The Effectiveness and Safety of DA-3030 ( rhG-CSF ) for Chemotherapy - induced Neutropenia: A Randomized Controlled Trial / 대한암학회지
Journal of the Korean Cancer Association
;
: 995-1002, 1999.
Article
Dans Coréen
| WPRIM
| ID: wpr-32468
ABSTRACT
PURPOSE:
We investigated the effectiveness and safety of DA-3030 for prophylatic use in patients receiving chemotherapy for malignant disease. MATERIALS ANDMETHODS:
Seventy cancer patients were randomized to receive chemotherapy alone (36 patients) or with DA-3030 administered (34 patients) after stratified block randomization according to chemotherapeutic regimen. DA-3030 was subcutaneously 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 therapyCONCLUSION:
The use of DA-3030 was effective in preventing chemotherapy-induced neutropenia.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Répartition aléatoire
/
Incidence
/
Traitement médicamenteux
/
Myalgie
/
Neutropénie
/
Granulocytes neutrophiles
Type d'étude:
Essai clinique contrôlé
/
Etude d'étiologie
/
Etude d'incidence
/
Étude pronostique
Limites du sujet:
Humains
langue:
Coréen
Texte intégral:
Journal of the Korean Cancer Association
Année:
1999
Type:
Article
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