新型重组人肿瘤坏死因子的Ⅲ期临床对照试验

A randomized phase Ⅲ trial of domestic product of nrhTNF in the treatment of malignant tumor

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 effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatraent of patients with malignant tumor.METHODS 74 patients were randomly derided into trial group , control group, and open group of 5 patients. Chemotherpay with CAP, FCP, FAM, FC and DVP regimen were given for the patients in both the groups. Meanwhile, nrhTNF injection of 4 ×10^6 U·m^-2 was also given in the trail group. NrhTNF alone was given in the open group. Two cycles were given to each patients, with 21 days as a cycle. RESULTS 52 and 19 cases could be used to analyze the clinical effects and toxicity, respectively. The response rate of chemotherapy was 50.0% in the trial group and 15.8% in the control group , respectively. 1 out of 3 patients in the open group was effective. The KPS was 88.46 ±11.80 in the trial group, and 81.05±9.37 in the control group. No significant difference of degree Ⅲ＋Ⅳ toxicity was observed between tbe trial group and control group （ P 〉 0.05）. CONCLUSION Th e results demonstrate that the efficiency of domestic nrhTNF combined with chemotherapy is remarkably higher than that of chemotherapy alone in the treatment of malignant tumor.