紫龙金维持治疗局部晚期非小细胞肺癌40例的临床疗效观察

Clinical observation on treating 40 cases of local advanced non-small-cell lung cancer with the Zilongjin tablet

目的:观察紫龙金片维持治疗同步放化疗后局部晚期非小细胞肺癌(NSCLC)的疗效和不良反应。方法:将78例同步放化疗后局部晚期非小细胞肺癌患者随机分为两组,其中紫龙金片维持治疗组40例,安慰剂对照组38例。观察两组患者1年生存率、2年生存率的差别,用卡氏评分法比较两组患者生活质量的改变情况,并观察毒副作用发生情况。结果:入组78例患者,4例出组,74例患者可评价疗效。其中,紫龙金片维持治疗组的1年生存率、2年生存率分别为72.2%、55.6%,安慰剂对照组1年生存率、2年生存率分别为54.5%、32.7%,两组比较差异有统计学意义(P<0.05);两组患者生活质量改善比较差异亦有统计学意义(P<0.05)。紫龙金片治疗组有2例出现轻度胃肠道副反应,1例出现一过性头晕。结论:晚期非小细胞肺癌患者放化疗稳定后应用紫龙金片治疗是安全的,并能明显延长患者的生存时间,同时不良反应可耐受。

Objective： To observe adverse reactions and clinical efficacy of TCM plus the Zilongjin tablet on local advanced non- small-cell lung cancer in patients after concurrent chemoradiotherapy. Methods： 78 patients with local advanced NSCLC were randomly assigned to two groups; 40 patients in the treatment group received the Zilongjin tablet, and the other patients in the control group received placebo. One-year survival, two-years survival and adverse reactions were observed; the quality of life was evaluated regularly by Kaplan- Meier analysis. Results： 74 patients were included in the trial; 4 patients excluded. One-year survial and two-years survival were 72.2% and 55.6% in treatment group; compared with 54.5% and 32.7% in the control group, there was statistical difference （P〈0.05）. The quality of life in groups also was statistically different （P〈0.05）. 3 patients showed mild adverse reactions in the treatment group. Conclusion： The Zilongjin tablet on local advanced NSCLC was safe and feasible, could prolong the life time, and adverse reactions could be tolerated.