小児に対するHuman Urinary CSF (P-100)の臨床第II相試験結果

抄録

It has been shown that P-100 prepared from human urine as colony-stimulating factor enhances granulopoiesis through the stimulation of human monocytes to proliferate and produce human granulocytic colony-stimulating factor (G-CSF).
A cross over clinical study was performed in order to investigate the protective effect of P-100 on granulocytopenia in 64 pediatric patients during anti-tumor chemotherapy. We also administered P-100 to 28 patients with various types of neutropenias in childhood.
Objective scoring system was applied to evaluate the effect of P-100 injection. The rates of effect were 28% (7 out of 25 evaluable patients) in case of acute leukemias, and 41% (9 out of 22) in case of solid tumors. The response rate of P-100 in the 22 evaluable patients with various types of neutropenia was 38% (10 out of 22).
There were no serious side effects during and after P-100 administration.
We conclude that P-100 may, to certain extent, protect the granulocytopenia induced by anti-tumor chemotherapy. We can also expect P-100 to be a tool in the analysis of pathophysiology of the unique childhood neutropenias.