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A multicenter randomized phase Ⅱ trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer

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 4×106U/m2,21天为一周,连用二个周期.对照组仅给予化疗,21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%(20/42),对照组为19.05%(8/4... Full description

Journal Title: Zhongguo Fei Ai Za Zhi 2003, Vol.6(1), pp.42-45
Main Author: Zhou, Qinghua
Other Authors: Hou, Mei , Lu, LI , Li, Ren , Qiu, Meng , Yang, Yuqiong , Huang, Wenxia , Chen, Zhen , Meng, Zhiqiang , Song, Mingzhi , LI, Mingzhong , LI, Enxiao , LI, Yi , Yao, Yu , Zheng, Zhiwen , Liu, Xing , Zhang, Xiangfu , Lu, Huishan , Zhang, Maohong , Wang
Format: Electronic Article Electronic Article
Language: chi
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ID: ISSN: 10093419 ; E-ISSN: 19996187 ; DOI: 10.3779/cjlc.v6i1.2696
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title: A multicenter randomized phase Ⅱ trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer
format: Article
creator:
  • Zhou, Qinghua
  • Hou, Mei
  • Lu, LI
  • Li, Ren
  • Qiu, Meng
  • Yang, Yuqiong
  • Huang, Wenxia
  • Chen, Zhen
  • Meng, Zhiqiang
  • Song, Mingzhi
  • LI, Mingzhong
  • LI, Enxiao
  • LI, Yi
  • Yao, Yu
  • Zheng, Zhiwen
  • Liu, Xing
  • Zhang, Xiangfu
  • Lu, Huishan
  • Zhang, Maohong
  • Wang
subjects:
  • Lung Cancer
  • Entrepreneurs
  • Chemotherapy
ispartof: Zhongguo Fei Ai Za Zhi, 2003, Vol.6(1), pp.42-45
description: 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 4×106U/m2,21天为一周,连用二个周期.对照组仅给予化疗,21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%(20/42),对照组为19.05%(8/42)(P=0.002).试验组治疗后KPS评分为85.02±10.74,对照组为81.35±9.63(P=0.038).试验组和对照组Ⅲ+Ⅳ度不良反应无显著差异(P>0.05).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 evaluate and 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 treatment of patients with non-small cell lung cancer (NSCLC). Methods Ninety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile,...
language: chi
source:
identifier: ISSN: 10093419 ; E-ISSN: 19996187 ; DOI: 10.3779/cjlc.v6i1.2696
fulltext: fulltext_linktorsrc
issn:
  • 10093419
  • 1009-3419
  • 19996187
  • 1999-6187
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titleA multicenter randomized phase Ⅱ trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer
creatorZhou, Qinghua ; Hou, Mei ; Lu, LI ; Li, Ren ; Qiu, Meng ; Yang, Yuqiong ; Huang, Wenxia ; Chen, Zhen ; Meng, Zhiqiang ; Song, Mingzhi ; LI, Mingzhong ; LI, Enxiao ; LI, Yi ; Yao, Yu ; Zheng, Zhiwen ; Liu, Xing ; Zhang, Xiangfu ; Lu, Huishan ; Zhang, Maohong ; Wang
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description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 4×106U/m2,21天为一周,连用二个周期.对照组仅给予化疗,21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%(20/42),对照组为19.05%(8/42)(P=0.002).试验组治疗后KPS评分为85.02±10.74,对照组为81.35±9.63(P=0.038).试验组和对照组Ⅲ+Ⅳ度不良反应无显著差异(P>0.05).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 evaluate and 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 treatment of patients with non-small cell lung cancer (NSCLC). Methods Ninety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile,...
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titleA multicenter randomized phase Ⅱ trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer
description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 4×106U/m2,21天为一周,连用二个周期.对照组仅给予化疗,21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%(20/42),对照组为19.05%(8/42)(P=0.002).试验组治疗后KPS评分为85.02±10.74,对照组为81.35±9.63(P=0.038).试验组和对照组Ⅲ+Ⅳ度不良反应无显著差异(P>0.05).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 evaluate and 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 treatment of patients with non-small cell lung cancer (NSCLC). Methods Ninety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile,...
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titleA multicenter randomized phase Ⅱ trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer
authorZhou, Qinghua ; Hou, Mei ; Lu, LI ; Li, Ren ; Qiu, Meng ; Yang, Yuqiong ; Huang, Wenxia ; Chen, Zhen ; Meng, Zhiqiang ; Song, Mingzhi ; LI, Mingzhong ; LI, Enxiao ; LI, Yi ; Yao, Yu ; Zheng, Zhiwen ; Liu, Xing ; Zhang, Xiangfu ; Lu, Huishan ; Zhang, Maohong ; Wang
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abstract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 4×106U/m2,21天为一周,连用二个周期.对照组仅给予化疗,21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%(20/42),对照组为19.05%(8/42)(P=0.002).试验组治疗后KPS评分为85.02±10.74,对照组为81.35±9.63(P=0.038).试验组和对照组Ⅲ+Ⅳ度不良反应无显著差异(P>0.05).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 evaluate and 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 treatment of patients with non-small cell lung cancer (NSCLC). Methods Ninety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile,...
copTianjin
pubChinese Anti-Cancer Association Chinese Antituberculosis Association
doi10.3779/j.issn.1009-3419.2003.01.11
urlhttp://search.proquest.com/docview/2127760181/
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date2003-01-01