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目的 观察比较国产新型重组人肿瘤坏死因子 (nrhTNF)加化疗和单纯化疗治疗非小细胞肺癌(NSCLC)的临床疗效和不良反应。方法 采用多中心、随机对照试验将 90例NSCLC患者随机分为试验组和对照组 ,两组各 45例患者。试验组在化疗的同时 ,分别在第 1～ 7天 ,第 11～ 17天肌肉注射nrhTNF 4×10 6U/m2 ,2 1天为一周 ,连用二个周期。对照组仅给予化疗 ,2 1天为一周期 ,连用二个周期。试验结束后比较试验组和对照组的有效率和不良反应。结果 试验组和对照组各有 3例患者因依从性原因出组 ,各有 42例可供临床疗效分析和不良反应分析。试验组有效率为 47.62 % ( 2 0 /4 2 ) ,对照组为 19.0 5 % ( 8/4 2 ) (P =0 .0 0 2 )。试验组治疗后KPS评分为 85 .0 2± 10 .74,对照组为 81.3 5± 9.63 (P =0 .0 3 8)。试验组和对照组Ⅲ+Ⅳ度不良反应无显著差异 (P >0 .0 5 )。与nrhTNF有关的不良反应主要有轻度发热、感冒样症状 ,注射局部疼痛 ,注射局部红肿硬结 ,均不需作特殊处理 ,治疗结束后均能自行消失。结论 国产nrhTNF联合化疗药物治疗NSCLC能显著提高化疗的有效率 ,改善患者的生活质量。nrhTNF临床应用安全、有效 ,不良反应轻微 ,值得在临床扩大应用
Objective To observe the clinical efficacy and adverse reactions of domestic recombinant recombinant human tumor necrosis factor (nrhTNF) plus chemotherapy and chemotherapy alone in the treatment of non-small cell lung cancer (NSCLC). Methods Ninety patients with NSCLC were randomly divided into experimental group and control group by multi-center and randomized controlled trial, 45 patients in each group. In the experimental group, nrhTNF 4 × 10 6U / m 2 was injected intramuscularly on days 1 to 7, and on days 11 to 17, respectively, for 21 days for one week for two cycles. The control group was given only chemotherapy, 21 days for a cycle, once every two cycles. Efficacy and adverse reactions of the experimental group and the control group were compared after the experiment. Results The experimental group and the control group each have 3 patients because of compliance reasons out of the group, 42 cases each for clinical efficacy analysis and adverse reaction analysis. The effective rate was 47.62% (20/42) in the experimental group and 19.0 5% (8/42) in the control group (P = 0.002). The KPS score of the experimental group was 85.02 ± 10.74 and that of the control group was 81.3 5 ± 9.63 (P = 0.308). There was no significant difference in grade Ⅲ + Ⅳ adverse reactions between test group and control group (P> 0.05). Adverse reactions associated with nrhTNF are mainly mild fever, flu-like symptoms, local pain injection, injection of local inflamed sclerosis, are not required for special treatment, can disappear after treatment. Conclusion The domestic nrhTNF combined with chemotherapy drugs can significantly improve the efficiency of chemotherapy and improve the quality of life of patients with NSCLC. nrhTNF clinical application of safe, effective, minor adverse reactions, it is worth in the clinical expansion of the application