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目的比较国产新型重组人肿瘤坏死因子(nrhTNF)加化疗与单纯化疗治疗恶性肿瘤的疗效和不良反应。方法将74例恶性肿瘤患者随机分为试验组、对照组和开放组。试验组在化疗的同时,im nrhTNF 4×106U.m-2;对照组仅给予化疗;开放组单用nrhTNF。各组均21 d为1疗程,连用2疗程。结果试验组有效率为50.0%,对照组为15.8%。开放组3例中1例有效。试验组治疗后KPS评分为88.46±11.80,对照组为81.05±9.37。试验组和对照组Ⅲ+Ⅳ度不良反应无显著性差异(P>0.05)。结论国产nrhTNF联合化疗药物治疗恶性肿瘤可能提高化疗的有效率,改善患者的一般状况,不良反应轻微。
Objective To compare the efficacy and adverse reactions of the domestic new recombinant human tumor necrosis factor (nrhTNF) plus chemotherapy and chemotherapy alone in the treatment of malignant tumors. Methods Totally 74 patients with malignant tumor were randomly divided into experimental group, control group and open group. In the experimental group, while chemotherapy, im nrhTNF 4 × 106U.m-2; control group only given chemotherapy; open group single nrhTNF. Each group was 21 days for a course of treatment, once every 2 courses. Results The effective rate was 50.0% in the experimental group and 15.8% in the control group. One of 3 patients in the open group was effective. The KPS score of the experimental group after treatment was 88.46 ± 11.80 and that of the control group was 81.05 ± 9.37. There was no significant difference in grade Ⅲ + Ⅳ adverse reactions between experimental group and control group (P> 0.05). Conclusion Domestic nrhTNF combined with chemotherapy drugs may improve the efficiency of chemotherapy and improve the general condition of patients with mild adverse reactions.