国产与进口吉西他滨联合顺铂治疗非小细胞肺癌疗效与毒副作用观察

Domestic or imported gemcitabine used in combination with cisplatin in the treatment of advanced non-small-cell lung cancer

目的观察比较国产吉西他滨(商品名泽菲)与进口吉西他滨(商品名健择)加顺铂联合化疗(GP方案)非小细胞肺癌(NSCLC)的疗效与毒副作用.方法将62例NSCLC患者随机分为国产吉西他滨组(A组)和进口吉西他滨组(B组),每组各31例.每组化疗药物用法分别为:A组,国产吉西他滨1000 mg/m2 d1,8静脉滴注,顺铂25mg/m2 d1～3静脉滴注;B组,进口吉西他滨1 000 mg/m2 d1,8静脉滴注,顺铂25mg/m2 d1～3静脉滴注.2组均21天为1个周期,使用4～6个周期后评价总有效率、中位疾病无进展时间(TTP)、中位生存期、1年生存率及不良反应.结果无论是国产吉西他滨还是进口吉西他滨,两者联合顺铂治疗NSCLC均取得较好疗效,分别获得48.4%、45.2%的总有效率和41.9%、45.2%的1年生存率及较长的中位TTP、中位生存期,且两者毒副作用相近,差异均无统计学意义.结论GP方案是治疗NSCLC的较好方案,国产吉西他滨与进口吉西他滨的疗效相当,毒副作用相近,值得临床推广应用.

Objective To investigate the clinical efficacy and side effects of combined domestic or imported gemcitabine and cisplatin （GP） in treating advanced non- small- cell lung cancer （NSCLC）. Methods Sixty - two cases of NSCLC patients were divided into two groups （ n = 31, each） to undergo domestic gemcitabine and imported gemcitabine regimens, respectively. The dosage of gemcitabine, either domestic or imported, was 1 000 mg/m^2 iv on d1.8, and that of cisplatin was 25 mg/m^2 iv on d1-3 , Each therapeutic cycle lasted 21 days. The response rate （RR）, median time to progress （TTP）, median survival time （MST）, and 1 - year survival rate were evaluated after 4 - 6 cycles. Results Both domestic gemcitabine and imported gemcitabine projects produced satisfactory clinical efficacy, with the RR being 48.4% and 45.2% respectively, and the 1 - year survival rate 41.9% and 45.2% respectively. The median TIP and MST were prolonged. There were no statistical differences in side effects between domestic gemcitabine and imported gemcitabine. Conclusion GP project is an acceptable project to treat NSCLC. The clinical efficacy and side effects of domestic gemcitabine are similar to those of the imported gemcitabine, so the domestic drug is worthy of popularized adoption.