国产盐酸吉西他滨治疗晚期非小细胞肺癌的Ⅱ期临床研究

Phase Ⅱ clinical trial on gemcitabine in the treatment of stage ⅢB-Ⅳ non-small cell lung cancer

目的 评价国产注射用盐酸吉西他滨治疗ⅢB～Ⅳ期非小细胞肺癌 (NSCLC)的疗效及安全性。方法 12 4例NSCLC患者随机分为 3组 :单药试验组 (A组 ) :盐酸吉西他滨 10 0 0mg/m2 加生理盐水 10 0ml或 2 0 0ml ,于 3 0～ 60min内静脉滴注 ,第 1,8,15天各 1次 ,每 2 8d为 1个周期 ;联合试验组 (B组 ) :在单药方案基础上加顺铂 3 0mg/m2 ,60～ 12 0min内静脉滴注 ,第 1,2 ,3天各 1次 ,2 8d为1个周期 ;联合对照组 (C组 ) :以健择代替盐酸吉西他滨。治疗 8周后评价疗效及不良反应。结果入组的 12 4例中 ,可评价疗效病例 115例。A组 40例中 ,9例 (2 2 .5% )达PR ;B组 3 6例中 ,15例(41.7% )达PR ;C组 3 9例中 ,15例 (3 8.5% )达PR。B组与C组间疗效差异无显著性 (P =0 .552 )。第二周期后 ,有 117例患者可评价不良反应。Ⅲ～Ⅳ度恶心、呕吐、纳差的发生率以B组为高 ,C组的血液学毒性高于A组 ,B、C两组间差异无显著性。结论 国产盐酸吉西他滨是治疗晚期NSCLC的有效药物 ,使用安全 。

Objective To evaluate the efficacy and safety of domestic Gemcita bine in the treatment of patients with stage ⅢB～Ⅳ non-small cell lung cance r(NSCLC). Methods 124 NSCLC patients were randomized into three groups: Group A: single drug group, 40 cases, gemcitabine 1 000 mg/m 2 + NS 100 ml or 200 ml wa s infused within 30～60 minutes on D1, 8 and 15, with 28 days taken as one cycle . Group B: combined t reatment group, 36 cases, in addition to the above protocol, cisplatin 30 mg/m 2 was infused within 60～120 min, on D1,2 and 3. Group C: combined control group: 3 9 cases, the protocol applied was the same as group B except domestic g emcitabine being replaced by imported gemzar. The efficacy and side effects of t reatment were e valuated after 8 weeks of treatment. Results 115 patients could be evaluated fo r response rate. PR was observed in 9/40 (22.5%) of group A, 15/36 (41.6%) i n gr oup B and 15/39 (38.36%) in group C. There was no significant difference of PR r ates between group B and group C (P=0.552). 117 patients who received the se cond cycle of treatment were evaluated for toxicity. The incidence of grade Ⅲ～Ⅳ na u sea, vomiting and loss of appetite was much higher in group B. Hematological tox icity of groups B and C was higher than that of group A. There was no significa nt difference between groups B and C. Conclusion The efficacy and incidence of side effects between domestic gemcitabine and the imported gemzar are similar.