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学科主题: 临床医学
题名:
Safety and efficacy of a sucrose-formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China
作者: Shi, J.; Zhao, Y.; Wu, J.; Sun, J.; Wang, L.; Yang, R.
关键词: clinical trial ; haemophilia A ; recombinant factor VIII
刊名: HAEMOPHILIA
发表日期: 2007-07-01
DOI: 10.1111/j.1365-2516.2007.01472.x
卷: 13, 期:4, 页:351-356
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Hematology
研究领域[WOS]: Hematology
关键词[WOS]: HEPATITIS-A ; VIRUS ; INFECTION ; TRANSMISSION ; CONCENTRATE ; MULTICENTER ; POPULATION ; CHILDREN
英文摘要:

The use of plasma-derived products has contributed to a high rate of blood-borne infections among haemophilia patients in China. Recombinant factor VIII (rFVIII) products that are manufactured without human or bovine albumin and include dedicated viral inactivation steps, hold a significant safety advantage over plasma products. However, there is little information published on the use of rFVIII products in non-caucasian populations. This is the first reported evaluation of the efficacy and safety of a rFVIII product in Chinese haemophiliacs. An open-label, non-randomized, prospective, multicentre trial enroled previously treated Chinese patients with haemophilia A. All treatments were administered using a sucrose-formulated rFVIII-FS (Kogenate((R))). Forty-nine patients received totals of 291 infusions (mean, 5.94/patient) and 742 140 IU rFVIII-FS (mean, 2550.3 IU/infusion). Of the 60 acute bleeding episodes that were treated, 90% were successfully managed with only one (81.7%) infusion or two (8.3%) infusions. Physicians reported haemostasis control for acute bleeds to be ′Excellent′ or ′Improved′ with rFVIII-FS therapy. No FVIII inhibitors were detected in any patient. Only one treatment-related adverse event was reported, which was mild dizziness that resolved spontaneously. rFVIII-FS was efficacious, safe and well tolerated in the treatment of previously treated patients with haemophilia A in China.

语种: 英语
WOS记录号: WOS:000247755100002
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64645
Appears in Collections:北京大学第三临床医学院_血液内科_期刊论文

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作者单位: 1.Bayer Healthcare Co Ltd, Dept Med, Beijing, Peoples R China
2.Peking Univ, Coll Med, Tianjin, Peoples R China
3.Peking Univ Med Coll Hosp, Dept Hematol, Beijing, Peoples R China
4.Anhui Prov Hosp, Dept Hematol, Hefei, Peoples R China
5.Chinese Acad Med Sci, Inst Hematol, Tianjin 300020, Peoples R China
6.Chinese Acad Med Sci, Blood Dis Hosp, Tianjin 300020, Peoples R China
7.Nanfang Med Univ, Dept Hematol, Nanfang Hosp, Guangzhou, Peoples R China

Recommended Citation:
Shi, J.,Zhao, Y.,Wu, J.,et al. Safety and efficacy of a sucrose-formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China[J]. HAEMOPHILIA,2007,13(4):351-356.
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