Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis: support for the 2009 IDSA treatment guidelines for candidiasis.

Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis: support for the 2009 IDSA treatment guidelines for candidiasis.
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DOI:
10.1186/cc10514
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发表时间:
2011
期刊:
Critical care (London, England)
影响因子:
--
通讯作者:
Schlamm HT
Schlamm HT
中科院分区:
其他
文献类型:
--
作者:
Kett DH;Shorr AF;Reboli AC;Reisman AL;Biswas P;Schlamm HT

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在过去十年中,住院患者中念珠菌感染的发生率有所增加,氟康唑是治疗这些感染最常用的全身抗真菌药物。然而,2009年美国传染病学会(IDSA)念珠菌病指南推荐使用棘白菌素治疗被认为是“中度或重度”疾病的念珠菌病/侵袭性念珠菌病。为了验证这些指南,我们回顾了临床试验数据。对先前发表的前瞻性、随机、双盲临床试验数据进行二次分析;比较阿尼杜冯宁与氟康唑治疗侵袭性念珠菌病和念珠菌病的疗效。在研究开始时,使用以下标准确定危重疾病患者:急性生理和慢性健康评估(APACHE) II评分≥15,存在严重脓毒症(脓毒症和一种或多种终末器官功能障碍)的证据,和/或患者处于重症监护中。在静脉注射研究治疗结束时(原始研究的主要终点),比较了该组患者的总体缓解率和研究开始后14天和28天的全因死亡率。245例患者中有163例(66.5%)至少满足一项危重疾病标准(阿尼杜拉芬,89例;氟康唑,74例)。两个治疗组的基线特征无显著差异。anidulafungin的总体缓解率为70.8%,氟康唑为54.1% (P = 0.03; 95%可信区间(CI): 2.0 ~ 31.5);anidulafungin和氟康唑14天的全因死亡率分别为10.1%和20.3% (P = 0.08; 95% CI, -0.9至21.3),28天的全因死亡率分别为20.2%和24.3% (P = 0.57; 95% CI, -8.8至17.0)。在这项事后分析中,anidulafungin在治疗念珠菌病重症患者方面比氟康唑更有效,从而支持了2009年IDSA指南。Clinicaltrials.gov NCT00058682。
During the past decade, the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. However, the 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be "moderately severe or severely" ill. To validate these guidelines, clinical trial data were reviewed. A secondary analysis of data from a previously published prospective, randomized, double-blind clinical trial was performed; it compared anidulafungin with fluconazole for the treatment of invasive candidiasis and candidemia. Patients with critical illness were identified at study entry by using the following criteria: Acute Physiology and Chronic Health Evaluation (APACHE) II score of ≥ 15, evidence of severe sepsis (sepsis and one or more end-organ dysfunctions) present, and/or patient was in intensive care. Global response rates were compared at the end of intravenous study treatment (the primary end point of the original study) and all-cause mortality at 14 and 28 days from study entry in this group. The patients (163 (66.5%) of 245) fulfilled at least one criterion for critical illness (anidulafungin, n = 89; fluconazole, n = 74). No significant differences were found in baseline characteristics between the two treatment groups. The global response rate was 70.8% for anidulafungin and 54.1% for fluconazole (P = 0.03; 95% confidence interval (CI): 2.0 to 31.5); all-cause mortality was 10.1% versus 20.3% at 14 days (P = 0.08; 95% CI, -0.9 to 21.3) and was 20.2% versus 24.3% at 28 days (P = 0.57; 95% CI, -8.8 to 17.0) for anidulafungin and fluconazole, respectively. In this post hoc analysis, anidulafungin was more effective than fluconazole for treatment of severely ill patients with candidemia, thus supporting the 2009 IDSA guidelines. Clinicaltrials.gov NCT00058682.
DOI: 10.1186/cc8117
发表时间: 2009
期刊: Critical care (London, England)
影响因子: --
作者:
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