疗获益患者的疾病PFS.

Clinical Research on Shenyi Capsule Combined with Gefitinib for Advanced Non-Small Cell Lung Cancer: A Report of 50 Cases

Objective To observe the therapeutic effect of Shenyi Capsule(capsule of ginsenoside) combined with gefitinib on advanced non-small cell lung cancer (NSCLC).Methods Totally 100 NSCLC patients who failed in chemotherapy in the Ⅲb-Ⅳ stage were randomized into treatment group and control group with 50 cases in each.Gefitinib 250mg,once daily was given to the control group and Shenyi Capsule 20mg,twice daiyly was added to the treatment group.Sixty days later,the short-term effect,quality of life (QOL) and adverse reactions were observed.Progression-free survival(PFS) was observed according to 2 years of follow-up.Results The effective rate including complete remission(CR) and partial remission(PR) of the treatment group and the control group was 26.53% and 22.92% respectively.The control rate including CR,PR and stable disease(SD) of the treatment group and the control group was 59.18% and 50% respectively.There was no significant difference between groups(P>0.05).The median PFS was 132.00±6.22 and 112.00±9.39 days in the treatment group and the control group respectively, with significant difference(P=0.037).The improvement rate of QOL was 91.8 4% and 66.67% in the treatment group and the control group respective ly,with significant difference(P<0.05).The incidence of diarrhea in the treatment group was significantly lower than that in the control group(P<0.01). The incidence of grade Ⅲ-Ⅳ rash,nausea,vomiting and abnormal liver function in the treatment group was lower as compared with the control group,but the differ ence between was not statistically significant.Conclusion The therapeutic effect of Shenyi Capsule combined with gefinitib for advanced NSCLC is superior to that of single-agent treatment with gefinitib,especially prolonging the PFS of p atients benefited from gefinitib.