重组人凝血因子Ⅷ治疗411例中重型血友病A患者的抑制物产生及安全性的回顾性分析

王诗轩; 孙竞; 李长钢; 周荣富; 裘哲君; 张心声; 周郁鸿; 胡群; 方拥军; 杜欣; 王思力; 李晓静; 洪珞珈; 曾小菁; 雷平冲; 程淑琴; 马军; 刘安生; 薛峰; 杨仁池

doi:10.13201/j.issn.1004-2806.2018.01.007

重组人凝血因子Ⅷ治疗411例中重型血友病A患者的抑制物产生及安全性的回顾性分析

- 1. 中国医学科学院北京协和医学院血液学研究所血液病医院(天津, 300020);
- 2. 南方医科大学南方医院;
- 3. 深圳市儿童医院;
- 4. 南京大学医学院附属鼓楼医院;
- 5. 中国人民解放军第113医院;
- 6. 山东省血液中心;
- 7. 浙江省中医院;
- 8. 华中科技大学同济医学院附属同济医院;
- 9. 南京医科大学附属南京儿童医院;
- 10. 深圳市第二人民医院;
- 11. 厦门大学附属第一医院;
- 12. 成都新世纪妇女儿童医院;
- 13. 哈尔滨医科大学附属第四医院;
- 14. 贵州医科大学附属医院;
- 15. 河南省人民医院;
- 16. 广州市番禺中心医院;
- 17. 哈尔滨血液病肿瘤研究所;
- 18. 西安市儿童医院

详细信息

通讯作者: 薛峰,E-mail:justmexf@163.com

中图分类号: R554.1

收稿日期: 2017-04-10

Evaluation of safety and inhibitor development of recombinant factor Ⅷ treatment in hemophilia A patients:a retrospective nationwide multicenter analysis in China

- 1. Institute of Hematology&Blood Disease Hospital, CAMS&PUMC, Tianjin, 300020, China;
- 2. Nanfang Hospital, Southern Medical University;
- 3. Shenzhen Children's Hospital;
- 4. Nanjing Drum Tower Hospital;
- 5. 113 Military Hospital of China;
- 6. Blood Center of Shandong Province;
- 7. Zhejiang Provincial Hospital of TCM;
- 8. Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology;
- 9. Children's Hospital of Najing Medical University;
- 10. he Second People's Hospital of Shenzhen;
- 11. The First Affiliated Hospital of Xiamen University;
- 12. New Century Women's and Children's Hospital;
- 13. Fourth Hospital of Harbin Medical University;
- 14. Affiliated Hospital of Guizhou Medical University School;
- 15. He'nan Province People's Hospital;
- 16. Guangzhou Panyu Center Hospital;
- 17. Harbin Institute of Hematology&Oncology, Harbin the First Hospital;
- 18. The Children's Hospital of Xi'an City

More Information

Corresponding author: XUE Feng, E-mail: justmexf@163.com

Received Date: 10 April 2017

摘要

摘要: 目的:分析国内血友病A患者接受第3代重组人凝血因子Ⅷ(FⅧ)替代治疗后FⅧ抑制物产生和相关安全性情况。方法:对411例重型和中型血友病A患者进行回顾性分析。结果:411例血友病A患者均为男性,46例仅接受百因止治疗,包括18例既往未接受过FⅧ治疗(PUP)和28例既往接受过FⅧ治疗(PTP);365例接受百因止与其他FⅧ制剂治疗,包括9例PUP和356例PTP。411例患者中13例(3.2%)报告了抑制物产生阳性,包括27例PUP中的3例(11.1%)和384例PTP中的10例(2.6%)。在365例接受百因止与其他FⅧ制剂治疗的患者中,分别有7例(1.9%)、36例(9.9%)和11(3.0%)报告了乙肝表面抗原阳性、乙肝表面抗体阳性和丙肝表面抗体阳性,同时有9例(2.5%)和1例(0.3%)报告了人类免疫缺陷病毒抗体和梅毒螺旋体抗体阳性。在46例仅接受百因止治疗的患者中,未见病毒学阳性结果。结论:中国血友病A患者接受百因止替代治疗总体安全且耐受性良好,抑制物发生率较低。
- 血友病A /
- 百因止 /
- 抑制物
Abstract: Objective:To evaluate the safety and inhibitor development of recombinant factor Ⅷ treatment in hemophilia A patients from multicenter in China.Method:The data of 411 patients with hemophilia A were retrospectively analyzed.Result:All the 411 hemophilia A patients were male.Among them,46 patients received ADVATE only (18 PUP,28 PTP),365 patients received ADVATE plus other factor FⅧ therapy (9 PUP,356 PTP).Overall,13/411(3.2%) patients reported positive for inhibitor development,including 3/27(11.1%) PUP and 10/384(2.6%) PTP.Among 365 patients who received ADVATE plus additional factor Ⅷ therapy,there were 7(1.9%),36(9.9%) and 11(3.0%) patients reported positive for HBs-Ag,HBs-Ab and HCV-Ab;Moreover,there were 9(2.5%) and 1(0.3%) patients reported positive for HIV-Ab and TP-Ab.For 46 patients with ADVATE only,there were no positive virology findings or confirmed exposure to blood components.Conclusion:ADVATE is generally safe and well-tolerated to hemophilia A patients in China,with lower incidence of inhibitors.
- haemophilia A /
- ADVATE /
- inhibitor

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