Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis
Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis
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DOI：
10.1086/520980
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发表时间：
2007-10-01
影响因子：
11.8
通讯作者：
Buell, Donald N.
中科院分区：
文献类型：
--
作者：
Pappas, Peter G.;Rotstein, Coleman M. F.;Buell, Donald N.
背景资料。侵袭性念珠菌病是卫生保健相关感染患者发病率和死亡率的重要原因。棘球菌素对大多数念珠菌有很强的杀菌活性，但比较棘球菌素治疗侵袭性念珠菌的安全性和有效性的资料很少。这是一项国际随机双盲试验，将米卡芬净(每天100毫克)和米卡芬净(每天150毫克)与标准剂量的卡泊芬净(70毫克，然后每天50毫克)用于患有念珠菌症和其他形式侵袭性念珠菌病的成年人进行比较。主要终点是治疗成功，定义为在盲目静脉治疗结束时的临床和真菌学成功。共有595名患者被随机分配到其中一个治疗组，并接受至少1剂研究药物。在改良的意向治疗人群中，191名患者被分配到米卡芬净100 mg组，199名患者被分配到米卡芬净150 mg组，188名患者被分配到卡泊芬净组。人口统计特征和潜在的疾病在所有组中都是相似的。大约85%的患者患有念珠菌血症；其余的患者患有非念珠菌病侵袭性念珠菌病。在盲目静脉治疗结束时，米卡芬净100 mg组、米卡芬净150 mg组和卡泊芬净组分别有76.4%、71.4%和72.3%的患者被认为是治疗成功。米卡芬净100 mg组和卡泊芬净组培养阴性的中位时间为2天，而米卡芬净150 mg组为3天。两组患者在死亡率、复发和紧急感染以及不良事件方面没有显著差异。米卡芬净每天100毫克和150毫克的剂量不逊于卡泊芬净的标准剂量，用于治疗念珠菌症和其他形式的侵袭性念珠菌病。
Background. Invasive candidiasis is an important cause of morbidity and mortality among patients with health care-associated infection. The echinocandins have potent fungicidal activity against most Candida species, but there are few data comparing the safety and efficacy of echinocandins in the treatment of invasive candidiasis.Methods. This was an international, randomized, double-blind trial comparing micafungin (100 mg daily) and micafungin ( 150 mg daily) with a standard dosage of caspofungin ( 70 mg followed by 50 mg daily) in adults with candidemia and other forms of invasive candidiasis. The primary end point was treatment success, defined as clinical and mycological success at the end of blinded intravenous therapy.Results. A total of 595 patients were randomized to one the treatment groups and received at least 1 dose of study drug. In the modified intent-to-treat population, 191 patients were assigned to the micafungin 100 mg group, 199 to the micafungin 150 mg group, and 188 to the caspofungin group. Demographic characteristics and underlying disorders were comparable across the groups. Approximately 85% of patients had candidemia; the remainder had noncandidemic invasive candidiasis. At the end of blinded intravenous therapy, treatment was considered successful for 76.4% of patients in the micafungin 100 mg group, 71.4% in the micafungin 150 mg group, and 72.3% in the caspofungin group. The median time to culture negativity was 2 days in the micafungin 100 mg group and the caspofungin group, compared with 3 days in the micafungin 150 mg groups. There were no significant differences in mortality, relapsing and emergent infections, or adverse events between the study arms.Conclusions. Dosages of micafungin 100 mg daily and 150 mg daily were noninferior to a standard dosage of caspofungin for the treatment of candidemia and other forms of invasive candidiasis.