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韩国一项前瞻性多中心观察性研究:血液病患者经验性伊曲康唑抗真菌治疗的临床转归和预后因素。

Clinical outcomes and prognostic factors of empirical antifungal therapy with itraconazole in the patients with hematological malignancies: a prospective multicenter observational study in Korea.

机构信息

Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.

出版信息

Yonsei Med J. 2014 Jan;55(1):9-18. doi: 10.3349/ymj.2014.55.1.9.

Abstract

PURPOSE

To identify prognostic factors for the outcomes of empirical antifungal therapy, we performed a multicenter, prospective, observational study in immunocompromised patients with hematological malignancies.

MATERIALS AND METHODS

Three hundred seventy-six patients (median age of 48) who had neutropenic fever and who received intravenous (IV) itraconazole as an empirical antifungal therapy for 3 or more days were analyzed. The patients with possible or probable categories of invasive fungal disease (IFD) were enrolled.

RESULTS

The overall success rate was 51.3% (196/376). Age >50 years, underlying lung disease (co-morbidity), poor performance status [Eastern Cooperative Oncology Group (ECOG) ≥2], radiologic evidence of IFD, longer duration of baseline neutropenic fever (≥4 days), no antifungal prophylaxis or prophylactic use of antifungal agents other than itraconazole, and high tumor burden were associated with decreased success rate in univariate analysis. In multivariate analysis, age >50 years (p=0.009) and poor ECOG performance status (p=0.005) were significantly associated with poor outcomes of empirical antifungal therapy. Twenty-two patients (5.9%) discontinued itraconazole therapy due to toxicity.

CONCLUSION

We concluded that empirical antifungal therapy with IV itraconazole in immunocompromised patients is effective and safe. Additionally, age over 50 years and poor performance status were poor prognostic factors for the outcomes of empirical antifungal therapy with IV itraconazole.

摘要

目的

为了确定经验性抗真菌治疗结果的预后因素,我们在患有血液恶性肿瘤的免疫功能低下患者中进行了一项多中心、前瞻性、观察性研究。

材料和方法

分析了 376 名(中位年龄 48 岁)中性粒细胞减少性发热且接受静脉注射(IV)伊曲康唑作为经验性抗真菌治疗超过 3 天的患者。纳入了可能或可能患有侵袭性真菌病(IFD)的患者。

结果

总体成功率为 51.3%(196/376)。年龄>50 岁、肺部疾病(合并症)、较差的表现状态[东部合作肿瘤组(ECOG)≥2]、IFD 的影像学证据、基线中性粒细胞减少性发热持续时间较长(≥4 天)、无抗真菌预防或除伊曲康唑以外的预防性使用抗真菌药物、以及高肿瘤负荷与单变量分析中较低的成功率相关。在多变量分析中,年龄>50 岁(p=0.009)和较差的 ECOG 表现状态(p=0.005)与经验性抗真菌治疗的不良结果显著相关。22 名患者(5.9%)因毒性而停止伊曲康唑治疗。

结论

我们得出结论,在免疫功能低下的患者中,静脉注射伊曲康唑的经验性抗真菌治疗是有效且安全的。此外,年龄>50 岁和表现状态不佳是静脉注射伊曲康唑经验性抗真菌治疗结果的不良预后因素。

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