Document Detail

Amphotericin B infusion-related toxicity: comparison of two- and four-hour infusions.
MedLine Citation:
PMID:  8573948     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To investigate the influence of infusion duration on infusion-related adverse effects (IRAEs) associated with prophylactic or treatment regimens of amphotericin B in patients with leukemia/bone marrow transplant (BMT). DESIGN: Randomized, double-blind, 2-arm, complete crossover, prospective clinical trial. SETTING: A university-affiliated tertiary care teaching hospital. PARTICIPANTS: The study population consisted of 25 consecutive patients with leukemia/BMT who received 162 prophylactic regimen infusions and 169 treatment regimen infusions of amphotericin B via a central line. Prior to each infusion all patients received a parenteral IRAE prophylaxis regimen of diphenhydramine 25 mg and hydrocortisone 25 mg. No test doses or incremental amphotericin B doses were administered. Patients were monitored closely for IRAEs, which were documented by using a standardized data collection form. MAIN OUTCOME MEASURES: The incidence and nature of IRAEs during a 6-hour monitoring period following the initiation of each infusion was measured. Patients served as their own controls. IRAEs were compared according to infusion duration and therapeutic indication. RESULTS: Three hundred and thirty-one 2- and 4-hour amphotericin B infusions were administered. We found no difference between 2- and 4-hour infusions in the incidence and severity of IRAEs, including overall events (29% of 166 2-hour infusions vs. 25% of 165 4-hour infusions), chill scores (8% of 166 2-hour infusions vs. 7% of 165 4-hour infusions; highest score 7 vs. 6), nausea and vomiting (7% vs. 12%; highest score 4 in both groups), fever (3% vs. 2%), highest temperature increase (2.4 vs. 1.6 degrees C), systolic hypotension (6% vs. 2%), greatest decrease from baseline (40 vs. 62 mm Hg), diastolic hypotension (5% vs. 3%), and greatest decrease (30 vs. 28 mm Hg) (p > 0.05). Overall, IRAEs were less common in prophylactic treatment regimens (35 events [22%] in 162 infusions) than in treatment regimens (55 events [32%] in 169 infusions) (p < 0.05). CONCLUSIONS: This study demonstrates that patients with leukemia/BMT without myocardial or renal dysfunction who receive hydrocortisone and diphenhydramine as premedications can tolerate 2-hour central line infusions of prophylactic or treatment regimens of amphotericin B as well as 4-hour infusions.
T A Nicholl; C R Nimmo; J D Shepherd; P Phillips; P J Jewesson
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  29     ISSN:  1060-0280     ISO Abbreviation:  Ann Pharmacother     Publication Date:  1995 Nov 
Date Detail:
Created Date:  1996-03-14     Completed Date:  1996-03-14     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1081-7     Citation Subset:  IM    
Department of Pharmacy, Vancouver Hospital and Health Sciences Centre, British Columbia, Canada.
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MeSH Terms
Amphotericin B / administration & dosage,  adverse effects*
Antifungal Agents / administration & dosage,  adverse effects*
Bone Marrow Transplantation*
Cross-Over Studies
Double-Blind Method
Drug Tolerance
Hospitals, University
Immunocompromised Host
Infusions, Intravenous / methods
Leukemia / complications*
Middle Aged
Mycoses / drug therapy*,  prevention & control
Prospective Studies
Time Factors
Reg. No./Substance:
0/Antifungal Agents; 1397-89-3/Amphotericin B

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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