国产吉西他滨联合顺铂治疗晚期非小细胞肺癌的临床研究

Clinical trial on homemade gemcitabine plus cisplatin in the treatment of advanced non-small cell lung cancer

目的：探讨国产注射用盐酸吉西他滨治疗晚期（ⅢB～Ⅳ期）NSCLC的疗效和不良反应。方法：将67例晚期NSCLC患者抽签法随机分成2组，治疗组35例：国产吉西他滨1000mg／m^2，30min内静脉滴入，d1、d8和d15；顺铂30mg／m^2，30min内静脉滴入，d1～d3；28d为1个周期。对照组32例：以健择代替吉西他滨。结果：治疗组CR1例（1／35），PR12例（12／35）；对照组PR12例（12／32）。两组疗效比较差异无统计学意义，P=0．976。血液学毒性和恶心呕吐发生率两组间差异无统计学意义。结论：国产吉西他滨联合顺铂与进口健择联合顺铂治疗晚期NSCLC疗效和不良反应均相近。费用相对比较经济。

OBJECTIVE： To evaluate the efficacy and toxicity of homemade gemcitabine in the treatment of patients with advanced （ⅢB-Ⅳ stage） NSCLC. METHODS： Sixty-seven NSCLC patients were randomized into two groups： 35 patients were in treatment group, and they were treated with homemade gemcitabine （1 000 mg/m^2） that was infused with in 30 min on d1, d8 and d15, cisplatin 30 mg/m^2 that was infused within 30 min on d1 - d3. The regimen was repeated every 28 d. Thirty-two patients were in control group, the protocol applied was the same as treatment group except homemade gemcitabine being replaced by imported gemzar. RESULTS： There were 1 CR （1/35）, 12 PR （12/35） in the treatment group, and 12 PR （12/32） in control group. There was no significant difference （PR rates） between the treatment group and control group, P=0.976. There major toxic reactions were nausea, vomiting, lose of appectite and hematological toxicity. There was no significant difference between the two groups either. CONCLUSION： The efficacy and incidence of side effects of homemade gemcitabine and the imported gemzar are similar. Compared with imported gemzar homemade gemcitabine is a economical choice.