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[皮下每两周注射重组人促红细胞生成素对持续性非卧床腹膜透析(CAPD)患者贫血的维持治疗——一项多中心试验]

[Maintenance therapy on the anemia in continuous ambulatory peritoneal dialysis (CAPD) patients using subcutaneous administration of recombinant human erythropoietin fortnightly--a multicenter trial].

作者信息

Kubota M, Kawaguchi Y, Nomoto Y, Tsuchida H, Nihei H, Kubo K, Omori Y, Babazono T, Ogura Y, Hara S

机构信息

Department of Medicine, Juntendo University.

出版信息

Nihon Jinzo Gakkai Shi. 1993 Sep;35(9):1081-90.

PMID:8230819
Abstract

Eighty-seven CAPD patients whose hematocrit (Ht) level was maintained by recombinant human erythropoietin (rHuEPO) were enrolled in this trial for a new formulation of rHuEPO suitable for subcutaneous injection. 6000IU rHuEPO was administered every 2 weeks for 12 weeks. Fortnightly doses were increased to 9000IU or 12000IU at 4 or 6 weeks if the Ht level decreased by 2% or more. During the study period, Ht values were maintained at the appropriate level in 88% of patients. 6000IU or lower was selected as a maintenance dose given every 2 weeks in 57 (76.0%) patients, 9000IU was selected in 8 patients and 12000IU was chosen in one patient. In 9 patients, the Ht could not be maintained during the study and the appropriate dose, therefore, remained unclear. Hypertension was observed in 2 patients as a side effect, and headache occurred in 2 other patients during the trial. Cutaneous abnormalities were not observed in the course of the subcutaneous injections. We conclude that anemia in most CAPD patients could be controlled with fortnightly injections in the dose range of 6000 to 12000IU rHuEPO given subcutaneously.

摘要

87名通过重组人促红细胞生成素(rHuEPO)维持血细胞比容(Ht)水平的持续性非卧床腹膜透析(CAPD)患者参加了本次试验,以研究一种适合皮下注射的rHuEPO新制剂。每2周给予6000IU rHuEPO,共12周。如果Ht水平下降2%或更多,则在4周或6周时将每两周的剂量增加至9000IU或12000IU。在研究期间,88%的患者Ht值维持在适当水平。57名(76.0%)患者选择每2周给予6000IU或更低剂量作为维持剂量,8名患者选择9000IU,1名患者选择12000IU。9名患者在研究期间Ht无法维持,因此合适的剂量仍不清楚。试验期间观察到2名患者出现高血压副作用,另外2名患者出现头痛。皮下注射过程中未观察到皮肤异常。我们得出结论,大多数CAPD患者的贫血可以通过每两周皮下注射6000至12000IU rHuEPO来控制。

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