Anidulafungin versus fluconazole for invasive candidiasis
Anidulafungin versus fluconazole for invasive candidiasis
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DOI：
10.1056/nejmoa066906
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发表时间：
2007-06-14
影响因子：
158.5
通讯作者：
Zapata-Molina, N.
中科院分区：
文献类型：
--
作者：
Reboli, Annette C.;Rotstein, Coleman;Zapata-Molina, N.
背景：阿尼芬净是一种新的棘白菌素，具有较强的抗念珠菌活性。我们比较了阿尼芬净与氟康唑在一项随机，双盲，非劣效性试验的治疗侵袭性念珠菌病。方法：成人侵袭性念珠菌病随机分配到接受静脉注射阿尼芬净或静脉注射氟康唑。所有患者静脉滴注10天后均可口服氟康唑。主要疗效分析评估了基线培养阳性患者静脉治疗结束时的总体缓解（临床和微生物学）。疗效也在其他时间点进行了评估。结果：89%的245例患者在主要分析有念珠菌血症。245例患者中62%分离出白色念珠菌。体外氟康唑耐药罕见。大多数患者（97%）没有中性粒细胞减少症。静脉治疗结束时，阿尼芬净治疗患者的治疗成功率为75.6%，而氟康唑治疗患者的治疗成功率为60.2%（差异，15.4个百分点; 95%置信区间[CI]，3.9至27.0）。其他疗效终点的结果相似。统计分析未能显示“中心效应”;当从招募最多患者的研究中心删除数据时，阿尼芬净组静脉治疗结束时的成功率为73.2%，氟康唑组为61.1%（差异，12.1个百分点; 95%CI，-1.1至25.3）。两组不良事件的发生频率和类型相似。全因死亡率氟康唑组为31%，阿尼芬净组为23%（P=0.13）。结论：阿尼芬净在治疗侵袭性念珠菌病方面不劣于氟康唑。
BACKGROUND:Anidulafungin, a new echinocandin, has potent activity against candida species. We compared anidulafungin with fluconazole in a randomized, double-blind, noninferiority trial of treatment for invasive candidiasis.METHODS:Adults with invasive candidiasis were randomly assigned to receive either intravenous anidulafungin or intravenous fluconazole. All patients could receive oral fluconazole after 10 days of intravenous therapy. The primary efficacy analysis assessed the global response (clinical and microbiologic) at the end of intravenous therapy in patients who had a positive baseline culture. Efficacy was also assessed at other time points.RESULTS:Eighty-nine percent of the 245 patients in the primary analysis had candidemia only. Candida albicans was isolated in 62% of the 245 patients. In vitro fluconazole resistance was infrequent. Most of the patients (97%) did not have neutropenia. At the end of intravenous therapy, treatment was successful in 75.6% of patients treated with anidulafungin, as compared with 60.2% of those treated with fluconazole (difference, 15.4 percentage points; 95% confidence interval [CI], 3.9 to 27.0). The results were similar for other efficacy end points. The statistical analyses failed to show a ``center effect''; when data from the site enrolling the largest number of patients were removed, success rates at the end of intravenous therapy were 73.2% in the anidulafungin group and 61.1% in the fluconazole group (difference, 12.1 percentage points; 95% CI, -1.1 to 25.3). The frequency and types of adverse events were similar in the two groups. The rate of death from all causes was 31% in the fluconazole group and 23% in the anidulafungin group (P=0.13).CONCLUSIONS:Anidulafungin was shown to be noninferior to fluconazole in the treatment of invasive candidiasis.