Pharmacy Division, Hadassah-Hebrew University Medical Center, Kiryat-Hadassah, 91120, Jerusalem, Israel.
Int J Clin Pharm. 2012 Aug;34(4):611-7. doi: 10.1007/s11096-012-9654-y. Epub 2012 Jun 7.
Amphotericin-B (AMB) is associated with toxicity such as renal impairment, hypokalemia and infusion-related events (IRE). With the advent of AMB lipid formulations and newer antifungal drugs, presenting improved safety profiles, it was suggested that using the conventional deoxycholate (AMB-D) formulation should no longer be regarded acceptable.
Evaluation of real-life incidence of AMB-D-related adverse-drug effects (ADE) and associated costs.
Hadassah Hebrew University Medical Center, Jerusalem, Israel, a tertiary 1,100-bed teaching hospital.
A 1-year single-center prospective observational study following all patients administered AMB-D. Various parameters related to AMB-D administration were recorded. Main outcome measures Subsequent ADE-related events, discontinuations, switch to alternative antifungals and related resource-utilization were monitored.
Among 119 patients (60 children, 59 adults) receiving AMB-D, serum creatinine doubling from baseline, hypokalemia and IRE occurred in 14.3 % (15 % in children, 13.6 % in adults), 16.8 % (16.6 % in children, 16.9 % in adults) and 10.9 % (10 % in children, 11.8 % in adults), respectively. AMB-D was discontinued due to an ADE in 12.6 % of patients (6.7 % in children, 18.6 % in adults). The total annual cost associated with AMB-D use was
The clinical as well as economic burden of AMB-D associated ADE, as observed in real-life settings, appears to be manageable. Considering the significant cost implications associated, as suggested by simulated evaluation of an overall theoretic replacement of AMB-D by an equivalent volume of alternative antifungals, total abandonment of AMB-D appears unjustified.
两性霉素 B（AMB）与肾损伤、低钾血症和输注相关事件（IRE）等毒性相关。随着 AMB 脂质制剂和新型抗真菌药物的出现，安全性得到改善，有人认为不再应该使用传统去氧胆酸盐（AMB-D）制剂。
评估 AMB-D 相关不良药物事件（ADE）的真实发生率及其相关成本。
以色列耶路撒冷哈达萨希伯来大学医学中心，一家拥有 1100 张病床的三级教学医院。
对所有接受 AMB-D 治疗的患者进行为期 1 年的单中心前瞻性观察研究。记录与 AMB-D 给药相关的各种参数。主要观察指标为后续 ADE 相关事件、停药、改用其他抗真菌药物以及相关资源利用情况。
在 119 例接受 AMB-D 治疗的患者中（60 例儿童，59 例成人），血清肌酐从基线水平升高 14.3%（儿童 15%，成人 13.6%），低钾血症 16.8%（儿童 16.6%，成人 16.9%）和 IRE 10.9%（儿童 10%，成人 11.8%）。由于 ADE，12.6%的患者（儿童 6.7%，成人 18.6%）停用 AMB-D。AMB-D 使用相关的年总成本为<欧元>58600。
在真实环境中观察到的 AMB-D 相关 ADE 的临床和经济负担似乎是可控的。考虑到与替代 AMB-D 制剂相关的显著成本影响，如通过模拟评估总体理论替代的结果，完全放弃 AMB-D 似乎是不合理的。
