title: Results of a randomized trial of granulocyte colony-stimulating factor in patients with infection and severe granulocytopenia.
abstract: A study was carried out to investigate the efficacy and toxicity of granulocyte colony-stimulating factor (G-CSF) in the treatment of infection in 119 severely granulocytopenic patients with hematological malignancies after intensive chemotherapy. Patients were assigned randomly to receive either antibiotics alone (ceftazidime, 2 g, i.v., every 8 h + amikacin 7.5 mg/kg, i.v., every 12 h) or the same antimicrobial regimen plus G-CSF (5 micrograms/kg/day, s.c.). Measurements were clinical improvement, eradication of infection and toxicity. Patients who received antibiotics plus G-CSF had more clinical responses (82 versus 60%), less superinfections (6 versus 20%), less mortality (5 versus 15 patients), less days in hospital (median 10 versus 27) and reduced antibiotic usage compared to patients who received only antibiotics. Hematological recovery (granulocytes > 1.0 x 10(9)/l) was also shorter in these patients (12 versus 23 days). Fungal infections occurred only in the group treated with antibiotics alone. Toxicity secondary to G-CSF was absent. We conclude that the addition of G-CSF to broad spectrum antibiotics is useful in selected patients with severe granulocyctopenia after intensive chemotherapy and infection, because if may prove the outcome in these patients.
authors.affiliation: Department of Hematology, Oncology Hospital, National Medical Center, México, DF Mexico.
authors.forename: A
authors.initials: A
authors.lastname: Avilés
authors.forename: R
authors.initials: R
authors.lastname: Guzmán
authors.forename: E L
authors.initials: EL
authors.lastname: García
authors.forename: A
authors.initials: A
authors.lastname: Talavera
authors.forename: J C
authors.initials: JC
authors.lastname: Díaz-Maqueo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000380:Agranulocytosis / Q000139:chemically induced / Q000150:complications / Q000188:drug therapy*; D000583:Amikacin / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects; D002442:Ceftazidime / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006689:Hodgkin Disease / Q000150:complications / Q000188:drug therapy; D006801:Humans; D008223:Lymphoma / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy; D009181:Mycoses / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D015163:Superinfection / Q000188:drug therapy* / Q000209:etiology
chemical_list: D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D000583:Amikacin; D002442:Ceftazidime