B Ba ac ck kg gr ro ou un nd d: : The primary objective of this study was to assess the number of erythropoietin (EPO) injections required to reach a hematocrit (Ht) of 40% in moderately anemic patients. The secondary objective was to compare this strategy with autologous blood donation (ABD) in elective orthopedic surgery in terms of red blood cell (RBC) production.S St tu ud dy y d de es si ig gn n a an nd d m me et th ho od ds s: : 93 patients with a baseline Ht between 30 and 39% were randomized into two groups the day of the preoperative assessment. In the EPO group, patients received 40,000 UI/week sc until they reached a maximal Ht of 40%. In the ABD group, a RBC pack was collected every week as long as the Ht was above 33%.R Re es su ul lt ts s: : Two EPO injections were necessary to reach a 40% Ht in 63% of the patients. It was possible to collect two RBC packs in 45% of the patients in the ABD group. Volume of RBC production was significantly higher in the EPO group: 268 ± 142 mL vs 141 ± 129 (P = 0.0001). In the EPO group, Ht was significantly higher on days one and three after surgery and at discharge. The energy score was better in the EPO group. In the ABD group, 12.6% patients vs 6.5% in the EPO group received allogeneic transfusion (ns).C Co on nc cl lu us si io on n: : Only two EPO injections were sufficient to reach a Ht of 40% in the majority of patients. Therefore, to improve cost/effectiveness, the number of EPO injections should be related to baseline Ht instead of the four injections recommended in the product monograph. Objectif : Évaluer le nombre d'injections d'érythropoïétine (EPO) nécessaires pour atteindre un hématocrite (Ht) de 40 % chez des patients modérément anémiques. Aussi, comparer cette stratégie avec le don de sang autologue (DSA) en chirurgie orthopédique réglée en termes de production de globules rouges (GR). Méthode : Des patients (n = 93) présentant un Ht de base de 30 à 39 % ont été répartis en deux groupes le jour de l'évaluation
Between March 1992 and August 1993, thirty patients with hairy cell leukemia (HCL) were treated in a single institution with 2-chlorodeoxyadenosine (2-CdA) for one course (N=27) or two courses at six month interval (N=3). Sixteen patients were previously untreated, 14 had been treated with alpha interferon (alpha IFN) (N=5), alpha IFN and splenectomy (N=8) and splenectomy, alpha IFN and Deoxycoformycin (N=1). Overall results in 29 evaluable patients were: 25 CR (86%), 3 PR (10%), one failure. The three PR patients relapsed after 18, 24 months and five years. Two were retreated successfully. Two CR patients relapsed after five years. Careful clinical survey, sequential bone marrow biopsies (BMB) with DBA44 immunostaining for assessment of response and detection of residual disease and serially evaluation of lymphocyte subsets counts were performed. Results of bone marrow biopsies study show 1) a progressive reduction in hairy cell infiltration during the first six months after therapy and not after that indicating that the best moment for the evaluation of response may be the sixth month, 2) the persistence of a very small number of DBA44+ cells (80% of BMB). There was a correlation between the presence of > 5% DBA44 positive cells on 6th month BMB and relapse. 60% had an absolute CD4+ lymphocyte count less than 0.2 10(9)/l at least on one examination after treatment. CD4+ lymphocyte level persisted less than baseline level in 8/18 patients tested after four and/or five years. Lymphopenia was less marked in splenectomized patients: 7/7 splenectomized patients tested have recovered a CD4+ lymphocyte count equal to pretherapy level compared to 3/11 non splenectomized patients (p: 0.004). Three opportunistic infections were observed early (first 6 months) after 2CdA therapy: pneumocystis pneumonia, retinitis due to toxoplasma in the patient who failed and legionella pneumonia in a patient retreated after relapse. Two patients developed a second carcinoma 6 and 12 months after therapy. Five patients died, three from a cause unrelated to HCL, one from HCL and one from infection while in second CR. At five years, overall survival is 83% and progression free survival is 66%. Our study shows 1) long-lasting response in the majority of patients after 2-CdA, 2) a correlation between persistent minimal residual disease detected with DBA44 immunostaining and occurrence of relapse and 3) a profound and persistent CD4+ lymphopenia more marked in non splenectomized patients.
We studied the efficacy of high doses (100,000 IU intravenously (IV)/twice a week) of human recombinant erythropoietin (rHuEpo) in patients with transfusion dependent myelodysplastic syndromes (MDS). Rationale for such dose of IV Epo was the poor in vitro response of MDS erythroid progenitors (CFU-E) to physiological concentrations of Epo, and the usual high endogenous serum Epo levels of MDS patients. Seventeen patients (nine males, eight females) were included, five refractory anaemia (RA), six RA with blasts excess (RAEB), five RA with ringed sideroblasts (RARS). Tolerance was good, except in three patients who experienced severe flu-like syndrome after Epo injection. None of the patients showed hypertension or developed anti rHuEpo antibodies. Three patients (17.6%) with RAEB had 35-60% reduction of transfusion requirements. No progression of disease occurred. Percentage of erythroblasts, endogenous baseline Epo level and in vitro cultures of erythroid progenitors did not correlate with response to Epo treatment. This study shows that very high IV doses induce only seldom and partial improvement in the status of transfusion dependent MDS. This rate of response, not higher than described with lower dosage, probably represents the maximum expectable response to rHuEpo in this category of patients.
As the importance of recombinant human erythropoietin (r-HuEPO) therapy has been clearly demonstrated in anaemic patients with chronic renal failure (CRF), we carried out an open, non-randomized, non-placebo-controlled trial of high-dose intravenous (i.v.) r-HuEPO (100,000 U twice weekly) therapy in 14 anaemic, transfusion-dependent patients. Clinical response was defined by a rise in haemoglobin concentration to 9-11 g/dl and/or a reduction in the transfusion requirement during the treatment period compared with the 12 weeks before treatment. Eight patients completed the 12-week treatment and 4 were still under treatment, 1 at 10 weeks, 2 at 8 weeks and 1 at 4 weeks. Only those patients completing treatment were included in the efficacy evaluation. After treatment there was no significant change in haemoglobin concentrations, reticulocyte counts, or transfusion requirements. However, the number of patients included is too low to allow any definitive conclusion to be made.
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