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
作者：曹洁;侯梅;邱萌;易成;罗德云;任莉;鄢希;
Author：
收稿日期： 年卷（期）页码：2006,(01):-104-106
期刊名称：华西药学杂志
Journal Name：WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
关键字：肿瘤;新型重组人肿瘤坏死因子;联合化疗;Ⅲ期临床试验;随机对照
Key words：
基金项目：
中文摘要
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。
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