清肺化瘀解毒方治疗非小细胞肺癌吉非替尼获得性耐药临床疗效观察

Clinical effect of acquired resistance to gefitinib in non-small cell lung cancer treated by Qingfei Huayu Jiedu Formula

目的:观察清肺化瘀解毒方对吉非替尼耐药非小细胞肺癌患者的疗效,探索延缓或克服吉非替尼获得性耐药的新的治疗策略。方法:60例吉非替尼耐药肺癌患者随机分为对照组和观察组,每组30例,对照组采用吉非替尼治疗,观察组在对照组基础上服用清肺化瘀解毒方治疗,30 d为1个疗程,持续治疗至病情进展、患者死亡或自行停药。比较两组患者的近期疗效、远期疗效、一年存活率及不良反应。结果:观察组客观缓解率[ORR,46.7%(14/30)]和疾病控制率[DCR,83.3%(25/30)]显著高于对照组[ORR为23.3%(7/30),DCR为36.7%(11/30)](P<0.05);观察组中位无进展生存期(PFS)为10.6个月,中位总生存期(OS)为11.7个月,显著高于对照组(中位PFS为3.8个月,中位OS为6.4个月)(P<0.05);观察组一年存活率为60.0%(18/30),显著高于对照组的23.3%(7/30)(P<0.05);观察组Ⅱ度以上皮疹发生率为23.3%(7/30)显著低于对照组的76.7%(23/30)(P<0.05)。结论:肺癌患者吉非替尼耐药后采用清肺化瘀解毒方联合吉非替尼治疗可延缓疾病进展。

Objective:To observe the efficacy of Qingfei Huayu Jiedu Formula on gefitinib resistance of patients with non-small cell lung cancer,and explore the new therapeutic strategies to delay or overcome gefitinib acquired resistance.Methods:A total of 60 cases of lung cancer patients with gefitinib resistance were randomly divided into observation group and control group,30 cases in each group,the control group was treated with gefitinib,while the observation was treated with Qingfei Huayu Jiedu Formula combined with gefitinib,30 days as one course of treatment,the treatment was continued except for progressing in to the disease,having intolerable side effects,death or quiting voluntarily.The short-term effect,long-term effect,one year survival rate and adverse reactions of two groups were compared.Results:The objective response rate[ORR,46.7%(14/30)]and disease control rate[DCR,83.3%(25/30)]of the observation group were significantly higher than that of the control group[ORR,23.3%(7/30),DCR,36.7%(11/30)],the difference was statistically significant(P<0.05);The median PFS(10.6 months)and median OS(11.7 months)of the observation group significantly greater than the control group(median PFS=3.8 months,the median OS=6.4 months)(P<0.05);The one year survival rate of observation group was 60.0%(18/30),which was significantly higher than that of the control group(23.3%,7/30),statistically significant differences(P<0.05);The rash occurrence rate above degreeⅡof observation group(23.3%,7/30)was significantly lower than the control group(76.7%,23/30)(P<0.05).Conclusion:The Qingfei Huayu Jiedu Formula combined with gefitinib treatment can delay the progression of the disease of lung cancer patients with gefitinib acquired resistance,Qingfei Huayu Jiedu Formula had the effect of reversing gefitinib resistance.