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Adverse effect profile of amphotericin B deoxycholate administered with a standardized infusion protocol in
Sreeraj Vasudevan1, Govind R Patel1, Pravas Mishra1
1Department of Hematology, All India Institute of Medical Sciences, New Delhi, India.
Background:
Amphotericin B deoxycholate (AmBD), an effective and inexpensive antifungal agent, has significant adverse effects. Studies demonstrating the use of protective measures to prevent or reduce different adverse effects of AmBD are scarce in patients with hematological disorders. Therefore, we aimed to evaluate the adverse effect profile of AmBD administered with a standardized infusion protocol among hematologic patients.
Methods:
This prospective observational study was conducted at a tertiary care center of India among 150 hospitalized patients of all ages with different hematological disorders who had received AmBD administered with standardized infusion protocol consisting of premedication use, intravenous hydration and salt loading, and electrolyte supplementation. The clinical characteristics were recorded. Renal function parameters and serum electrolyte levels were measured at regular interval. AmBD-associated infusion-related adverse events (IRAEs), electrolyte imbalances and nephrotoxicity were assessed.
Results:
AmBD-associated IRAEs, hypokalemia, hypomagnesemia, and nephrotoxicity were observed in 48 (32%), 90 (60%), 123 (82%), and 42 (28%) patients, respectively. In majority of patients, these adverse effects were reversible. AmBD was stopped due to severe IRAEs in 8 (5.3%), hypokalemia in 4 (2.7%), and nephrotoxicity in 6 (4%) patients. Baseline invasive fungal infection (IFI) and AmBD dose >1 mg/kg were risk factors for developing nephrotoxicity.
Conclusion:
We have demonstrated that the AmBD use in hematologic patients is associated with a relatively lower and the reversible IRAEs and nephrotoxicity along with manageable electrolyte imbalances, if it is administered with standardized infusion protocol. Therefore, AmBD should be considered as an inexpensive antifungal agent for IFIs among hematologic patients in resource-constrained settings.
Insights
Amphotericin B deoxycholate (AmBD) can be safely administered to hematologic patients using a standardized infusion protocol. This approach minimizes adverse events and electrolyte imbalances, making AmBD a viable antifungal option in resource-limited settings.
Area of Science:
- Hematology
- Infectious Diseases
- Pharmacology
Background:
- Amphotericin B deoxycholate (AmBD) is an effective, inexpensive antifungal but causes significant adverse effects.
- Limited studies exist on mitigating AmBD's adverse effects in hematologic patients.
- Hematologic disorders increase susceptibility to invasive fungal infections (IFIs).
Purpose of the Study:
- To evaluate the adverse effect profile of AmBD administered with a standardized infusion protocol in hematologic patients.
- To assess the incidence and reversibility of AmBD-associated adverse events.
- To identify risk factors for AmBD-induced nephrotoxicity.
Main Methods:
- Prospective observational study of 150 hospitalized hematologic patients receiving AmBD.
- Standardized infusion protocol included premedication, IV hydration, salt loading, and electrolyte supplementation.
- Monitoring of renal function, electrolytes, and AmBD-associated infusion-related adverse events (IRAEs).
Main Results:
- AmBD-associated IRAEs, hypokalemia, hypomagnesemia, and nephrotoxicity occurred in 32%, 60%, 82%, and 28% of patients, respectively.
- Most adverse effects were reversible, with low rates of treatment discontinuation.
- Baseline IFI and AmBD dose >1 mg/kg were risk factors for nephrotoxicity.
Conclusions:
- A standardized infusion protocol significantly reduces AmBD-related IRAEs and nephrotoxicity in hematologic patients.
- Electrolyte imbalances are manageable with this protocol.
- AmBD is a cost-effective antifungal for IFIs in hematologic patients, especially in resource-constrained settings.
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