Confusion between Two Amphotericin B Formulations Leading to a Paediatric Rehospitalisation.

Mapi Fleury, Caroline Fonzo-Christe, Charline Normand, Pascal Bonnabry
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Abstract

A heavily immunosuppressed, 43-kg, 9-year-old patient was recovering from a bone marrow transplant. Primary prophylaxis against invasive fungal infections was liposomal amphotericin B (AmBisome®, 2.3 mg/kg [100 mg] two times per week). Once home, following a first amphotericin B infusion, he presented with strong diarrhoea and vomiting; this was repeated after the second infusion. The clinical situation worsened rapidly and the patient was rehospitalised. On admission, he presented with acute renal failure. During the 2-week hospitalisation, renal function recovered progressively. A few days after returning home, a new administration of amphotericin B was again followed by diarrhoea and vomiting, together with shivering and fever. The child was again rapidly rehospitalised. Investigation revealed that the community pharmacist, relying on drug software, had selected an inappropriate substitute drug: the patient had been administered amphotericin B deoxycholate (Fungizone®) and not liposomal amphotericin B. Depending on the indication, intravenous AmBisome® is usually administered at a dose between 3 and 5 mg/kg bodyweight; this dose can be increased to up to 10 mg/kg/day. Intravenous Fungizone®, however, should be administered using an initial dose of 0.25 mg/kg bodyweight, up to a recommended 1-mg/kg/day dose. The child had thus received 100 mg of Fungizone®, or ten times the recommended dose.

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混淆两性霉素 B 两种配方导致一名儿童再次入院。
一名重度免疫抑制、体重 43 公斤的 9 岁患者正在从骨髓移植中恢复。预防侵袭性真菌感染的主要药物是脂质体两性霉素 B(AmBisome®,2.3 毫克/千克 [100 毫克],每周两次)。回家后,第一次输注两性霉素 B 后,他出现了强烈的腹泻和呕吐;第二次输注后又出现了腹泻和呕吐。临床情况迅速恶化,患者再次入院。入院时,他出现了急性肾衰竭。住院两周期间,肾功能逐渐恢复。回家几天后,再次注射两性霉素 B 后又出现腹泻和呕吐,并伴有颤抖和发烧。患儿再次被迅速转入医院治疗。调查显示,社区药剂师依靠药物软件选择了不恰当的替代药物:患者服用的是脱氧胆酸两性霉素 B(Fungizone®),而不是两性霉素 B 脂质体。根据不同的适应症,静脉注射 AmBisome® 的剂量通常在 3 至 5 毫克/千克体重之间;这一剂量可增加到 10 毫克/千克/天。然而,静脉注射真菌松®的初始剂量为0.25毫克/千克体重,推荐剂量为1毫克/千克/天。因此,该患儿服用了100毫克的Fungizone®,即建议剂量的10倍。
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