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目的:观察重组改构人肿瘤坏死因子(Recombinant mutant human tumor necrosis factor,rmhTNF)治疗晚期恶性肿瘤的有效性和安全性。方法:92例患者随机纳入试验组和对照组。试验组在化疗的同时,rmhTNF 400万u/m2,肌注,第1～7天和第11～17天;对照组仅给联合化疗;两组均每21天重复,连用二个周期。结果:①试验组和对照组的有效率分别为11.11％和2.78％,两组疗效无显著性差异(P>0.05);②试验组和对照组治疗前后KPS评分及其差值无显著性差异(P>0.05);③rmhTNF的主要不良反应为一过性轻度注射局部疼痛63.0％、骨骼肌痛38.9％、发热24.1％、感冒样症状22.0％和局部红肿硬结13.0％。结论:受病例数等因素影响rmhTNF联合化疗药物治疗晚期肺癌、头颈癌、胃肠道癌、肾癌及恶性黑色素瘤的疗效不优于单纯化疗。rmhTNF联合化疗的耐受性和安全性良好,为进一步扩大病例临床研究提供了可靠的保证。
Objective: To observe the efficacy and safety of recombinant mutant human tumor necrosis factor (rmhTNF) in the treatment of advanced malignant tumors. Methods: 92 patients were randomly divided into experimental group and control group. The experimental group in the chemotherapy, rmhTNF 4 million u / m2, intramuscular injection, 1 to 7 days and 11 to 17 days; the control group was given only with chemotherapy; two groups were repeated every 21 days, once every two cycles. Results: ① The effective rates of the experimental group and the control group were 11.11% and 2.78%, respectively, with no significant difference between the two groups (P> 0.05). ② There was no significant difference in the KPS scores between the experimental group and the control group before and after treatment (P> 0.05). The main adverse reactions of rmhTNF were transient mild injection of local pain 63.0%, skeletal muscle pain 38.9%, fever 24.1%, cold-like symptoms 22.0% and local inflamed induration 13.0%. Conclusion: The effect of rmhTNF combined with chemotherapy drugs on advanced lung cancer, head and neck cancer, gastrointestinal cancer, kidney cancer and malignant melanoma is not superior to chemotherapy alone. The tolerability and safety of rmhTNF combined with chemotherapy are good, which provide a reliable guarantee for further clinical research.