癌化学療法後の白血球,穎粒球減少症に対するCSF-HU (colony-stimulating factor human urine) の臨床試験成績 - 各種尿路性器癌における二重盲検試験 -

Abstract

尿路性器癌での化学療法剤投与による白血球, 顆粒球減少に対するP-100の抑制および改善効果を検討するため, 多施設二重盲検試験を実施した.1)総実施症例数は261例であり, 効果判定症例は241例, 数値解析症例は240例であった.P-100群, プラセボ群の間において背景因子に偏りはなかった.2)有効度評価において有効以上はP-100群53.0%, プラセボ群38.9%であり, P-100群がプラセボ群に比し有意に優れていた.また, 化学療法開始日より白血球数4, 000/mm3まで回復するのに要した日数はそれぞれ19.6日, 22.6日であり両群間に有意差を認めた.3)副作用はP-100群6例(4.8%), プラセボ群6例(4.4%)に出現し両群間に差はなく, P-100群における副作用の程度は軽症または中等度であり, 投与中止に至ったものは1例のみであった.4)有用度評価においては有用以上がP-100群54.8%, プラセボ群38.1%であり, P-100群がプラセボ群に比し有意に優れていた

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.