Study of recombinant human erythropoietin treatment on the anemia of predialysis patients
We conducted a multiplecenter joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A...
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| Published in | Nihon Jinzo Gakkai shi Vol. 34; no. 6; pp. 693 - 700 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Japan
Japanese Society of Nephrology
01.06.1992
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0385-2385 1884-0728 |
| DOI | 10.14842/jpnjnephrol1959.34.693 |
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| Abstract | We conducted a multiplecenter joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A (28 cases)in which rEPO was administered twice a week, and group B (14 cases) with rEPO administration once a week. The initial adminis-tration dosage was 60001U/week. The Ht levels were 22.6±3.3% for group A and 23.2±2.7% for group B before the administration of rEPO, and increased to 31.0±4.0% and 27.7±3.7% respectively twelve weeks after initiating administraion. The levels of effective improvement on anemia included 'markedly effective' in 17 cases (80.9%) and 'effective' in 2 cases (9.5%) in group A, and 'markedly effective' in 5 cases (41.7%) and 'effective' in 3 cases (25.0%) in group B. No significant change was seen in serum creatinine (Cr) levels during the study period. In the evaluation of renal function by reciprocal serum creatinine (1/Cr), a consistent tendency was not recognized; thus, suggesting that the rEPO administration had no effect on the renal function. No variation of blood pressure was seen. As far as side effects were concerned, headache and heavy headedness were recognized in four cases. There were, however, no cases in which the severity of the side effects dictated the discontinuation of the rEPO administration. In conclusion, rEPO was judged to be a safe and effective treatment for the anemia of predialysis patients. |
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| AbstractList | We conducted a multiple-center joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A (28 cases) in which rEPO was administered twice a week, and group B (14 cases) with rEPO administration once a week. The initial administration dosage was 6000IU/week. The Ht levels were 22.6 +/- 3.3% for group A and 23.2 +/- 2.7% for group B before the administration of rEPO, and increased to 31.0 +/- 4.0% and 27.7 +/- 3.7% respectively twelve weeks after initiating administration. The levels of effective improvement on anemia included 'markedly effective' in 17 cases (80.9%) and 'effective' in 2 cases (9.5%) in group A, and 'markedly effective' in 5 cases (41.7%) and 'effective' in 3 cases (25.0%) in group B. No significant change was seen in serum creatinine (Cr) levels during the study period. In the evaluation of renal function by reciprocal serum creatinine (1/Cr), a consistent tendency was not recognized; thus, suggesting that the rEPO administration had no effect on the renal function. No variation of blood pressure was seen. As far as side effects were concerned, headache and heavy headedness were recognized in four cases. There were, however, no cases in which the severity of the side effects dictated the discontinuation of the rEPO administration. In conclusion, rEPO was judged to be a safe and effective treatment for the anemia of predialysis patients.We conducted a multiple-center joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A (28 cases) in which rEPO was administered twice a week, and group B (14 cases) with rEPO administration once a week. The initial administration dosage was 6000IU/week. The Ht levels were 22.6 +/- 3.3% for group A and 23.2 +/- 2.7% for group B before the administration of rEPO, and increased to 31.0 +/- 4.0% and 27.7 +/- 3.7% respectively twelve weeks after initiating administration. The levels of effective improvement on anemia included 'markedly effective' in 17 cases (80.9%) and 'effective' in 2 cases (9.5%) in group A, and 'markedly effective' in 5 cases (41.7%) and 'effective' in 3 cases (25.0%) in group B. No significant change was seen in serum creatinine (Cr) levels during the study period. In the evaluation of renal function by reciprocal serum creatinine (1/Cr), a consistent tendency was not recognized; thus, suggesting that the rEPO administration had no effect on the renal function. No variation of blood pressure was seen. As far as side effects were concerned, headache and heavy headedness were recognized in four cases. There were, however, no cases in which the severity of the side effects dictated the discontinuation of the rEPO administration. In conclusion, rEPO was judged to be a safe and effective treatment for the anemia of predialysis patients. We conducted a multiple-center joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A (28 cases) in which rEPO was administered twice a week, and group B (14 cases) with rEPO administration once a week. The initial administration dosage was 6000IU/week. The Ht levels were 22.6 +/- 3.3% for group A and 23.2 +/- 2.7% for group B before the administration of rEPO, and increased to 31.0 +/- 4.0% and 27.7 +/- 3.7% respectively twelve weeks after initiating administration. The levels of effective improvement on anemia included 'markedly effective' in 17 cases (80.9%) and 'effective' in 2 cases (9.5%) in group A, and 'markedly effective' in 5 cases (41.7%) and 'effective' in 3 cases (25.0%) in group B. No significant change was seen in serum creatinine (Cr) levels during the study period. In the evaluation of renal function by reciprocal serum creatinine (1/Cr), a consistent tendency was not recognized; thus, suggesting that the rEPO administration had no effect on the renal function. No variation of blood pressure was seen. As far as side effects were concerned, headache and heavy headedness were recognized in four cases. There were, however, no cases in which the severity of the side effects dictated the discontinuation of the rEPO administration. In conclusion, rEPO was judged to be a safe and effective treatment for the anemia of predialysis patients. We conducted a multiplecenter joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously administered to 42 predialysis patients (13 males and 29 females) with hematocrit (Ht) levels of less than 30%. The subjects were divided into group A (28 cases)in which rEPO was administered twice a week, and group B (14 cases) with rEPO administration once a week. The initial adminis-tration dosage was 60001U/week. The Ht levels were 22.6±3.3% for group A and 23.2±2.7% for group B before the administration of rEPO, and increased to 31.0±4.0% and 27.7±3.7% respectively twelve weeks after initiating administraion. The levels of effective improvement on anemia included 'markedly effective' in 17 cases (80.9%) and 'effective' in 2 cases (9.5%) in group A, and 'markedly effective' in 5 cases (41.7%) and 'effective' in 3 cases (25.0%) in group B. No significant change was seen in serum creatinine (Cr) levels during the study period. In the evaluation of renal function by reciprocal serum creatinine (1/Cr), a consistent tendency was not recognized; thus, suggesting that the rEPO administration had no effect on the renal function. No variation of blood pressure was seen. As far as side effects were concerned, headache and heavy headedness were recognized in four cases. There were, however, no cases in which the severity of the side effects dictated the discontinuation of the rEPO administration. In conclusion, rEPO was judged to be a safe and effective treatment for the anemia of predialysis patients. |
| Author | SUMIKURA, TOHRU NAKAZORA, HIROSHI MIKI, SHIGEHIRO KAGAWA, SUSUMU IMAGAWA, AKIO MIYAKE, HAYASHI OBAYASHI, SEIICHI NUMATA, AKIRA MIYAKE, SUSUMU TAKARA, MINORU KAIFU, YASUO TAMAMA, SHOJI SHINNO, HIDEKI CHIKAMORI, MASAAKI TAKISHITA, YOSHIHIRO HARADA, ATSUMI MURAKAMI, BONPEI TAKASUGI, KENTA YAMANE, YUKIO MIZUTAN, YOSHIHARU FURUKAWA, ATSUKO HIROHATA, MAMORU SHIRAKATA, MASATO KAWASHIMA, SHU TARUMI, YOSHINAO |
| Author_xml | – sequence: 1 fullname: NAKAZORA, HIROSHI organization: Nakazora Hospital – sequence: 1 fullname: TAKASUGI, KENTA organization: Department of Internal Medicine, Sumitomo Besshi Hospital – sequence: 1 fullname: MIKI, SHIGEHIRO organization: Department of Internal Medicine, National Sanatorium – sequence: 1 fullname: TAMAMA, SHOJI organization: Department of Internal Medicine, Tamama Hospital – sequence: 1 fullname: YAMANE, YUKIO organization: Department of Internal Medicine, Juzen General Hospital – sequence: 1 fullname: HARADA, ATSUMI organization: Kidney Center, Matsuyama Red Cross Hospital – sequence: 1 fullname: TAKARA, MINORU organization: Department of Urology, Matsuyama Nishi Hospital – sequence: 1 fullname: SHINNO, HIDEKI organization: Department of Cardiovascular Surgery, Health Insurance Naruto Hospital – sequence: 1 fullname: MURAKAMI, BONPEI organization: Department of Internal Medicine, Murakami Memorial Hospital – sequence: 1 fullname: MIYAKE, HAYASHI organization: Department of Internal Medicine, Kagawa Central Hospital – sequence: 1 fullname: TAKISHITA, YOSHIHIRO organization: Department of Internal Medicine, Tokushima Prefectural Central Hospital – sequence: 1 fullname: KAIFU, YASUO organization: Kaifu Clinic – sequence: 1 fullname: KAWASHIMA, SHU organization: Department of Internal Medicine, Kawashima Hospital – sequence: 1 fullname: NUMATA, AKIRA organization: Department of Urology, Takamatsu Red Cross Hospital – sequence: 1 fullname: SHIRAKATA, MASATO organization: Department of Surgery, Minami Matsuyama Hospital – sequence: 1 fullname: TARUMI, YOSHINAO organization: Department of Internal Medicine, Minami Matsuyama Hospital – sequence: 1 fullname: SUMIKURA, TOHRU organization: Second Department of Internal Medicine, Kagawa Medical School – sequence: 1 fullname: IMAGAWA, AKIO organization: Department of Urology, Takamatsu Red Cross Hospital – sequence: 1 fullname: OBAYASHI, SEIICHI organization: Department of Internal Medicine, Kinashi Obayashi Hospital – sequence: 1 fullname: KAGAWA, SUSUMU organization: Department of Urology, School of Medicine, The University of Tokushima – sequence: 1 fullname: MIYAKE, SUSUMU organization: Department of Internal Medicine, Kochi Municipal Central Hospital – sequence: 1 fullname: CHIKAMORI, MASAAKI organization: Department of Urology, Chikamori Hospital – sequence: 1 fullname: FURUKAWA, ATSUKO organization: Department of Urology, Takamatsu Red Cross Hospital – sequence: 1 fullname: MIZUTAN, YOSHIHARU organization: Department of Internal Medicine, Kochi Red Cross Hospital – sequence: 1 fullname: HIROHATA, MAMORU organization: Department of Internal Medicine, Mitoyo General Hospital |
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| References | 5) McGonigle RJS, Wallin JD, Shadduck RK, Fisher JW: Erythropoietin deficiency and inhibition of erythropoiesis in renal insufficiency. Kidney Int 25: 437-444, 1984 11) 高久史麿,三村信英,前田貞亮,越川昭三,秋山暢夫,太田和夫,溝口秀昭,丸茂文昭,大坪 修,浦部晶夫,川口良人,秋沢忠男,鈴木好夫,久保和雄,片岡是充,山本 實,三浦 亮,荒川正昭,柴田昌雄,澤西謙次,前川正信,森井浩世,藤見 惺,大澤 炯:腎性貧血に対するrecombinant human erythropoietin(KRN5702)の臨床効果―多施設共同二重盲検比較試験による至適投与量の検討―,腎と透析26:279-306,1989 6) Radtke HW, Rege AB, LaMarche MB, Bartos D, Bartos F, Campbell RA, Fisher JW: Identification of spermine as an inhibitor of erythropoiesis in patients with chronic renal failure. J Clin Invest 67: 1623-1629,1981 2) Eschbach JW, Adamson JW: Anemia of end stage renal disease. Kidney Int 28: 1-5, 1985 18) Myers BD, Deen WM, Robertson CR, Brenner BM: Dynamics of glomerular ultrafiltration in the rat VIII. Effects of hematocrit. Circ Res 36: 425-435, 1975 4) Wallner SF,Vautrin RM:Evidence thatinhibition of erythropoiesis is important in the anemia of chronic renal failure. J Lab Clin Med 97:170-178, 1981 20) Kleinman KS, Schweitzer SU, Perdue ST, Bleifer KH, Abels RI: The use of recombinant human erythropoietin in the correction of anemia in predialysis patients and its effects on renal function: A double blind placebo controlled trial. Kidney Int 35: 229, 1989 9) Eschback JW: Correction of anemia in progressive renal failure with recombinant human erythropoietin (rHuEpo). Kidney Int 35: 193, 1989 1) Adamson JW, Eschbach JW, Finch CA: The kidney and erythropoiesis. Am J Med 44: 725-733, 1968 12) 中塚喜義,日野雅之,三木隆己,西沢良記,田畑 勉,井上 隆,森井浩世:血液透析患者における貧血改善後のリコンビナント・ヒト・エリスロポエチンの維持投与の検討,透析会誌22:1365-1371,1989 17) Garcia DL, Anderson S, Rennke HG, Brenner BM: Anemia lessens and its prevention with recombinant human erythropoietin worsens glomerular injury and hypertension in rats with reduced renal mass. Proc Natl Acad Sci USA 85: 6142-6146, 1988 10) 山崎親雄,小林正樹,伊藤 晃:慢性腎不全保存療法期のrEPO投与,透析会誌24:81-82,1991 15) 高久史麿,二村信英,前田貞亮,清水直容,越川昭三,秋山暢夫,太田和夫,溝口秀昭,大坪 修,二瓶 宏,丸茂文昭,浦部晶夫,川口良人,秋沢忠男,鈴木好夫,久保和雄,大坪公子,赤羽清彬,関口孝,小路良:腎性貧血に対するrecombinant human erythropoietin製剤KRN5702の効果-多施設共同臨床試験-,腎と透析24:1009-1025,1988 7) Delwiche F, Segal GM, Eschbach JW, Adamson JW: Hematopoietic inhibitors in chronic renal failure: Lack of in vitro specificity. Kidney Int 29: 641-648, 1986 16) 前田貞亮,瀬在義則,高久史麿,三村信英,清水直容,宮崎 保,片岡是充,山本 實,三浦 亮,浦部晶夫,黒川 清,秋山暢夫,大坪 修,丸茂文昭,鈴木好夫,太田和夫,久保和雄,溝口秀昭,川口良人,越川昭三,秋沢忠男,柴田昭,荒川正昭,斉藤英彦,柴田昌雄,内野治人,澤西謙次,前川正信,森井浩世,永井清保,木村郁郎,千葉省三,仁保喜之,藤見 惺,大澤 炯:リコンビナント・ヒト・エリスロポエチン(KRN5702)の透析患者の腎性貧血に対する臨床的有用性の検討,腎と透析26:129-150,1989 13) Eschbach JW, Kelly MR, Haley NR, Abels RI, Adamson JW: Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Eng J Med 321: 158-163, 1989 8) 伊藤克己,小松康宏:小児保存期腎不全患者の腎性貧血に対するrEPOの臨床効果について,透析会誌24:31-36,1991 14) Lim VS, DeGowin RL, Zavala D, Kirchner PT, Abels R, Perry P, Fangman J : Recombinant human erythropoietin treatment in predialysis patients. a double-blind placebo-controlled trial. Ann Intern Med 110: 108-114,1989 3) Eschbach JW: The anemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin. Kidney Int 35: 134-148, 1989 19) Lim VS, Fangman J, Flanigan MJ, DeGowin RL, Abels RT: Effect of recombinant human erythropoietin on renal function in humans. KidneyInt 37: 131-136, 1990 |
| References_xml | – reference: 14) Lim VS, DeGowin RL, Zavala D, Kirchner PT, Abels R, Perry P, Fangman J : Recombinant human erythropoietin treatment in predialysis patients. a double-blind placebo-controlled trial. Ann Intern Med 110: 108-114,1989 – reference: 7) Delwiche F, Segal GM, Eschbach JW, Adamson JW: Hematopoietic inhibitors in chronic renal failure: Lack of in vitro specificity. Kidney Int 29: 641-648, 1986 – reference: 16) 前田貞亮,瀬在義則,高久史麿,三村信英,清水直容,宮崎 保,片岡是充,山本 實,三浦 亮,浦部晶夫,黒川 清,秋山暢夫,大坪 修,丸茂文昭,鈴木好夫,太田和夫,久保和雄,溝口秀昭,川口良人,越川昭三,秋沢忠男,柴田昭,荒川正昭,斉藤英彦,柴田昌雄,内野治人,澤西謙次,前川正信,森井浩世,永井清保,木村郁郎,千葉省三,仁保喜之,藤見 惺,大澤 炯:リコンビナント・ヒト・エリスロポエチン(KRN5702)の透析患者の腎性貧血に対する臨床的有用性の検討,腎と透析26:129-150,1989 – reference: 13) Eschbach JW, Kelly MR, Haley NR, Abels RI, Adamson JW: Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Eng J Med 321: 158-163, 1989 – reference: 11) 高久史麿,三村信英,前田貞亮,越川昭三,秋山暢夫,太田和夫,溝口秀昭,丸茂文昭,大坪 修,浦部晶夫,川口良人,秋沢忠男,鈴木好夫,久保和雄,片岡是充,山本 實,三浦 亮,荒川正昭,柴田昌雄,澤西謙次,前川正信,森井浩世,藤見 惺,大澤 炯:腎性貧血に対するrecombinant human erythropoietin(KRN5702)の臨床効果―多施設共同二重盲検比較試験による至適投与量の検討―,腎と透析26:279-306,1989 – reference: 3) Eschbach JW: The anemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin. Kidney Int 35: 134-148, 1989 – reference: 9) Eschback JW: Correction of anemia in progressive renal failure with recombinant human erythropoietin (rHuEpo). Kidney Int 35: 193, 1989 – reference: 8) 伊藤克己,小松康宏:小児保存期腎不全患者の腎性貧血に対するrEPOの臨床効果について,透析会誌24:31-36,1991 – reference: 18) Myers BD, Deen WM, Robertson CR, Brenner BM: Dynamics of glomerular ultrafiltration in the rat VIII. Effects of hematocrit. Circ Res 36: 425-435, 1975 – reference: 12) 中塚喜義,日野雅之,三木隆己,西沢良記,田畑 勉,井上 隆,森井浩世:血液透析患者における貧血改善後のリコンビナント・ヒト・エリスロポエチンの維持投与の検討,透析会誌22:1365-1371,1989 – reference: 20) Kleinman KS, Schweitzer SU, Perdue ST, Bleifer KH, Abels RI: The use of recombinant human erythropoietin in the correction of anemia in predialysis patients and its effects on renal function: A double blind placebo controlled trial. Kidney Int 35: 229, 1989 – reference: 2) Eschbach JW, Adamson JW: Anemia of end stage renal disease. Kidney Int 28: 1-5, 1985 – reference: 4) Wallner SF,Vautrin RM:Evidence thatinhibition of erythropoiesis is important in the anemia of chronic renal failure. J Lab Clin Med 97:170-178, 1981 – reference: 15) 高久史麿,二村信英,前田貞亮,清水直容,越川昭三,秋山暢夫,太田和夫,溝口秀昭,大坪 修,二瓶 宏,丸茂文昭,浦部晶夫,川口良人,秋沢忠男,鈴木好夫,久保和雄,大坪公子,赤羽清彬,関口孝,小路良:腎性貧血に対するrecombinant human erythropoietin製剤KRN5702の効果-多施設共同臨床試験-,腎と透析24:1009-1025,1988 – reference: 17) Garcia DL, Anderson S, Rennke HG, Brenner BM: Anemia lessens and its prevention with recombinant human erythropoietin worsens glomerular injury and hypertension in rats with reduced renal mass. Proc Natl Acad Sci USA 85: 6142-6146, 1988 – reference: 19) Lim VS, Fangman J, Flanigan MJ, DeGowin RL, Abels RT: Effect of recombinant human erythropoietin on renal function in humans. KidneyInt 37: 131-136, 1990 – reference: 1) Adamson JW, Eschbach JW, Finch CA: The kidney and erythropoiesis. Am J Med 44: 725-733, 1968 – reference: 5) McGonigle RJS, Wallin JD, Shadduck RK, Fisher JW: Erythropoietin deficiency and inhibition of erythropoiesis in renal insufficiency. Kidney Int 25: 437-444, 1984 – reference: 10) 山崎親雄,小林正樹,伊藤 晃:慢性腎不全保存療法期のrEPO投与,透析会誌24:81-82,1991 – reference: 6) Radtke HW, Rege AB, LaMarche MB, Bartos D, Bartos F, Campbell RA, Fisher JW: Identification of spermine as an inhibitor of erythropoiesis in patients with chronic renal failure. J Clin Invest 67: 1623-1629,1981 |
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| Snippet | We conducted a multiplecenter joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously... We conducted a multiple-center joint study on the effects of recombinant human erythropoietin (rEPO) for predialysis patients. rEPO was intravenously... |
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| SubjectTerms | Adult Aged Aged, 80 and over Anemia - etiology Anemia - therapy Drug Administration Schedule Erythropoietin - administration & dosage Erythropoietin - therapeutic use Female Humans Kidney Failure, Chronic - complications Male Middle Aged predialysis patients, recombinant human erythropoietin Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Renal Dialysis - adverse effects |
| Title | Study of recombinant human erythropoietin treatment on the anemia of predialysis patients |
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