[Can anemia be corrected in hemodialysis patients with thalassaemia minor? ]. / La correzione dell'anemia nei pazienti in emodialisi con Talassemia minor e' possibile?

BACKGROUND: Anemia is an important negative prognostic factor for dialysis patients, whose correction reduces hospitalisation and mortality. Besides, the presence of the thalassaemia minor (Thal-m) in haemodialysed patients causes erythropoietin resistance and more serious anemia. The goal of this study is the correction of anemia (Hb >11 g/dL) in haemodialysed Thal-m patients. MATERIALS AND METHODS: Multicentric, prospective and controlled 12-month study for the correction of anemia (up to values ranging from 11 to 12 g/dL) followed by a 12-month observation period. Ten Thal-m patients with inadequate anemia correction were studied after therapy with rHuEPO. Their age at the beginning of the study was 62.8+/-4 years while their dialytic age was 89+/-20 months. RESULTS: During the study we observed no changes in dry weight (p=NS), no increase in interdialytic weight (p=NS), cardiac frequency (p=NS), serum albumin (p=NS), serum aluminium (p=NS), PTH (p=NS), URR (p=NS), flow FAV (p=NS), TSAT (p=NS) and ferritin (p=NS) (maintained at their optimal values by means of intravenous therapy with trivalent iron. The hypotensive therapy (1.6 drug/patient/year) required no modifications during the 24-month study. The rHuEPO dose varied from 200.3+/-94.3 to 286.6+/-116.2, 317.0+/-119.5, 446.9+/-142.3, and 407.0+/-130.5 U/kg/wk (p < 0.0001 vs. initial value) (from the start to the 3rd, 6th, 9th and 12th month, respectively). The dose was subsequently reduced to 385.2+/-119.7 U/kg/wk at 15 months (p < 0.0001 vs. initial value) and remained unchanged until the end of the study. Simultaneously, the Hb values at corresponding times were 9.2+/-0.9, 9.4+/-1.1, 10.2+/-1.4, 10.9+/-1.5, 11.2+/-1.4 and 11.0+/-1.4 (p=0.002 vs. initial value). The correction of anemia produced progressive reduction in cardiac mass from 141+/-12 to 120+/-10 and 110+/-8 g/mq at the beginning, 12th month and 24th month (p < 0.0001), respectively. During the study the hospitalisation time was 4.3+/-1.2 day/patient/year during the 3-month run-in period, 3.4+/-1.4 day/patient/year during the first year, and 3.1+/-1.1 day/patient/year during the second year (p=0.098). CONCLUSIONS: In conclusion we can say that the question of Thal-m in dialysis patients cannot be ignored or underestimated. The rHuEPO dosage in these patients must be reassessed (a dose of 450 U/kg/wk corresponding to approximately 60,000 units/week is acceptable and does not produce an increase in side effects if the correction is done gradually); moreover, other factors responsible for EPO-resistance must be eliminated (hyperthyroidism, aluminium intoxication, iron overloaded or deficiency).

Double-blind study of a total liver extract in patients with hepatic dysfunction.

Forty hospitalized male patients with hepatic functional deficit were treated i.m. for 3 weeks with a total liver extract or placebo. The study was a double-blind. Statistical analysis (Student's t test, analysis of variance. Mann-Whitney test and Fisher's probability test) showed that liver extract therapy was more effective than placebo in improving liver function as indicated by changes in clinical features(digestive disorders, constipation, hepatomegaly) and colloidal and other laboratory tests, e.g. plasma cholesterol, prothrombin time, red cell count and hemoglobin concentration. An overall clinical assessment showed that 60% of patients treated with the liver extract were improved. In addition, no local or general side effects were observed. Present results are in favour of an hepatoprotective activity of a total liver extract.