重组改构人肿瘤坏死因子与化疗联合治疗非小细胞肺癌临床疗效及生存情况观察

Study of the Efficacy and Survival Time of the rmhTNF Combined with Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

目的：肿瘤坏死因子（TNFα）是由激活的单核-巨噬细胞产生的一种可溶性多功能细胞因子。它对多种肿瘤细胞有直接的细胞毒作用,并具有调节细胞免疫功能的作用。本研究主要比较重组改构人肿瘤坏死因子（rmh-TNF）联合化疗与单纯化疗中晚期非小细胞肺癌（NSCLC）的临床疗效及生存情况。方法：132例中晚期NSCLC患者随机分入试验组（78例）与对照组（54例）,两组均采用CAP、TP或NP方案化疗,21天为一周期,连用两个周期。在试验组化疗的第1-7天和第11-17天肌肉注射rmhTNF500万U。结果：试验组与对照组有效率分别为34.6%（27/78）和27.8%（15/54）（P=0.041）。治疗前后KPS评分差值分别为3.44±0.43和2.28±2.84（P=0.637）,中位生存时间分别为8.2个月和6.7个月（P=0.034）,中位疾病进展时间6.4个月和5.9个月（P=0.138）,1年生存率分别为51.8%和42.6%（P=0.039）,2年和3年生存率分别为22.6%和20.8%（P=0.734）,15.2%和14.7%（P=0.863）。试验组有67.6%患者产生与rmh-TNF相关的不良反应,但不需特别处理,停药后自行消退。不良反应两组间差异无统计学意义。结论：rmh-TNF联合化疗药物治疗NSCLC的近期疗效优于单纯化疗,中位生存时间和1年生存率更高,但在改善生活质量、中位疾病进展时间、2年和3年生存率未见明显优势。

Objective：To evaluation and compare the effects,toxicity quality of life and survival time of the domestic product of recombinant mutant human tumor necrosis factor （rmhTNF） combined with chemotherapy and chemotherapy alone in the treatment of patients with non-small cell lung cancer（NSCLC）.Methods：132 patients with NSCLC were randomly divided into trial group （78 cases） and control group （54 cases）.The trial group received rmhTNF combined with chemotherapy.The chemotherapy with CAP,TP or NP regimen was given to the patients.Meanwhile,rmhTNF injection of 5×10^6u was also give fore the 1st to 7th days and the 11th to 17th days on the chemotherapy cycle in the trial group.The control group received chemotherapy alone.Twenty-one days were as a cycle,2 cycles were given to each patient.The side effects related to rmhTNF included slight fever,coldlike symptoms,pain and red and swelling in injection site.All off them were mild and didn＇t need any treatment and disappeared.Results：The response rate was 34.6%（27/78） in the trial group and 27.8%（15/54） in the control group respectively（P=0.041）.The difference of KPS scores of the prior to one＇s treatment was 3.44±0.43 in the trial group,and 2.28±2.84 in the control group（P=0.637）.The median survival time （MST） was 8.2 month and 6.7 month in two group respectively（P=0.034）.The median time to progression （TTP） was 6.4 month and 5.9 month in two group respectively （p=0.138）.The 1year survival was 51.8% and 42.6% in two group respectively（P=0.039）.The 2-and 3-years survival were 22.6% and20.8%（P=0.734）,15.2% and 14.7%（P=0.863） in two group respectively.No significant difference of the others side effect between the two group （p〉0.05）.Conclusion：The effect of domestic rmhTNF combined with chemotherapy alone in the treatment of NSCLC.rmhTNF can improve the quality of life,MST and 1 year survival of the patients.But rmhTNF can＇t improve their 2-and 3-years survival.