重组改构人肿瘤坏死因子对小细胞肺癌化疗的干预

A study of rmhTNF combined with chemotherapy on the treatment of small cell lung cancer

目的：对比研究国产新药重组改构人肿瘤坏死因子（rmhTNF）加化学治疗和单纯化学治疗人小细胞肺癌（SCLC）的临床疗效和安全性。方法：采用随机对照试验，试验组15例．对照组17例。对照组仅给予EP方案化疗，而试验组在EP方案化疗的同时，分别在第1～7天，第11～17天肌内注射rmh．TNF4×10^6U·m^-2，两组均以21d为一周期。连用两个周期。结果：试验组治疗有效率为80．0％（12／15），对照组为58．8％（10／17），疗后KPS评分两组分别为（78.2±9．7）和（72．1±9．5），试验组有效率和治疗后KPS评分改善情况均显著高于对照组（P〈0．05）。试验组和对照组均未见有严重的不良反应发生。结论：新型基因工程药物rmhTNF联合化疗治疗人SCLC的疗效显著优于单纯化疗，能明显改善SCLC患者的生活质量，且临床应用安全。

OBJECTIVE To evaluate and compare the efficacy and safety of the recombinant mutant human tumor necrosis factor （rmhTNF） combined with chemotherapy and chemotherapy alone on the treatment of patients with small cell lung cancer （SCLC）, METHODS Selecting patients with SCLC, patients were divided into trial group（15 patients）and control group（17 patients）. Chemotherapy with EP regimen was given to the all patients, Meanwhile, a regimen of rmhTNF injection of 4×10^6 U·m^-2 was given from the lst to 7th days, the l lth to 17th days on the chemotherapy cycle in the trial group as well as the control patients received chemotherapy alone. Twenty one days were as a cycle and all patients with 2 cycles. RESULTS The response rate was 80.0% （12/15） in the trial group and 58. 8% （10/17） in the control group（P〈0.05）. The KPS score after treatment was （78.2±9.7） in the trial group as well as （72.1±9.5） in the control group, and the difference of improvement was significant （P〈0.05）. The adverse effects rclated to rmhTNF were mild and didn＇t need any treatment. CONCLUSION The rmhTNF combined with chemotherapy are remarkably higher than chemotherapy alone on the treatment of SCLC It can increase the sensitivity to chemotherapy and improve the quality of life of the patients with SCLC.