A multicenter clinical trial of a recombinant human erythropoietin was performed on regular hemodialysis patients to study the effects. To 77 uncomplicated and hematologically stable, adult patients. 3000IU of Epoetin beta was given
intravenously,
after
each hemodialysis, three times a week for 12 week, for 12 week, and iron tablets by mouth. When the hemoglobin level (Hb) reached 10g/dl, 1500 IU was given 2 to 3 times a week for maintenance.
@ES The results were as following;
@EN 1) There were three dropouts. In 62 patients (83.8%) of 74, the hemoglobin(Hb) increased to more than 9.0g/dl. In 43(58.1%), it increased to 10.0g/dl from 6.08±0.79.
2) As blood Hb increased, many patients felt better with decreased symtoms of easy fatigability, muscle weakness, palpitation, and anorexia.
3) As side-effects, headache, flu-like symptoms, and hypertension developed in some patients. However, these symptoms were not sever enough to discontinue the treatment. There was no incidence of convulsion or thrombosis.
4) In predicting the poor responders to the drug from the good, clinical parameters, such as sex, blood corpuscular indices, serum total protein, BUN, alkaline phosphatase, iron, and ferritin did not differenciate.
5) On the other hand, the patterns of Hb increase during the regular Epo administration were significantly different; in the poor responders, the average "incubation" period before Hb rise by 1.0g/dl was longer (35.6±0.6 v.s. 22.6±7.2 days),
the
rate
of increment was slower, and Hb level fluctuated more frequently during the study period.
It is concluded that small dose of rHuEpo carries less side effects but slow anddiminished Hb rise. Monitoring the Hb increase may help differenciate the poor responders.
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