A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. L Amph/ABLC Collaborative Study Group.

A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. L Amph/ABLC Collaborative Study Group.
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一项随机、双盲比较试验,评估脂质体两性霉素 B 与两性霉素 B 脂质复合物在发热性中性粒细胞减少症经验治疗中的安全性。

DOI:
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发表时间:
2000
影响因子:
11.8
通讯作者:
A. Arrieta
A. Arrieta
中科院分区:
医学1区
文献类型:
--
作者:
J. Wingard;M. White;E. Anaissie;J. Raffalli;J. Goodman;A. Arrieta

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为比较两性霉素B两种脂质体制剂的安全性,将经抗菌治疗3天后出现发热症状的中性粒细胞减少症患者按1:1:1随机分为3组,分别给予两性霉素B脂质体5 mg/kg/d(78例)、两性霉素B脂质体3 mg/kg/d(85例)和L安非他明5 mg/kg/d(81例)。L安非他明(3 mg/kg/d和5 mg/kg/d)的发热(23.5%和19.8%比第1天的57.7%)、寒战/僵硬(18.8%和23.5%比第1天的79.5%;P&t;0.01)、肾毒性(14.1%和14.8%比42.3%;P<0.01)以及毒性相关的中止治疗(12.9%和12.3%比32.1%;P<0.01)较低。P=.004)。第一天后,ABLC的输液反应较少,但寒战/僵硬仍较高(21.0%和24.3%vs.50.7%;P<.001)。三组患者的治疗成功情况相似。
In this double-blind study to compare safety of 2 lipid formulations of amphotericin B, neutropenic patients with unresolved fever after 3 days of antibacterial therapy were randomized (1:1:1) to receive amphotericin B lipid complex (ABLC) at a dose of 5 mg/kg/d (n=78), liposomal amphotericin B (L Amph) at a dose of 3 mg/kg/d (n=85), or L Amph at a dose of 5 mg/kg/d (n=81). L Amph (3 mg/kg/d and 5 mg/kg/d) had lower rates of fever (23.5% and 19.8% vs. 57.7% on day 1; P<.001), chills/rigors (18.8% and 23.5% vs. 79.5% on day 1; P<.001), nephrotoxicity (14.1% and 14.8% vs. 42.3%; P<.01), and toxicity-related discontinuations of therapy (12.9% and 12.3% vs. 32.1%; P=.004). After day 1, infusional reactions were less frequent with ABLC, but chills/rigors were still higher (21.0% and 24.3% vs. 50.7%; P<.001). Therapeutic success was similar in all 3 groups.