13-cis retinoic acid treatment for myelodysplastic syndromes.

To test the biologic activity of 13-cis retinoic acid (13-CRA) in patients with myelodysplastic states (MDS), we administered 13-CRA orally (2.5 mg/kg/d initially, escalated to 4 mg/kg/d) for 8 weeks to 15 consecutive patients. Eight of 15 patients (53%) experienced an increase in peripheral granulocyte counts of greater than 20% (range, 22% to 700%). In five patients, the absolute increase in peripheral granulocyte count was greater than 500 cells/microL. Two of 15 patients experienced a decrease in the circulating granulocyte count of greater than or equal to 20%. Comparable values for peripheral platelet counts were 27% (4/15 patients) greater than 20% increase and 33% (5/15 patients) greater than 20% decrease. No patient experienced a major change in erythrocyte transfusion requirement while receiving 13-CRA in comparison with pretreatment status. Thirteen patients had morphologic and cytogenetic evaluation of marrow cells before 13-CRA treatment, and with one exception, marrow morphologic and cytogenetic abnormalities persisted following 13-CRA administration. The exception occurred in the patient with the most dramatic response, whose granulocyte count increased from 400 to 2,800 cells/microL along with a normalization of the leukocyte alkaline phosphatase score, a morphologic improvement in granulocyte maturation, and a disappearance of the initial chromosome abnormality. These changes did not persist after cessation of 13-CRA administration, but were reproduced following drug readministration. No patients experienced serious decrements in peripheral blood counts or leukemic transformation while receiving 13-CRA. All patients had mild to marked dermatologic toxicity (cheilosis, skin dryness). No other major toxicity was encountered. We conclude that 13-CRA may be safely administered and may increase peripheral granulocyte counts in a proportion of patients with MDS.

Ambulatory antibiotic infusion devices: extending the spectrum of outpatient therapies.

STUDY OBJECTIVE: To examine the safety and efficacy, as well as the economic impact, of outpatient intravenous antibiotic administration using an ambulatory infusion pump. DESIGN: Retrospective analysis of patients treated through a single home care pharmacy. SETTING: General community and skilled nursing facilities of the greater Monterey (California) area. PATIENTS: Ninety-eight consecutive patients with infections requiring parenteral antibiotics, treated outside the acute-care setting and not eligible for traditional intravenous minibag administration. INTERVENTIONS: Patients received intravenous antibiotics either in the home setting (86%) or in skilled nursing facilities (11%) using a Pharmacia Deltec CADD-VT ambulatory infusion device. MEASUREMENTS AND MAIN RESULTS: Between April 1, 1986, and July 30, 1988, 98 patients received parenteral antibiotics using an infusion pump, and complete data were available on 96 (98%). A total of 109 treatment courses were given over 1,917 treatment days, with a mean duration of therapy of 18 days. Twenty-three different infections were treated by the use of 12 separate antibiotics. The most common complications included vein irritation (11%) and the inability to maintain venous access (6.2%). Therapy costs were equivalent to or less than the intravenous minibag system depending on the frequency of antibiotic administration. Eighty percent of patients experienced successful resolution of their infection. CONCLUSIONS: Ambulatory antibiotic infusion pumps can be used safely and effectively in the outpatient setting. Use of these pumps should increase the number of patients eligible for out-of-hospital treatment, resulting in a marked reduction in treatment costs.