扶正化痰方联合EGFR-TKI治疗晚期肺腺癌的疗效研究

Effect of Fuzheng Huatan decoction combined with EGFR-TKI on patients with advanced lung adenocarcinoma

目的分析扶正化痰方联合表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)对晚期EGFR敏感突变肺腺癌患者的疗效,探讨扶正化痰方的增效减毒作用,评估该药对患者预后的影响。方法选择济宁市第一人民医院自2017年7月至2019年12月初始治疗的ⅢB期或Ⅳ期肺腺癌伴EGFR敏感突变患者78例(治疗组40例、对照组38例)。其中男36例,女42例,年龄(60.65±12.12)岁,治疗前卡式功能状态量表(KPS)评分(63.84±15.30)分。治疗方案:对照组给予EGFR-TKI靶向药物治疗;治疗组给予靶向治疗联合扶正化痰方。观察指标:比较两组客观缓解率(ORR)、无疾病进展生存期(PFS)、KPS评分、不良反应。采用独立样本t检验、χ2检验、Fisher确切概率法、Kaplan-Meier法。结果(1)疗效:两组患者ORR、PFS差异均无统计学意义[82.50%(33/40)比81.57%(31/38),(10.86±2.60)个月比(10.08±1.56)个月](均P>0.05)。(2)不良反应:治疗组与对照组比较,肝损害、皮疹、腹泻、间质性肺炎、口腔黏膜炎发生率较低,但差异均无统计学意义(均P>0.05)。(3)治疗组KPS评分改善比例明显较对照组高[77.50%(31/40)比55.26%(21/38),P<0.05]。结论扶正化痰方联合EGFR-TKI治疗晚期肺腺癌患者可提高患者生活质量,可能会减少不良反应的发生,但不能明显延长患者PFS。

Objective To analyze the efficacy of Fuzheng Huatan decoction combined with epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)in patients with advanced EGFR-sensitive mutant lung adenocarcinoma,to explore the synergistic and toxic attenuation effects of Fuzheng Huatan decoction,and to evaluate the influence of Fuzheng Huatan decoction on the patients'prognosis.Methods This study selected 78 patients with stage IIIB or IV EGFR gene mutation lung adenocarcinoma in Jining No.1 People's Hospital from July 2017 to December 2019,who were divided into a control group(38 cases)and an observation group(40 cases).Among them,there were 36 males and 42 females,aged(60.65±12.12)years,and the Karnofsky Performance Status(KPS)score before treatment was(63.84±15.30).The observation group was given EGFR-TKI combined with Fuzheng Huatan decoction,and the control group was given EGFR-TKI only.The objective response rate(ORR),progression-free survival(PFS),KPS score,and adverse reactions were compared between the two groups.Independent sample t test,χ^(2) test,Fisher exact probability method,and Kaplan-Meier method were used.Results(1)There were no statistically significant differences in the ORR and PFS between the two groups[82.50%(33/40)vs.81.57%(31/38),(10.86±2.60)months vs.(10.08±1.56)months](both P>0.05).(2)Compared with those in the control group,the incidences of liver damage,rash,diarrhea,interstitial pneumonia,and oral catarrh in the observation group were lower,but the differences were not statistically significant(all P>0.05).(3)The improvement rate of KPS score in the observation group was significantly higher than that in the control group[77.50%(31/40)vs.55.26%(21/38),P<0.05].Conclusion Fuzheng Huatan decoction combined with EGFR-TKI in the treatment of advanced EGFR mutant lung adenocarcinoma patients can improve their quality of life and may reduce the occurrence of adverse reactions,but can not significantly prolong their PFS.