伊曲康唑在化疗及造血干细胞移植患者不同治疗策略中的疗效和安全性分析

Efficacy and safety of intravenous itraconazole in different antifungal strategies for patients undergoing intensive chemotherapy or hematopoietic stem cell transplantation

目的 探讨伊曲康唑静脉注射在接受高强度化疗或造血干细胞移植血液肿瘤患者不同治疗策略下的有效性和安全性.方法 采用全国多中心的观察性病例资料进行回顾性分析,比较各种治疗策略下伊曲康唑的有效率,并对与疗效相关的各种影响因素进行回归分析.结果 全部174例患者中,确诊侵袭性真菌病（IFD）2例,临床诊断IFD 20例,拟诊IFD 19例,未确定IFD 133例.伊曲康唑对全部患者的有效率为33.7％,目标治疗、诊断驱动治疗、经验治疗的有效率分别为50.0％、57.4％、13.5％,三者之间差异均有统计学意义（P＜0.01）.多因素分析显示,患者在治疗前或治疗中出现IFD的诊断依据与伊曲康唑治疗有效显著相关（P＜0.01）.伊曲康唑相关不良反应发生率为2.9％.结论 应用伊曲康唑静脉注射对广谱抗生素治疗无效的持续发热化疗及造血干细胞移植血液肿瘤患者进行目标治疗和诊断驱动治疗是一种安全、有效的措施.

Objective To explore the efficacy and safety of intravenous itraconazole for patients undergoing intensive chemotherapy or hematopoietic stem cell transplantation in different strategies.Methods Based on multicenter,observational data,the efficacies of antifungal therapy for patients with persistent fever and suspected IFD in different strategies were calculated retrospectively,and the factors associated with the response of antifungal therapy were explored by logistic analysis.Results In accordance with the latest published diagnostic criteria and treatment consensus in China,there were 2 patients who were diagnosed as proven IFD ultimately,20 probable IFD,19 possible IFD and 133 undefined IFD,respectively.Accordingly,the response rates in targeted therapy for proven/probable IFD patients,diagnostic-driven therapy for possible and undefined IFD patients with clinical or microbiological evidence of IFD,and empirical therapy for undefined patients without any evidence of IFD were 50.0％,57.4％ and 13.5％,respectively （P＜0.01）.And the multivariable analysis indicated that the presence of radiological or microbiological evidence of IFD before or after the initiation of antifungal therapy was markedly associated with the response to antifungal therapy （P＜0.01）.The incidence of itraconazolerelated adverse effect was only 2.9％.Conclusion Itraconazole injection was an effective and safe agent in targeted and diagnostic-driven antifungal therapy for immunocompromised or neutropenic febrile patients with hematological malignancies.