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

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.