Multicenter randomized trial of fluconazole versus amphotericin B for treatment of candidemia in non-neutropenic patients
Multicenter randomized trial of fluconazole versus amphotericin B for treatment of candidemia in non-neutropenic patients
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氟康唑与两性霉素 B 治疗非中性粒细胞减少症患者念珠菌血症的多中心随机试验
DOI：
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发表时间：
1997
影响因子：
4.5
通讯作者：
F. T. P. Group
中科院分区：
文献类型：
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作者：
P. Phillips;S. Shafran;G. Garber;C. Rotstein;F. Smaill;I. Fong;I. Salit;M. Miller;K. Williams;J. Conly;J. Singer;S. Ioannou;F. T. P. Group
我们进行了一项随机试验，比较氟康唑与阿替霉素B治疗非念珠菌血症成人念珠菌血症的疗效和安全性。根据疾病严重程度（APACHE II评分）对入组进行分层。患者按1∶ 1比例随机分为两组，一组接受阿替霉素B 0.6 mg/kg/d（累积剂量8 mg/kg），另一组接受氟康唑800 mg静脉负荷剂量，然后400 mg/d，持续4周（静脉至少10 d）。患者被监测了6个月。共入组106例患者。在试验中途实施的一项方案修正案要求，如果菌种鉴定表明念珠菌血症是由光滑念珠菌或克柔念珠菌引起的，则将患者从研究中排除，并接受阿替霉素B治疗。两组的基线特征相似; 103例患者（氟康唑组，50例;阿替霉素B组，53例）符合主要入选标准。意向性治疗分析表明，氟康唑组50%的患者成功治疗，而阿替霉素B组为58%（p=0.39;单侧95% CI，−8 - 24%）。疗效分析包括84例患者（氟康唑，42例;阿替霉素B，42例）;氟康唑组和阿替霉素B组分别有57%和62%的病例观察到成功结局（p=0.66：单侧95% CI，−12至22%）。氟康唑组第14天的死亡率为26%，阿替霉素B组为21%（p=0.52;卡方检验），在整个随访过程中保持相似。与氟康唑组相比，阿替霉素B组的药物相关不良事件发生率更高，分别有2例（4%）和0例患者需要转换治疗。氟康唑和阿替霉素B治疗非念珠菌血症患者的临床反应率和生存率相似;然而，阿替霉素B的药物相关不良事件更常见。
A randomized trial was conducted to compare the efficacy and safety of fluconazole versus that of amphotericin B in the treatment of candidemia in non-neutropenic adults. Enrollment was stratified by disease severity (APACHE II score). Patients were randomized (1∶:1) to receive amphotericin B 0.6 mg/kg/day (cumulative dose 8 mg/kg) or fluconazole 800 mg intravenous loading dose, then 400 mg daily for four weeks (intravenous for at least 10 days). Patients were monitored for six months. A total of 106 patients were enrolled. A protocol amendment implemented midway through the trial required patients to be removed from the study and treated with amphotericin B if species identification indicated candidemia due toCandida glabrata orCandida krusei. Baseline characteristics were similar for the two groups; 103 patients (fluconazole, 50; amphotericin B, 53) met the major enrollment criteria. The intention-to-treat analysis indicated successful therapy in 50% of fluconazole recipients compared to 58% of the amphotericin B group (p=0.39; one-sided 95% Cl, −8 to 24%). The efficacy analysis included 84 patients (fluconazole, 42; amphotericin B, 42); successful outcomes were observed in 57% and 62% of cases in the fluconazole and amphotericin B groups, respectively (p=0.66: one-sided 95% Cl, −12 to 22%). The mortality at day 14 for the fluconazole group was 26% and for the amphotericin B group 21% (p=0.52; chi-square test) and remained similar throughout the course of follow-up. Drug-related adverse events were more frequent with amphotericin B than with fluconazole and prompted switching of therapy for two (4%) and zero cases, respectively. Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia among non-neutropenic patients; however, drug-related adverse events were more frequent with amphotericin B.
影响因子：
11.8
作者：
FRASER, VJ;JONES, M;DUNAGAN, WC
通讯作者：
DUNAGAN, WC
当前治疗侵袭性念珠菌病的策略：强调非中性粒细胞减少症患者的感染。
DOI：
10.1093/clinids/14.supplement_1.s106
发表时间：
1992
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
EdwardsJr,JE;Filler,SG
通讯作者：
Filler,SG
影响因子：
158.5
作者：
WINGARD, JR;MERZ, WG;SARAL, R
通讯作者：
SARAL, R