Comparison of caspofungin and amphotericin B for invasive candidiasis.
Comparison of caspofungin and amphotericin B for invasive candidiasis.
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DOI：
10.1056/nejmoa021585
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发表时间：
2002-12-19
影响因子：
158.5
通讯作者：
Perfect, J
中科院分区：
文献类型：
--
作者：
Mora-Duarte, J;Betts, R;Perfect, J
背景：卡泊芬净是一种棘白菌素类药物，对念珠菌具有杀真菌活性。我们进行了一项双盲试验，比较卡泊芬净与阿替霉素B脱氧胆酸盐的侵袭性candidiasi.Methods的主要治疗：我们招募患者谁有感染的临床证据和阳性培养念珠菌属从血液或其他网站。根据急性生理学和慢性健康评估（APACHE II）评分以及是否存在中性粒细胞减少症的疾病严重程度对患者进行分层，并随机分配接受卡泊芬净或阿替霉素B治疗。该研究的目的是比较卡泊芬净与阿替霉素B在侵袭性念珠菌病患者和念珠菌血症的亚组中的疗效。结果：在239例入选患者中，224例被纳入修改后的意向治疗分析。两个治疗组的基线特征（包括中性粒细胞减少症患者百分比和平均APACHE II评分）相似。一项改良的意向治疗分析显示，卡泊芬净的疗效与阿替霉素B相似，卡泊芬净治疗的患者中有73.4%的患者成功，阿替霉素B治疗的患者中有61.7（调整APACHE II评分和贫血状态后的差异为12.7个百分点; 95.6%置信区间为-0.7至26.0）。对符合预先规定的评估标准的患者进行的分析显示，卡泊芬净是上级的，80.7%的患者有良好的反应，而接受阿替霉素B的患者有64.9%的反应（差异，15.4个百分点; 95.6%置信区间，1.1至29.7）。卡泊芬净与阿替霉素B在念珠菌血症患者中同样有效，分别有71.7%和62.8%的患者有良好的反应（差异为10.0个百分点; 95.0%置信区间为-4.5至24.5）。有显着减少药物相关的不良事件在卡泊芬净组比在阿替霉素B group.Conclusions：卡泊芬净至少是有效的阿替霉素B治疗侵袭性念珠菌病，更具体地说，念珠菌血症。
Background: Caspofungin is an echinocandin agent with fungicidal activity against candida species. We performed a double-blind trial to compare caspofungin with amphotericin B deoxycholate for the primary treatment of invasive candidiasis.Methods: We enrolled patients who had clinical evidence of infection and a positive culture for candida species from blood or another site. Patients were stratified according to the severity of disease, as indicated by the Acute Physiology and Chronic Health Evaluation (APACHE II) score, and the presence or absence of neutropenia and were randomly assigned to receive either caspofungin or amphotericin B. The study was designed to compare the efficacy of caspofungin with that of amphotericin B in patients with invasive candidiasis and in a subgroup with candidemia.Results: Of the 239 patients enrolled, 224 were included in the modified intention-to-treat analysis. Base-line characteristics, including the percentage of patients with neutropenia and the mean APACHE II score, were similar in the two treatment groups. A modified intention-to-treat analysis showed that the efficacy of caspofungin was similar to that of amphotericin B, with successful outcomes in 73.4 percent of the patients treated with caspofungin and in 61.7 percent of those treated with amphotericin B (difference after adjustment for APACHE II score and neutropenic status, 12.7 percentage points; 95.6 percent confidence interval, -0.7 to 26.0). An analysis of patients who met prespecified criteria for evaluation showed that caspofungin was superior, with a favorable response in 80.7 percent of patients, as compared with 64.9 percent of those who received amphotericin B (difference, 15.4 percentage points; 95.6 percent confidence interval, 1.1 to 29.7). Caspofungin was as effective as amphotericin B in patients who had candidemia, with a favorable response in 71.7 percent and 62.8 percent of patients, respectively (difference, 10.0 percentage points; 95.0 percent confidence interval, -4.5 to 24.5). There were significantly fewer drug-related adverse events in the caspofungin group than in the amphotericin B group.Conclusions: Caspofungin is at least as effective as amphotericin B for the treatment of invasive candidiasis and, more specifically, candidemia.