康莱特加同步放化疗治疗局部晚期非小细胞肺癌临床研究

目的：观察康莱特注射液（KLT）联合同步放化疗对局部晚期非小细胞肺癌的治疗效果。方法：48例局部晚期非小细胞肺癌患者,随机分为两组,综合组：25例,采用盖诺＋顺铂方案同步放化疗,放疗予常规分割,2Gy/f,总量56～60Gy,同时加用康莱特注射液200ml/d静脉滴入,21天为1个疗程,共2个疗程。对照组：23例,采用盖诺＋顺铂方案同步放化疗。2疗程后评价疗效,通过KPS评分、体重变化观察生存质量改善情况。结果：两组完全缓解率分别为20.0%和13%（P〉0.05）;有效率分别为80.0%和69.5%（P〉0.05）;综合组3级以上骨髓抑制发生率为40.0%,而对照组为69.6%（P〈0.05）;综合组3级以上消化道不良反应发生率为8.0%,对照组为34.8%（P〈0.05）;综合组无3级以上放射性肺炎发生,而对照组为4.4%（P〉0.05）;综合组3级以上放射性食管炎发生率16.0%,对照组为43.5%（P〈0.05）;综合组治疗前后KPS评分及体重评分明显高于对照组（P〈0.05）。结论：康莱特联合同步放化疗可以减轻放化疗引起的胃肠道反应,减少3级以上骨髓抑制和3级以上放射性食管炎的发生,使患者的生存质量得到改善，但从疗效分析，NP方案同步放化疗是否联合使用康莱特，无统计学差异。

Kanglaite injection combined with concurrent chemoradiotherapy in the treatment of locally advanced non-small cell lung cancer

Objective：To evaluate the clinical toxicity and efficacy of Kanglaite injection combined with concurrent chemora-diotherapy in the treatment of locally advanced non-small cell lung cancer.Methods：Forty-eight patients with locally advanced non-small cell lung cancer were randomized into two groups.The combination group received chemotherapy of NVB＋DDP regimen,radio-therapy was given with conventional fraction in 2Gy per fraction and five fractions per week.The total tumor doses were 56～60Gy.Combined with Kanglaite injection 200 ml/d for consecutive twenty-one days for two courses, and the control group was chemoradiother-apy only. Toxicities and effects were evaluated according to the criteria of WHO. Results; The CR in combination group and control group were 20.0% and 13% ,respectively（P〉0.05）. Response rate of combination group was 80.0% and 69.5% in control group （P〉0.05）. Grade 3-4 leukocytopema,grade 3--4 digestive system and grade 3-4 radiation esophagitisin combination group and control group were 40.0 % , 8.0 % , 16.0 % and 69.6 % , 34.8 % , 43.5 %, respectively（P〈0.05）. KPS and bodyweight score significantly increased in combination group after the combinedtreatment （P〈0.05）. Conclusions： Kanglaite injection combined with concurrent chemoradiotherapy could relieve side effects of chemo radiotherapy in the treatment of locally advanced non-small cell lung cancer,and improved life quality. Kanglaitc could increase effectiverate of locally advanced non small cell lung cancer combined with concurrent chemoradiothrapy.