两性霉素B脂质复合物用于预防急性髓性白血病和骨髓增生异常综合征患者诱导化疗期间的侵袭性真菌感染。
Amphotericin B lipid complex as prophylaxis of invasive fungal infections in patients with acute myelogenous leukemia and myelodysplastic syndrome undergoing induction chemotherapy.
作者信息
Mattiuzzi Gloria N, Kantarjian Hagop, Faderl Stefan, Lim JoAnn, Kontoyiannis Dimitrios, Thomas Deborah, Wierda William, Raad Isaam, Garcia-Manero Guillermo, Zhou Xian, Ferrajoli Alexandra, Bekele Nebiyou, Estey Elihu
机构信息
Department of Leukemia, The University of Texas M D Anderson Cancer Center, Houston, Texas 77030, USA.
出版信息
Cancer. 2004 Feb 1;100(3):581-9. doi: 10.1002/cncr.11936.
BACKGROUND
The optimal antifungal prophylactic regimen for patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) undergoing induction chemotherapy has yet to be identified. A prospective historical control study evaluated the efficacy and safety of amphotericin B lipid complex (ABLC) in this patient population.
METHODS
Newly diagnosed patients with AML or high-risk MDS who were undergoing induction chemotherapy received prophylactic ABLC 2.5 mg/kg intravenously 3 times weekly. This treatment group was compared with a historical control group that had similar baseline characteristics and received prophylactic liposomal amphotericin B (L-AmB) 3 mg/kg 3 times weekly. The primary endpoint was the incidence of documented or suspected fungal infections during and up to 4 weeks after cessation of prophylaxis. Reported adverse events were used to assess tolerability.
RESULTS
The overall efficacy of antifungal prophylaxis was similar in patients who received ABLC and patients who received L-AmB (P=0.95). Among 131 ABLC-treated patients and 70 L-AmB-treated patients who were assessed for efficacy and safety, 49% of patients in each group completed therapy without developing a documented or suspected fungal infection. Documented fungal infections occurred in 5% of ABLC-treated patients and in 4% of L-AmB-treated patients. Alternative antifungal strategies were required because of persistent fever or pneumonia of unknown pathogen in 28% and 32% of ABLC-treated and L-AmB-treated patients, respectively. Grade 3 and 4 adverse events, therapy discontinuations due to adverse events, and survival rates also were similar between treatment groups.
CONCLUSIONS
ABLC and L-AmB appeared to have similar efficacy and were tolerated well as antifungal prophylaxis in patients with AML and high-risk MDS who were undergoing induction chemotherapy.
背景
对于接受诱导化疗的急性髓系白血病（AML）或高危骨髓增生异常综合征（MDS）患者，最佳抗真菌预防方案尚未确定。一项前瞻性历史对照研究评估了两性霉素B脂质复合物（ABLC）在此类患者群体中的疗效和安全性。
方法
新诊断的AML或高危MDS患者在接受诱导化疗时，每周静脉注射3次预防性ABLC，剂量为2.5mg/kg。将该治疗组与具有相似基线特征且每周静脉注射3次预防性脂质体两性霉素B（L-AmB）、剂量为3mg/kg的历史对照组进行比较。主要终点是在预防期间及预防停止后长达4周内记录或疑似真菌感染的发生率。通过报告的不良事件来评估耐受性。
结果
接受ABLC治疗的患者和接受L-AmB治疗的患者抗真菌预防的总体疗效相似（P=0.95）。在131例接受ABLC治疗和70例接受L-AmB治疗且接受疗效和安全性评估的患者中，每组49%的患者完成治疗且未发生记录或疑似真菌感染。ABLC治疗组5%的患者和L-AmB治疗组4%的患者发生了记录在案的真菌感染。分别有28%接受ABLC治疗的患者和32%接受L-AmB治疗的患者因不明病原体持续发热或肺炎而需要采取替代抗真菌策略。3级和4级不良事件、因不良事件导致的治疗中断以及生存率在治疗组之间也相似。
结论
对于接受诱导化疗的AML和高危MDS患者，ABLC和L-AmB作为抗真菌预防药物似乎具有相似的疗效且耐受性良好。
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