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CHOP方案联合重组人肿瘤坏死因子α衍生物K2治疗非霍奇金淋巴瘤Ⅲ期临床研究

Clinical Trial (Phase Ⅲ) of Recombinant Human TNFα-DK2 Combined With CHOP in Treatment of Non-Hodgkin's Lymphoma
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摘要 目的:评价CHOP方案联合重组人肿瘤坏死因子α衍生物K2(rh-TNFα-DK2)治疗非霍奇金淋巴瘤(NHL)的临床疗效、安全性和耐受性。方法:对46例NHL患者进行随机、双盲、对照的临床研究,分别以CHOP方案+rh-TNFα-DK2(试验组)和CHOP方案+安慰剂(对照组)化疗2个疗程。结果:试验组和对照组的缓解率/好转率分别为80.0%及43.8%(P<0.05)。治疗后试验组NK细胞数增加,与对照组有明显差异(P<0.05)。rh-TNFα-DK2最常见的不良反应为寒战和发热,发生率分别为34.4%和21.9%。结论:rh-TNFα-DK2与CHOP方案联合治疗NHL具有一定的协同作用,可提高临床缓解率和好转率,临床安全性较好,不增加CHOP方案的不良反应发生率。 Objective： To evaluate the clinical effect and safety of recombinant human TNFα-DK2 combined with CHOP in treatment of non-Hodgkin＇s lymphoma （NHL）. Methods： Fourty-six NHL patients were enrolled in a randomized, double-blind, placebo-controlled trial： CHOP plus rh-TNFα--DK2 group （trial group） and CHOP plus placebo group （control group） for 2 cycles. Results： The remission rate/improvement rate were 80. 0% and 43. 8% respectively in trial group and control group （P〈0.05）. The number of NK cells was significantly increased after treatment in trial group compared with that in control group （P〈0. 05）. The common side effects of rh-TNFα-DK2 were chills（34.4 %and fever（21.9 % ）. Conclusion： Treatment with recombinant human TNFα-DK2 combined with CHOP showed a synergic effects in treatment of NHL, which may increase clinical remission rate and improvement rate, without increment of side effects of CHOP.
作者 高蕾 陈幸华 王庆余 张曦 孔佩艳 刘红 刘林 曾东风
机构地区 第三军医大学新桥医院
出处 《内科急危重症杂志》 2006年第5期227-229,共3页 Journal of Critical Care In Internal Medicine
关键词 肿瘤坏死因子 非霍奇金淋巴瘤 临床研究 TNF-α Non-Hodgkin＇s lymphoma Clinical research
分类号 R557.4 [医药卫生—血液循环系统疾病]
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参考文献4

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内科急危重症杂志
2006年 第5期

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