摘要目的:探讨国产吉非替尼与原研吉非替尼在表皮生长因子受体（EGFR）敏感突变的晚期非小细胞肺癌（Ⅲ B、Ⅳ期）一线治疗中的效果差异。 方法:选取山东省德州市人民医院2017年1月至2019年7月治疗的91例EGFR敏感突变的晚期非小细胞肺癌患者，采用随机数字表法分为观察组（47例）和对照组（44例）。观察组采用国产吉非替尼治疗，对照组采用原研吉非替尼治疗。比较两组的治疗效果、不良反应、生存情况、治疗费用等指标。结果:观察组和对照组的客观缓解率分别为91.5%（43／47）、84.1%（37／44），疾病控制率分别为100.0%（47／47）、97.7%（43／44），差异均无统计学意义（ χ2＝2.708， P＝0.224； χ2＝1.080， P＝0.484）。观察组和对照组中位无进展生存（PFS）时间分别为13.26个月（95% CI 11.34～14.66个月）和13.19个月（95% CI 12.52～15.48个月），差异无统计学意义（ P＝0.735）；亚组分析显示，观察组和对照组第19号外显子缺失突变患者中位PFS时间分别为12.98个月（95% CI 11.25～14.75个月）和13.89个月（95% CI 12.04～15.96个月），差异无统计学意义（ P＝0.604）；观察组和对照组第21号外显子L858R错义突变的患者中位PFS时间分别为15.08个月（95% CI 11.79～18.21个月）和11.94个月（95% CI 9.20～14.79个月），差异无统计学意义（ P＝0.114）。两组患者皮疹、腹泻、间质性肺炎、口腔黏膜炎、恶心呕吐、骨髓抑制、氨基转移酶异常等不良反应发生率差异均无统计学意义（均 P>0.05）。观察组患者治疗期间的治疗费用为（2 118.43±137.93）元／月，对照组为（5 945.48±247.48）元／月，差异有统计学意义（ t＝12.854， P＝0.001）。 结论:国产吉非替尼治疗EGFR敏感突变晚期非小细胞肺癌的疗效与原研吉非替尼相当，不良反应发生情况相近，且国产吉非替尼更经济，可大幅减轻患者经济负担，可作为EGFR敏感突变晚期非小细胞肺癌患者一线治疗的重要选择。

abstractsObjective:To investigate the efficacy differences between domestic gefitinib and original gefitinib in the first-line treatment of patients with epidermal growth factor receptor (EGFR) sensitive mutation advanced non-small cell lung cancer (NSCLC) (stage Ⅲ B and Ⅳ). Methods:A total of 91 cases with EGFR sensitive mutation advanced NSCLC in Dezhou People's Hospital of Shandong Province from January 2017 to July 2019 were selected and were randomly divided into the observation group (47 cases) and the control group (44 cases) according to random number table method. The observation group was given the treatment of domestic gefitinib, and the control group was given the treatment of original gefitinib, and then the treatment outcome, adverse reactions, survival status and the cost of two groups were compared.Results:The objective response rate in the observation group and the control group was 91.5% (43/47) and 84.1% (37/44), respectively; the disease control rate in the observation group and the control group was 100.0% (47/47) and 97.7% (43/44), respectively; and the differences were not statistically significant ( χ2 = 2.708, P = 0.224; χ2 = 1.080, P = 0.484). The median progression-free survival (PFS) time of domestic gefitinib group and original gefitinib group was 13.26 months (95% CI 11.34-14.66 months) and 13.19 months (95% CI 12.52-15.48 months), respectively, and the difference was not statistically significant ( P = 0.735). The subgroup analysis showed that the median PFS time of patients with an exon 19 deletion mutation in the observation group and the control group was 12.98 months (95% CI 11.25-14.75 months) and 13.89 months (95% CI 12.04-15.96 months), respectively, and the difference was not statistically significant ( P = 0.604). The median PFS time of patients with an exon 21 L858R missense mutation in the observation group and the control group was 15.08 months (95% CI 11.79-18.21 months) and 11.94 months (95% CI 9.20-14.79 months), and the difference was not statistically significant ( P = 0.114). There was no statistically difference in the incidence of adverse reactions including skin rash, diarrhea, interstitial pneumonia, oral mucositis, nausea and vomiting, myelosuppression, abnormal aminotransferase of the two groups of patients (all P > 0.05). The treatment cost in the observation group and the control group during the treatment period was (2 118.43±137.93) yuan per month and (5 945.48±247.48) yuan per month, respectively, and the difference was statistically significant ( t = 12.854, P = 0.001). Conclusions:Domestic gefitinib and original gefitinib have the same therapeutic efficacy in the treatment of EGFR sensitive mutation advanced NSCLC. The adverse reactions are similar between domestic gefitinib and original gefitinib. Compared with the original gefitinib, the drug economy of domestic gefitinib is better and it can significantly reduce the financial burden of patients, and it can be used as an important option in the first-line treatment of patients with EGFR sensitive mutation advanced NSCLC.