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目的观察扶正抗癌方联合吉非替尼治疗晚期非小细胞肺癌(NSCLC)优势人群与非优势人群的有效性和安全性。方法共纳入晚期NSCLC患者70例,均经病理组织学或细胞学检查确诊,其中49例完全符合优势人群的标准,即东方人种、女性、腺癌和非吸烟者;21例不符合者作为非优势人群。均接受扶正抗癌方(250 ml,qd)联合吉非替尼(250 mg,qd)治疗。结果 49例优势人群患者中CR 0例,达到PR 16例(32.7%),SD 30例(61.2%),PD 3例(6.1%),ORR为32.7%,DCR为93.9%;中位疾病无进展生存时间(PFS)8.2个月,治疗后中位生存期9.9个月。21例非优势人群患者中CR 0例,达到PR 5例(23.8%),SD 9例(42.9%),PD 7例(33.3%),ORR为23.8%,DCR为66.7%;中位疾病无进展生存时间(PFS)4.6个月,治疗后中位生存期7.9个月。二者有统计学差异。一线治疗时,优势人群及非优势人群的客观缓解率一致,均为21.4%。毒副反应较轻,耐受性可,大部分为1~2级,经对症治疗后症状缓解,不影响治疗。结论扶正抗癌方联合吉非替尼治疗晚期非小细胞肺癌优势人群优于非优势人群。对于非优势人群,扶正抗癌方对吉非替尼可能有一定的增敏作用,值得进一步研究。
Objective To observe the effectiveness and safety of Fuzheng anticancer drug combined with gefitinib in the treatment of advanced and non-predominant population of advanced non-small cell lung cancer (NSCLC). Methods A total of 70 patients with advanced NSCLC were enrolled in this study. All of them were diagnosed by histopathology or cytology. Among them, 49 patients were fully matched to the predominant population, that is, ethnic group, female, adenocarcinoma and non-smoker; 21 patients who did not meet the criteria Non-dominant population. All patients received Fuzheng Kangai Fang (250 ml, qd) combined with gefitinib (250 mg, qd). Results CR was found in 49 patients with predominant disease (PR 16 cases (32.7%), SD 30 cases (61.2%), PD 3 cases (6.1%), ORR 32.7% and DCR 93.9% The median survival time (PFS) was 8.2 months, and the median survival time after treatment was 9.9 months. In 21 non-predominant patients, there were 0 cases of PR, 5 cases of PR (23.8%), 9 cases of SD (42.9%), 7 cases of PD (33.3%), ORR of 23.8% and DCR of 66.7% Duration of progression (PFS) 4.6 months, median survival after treatment 7.9 months. There are statistical differences between the two. The first-line treatment, the dominant and non-dominant population objective response rates were the same, were 21.4%. Toxicity mild, tolerable, most of 1 to 2, after symptomatic treatment of symptoms, does not affect the treatment. Conclusion Fuzheng anti-cancer combined with gefitinib treatment of advanced non-small cell lung cancer is superior to non-dominant population advantages. For non-dominant populations, Fuzheng anti-cancer side of gefitinib may have some sensitizing effect, it is worth further study.