康莱特注射液联合同步放化疗治疗68例中晚期非小细胞肺癌临床观察

目的：：观察康莱特注射液配合同步放化疗对局部晚期非小细胞肺癌（NSCLC）的疗效和不良反应。方法：68例Ⅲ期NSCLC患者随机分为二组：治疗组（同步放化疗＋康莱特注射液）35例,同步放化疗中放疗采用三维适形放疗技术,DT60-66Gy/30-33f/6-7W。化疗采用EP方案,依托泊苷50mg/m2,1次/日,d1-5,d29-33;顺铂50mg/m2,1次/日,d1、8、29、36。同步放化疗同时联合康莱特注射液2周期,每周期为200ml静脉滴注,1次/日,连续21天,休息7-10天进行第2周期。对照组33例只行同步放化疗,放化疗方式同治疗组。治疗完成后评价疗效和不良反应。结果：治疗组总有效率（CR＋PR）74.3%,完全缓解率（CR）22.9%;对照组总有效率51.5%,完全缓解率15.2%,两组间总有效率有显著统计学差异（P〈0.05）。中位生存期治疗组和对照组分别为17个月和13个月,1、2年生存率治疗组分别为62.9%、34.3%;对照组分别为51.5%、27.3%,两组间差异无显著性（P〉0.05）。不良反应主要是放射性肺炎、放射性食管炎和骨髓抑制,两组间差异无显著性。结论：康莱特注射液联合同步放化疗可明显提高局部晚期非小细胞肺癌（NSCLC）的近期疗效,远期疗效略有提高,但无统计学差异。

Clinical observation of patients with advanced non-small cell lung cancer treated by Kanglaite injection combined with concurrent chemo-radiotherapy

Objective： To observe the efficacy and toxicity of Kanglaite injection combined with concurrent chemo-radiotherapy on locally advanced non-small cell lung cancer（NSCLC）. Methods： Total of 68 patients of stage Ⅲ NSCLC patients were randomly divided into two groups：35 cases in treatment group（Concurrent chemo-radiotherapy combined with Kanglaite injection）,3 dimensional conformal radiotherapy（3-DCRT）,DT 60-66Gy/30-33f/6-7W.Conbined with EP regimen,etoposide 50mg/m2 d1-5,1 time a day,d29-33;cisplatin 50mg/m2 d1,8,29,36,Kanglaite injection 200ml by intravenous infusion,1 time a day for 21 consecutive days.Thirty three cases in control group,only used concurrent chemo-radiotherapy,same as treatment group. Results： In treatment group,total effective rate（CR＋ PR） was 74.3% and complete remission rate（CR） was 22.9%;in control group,the total efficiency was 51.5%,complete remission rate was 15.2%,treatment group had more efficacy and survival rate than that of control group（P 0.05）.The median survival time of the treatment and control groups were 17 months and 13 months respectively,and 1,2-year survival rates of treatment group were 62.9%,34.3%;51.5%,27.3% in control group（P0.05）.Toxicity were radiation pneumonitis,radiation esophagitis and bone marrow suppression（P0.05）. Conclusion： Kanglaite injection combined with concurrent chemo-radiotherapy can significantly improve the short-term efficacy of locally advanced non-small cell lung cancer（NSCLC）,and slightly higher in long-term efficacy,but there is no statistical difference.