国产与进口吉非替尼治疗晚期非小细胞肺癌疗效的对比研究

Effective comparison of domestic and imported gefitinib in the treatment of advanced non-small cell lung cancer

目的:比较国内仿制吉非替尼与原研吉非替尼治疗晚期非小细胞肺癌EGFR突变阳性患者的临床疗效。方法:选择2017年3月到2017年7月之间在吉林省内5家医院就诊的60例非小细胞肺癌EGFR突变阳性患者(使用仿制吉非替尼)作为观察组,选择同时间段内在相同医院就诊的60例非小细胞肺癌EGFR突变阳性患者(使用原研吉非替尼)作为对照组,对治疗的效果进行对比。结果:两组患者完成3个月治疗的治疗效果、治疗有效率和疾病控制率数据差异均不具有统计学意义(P>0.05);在两组患者的不良反应情况中,各项数据差异均不具有统计学意义(P>0.05);两组患者生活质量变化程度比较,数据差异不具有统计学意义(P>0.05);对照组患者的无进展生存时间中位数为9.986个月,观察组患者的无进展生存时间中位数为10.973个月;对照组患者的总生存时间中位数为11.981个月,观察组患者的总生存时间中位数为10.969个月,数据差异不具有统计学意义(P>0.05);对照组患者治疗期间的费用为(7070.69±536.89)元/月,观察组患者治疗期间的费用为(4860.53±322.81)元/月,数据差异具有统计学意义(P<0.05)。结论:利用国内仿制吉非替尼治疗晚期非小细胞肺癌EGFR突变阳性患者,可以取得与原研药较为类似的近期与远期治疗效果,但是患者的费用降低,值得在临床工作中推广使用。

Objective:To compare the effect of imitation gefitinib and original gefitinib in the treatment of advanced non-small cell lung cancer EGFR mutation-positive patients. Methods:Sixty non-small cell lung cancer EGFR mutation-positive patients(using imitation gefitinib) from 5 hospitals in Jilin Province between March2017 and July2017 were selected as observation group.Sixty non-small cell lung cancer EGFR mutation-positive patients(using the original gefitinib) in the same hospital at the same time were selected as the control group.Compare the effects of treatment. Results:There was no statistically significant difference in the treatment efficiency and disease control rate between the two groups ( P >0.05).In the adverse reactions of the two groups of patients,the data were not statistically significant( P >0.05).There was no statistically significant difference in the quality of life between the two groups( P >0.05).The median progression-free survival time of the control group was 9.986 months.The median progression-free survival time of the observation group was10.973 months.The median survival time of the control group was11.981 months.The median overall survival time of the obserration group was10.969 months.Data differences were not statistically significant( P >0.05).The cost of the control group was (7 070.69±536.89) yuan/month during the treatment period,and the cost of the observation group was (4 860.53±322.81) yuan/month.The difference was statistically significant( P <0.05). Conclusion:Using domestic imitation gefitinib to treat patients with advanced non-small cell lung cancer EGFR mutation positive,can obtain similar short-term and long-term treatment effects similar to the original drug,but the cost of patients is reduced.It is worth promoting in clinical work.