Prophylaxis by Aztreonam in the Neutropenic Children with Intensive Cancer Chemotherapy

The Randomized Envelope Method

Abstract

Prophylactic effect of aztreonam (AZT) was compared with a control group by injecting AZT intravenously to the pediatric patients with malignant tumor in the neutropenic conditions after aggressive anticancer chemotherapy. Whether AZT should be administered or not was randomly determined by the envelope method. AZT 80-100 mg/kg/day was injected to the nonfebrile patients with neutrophil count less than 250/μl. Amphotericin B, polymyxin B and a combination of sulfamethoxazole/trimethoprim were given to the both groups for intestinal decontamination. Total number of cases evaluated was 44 each in the AZT group and the control group. Underlying diseases were hematological malignancy 27 and solid tumor 17 cases in the AZT group, and 22 cases of each tumor in the control group. Average minimum neutrophil count and the duration of neutrophil count less than 250/μl were 27.2/μl±45.7 and 11.5 days ±6.3 in the AZT group and 26.1/μl±34.4 and 12.3 days ±6.7 in the control group, respectively. Overall prophylactic efficacy-rate of the AZT group was 72.7% and that of the control group was 50.0%, indicating significantly superior prophylactic effect of the AZT group (p<0.05). Prophylactic efficacy-rate by minimum neutrophil count was 66.7% in the AZT group and 36.4% in the control group with neutrophil count less than 10/μl; 66.7% and 50.0% with the count less than 10-50/Al; and 100% and 80% with the count 50-250/μl, respectively. Side effect was not observed. The above results suggested the usefulness of prophylactic intravenous injection of aztreonam in the cases with neutrophil count less than 50/μl.