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Title   악성종양환자에서 항암화학요법으로 인한 호중구감소증에 대하여 DA-3030 ( rhG-CSF ) 의 유효성 및 안전성에 대한 제 3 상 다기관 임상실험 ( The Effectiveness and Safety of DA-3030 ( rhG-CSF ) for Chemotherapy - induced Neutropenia : A Randomized Controlled Trial )
Publicationinfo   1999 Jan; 031(05): 995-1003.
Key_word   DA-3030 (rhG-CSF), Chemotherapy-induced neutropenia
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Abstract   Purpose: We investigated the effectiveness and safety of DA-3030 for prophylatic use in patients receiving chemotherapy for malignant disease. Materials and Methods: Seventy cancer patients were randomized to receive chemo- therapy alone (36 patients) or with DA-3030 administered (34 patients) after stratified block randomization according to chemotherapeutic regimen. DA-3030 was subcuta- neously administered at the dose of 100 pg/m/day for 10 days from 24 hours after the completion of chemotherapy. Results: Of the 70 enrolled patients, 62 patients were evaluable. The neutropenia (absolute neutrophil count [ANC] <1,000/mm) occurred in 9 of 32 (28.1%) of the DA-3030 group and 21 of 30 (90.0%) of the control group, giving relative risk for control group of 0.154 (95% confidence interval [CI], 0.05 to 0.45; p-0.0001). Severe neutropenia (ANC 500/mm') occurred in 4 of 32 (12.5%) of the DA-3030 group and in 20 of 30 (66.7%) of the control group (relative risk for control group of 0.316 [95% CI, 0,18 to 0.55]; p=0.0001). The mean duration of neutropenic period (±standard error) was 1.13±0.34 days in the DA-3030 group and 6.73±0.69 days in the control group respectively, and was significantly shorter in the DA-3030 group (p<0.0001). And, there was higher nadir ANC in the OA-3030 group than that in the control group (p=0.0001); the mean nadir ANC was 2,547± 343/mm and 442±120/mm, respectively. The DA-3030 group had significantly higher incidence of myalgia in comparison to the control group (43.8% compared with 3.3%; p=0.001). However, it was tolerable and was easily managed by conservative therapy Conclusion: The use of DA-3030 was effective in preventing chemotherapy-induced neut- ropenia.
저 자   이대호(Dae Ho Lee),서철원(Cheolwon Suh),박근칠(Keunchil Park),김태원(Tae Won Kim),김정균(Jung Gyun Kim),김원석(Won Seog Kim),강원기(Won Ki Kang),허대석(Dae Seog Heo),방영주(Yung Jue Bang),김노경(Noe Kyeong Kim)