A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis
A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis
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DOI：
10.1086/423378
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发表时间：
2004-09-15
影响因子：
11.8
通讯作者：
Henkel, T
中科院分区：
文献类型：
--
作者：
Krause, DS;Simjee, AE;Henkel, T
阿尼芬净是一种新型棘白菌素类抗真菌药物。这项随机、双盲、双模拟研究对 601 名经内镜和微生物学证明患有食管念珠菌病的患者进行了静脉注射阿尼芬净与口服氟康唑的疗效和安全性比较。患者接受静脉阿尼芬净（第 1 天 100 mg，随后每天 50 mg）或口服氟康唑（第 1 天 200 mg，随后每天 100 mg）治疗 7 天，直至症状消失（范围为 14 - 21 天）。治疗结束时，阿尼芬净（249 名接受治疗的患者中的 242 名 [97.2%]）的内窥镜成功率在统计学上不劣于氟康唑（255 名接受治疗的患者中的 252 名 [98.8%]；治疗差异，- 1.6%；95% 置信区间，- 4.1 至 0.8）。阿尼芬净的安全性与氟康唑相似；分别有 9.3% 和 12.0% 的患者发生与治疗相关的不良事件。治疗组之间的实验室参数相似。在治疗完成后进行评估时，阿尼芬净与口服氟康唑一样安全有效地治疗食管念珠菌病。
Anidulafungin is a novel antifungal agent of the echinocandin class. This randomized, double-blind, double-dummy study compared the efficacy and safety of intravenous anidulafungin to that of oral fluconazole in 601 patients with endoscopically and microbiologically documented esophageal candidiasis. Patients received intravenous anidulafungin (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14 - 21 days). At the end of therapy, the rate of endoscopic success for anidulafungin ( 242 [97.2%] of 249 treated patients) was found to be statistically noninferior to that for fluconazole (252 [98.8%] of 255 treated patients; treatment difference, - 1.6%; 95% confidence interval, - 4.1 to 0.8). The safety profile of anidulafungin was similar to that of fluconazole; treatment-related adverse events occurred in 9.3% and 12.0% of patients, respectively. Laboratory parameters were similar between treatment arms. Anidulafungin is as safe and effective as oral fluconazole for the treatment of esophageal candidiasis, when assessed at the completion of therapy.