[Clinical study on the effect of CSF-HU (colony stimulating factor human urine) on leukopenia and granulocytopenia induced by cancer chemotherapy--a double-blind study in patients with genito-urinary cancer].
The ability of CSF-HU (P-100) to inhibit and improve the leukocytopenia and granulocytopenia which occur following cancer chemotherapy was investigated in a double-blind study which included an inactive placebo. The drug was administered, 2 vials/day (8 X 10(6)U of P-100), by intravenous drip infusion consecutively for 7 days starting from the 5th day after cancer chemotherapy was initiated. The total cases included in the study numbered 261. The efficacy rate was 53.0% for the P-100 group and 38.9% for the placebo group, while the usefulness rate was 54.8% for the former and 38.1% for the latter. In either case, statistically significant differences were observed in favor of the P-100 group. The reduction in the number of days before the leukocyte count returned to 4,000/mm3 was statistically significant in the P-100 group. While side effects appeared in both the P-100 (4.8%) and the placebo (4.4%) groups, none of them were considered to be serious. Judging from these results, p-100 was considered to be a useful therapeutic drug for the treatment of leukocytopenia and granulocytopenia following cancer chemotherapy.
Niijima
T
T
Department of Urology, University of Tokyo, Faculty of Medicine.
Aso
Y
Y
Akaza
H
H
Kawai
T
T
Matsumoto
K
K
Tachibana
M
M
Nishio
Y
Y
Kotake
T
T
Takaku
F
F
Matsumura
Y
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced / Q000628:therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D003115:Colony-Stimulating Factors / Q000008:administration & dosage / Q000627:therapeutic use* / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D014565:Urogenital Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D003115:Colony-Stimulating Factors