Hema e-Chart: Italian Registry for prospective analysis of epidemiology, management and outcome of febrile events in patients with hematological malignancies.

The aim of the study was to create a prospective computerized registry to collect and analyze febrile events, particularly due to fungal infections, in patients with hematological malignancies. A systematic approach that starts from the registration of new diagnosis and complete follow-up can be of help for the study of treatment and evolution of these complications. The software allows several concurrent users to create and manage medical information in a website. Its aim is to improve the speed, quality and integration of information related to subjects with febrile event, ultimately resulting in improving patients' care.Patients included adults and children with acute and chronic myeloid or lymphoid leukemia, Hodgkin's and non-Hodgkin's lymphoma, myelodysplastic syndrome, or multiple myeloma. The registry also included data regarding event onset in hematopoietic stem cell transplants (HSCTs). In order to evaluate the incidence of febrile events, all new diagnoses of hematological malignancy and all HSCTs were reported.The Hema e-Chart can be a very useful network collecting information about febrile events in patients with hematological malignancy and HSCTs. Significant trends and treatment practices are expected to be observed. As enrollment continues, data will be analyzed and published, which will provide valuable information concerning the epidemiology, therapy, and outcome of infectious complications.

Assessment of human herpesvirus-6 infection in mesenchymal stromal cells ex vivo expanded for clinical use.

Infection or reactivation of human herpesvirus (HHV)-6 represents a potentially serious complication (often involving the central nervous system) in patients receiving either solid organ or hematopoietic stem cell transplantation. The objective of this study was to assess the risk of HHV-6 infection/reactivation in mesenchymal stromal cells (MSCs). MSCs are multipotent cells displaying immunomodulatory properties that have been already successfully used in the clinical setting to enhance hematopoietic stem cell engraftment and to treat steroid-refractory acute graft-versus-host disease. We analyzed 20 samples of ex vivo expanded MSCs, at different passages of culture, isolated both from bone marrow and from umbilical cord blood. Through Western blotting and immunocytochemistry techniques, we investigated the presence of the HHV-6 receptor (CD46) on cell surface, whereas the presence of HHV-6 DNA was evaluated by nested polymerase chain reaction assay. All of the MSC samples tested were positive for the virus receptor (CD46), suggesting their potential susceptibility to HHV-6. However, none of the MSC samples derived from cultures, performed in the perspective of clinical use, was found to harbor HHV-6. This preliminary observation on a consistent number of MSC samples, some of them tested at late in vitro passages, indicates a good safety profile of the product in terms of HHV-6 contamination. Nevertheless, it remains important to set up in vitro experimental models to study MSCs' susceptibility to HHV-6 (and HHV-7) infection, to verify their capacity to integrate the virus into cellular DNA, and to investigate which experimental conditions are able to induce virus reactivation.

A long-term time course of colorimetric assessment of the effects of imatinib mesylate on skin pigmentation: a study of five patients.

BACKGROUND: Imatinib mesylate (IM), the first-line treatment of chronic myeloid leukaemia (CML), is a tyrosine kinase inhibitor that targets those proteins involved in BCR-ABL signal transduction in CML, c-kit (KIT) and platelet-derived growth-factor (PDGFR) receptor. The use of IM has been associated with cutaneous reactions. In the last 2 years numerous studies have focused the attention on hypopigmentations, depigmentations and photosensitivity developing after the initiation of IM therapy. OBJECTIVE: The aim of this study is to evaluate the effects of IM therapy on the skin pigmentation of five patients affected by CML. METHODS: Skin pigmentation measurements were performed with a Minolta CR-200 Chromameter. results: All the studied patients show the gradual lightening of the skin on unexposed areas over the treatment with IM. In particular, this explorative colorimetric study indicates the association between IM and skin depigmentation with a significant increase of luminance value (L*) (P = 0.001) and a significant decrease of the pigmentation value (b*) (P = 0.028). CONCLUSION: Even if we do not know the clinical significance of the skin depigmentation caused by IM, the regulatory role of KIT and its ligand stem cell factor in melanocyte development and survival seems to suggest an objective mechanism of action for IM in the pathogenesis of this cutaneous depigmentation.

Peritoneal transport assessment by peritoneal equilibration test with 3.86% glucose: a long-term prospective evaluation.

The peritoneal equilibration test (PET) with 3.86% glucose concentration (3.86%-PET) has been suggested to be more useful than the standard 2.27%-PET in peritoneal dialysis (PD), but no longitudinal data for 3.86%-PET are currently available. A total of 242 3.86%-PETs were performed in 95 incident PD patients, who underwent the first test during the first year of treatment and then once a year. The classical parameters of peritoneal transport, such as peritoneal ultrafiltration (UF), D/D(0), and D/P(Creat), were analyzed. In addition, the absolute dip of dialysate sodium concentration (DeltaD(Na)), as an expression of sodium sieving, was studied. D/D(0) was stable, and a progressive decrease in UF was observed after the second PET, whereas D/P(Creat) firstly increased and then stabilized. DeltaD(Na) was the only parameter showing a progressive decrease over time. On univariate analysis, D/D(0) and DeltaD(Na) were found to be significantly associated with the risk of developing UF failure (risk ratio (RR) 0.987 (0.973-0.999), P=0.04, and RR 0.768 (0.624-0.933), P=0.007, respectively), but on multivariate analysis only DeltaD(Na) showed an independent association with the risk of developing UF failure (RR 0.797 (0.649-0.965), P=0.020). UF, D/D(0), and D/P(Creat) changed only in those patients developing UF failure, reflecting increased membrane permeability, whereas DeltaD(Na) significantly decreased in all patients. The 3.86%-PET allows a more complete study of peritoneal membrane transport than the standard 2.27%-PET. DeltaD(Na) shows a constant and significant reduction over time and is the only factor independently predicting the risk of developing UF failure in PD patients.

How to determine ionic dialysance for the online assessment of delivered dialysis dose.

BACKGROUND: Ionic dialysance may be equivalent to blood-water urea clearance corrected for recirculation (effective urea clearance); however, this is controversial. The aims of our study were (1) to verify in vivo whether the value of ionic dialysance is affected by the method of determination, given the effect of cardiopulmonary recirculation on inlet plasma water conductivity when the inlet dialysate conductivity is changed; and (2) to define the operative modalities for determining ionic dialysance to obtain an adequate estimate of effective urea clearance. METHODS: Thirty-three hemodialysis patients were studied during 186 dialysis sessions with low-flux polysulfone dialyzers using a modified Fresenius Medical Care 4008 B machine equipped with meters to measure inlet and outlet dialysate conductivities. This machine varied inlet dialysate conductivity (Cdi) according to the following pattern: starting from baseline (step 0), Cdi was increased by 8% (step 1). After Cdi had reached the target value, which took 8 to 10 minutes, it was lowered to 8% below the baseline value (step 2). After 8 to 10 minutes, when Cdi had reached the new target, it was returned to its starting value (step 3). Four values of conventional ionic dialysance (using the standard formula) and actual ionic dialysance (taking into account cardiopulmonary recirculation) were obtained for each cycle and were compared among them and with effective urea clearance (Kde). RESULTS: Mean conventional dialysance values at steps 0 to 2 and 2 to 3 (190 and 189 mL/min) were similar and higher than those at steps 0 to 1 and 1 to 2 (171 and 181 mL/min). Mean conventional ionic dialysance values underestimated Kde, particularly at steps 0 to 1 (-22.2 mL/min, P < 0.001) and 1 to 2 (-12.6 mL/min, P < 0.001). The actual dialysance values underestimated Kde by no more than 4.3 mL/min (P < 0.001). In steps 0 to 1 and 1 to 2, the underestimate of Kde by conventional dialysance increased at higher values of Kde, but this relationship did not exist when considering actual dialysance. CONCLUSIONS: The value of ionic dialysance is affected by the method of determination, given the effect of cardiopulmonary recirculation on inlet plasma water conductivity when inlet dialysate conductivity is changed. As a consequence, to provide a correct and direct estimate of effective urea clearance, ionic dialysance must be determined by changing inlet dialysate conductivity in such a way as to keep inlet plasma water conductivity constant by means of two symmetrical high and low dialysate conductivity steps.

Technical-economic management models in dialytic treatment: an evolving reality. The Italian experience.

Health care organisations and financial factors (particularly treatment reimbursement rates) may influence the management of ESRD. We analysed the organisation of renal replacement therapy (RRT) in Italy, focusing on RRT population trends, patient distribution by treatment modality and provision, reimbursement rates, accreditation and quality control. Data from the Italian Dialysis and Transplant Registry and market research studies indicate that Italy has one of the highest dialysis and treatment acceptance rates in Europe. There is a high rate of hemodialysis (HD) and good use of peritoneal dialysis (PD), whereas the prevalence of transplanted patients is lower than the European mean. Dialytic treatment in private centers is limited by law to HD (mainly in Central-Southern Italy) and covers nearly 25-30% of the demand for RRT which means that, although Italy has a public national health care system, the provision of RRT is based on a "mixed" model. Regions with a higher prevalence of "private" dialysis have more dialysis centers, but a lower prevalence of PD since it is not permitted in private facilities, and fewer transplanted patients. The "public" system is not an automatic guarantee of quality and efficacy, and the "private" system is not necessarily a synonym of poor quality treatment due to its need to make a profit. The coexistence of private and public facilities (if well balanced and integrated) may in fact help overcoming bureaucracy in the public administration in relation to the demand for innovation and improving performances by means of fair competition.

A model for analysing the cost of autologous peripheral blood progenitor cell (PBPC) transplantation.

Data from autologous peripheral blood progenitor cell (PBPC) transplant recipients were used for cost analysis and modelling so as to link the main intervention procedures and clinical events to resource use and costs. This cohort consisted of 64 patients from 4 to 62 years old at transplantation (mean, 36.9 years) who underwent a first transplant between August 1994 and May 1997. The main indications for transplantation were non-Hodgkin's lymphomas (47%), multiple myeloma (30%) and Hodgkin's lymphomas (15%). The course of a patient during the whole transplant procedure was modelled using a Markov chain of six states of health: (1) mobilisation and recovery of PBPC; (2) post-mobilisation phase; (3) conditioning and transplant; (4) critical haematological reconstitution; (5) non-critical haematological reconstitution; (6) death. The probability of transition between the different health states, together with the estimated costs, were the input for the Markov model. The model also managed transition probabilities depending both on the current health state and on various demographic, clinical and procedure-related covariates unique to the patient. The expected time spent in each clinical state and the expected total cost were, therefore, estimated. This analysis gave an actual total cost per transplanted patient of $26,600 (95% range: $24,700 to $43,500) while mean duration was 197 days. The expenses for in-hospital stay accounted for 80% of the costs. Both the probability of staying in the different states, and the consequent cost were dependent on the number of CD34-positive cells collected, the phase and the type of the disease, the subset of patients (either children or adults), and the post-transplant G-CSF prophylaxis. The sensitivity of the estimates to alternative assumptions was studied, and the method of comparing alternative future scenarios by the model was explored.

Retrospective survival analysis and cost-effectiveness evaluation of second allogeneic bone marrow transplantation in patients with acute leukemia. Gruppo Italiano Trapianto di Midollo Osseo.

The therapeutic options for patients with acute leukemia who relapse after the initial transplant include second bone marrow transplantation (2BMT) and conventional chemotherapy (CC). In this work, we conducted an analysis of published survival data and we evaluated the cost-effectiveness of 2BMT in comparison with CC. We retrieved survival information on 167 patients treated with 2BMT and 299 patients treated with CC. Survival figures were derived from individual patient data and were compared between 2BMT and CC. The mean lifetime survival (MLS) was estimated for each of the two patient cohorts using standard techniques of survival-curve extrapolation. The cost data of patients given 2BMT or CC were estimated from published data. Our analysis of individual survival data showed that 2BMT improved survival at levels of statistical significance (survival gain = 19.6 months per patient). Using an incremental cost of $90000 per patient, the cost-effectiveness ratio of 2BMT in comparison with CC was calculated as $52215 discounted dollars per discounted life year gained. Our results indicate that, in patients with acute leukemia who relapse after their first transplant, 2BMT significantly prolongs survival in comparison with CC and seems to have an acceptable cost-effectiveness profile.

On-line assessment of delivered dialysis dose.

BACKGROUND: The adequacy of the delivered dialysis dose is essential to prevent patient morbidity and mortality. The determination of effective ionic dialysance (D) is easy, non-invasive and inexpensive, and its use instead of effective urea clearance (K) in kinetically determining apparent" urea distribution volume (Vt) is likely to lead to a correct Kt/V, even though the Vt value may be incorrect. The aim of this study was to test the possibility of using the measurement of D to monitor Kt/V on-line during each dialysis treatment. METHODS: Forty-four patients were dialyzed using a monitor equipped with specially designed "Diascan Module" (COT; Hospal) that measures effective D by means of a single conductivity probe. Vt was calculated according to the SPVV three BUN method urea kinetic model using D instead of K values. One month later, Kt/V was calculated as Dt/V, using actual D and T values and the predetermined Vt values updated for the current final body wt. Both the Dt/V and Kt/V determined according to the Smye and Daugirdas methods were compared with the Kt/V determined using the SPVV kinetic model (Kt/Veq) RESULTS: The Kt/V values calculated using ionic dialysance and predetermined Vt were approximately equivalent to those of Kt/Veq (1.14 +/- 0.16 vs. 1.14 +/- 0.17, mean difference 0.00 +/- 0.07), as were those determined according to the Smye and Daugirdas methods (1.10 +/- 0.18 and 1.13 +/- 0.17, mean difference -0.03 +/- 0.06 and 0.01 +/- 0.06, respectively). CONCLUSION: Once Vt has been determined, the evaluation of ionic dialysance in stable patients makes it possible to calculate the Kt/V accurately at each dialysis session without blood or dialysate sampling, and at no additional cost.

G-CSF administration following peripheral blood progenitor cell (PBPC) autograft in lymphoid malignancies: evidence for clinical benefits and reduction of treatment costs.

Clinical value and costs of G-CSF administration following autograft with mobilized peripheral blood progenitor cells (PBPC) were evaluated in two sequential groups of 20 patients each, treated for lymphoid neoplasms in the period February 1993 to January 1996. One group was given G-CSF (Filgrastim) (5 microg/kg/day), starting on day +1 until ANC was > 500/microl, the other received no G-CSF. All patients were conditioned with mitoxantrone 60 mg/m2 + L-PAM 180 mg/m2 and received large numbers of PBPC (median of 12 and 13 x 10(6) CD34+/kg, respectively). The median time to ANC > 500/microl was 10 days in the G-CSF group vs 14 days in controls (P < 0.0001). G-CSF was associated with a slightly faster platelet recovery (11 vs 13 days to plts > 20000/microl, P = 0.09). Median duration of fever (2.5 vs 5 days, P = 0.028), nonprophylactic antibiotics (8 vs 11 days, P = 0.019), and post-transplant hospitalization (13 vs 16 days, P = 0.0028) were also significantly reduced. The average cost per treatment in the G-CSF group amounted to about US$18241 as compared to US$21868 in the control group, implying a cost reduction of approximately 16%. Thus, G-CSF reduced morbidity with cost containment, supporting its use even if autograft is performed with large quantities of PBPC.

Intradermal versus intramuscular hepatitis b re-vaccination in non-responsive chronic dialysis patients: a prospective randomized study with cost-effectiveness evaluation.

BACKGROUND: It has been calculated that 30% of chronic uraemic patients fail to produce antibodies to HBsAg antigen after hepatitis B (HB) vaccination. Low-dose intradermal (i.d.) inoculations and supplementary intramuscular (i.m.) injections have been reported to improve the response rate in previous non-responder chronic uraemic patients, but no cost-effectiveness evaluations have been made about this issue. METHODS: We re-vaccinated 50 chronic dialysis patients, who did not have any detectable anti-HBs antibody after a reinforced protocol of hepatitis B vaccine given by i.m. route, with hepatitis B recombinant DNA yeast vaccine (80 micrograms) by intradermal (25 patients) or intramuscular (25 patients) administration (randomly allocated). We used the same amount of HBsAg in order to exclude the confounding effect of the dose level administered on the immune response of uraemic patients. We studied, over a 20-month follow-up, the persistence of anti-HBs antibodies in our responder vaccinees. We made a comparison between the costs of our re-vaccination protocol and the other re-vaccination strategies that have been recently suggested. RESULTS: One month after completion of re-vaccination protocol, seroconversion rates (100% vs 48%, P = 0.008) and proportion of patients who elicited protective anti-HBs titres (96% vs 40%, P = 0.0001) were significantly higher in i.d. compared to i.m. patients. The levels of anti-HBs expressed as geometric mean titres and 95% confidence intervals (GMT (95% CI)), were significantly increased in i.d. than in i.m. groups, 100 (44-187) vs 26 (14-52) mUI/ml (P = 0.018). At month 12, the seroconversion rates were 57 vs 14% in i.d. and i.m. groups respectively (P = 0.158); the seroprotection rate was higher in i.d. individuals in comparison with i.m. patients, 50 vs 0%, P = 0.072. At month 20, the seroconversion rates were 54 and 0% among i.d. and i.m. patients respectively (P = 0.055); the seroprotection rate was higher in i.d. than in i.m. group (30 vs 0%, P = 0.2). At month 20, the median anti-HBs titres in i.d. patients were 21 mUI/ml, and GMT (95% CI) were 20.9 (2-54) mUI/ml. No important general or local side-effects were observed. The cost of our schedule was $92 US whereas the costs of other re-vaccination protocols ranged between 138 and $807 US. CONCLUSIONS: Our results show that the unresponsiveness to recombinant yeast-derived vaccine may be mostly reversed by repeated low-dose i.d. injections of the same agent. In spite of an equal amount of HBsAg received, i.d. hepatitis B re-vaccination shows higher immunogenicity compared to i.m. administration over a 20-month observation period. Cost-effectiveness analysis demonstrated that the intradermal administration of HB vaccine is the most clinically effective re-vaccination strategy; it is also the most unexpensive one. We strongly recommend low-dose intradermal inoculations in order to re-vaccinate chronic dialysis patients who fail to respond to hepatitis B vaccination.

Serologic survey for control of hepatitis C in haemodialysis patients: third-generation assays and analysis of costs.

There is little information about the serologic survey for control of hepatitis C by using third-generation assays among chronic haemodialysis (HD) patients, and no analysis of costs has been made to this end. A serologic survey for control of hepatitis C was performed in 190 HD patients attending a single dialysis unit, using second- and third-generation assays. Costs of both serologic surveys were calculated. Anti-HCV prevalence tested by third-generation assays increased from 25% (48/190) to 28% (53/190) compared to second-generation testing; 56% (9/16) of patients showing uncertain findings by second-generation tests gave unequivocal results by third-generation assays; median duration of HD treatment and raised aminotransferase levels were positively associated (P = 0.004 and P = 0.012, respectively) with anti-HCV detected by third-generation assays. The serologic survey for control of hepatitis C in HD patients at our centre was slightly more expensive by third-generation assays compared to second-generation testing (US$18866 vs US$17200 per year). In summary, the use of third-generation tests largely clarified the uncertain results of second-generation tests; new additional positive patients were detected by third-generation assays compared to second-generation testing. Third-generation assays showed the association of duration of HD treatment and raised aminotransferase levels with anti-HCV antibody, as previously found by first- and second-generation assays. To date, third-generation screening and confirmatory assays seem extremely useful in the serologic survey for control of hepatitis C in HD centres without a considerable outlay.

'Pulse oral' versus intravenous calcitriol therapy in chronic hemodialysis patients. A prospective and randomized study.

The aim of this prospective and randomized study was to compare the efficacy, side effects, and costs of 'pulse oral' versus intravenous calcitriol in the treatment of secondary hyperparathyroidism in hemodialysis (HD) patients. A total of 20 patients were randomized to receive over a 4-month period pulse orally administered calcitriol (pulse oral group; n = 10) or intravenous calcitriol (intravenous group; n = 10). All patients used standard dialysate calcium (1.75 mmol/l) throughout the study period. In accordance with the study design calcium dialysate concentrations were reduced when this was necessary to avoid hypercalcemic crises. The patients were stratified into two subgroups according to their initial serum PTH levels: patients with mild or moderate degree of hyperparathyroidism (17 patients) and patients with severe hyperparathyroidism (3 patients). Intravenous and pulse oral cacitriol did not significantly reduce serum PTH concentrations in patients with severe hyperparathyroidism (1,157 +/- 156 vs. 807 +/- 228 pg/ml [corrected], p = 0.09). Intermittent calcitriol, administered by intravenous or oral route, significantly reduced serum PTH levels (326 +/- 119 vs. 109 +/- 79 pg/ml [corrected], p = 0.0001) in patients with mild or moderate hyperparathyroidism. In patients with mild or moderate hyperparathyroidism, intravenous calcitriol significantly reduced PTH concentrations at the end of the 1st month, before the increase of serum ionized calcium levels, whereas 'pulse oral' calcitriol significantly suppressed parathyroid activity at the end of the 2nd month. Calcium dialysate concentration was reduced in 9 out of 10 (90%) patients of the pulse oral group and in all patients (10/10) of intravenous group. The incidence of hypercalcemic crises was 24% (39/160) in the pulse oral group and 14% (27/160) in the intravenous group. Analysis of costs showed that intravenous calcitriol was more expensive compared to pulse oral calcitriol. These data indicate that intermittent intensive calcitriol therapy, regardless of the route of administration, is effective in suppressing parathyroid activity in HD patients with mild or moderate hyperparathyroidism. In contrast, intermittent calcitriol therapy has a limited ability to achieve sustained serum PTH reductions in HD patients with severe hyperparathyroidism. Intravenous calcitriol was more expensive than pulse oral calcitriol, and we recommend the use of pulse oral calcitriol in HD patients with mild or moderate secondary hyperparathyroidism.

Use of recombinant human granulocyte colony-stimulating factor in children given allogeneic bone marrow transplantation for acute or chronic leukemia.

The role of recombinant human granulocyte colony-stimulating factor (rHuG-CSF) in myeloid recovery of children given an allogeneic bone marrow transplant (BMT) from an HLA-identical sibling for acute leukemia was evaluated in a retrospectively historically controlled study, involving 20 consecutive treated patients and 30 historical controls. In order to investigate the efficacy of rHuG-CSF in patients given a matched unrelated BMT with methotrexate as part of graft-versus-host disease (GVHD) prophylaxis, we also analyzed the kinetics of engraftment in eight further children with acute or chronic leukemia, transplanted using a volunteer donor. Patients were treated with 5 micrograms/kg/day of rHuG-CSF by 1-h intravenous infusion from day +5 until the absolute neutrophil count (ANC) was > or = 2 x 10(9)/l. No adverse effect related to treatment was observed in any patients. Children transplanted from an HLA-identical sibling and treated with rHuG-CSF reached an ANC count greater than 0.5 x 10(9)/l, 1 x 10(9)/l and of 2 x 10(9)/l in a significantly shorter time than the control group (day +9, +10 and +12, vs day +15, +22 and +29, respectively). An accelerated granulocyte production was also observed in patients receiving an unrelated transplant after a GVHD prophylaxis schedule including methotrexate, the median time to neutrophil recovery above 0.5 x 10(9)/l, 1 x 10(9)/l and 2 x 10(9)/l being +14, +15 and +17 days, respectively. In comparison to historical controls, all rHuG-CSF-treated patients had fewer days of fever, of antibiotic therapy and, only for children with HLA-compatible siblings, of hospitalization, whereas in the three groups the duration and severity of mucositis were comparable. No difference between the rHuG-CSF-treated patients and the historical controls given BMT from HLA-identical sibling was seen with regard to incidence of acute or chronic GVHD, relapse rate and actuarial event-free survival at day +100 and 1 year after transplantation. Our data suggest that in children given allogeneic BMT for acute or chronic leukemia, rHuG-CSF reduces duration of neutropenia, without increasing the rate of relapse or the incidence and severity of GVHD.

Recombinant hepatitis B vaccine use in chronic hemodialysis patients. Long-term evaluation and cost-effectiveness analysis.

The prevalence of hepatitis B virus (HBV) infection in our unit was 45% (86/190); there were 77 (40.5%) and 9 (4.7%) patients with previous and persistent HBV infection, respectively. Recombinant hepatitis B vaccine was given to 118 chronic HD patients with a regimen of 3 double doses administered intramuscularly at 0, 1 and 2 months, obtaining a seroprotection rate of 67% (79/118), 57% (45/79) being high responders. At month 24, 78% (40/51) maintained protective levels of anti-HBs, 45% (18/40) of them being high responders. There was a statistically significant difference between responder and non-responder patients with regard to nutritional parameters such as serum total proteins and mean levels of transferrinemia. The number of diabetic patients was significantly increased in the nonresponder group. Patients with persistent antibodies ('persistent responders') were younger and had a shorter duration of HD treatment compared to those responders who rapidly lost anti-HBs ('transient responders'). Serological positivity for antibodies against hepatitis B core antigen significantly facilitates the decrease of anti-HBs antibodies over time. We detected seven episodes of HBV infection among HD patients at our unit before the beginning of the vaccination program. On the contrary, there were no episodes of HBV infection among responder vaccinees during the 24-month follow-up period. After the initial cost of vaccination, a savings of US$ 3,272 per year was realized by the elimination of frequent serologic screening of vaccine responders.

Use of recombinant human erythropoietin after bone marrow transplantation in pediatric patients with acute leukemia: effect on erythroid repopulation in autologous versus allogeneic transplants.

We carried out a pilot study on the use of recombinant human erythropoietin (rHuEPO) in children undergoing allogeneic or mafosfamide-purged autologous BMT for ALL or AML. rHuEPO was administered intravenously at a dose of 75 U/kg/day for 30 days after transplant. Ten rHuEPO-treated patients receiving allogeneic BMT and 10 given autologous BMT were compared with 15 allogeneic and 10 autologous historical controls. Endogenous EPO production was appropriate for the degree of anemia after autologous BMT. In these patients, rHuEPO did not accelerate erythroid repopulation and did not modify transfusion requirements. With allogeneic BMT, erythroid marrow activity increased faster in patients given rHuEPO than in controls and resulted in higher red cell production, the mean reticulocyte count on day +30 being 187 +/- 51 x 10(9)/l in treated patients versus 107 +/- 63 x 10(9)/l in controls (p < 0.01). The total number of RBC units administered was 1.7 +/- 1.3 in the rHuEPO group versus 5.1 +/- 3.0 in the control group (p < 0.001). The total number of platelet transfusions was 4.0 +/- 2.3 for patients given allogeneic BMT and receiving rHuEPO versus 8.4 +/- 6.8 for historical controls (p < 0.05) whereas it was similar in rHuEPO-treated and control autologous BMT patients.(ABSTRACT TRUNCATED AT 250 WORDS)