Pappas Peter G, Rotstein Coleman M F, Betts Robert F, Nucci Marcio, Talwar Deepak, De Waele Jan J, Vazquez Jose A, Dupont Bertrand F, Horn David L, Ostrosky-Zeichner Luis, Reboli Annette C, Suh Byungse, Digumarti Raghunadharao, Wu Chunzhang, Kovanda Laura L, Arnold Leah J, Buell Donald N
Div. of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL 35294-0006, USA.
Clin Infect Dis. 2007 Oct 1;45(7):883-93. doi: 10.1086/520980. Epub 2007 Aug 29.
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.
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.
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.
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.
侵袭性念珠菌病是医疗保健相关感染患者发病和死亡的重要原因。棘白菌素类药物对大多数念珠菌属具有强大的杀菌活性,但比较棘白菌素类药物治疗侵袭性念珠菌病的安全性和有效性的数据较少。
这是一项国际随机双盲试验,在患有念珠菌血症和其他形式侵袭性念珠菌病的成人中,将米卡芬净(每日100毫克)和米卡芬净(每日150毫克)与标准剂量的卡泊芬净(70毫克,随后每日50毫克)进行比较。主要终点是治疗成功,定义为在盲法静脉治疗结束时临床和真菌学成功。
共有595例患者被随机分配到一个治疗组并接受至少1剂研究药物。在改良意向性治疗人群中,191例患者被分配到米卡芬净100毫克组,199例到米卡芬净150毫克组,188例到卡泊芬净组。各组的人口统计学特征和基础疾病具有可比性。约85%的患者患有念珠菌血症;其余患者患有非念珠菌血症的侵袭性念珠菌病。在盲法静脉治疗结束时,米卡芬净100毫克组76.4%的患者、米卡芬净150毫克组71.4%的患者和卡泊芬净组72.3%的患者被认为治疗成功。米卡芬净100毫克组和卡泊芬净组培养转阴的中位时间为2天,而米卡芬净150毫克组为3天。各研究组之间在死亡率、复发和新发感染或不良事件方面无显著差异。
每日100毫克和150毫克剂量的米卡芬净在治疗念珠菌血症和其他形式的侵袭性念珠菌病方面不劣于标准剂量的卡泊芬净。