康莱特注射液在中晚期非小细胞肺癌治疗中的临床应用研究

The clinical application of Kanglaite injection in the treatment of advanced nonsmall cell lung cancer

目的探讨康莱特注射液在中晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)治疗中的临床应用研究。方法按照随机分层分组法将100例中晚期NSCLC患者分为观察组(53例)和对照组(47例),对照组给予NP化疗方案,观察组在对照组治疗方案基础上加用康莱特注射液,观察两组临床症状评分、治疗效果、免疫功能指标及生活质量;随访3年,观察两组中位生存期及3年生存率。结果观察组临床症状评分明显低于对照组,而临床有效率及肺癌患者生存质量测定量表(FACT-L)评分则高于对照组,差异有统计学意义(P﹤0.05)。观察组白细胞计数、NK细胞、T细胞亚群及免疫球蛋白水平均明显高于对照组,差异有统计学意义(P﹤0.05)。随访3年,观察组中位生存时间高于对照组,两组差异有统计学意义(P﹤0.05)。结论康莱特注射液能提高中晚期NSCLC患者的化疗疗效和免疫功能,并且与NP化疗方案联用可起到增效减毒作用,在中晚期NSCLC治疗中具有一定的临床应用价值。

Objective To explore the efficacy of Kanglaite injection in the treatment of patients with advanced non- small cell lung cancer （non-small cell lung cancer, NSCLC）. Method According to a stratified randomization method, 100 patients with advanced NSCLC were randomized into study group （n=53） or control group （n=47）, the NP chemotherapy was administered in both groups, while the study group was additionally given Kanglaite injection, the clinical symp- tom score, clinical efficacy, immune function index and quality of life （Qol） of the two groups were compared, besides, the median survival time and 3-year survival rate of both groups were observed in a 3-year follow up. Result The clinical symptom score, and the clinical response rate and FACT-L scale score were apparently lower in the study group than those of the control group （P〈0.05）; However, the study group had a significantly higher level of WBC count, NK cell count, serum T cell subsets and immunoglobulin compared with the control group （P〈0.05）. In the 3-year follow up, the median survival time in study group was higher than that of the control group （P〈0.05）. Conclusion Kanglaite injection is effective in improving the clinical efficacy and immune function, and has a synergistic effect in combination with NP chemotherapy, which is clinically important in the treatment of patients with advanced non-small cell lung cancer.