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棘白菌素类药物治疗近平滑念珠菌所致念珠菌血症:6 项前瞻性临床研究汇总数据分析。

Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies.

机构信息

The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Department of Medicine, University of Udine, Udine, Italy.

出版信息

Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

Abstract

Concerns with echinocandin use for infections caused by Candida parapsilosis complex species have driven the need for data to support echinocandin clinical efficacy in such patients. Data from six prospective studies were pooled to assess efficacy and safety of anidulafungin in patients with candidaemia caused by C. parapsilosis. Patient-level data were pooled from patients with microbiologically confirmed candidaemia due to C. parapsilosis treated with anidulafungin. Patients received a 200 mg intravenous (IV) loading dose of anidulafungin (day 1) and 100 mg daily thereafter. IV treatment could be switched to oral azole therapy after ≥5 or ≥10 days. Primary endpoint was global response at end of IV therapy (EOIVT). Seventy patients had candidaemia caused by C. parapsilosis. Global response was 77.1% (95% CI: 67.3, 87.0) at EOIVT and 70.0% (95% CI: 59.3, 80.7) at end of treatment. Three of 55 isolates (with MICs available) were resistant to anidulafungin (MIC ≥8 mg/L). All-cause mortality was 5.7% (n=4/70) by day 14 and 14.3% (n=10/70) by day 28. IV anidulafungin was effective for the treatment of C. parapsilosis candidaemia in this population, consistent with efficacy previously demonstrated for other Candida species. (ClinicalTrials.gov identifiers: NCT00496197, NCT00548262, NCT00537329, NCT00689338, NCT00806351, NCT00805740).

摘要

对于由近平滑念珠菌复合种引起的感染,人们对棘白菌素类药物的使用存在担忧,这促使人们需要数据来支持此类患者使用棘白菌素类药物的临床疗效。对六项前瞻性研究的数据进行了汇总,以评估安尼芬净治疗近平滑念珠菌引起的念珠菌血症患者的疗效和安全性。汇总了经微生物学确认为近平滑念珠菌引起的念珠菌血症且接受安尼芬净治疗的患者的个体患者数据。患者在第 1 天接受 200mg 静脉(IV)负荷剂量的安尼芬净(第 1 天),此后每天 100mg。静脉治疗可在≥5 或≥10 天后转为口服唑类药物治疗。主要终点为 IV 治疗结束时的总体反应(EOIVT)。70 例患者患有由近平滑念珠菌引起的念珠菌血症。EOIVT 时的总体反应为 77.1%(95%CI:67.3,87.0),治疗结束时为 70.0%(95%CI:59.3,80.7)。在 55 株可供检测 MIC 的分离株中,有 3 株(MIC≥8mg/L)对安尼芬净耐药。在第 14 天,有 5.7%(n=4/70)的患者发生全因死亡率,在第 28 天,有 14.3%(n=10/70)的患者发生全因死亡率。在该人群中,静脉注射用安尼芬净对近平滑念珠菌引起的念珠菌血症有效,与先前对其他念珠菌种显示的疗效一致。(临床试验.gov 标识符:NCT00496197、NCT00548262、NCT00537329、NCT00689338、NCT00806351、NCT00805740)。

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