Once a week subcutaneous administration of recombinant human erythropoietin (KRN5702) for predeposit autologous blood donation. A multi-institutional early phase II study.
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- Wakimoto Nobuhiro
- Department of Orthopaedic Surgery, Faculty of Medicine, University of Tokyo
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- Kurokawa Takahide
- Department of Orthopaedic Surgery, Faculty of Medicine, University of Tokyo
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- Sugioka Yoichi
- Department of Orthopaedic Surgery, Faculty of Medicine, Kyushu University
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- Takaku Fumimaro
- National Medical Center
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- Kaneda Kiyoshi
- Department of Orthopaedic Surgery, School of Medicine, Hokkaido University
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- Asano Satoshi
- Department of Orthopaedic Surgery, School of Medicine, Hokkaido University
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- Moriya Hideshige
- Department of Orthopaedic Surgery, School of Medicine, Chiba University
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- Minami Shohei
- Department of Orthopaedic Surgery, School of Medicine, Chiba University
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- Morimoto Syuhei
- Department of Orthopaedic Surgery, Faculty of Medicine, University of Tokyo
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- Juji Takeo
- Department of Transfusion Medicine and Immunohematology, Faculty of Medicine, University of Tokyo
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- Takahashi Koki
- Department of Transfusion Medicine and Immunohematology, Faculty of Medicine, University of Tokyo
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- Yabe Yutaka
- Department of Orthopaedic Surgery, School of Medicine, Keio University
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- Sakamaki Toyonori
- Department of Orthopaedic Surgery, School of Medicine, Keio University
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- Ikeda Yasuo
- Department of Internal Medicine, School of Medicine, Keio University
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- Handa Makoto
- Blood Center, Keio University Hospital
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- Kawabata Masaya
- Department of Orthopaedic Surgery, Toranomon Hospital
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- Tachibana Shintaro
- Department of Orthopaedic Surgery, Toranomon Hospital
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- Shibata Yoichi
- Department of Immunohematology, Toranomon Hospital
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- Ogino Mikio
- Department of Orthopaedic Surgery, National Medical Center
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- Saito Takashi
- Department of Orthopaedic Surgery, National Medical Center
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- Matsumoto Mitsuhiro
- Department of Orthopaedic Surgery, National Medical Center
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- Matsumoto Hitoshi
- Department of Orthopaedic Surgery, National Medical Center
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- Tanaka Shigeru
- Department of Orthopaedic Surgery, Tokyo Metropolitan Fuchu Hospital
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- Hotokebuchi Takao
- Department of Orthopaedic Surgery, Faculty of Medicine, Kyushu University
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- Tsutsui Hideki
- Department of Orthopaedic Surgery, Faculty of Medicine, Kyushu University
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- Saikawa Isao
- Department of Orthopaedic Surgery, Faculty of Medicine, Kyushu University
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- Inaba Shoichi
- Blood Transfusion Service, Kyushu University Hospital
Bibliographic Information
- Other Title
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- 遺伝子組換えヒトエリスロポエチンKRN5702週1回皮下投与を併用する貯血式自己血輸血法 多施設共同初期第II相試験
- A Multi-Institutional Early Phase II Study
- 多施設共同初期第II相試験
Abstract
Forty-seven orthopaedic donor-patients in eight different institutions were evaluated as an early phase II open study to determine the efficacy and safety of once a week subcutaneous (SC) administration of recombinant human erythropoietin (rHuEPO) for weekly blood collection of 400ml. Of the 47 patients, 10 were excluded from efficacy evaluation for not meeting age (7) or hemoglobin (Hb) (2) criteria, or rHuEPO administration schedule (1). The remaining 37 patients, aged between 38 and 75, were divided into three groups by weekly SC dosage; 200IU/kg (12), 400IU/kg (13) and 600IU/kg (12). Weekly blood collection of 400ml began one week after an initial SC administration.<br>The 37 patients were able to donate autologous blood of 800ml/2 wks or 1200ml/3 wks and required no homologous blood during or after operation. At the time of the first phlebotomy, Hb was significantly increased in all three SC groups. One week after the second phlebotomy, Hb was not significantly decreased in the 600 group (101±6%), while it was decreased significantly in both the 200 group (96±6%) and the 400 group (97±4%) against the preadministration level. The Hb decrease in the 400 group was smaller than that in the 200 group, and it was clinically acceptable. Compared to previous studies at two institutions, equal dosages of rHuEPO at equal frequencies appeared to be more effective with SC administration than with intravenous (IV).<br>None of the 47 patients showed any adverse effects or abnormal laboratory data attributable to rHuEPO administration.<br>Our results indicated that a once a week SC administration of rHuEPO at a dose level of 400IU/kg or more could improve post-phlebotomy anemia as effectively as higher frequency IV administration.
Journal
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- Journal of the Japan Society of Blood Transfusion
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Journal of the Japan Society of Blood Transfusion 38 (6), 699-711, 1992
The Japan Society of Transfusion Medicine and Cell Therapy
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Details 詳細情報について
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- CRID
- 1390001204909040128
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- NII Article ID
- 130003852847
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- ISSN
- 18838383
- 05461448
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed