【摘要】 目的:评价比较以奈达铂(NDP)为主的化疗方案与以顺铂(DDP)为主的化疗方案对头颈部鳞癌、食管癌和非小细胞肺癌(nonsmallcelllungcancer,NSCLC)的疗效及不良反应。方法:患者随机分为两组。试验组:头颈部鳞癌及食管癌,NDP联合5氟尿嘧啶(5FU)和四氢叶酸(CF);NSCLCNDP联合诺维本(NVB);对照组:以DDP替代NDP,两组其他用药均相同。所有患者均接受2个周期以上的化疗。结果:2002年5月～2003年11月共有194例患者入组,其中188例完成试验,6例出组。头颈部鳞癌60例,食管癌60例,NSCLC68例。头颈部鳞癌试验组有效率为46.67%,对照组有效率为46.67%,χ2=0.2820,P=1.0000;食管癌试验组有效率为35.48%,对照组有效率为13.79%,χ2=2.4506,P=0.7470;NSCLC试验组有效率为31.43%,对照组有效率为15.15%,χ2=1.4315,P=0.1553。试验组与对照组的不良反应比较,除恶心、呕吐的发生率差异有统计学意义(χ2=3.4124,P=0.0006),前者明显低于后者外,血常规、腹泻、便秘、乏力等不良反应发生率差异均无统计学意义。结论:以NDP为主的联合化疗方案治疗头颈部鳞癌、食管癌、NSCLC疗效肯定,不良反应中呕吐明显减少,轻中度骨髓抑制,其余不良反应可以耐受。更多还原

【Abstract】 OBJECTIVE:To observe the clinical effect and toxicity of Nedaplatin combining chemotherapy in advanced head and neck squamous cell carcinoma, esophageal cancer, non-small cell lung cancer (NSCLC). METHODS: This is a multi-center phaseⅡ clinical trial.The chemnative patients with head and neck squamous cell carcinoma, esophageal cancer were randomized into two groups. The combination trial group was given with Nedaplatin +5-FU+CF regimen, and combination contral group was given with cisplatin +5-FU+CF regimen, The chemnative patients with NSCLC were randomized into two groups.The combination trial group was given with Nedaplatin +VDS regimen, and combination contral group was given with cisplatin +VDS regimen. RESULTS: Of 188 patients,60 cases were head and neck squamous cell carcinoma, 60 cases were esophageal cancer, 68 cases were NSCLC. It had the same response rate,which were 46.67% versus 46.67% in the trial and control groups in head and neck squamous cell carcinoma,χ2=0.282 0,P=1.000 0. Response rate was 35.48% for the combination trial group, or 13.79% for the combination control group in esophageal cancer,χ2=2.450 6,P=0.747 0. Response rate was 31.43%for the combination trial group,or 15.15%for the combination contral group in NSCLC,χ2= 1.431 5 , P=0.155 3. Nedaplatin had a possibility mild nausea and vomiting, The incidence rate of neutrpenia and anemia was similar in the two groups. CONCLUSIONS: Nedaplatin is an effective platinum drug in this clinical trial and has good clinical tolerance, and further evaluation of these treatment regimens is recommended in such patients.更多还原