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重组人源化抗CD25单克隆抗体治疗异基因造血干细胞移植后类固醇难治性急性移植物抗宿主病的临床研究

[Clinical study on recombinant humanized anti-CD25 monoclonal antibody used for treating steroid-resistant acute graft versus host disease following allo-hematopoietic stem cell transplantation].

作者信息

Li Xiao-Hong, Gao Chun-Ji, DA Wan-Ming, Cao Yong-Bin, Xu Li-Xin, Wu Ya-Mei, Liu Bei, Liu Zhou-Yang, Yan Bei, Li Song-Wei, Yang Xue-Liang, Wu Xiao-Xiong

机构信息

Department of hematology, The First Affiliated Hospital, Chinese PLA General Hospitall, Beijing 100037, China.

Department of hematology, The First Affiliated Hospital, Chinese PLA General Hospitall, Beijing 100037, China. E-mail:

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2013 Dec;21(6):1535-40. doi: 10.7534/j.issn.1009-2137.2013.06.032.

Abstract

This study was purposed to investigate the efficacy and feasibility of recombinant humanized anti-CD25 monoclonal antibody for treating steroid-resistant acute graft-versus-host disease (aGVHD ) following allo-hematopoietic stem cell transplantation (allo-HSCT) . Twenty-one cases with II-IV grade steroid-resistant aGVHD after allo-HSCT were treated by intravenous injection of recombinant humanized anti-CD25 monoclonal antibody at a dose of 1 mg/(kg·d) on days 1, 4, 8. Injection was repeated after 1 week for the patients who did not achieve CR. The results indicated that 13 cases (61.9%) got complete response (CR), 4 cases out of them have been still in disease-free survival, 8 cases have been in survival with mild cGVHD, 1 cases died from AML relapse, 6 cases (28.57%) got partial response (PR), 3 cases out of them have been in survival with mild cGVHD, 3 case died from pulmonary infection, 2 cases without response died from GVHD. Overall response rate was 90.5% and long term survival rate was 71.48%. There were no infusion-associated side-effects after treatment with recombinant humanized anti-CD25 monoclonal antibody.It is concluded that recombinant humanized anti-CD25 monoclonal antibody is effective and feasible for treatment of steroid-refractory grade II-IV aGVHD after allo-HSCT.

摘要

本研究旨在探讨重组人源化抗CD25单克隆抗体治疗异基因造血干细胞移植(allo-HSCT)后类固醇难治性急性移植物抗宿主病(aGVHD)的疗效和可行性。21例allo-HSCT后发生II-IV级类固醇难治性aGVHD的患者,于第1、4、8天静脉注射重组人源化抗CD25单克隆抗体,剂量为1mg/(kg·d)。未达到完全缓解(CR)的患者在1周后重复注射。结果显示,13例(61.9%)获得完全缓解,其中4例仍无病生存,8例生存且伴有轻度慢性移植物抗宿主病(cGVHD),1例死于急性髓系白血病(AML)复发,6例(28.57%)获得部分缓解(PR),其中3例生存且伴有轻度cGVHD,3例死于肺部感染,2例无反应者死于GVHD。总缓解率为90.5%,长期生存率为71.48%。重组人源化抗CD25单克隆抗体治疗后未出现输注相关副作用。结论:重组人源化抗CD25单克隆抗体治疗allo-HSCT后类固醇难治性II-IV级aGVHD有效且可行。

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