IR@PKUHSC  > 北京大学第二临床医学院  > 血液科
学科主题临床医学
Efficacy and safety of itraconazole as empirical antifungal therapy in febrile neutropenic patients with hematologic malignancies: an open-lable, multicenter, observational trial in a Chinese cohort
Cheng Shu1; Zhou Jian-feng2; Zou Ping3; Huang Xiao-jun4; Jin Jie5; Shen Zhi-xiang1
关键词itraconazole hematologic malignancy febrile neutropenia empirical therapy
刊名CHINESE MEDICAL JOURNAL
2011-11-20
DOI10.3760/cma.j.issn.0366-6999.2011.22.013
124期:22页:3670-3675
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
资助者Xian Janssen Pharmaceutical Ltd. ; Xian Janssen Pharmaceutical Ltd.
研究领域[WOS]General & Internal Medicine
关键词[WOS]LIPOSOMAL AMPHOTERICIN-B ; CLINICAL-PRACTICE GUIDELINES ; INFECTIOUS-DISEASES SOCIETY ; PERSISTENT FEVER ; CANCER-PATIENTS ; AMERICA
英文摘要

Background Invasive fungal infection (IFI) is a common and fatal complication in neutropenic patients with hematological malignancy. Empirical antifungal therapy is widely used in practice due to the difficulty of pathogens determination and illness of the hosts. The aim of this study was to evaluate the efficacy and safety of itraconazole as empirical antifungal therapy for persistent fever in neutropenic patients with hematologic malignancies.

Methods Two hundred and seventy-four patients with hematologic malignancies who had suspected fungal infections were enrolled in 18 centers across China between April 2008 and April 2009. Empirical antifungal therapy with intravenous itraconazole 200 mg twice daily was given for the first two days, followed by 200 mg once daily for the next 12 days. Oral itraconazole solution was sequential for follow-up therapy if necessary. Five composite end points were evaluated for the response, which was more restrictive and adopted for the first time in such study in China.

Results The intent-to-treat analysis included data from 274 patients (full analysis set, FAS), of whom 248 were included as the per-protocol population (PPS). As the composite end point of five indices was concerned, the overall response rate was 43.4%. Seperately, defervescence was achieved in 90% of patients in which 55.5% occured during neutropenia. The mean time to defervescence was 2.71 days. Absence of breakthrough IFI during drug administration or within the first 7 days after study completion was observed in 71.5% of patients. Fifty-five point five percent patients with IFI at baseline was successfully treated. Ninety point five percent patients survived for at least 7 days after completing the study. PPS analysis revealed that the duration of neutropenia >= 10 days was a statistically significant negative predictor for the response. The withdrawal rate due to drug-related toxicity or lack of efficacy was 11.0%. The incidence of adverse events was 22.6%, in which 11.6% was study drug related. The most frequent adverse events were mild to moderate liver toxicity.

Conclusion ltraconazole shows desirable efficacy and safety as empirical antifungal therapy for febrile neutropenic patients with hematologic malignancies. Chin Med J 2011;124(22):3670-3675

语种英语
资助者Xian Janssen Pharmaceutical Ltd. ; Xian Janssen Pharmaceutical Ltd.
WOS记录号WOS:000297658300013
Citation statistics
Cited Times:1[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67208
Collection北京大学第二临床医学院_血液科
作者单位1.Shanghai Jiao Tong Univ, Sch Med, Shanghai Ruijin Hosp, Dept Hematol, Shanghai 200025, Peoples R China
2.Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Hematol, Tongji Hosp, Wuhan 430030, Hubei, Peoples R China
3.Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Hematol, Wuhan 430030, Hubei, Peoples R China
4.Peking Univ, Peoples Hosp, Dept Hematol, Beijing 100044, Peoples R China
5.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Dept Hematol, Hangzhou 310003, Zhejiang, Peoples R China
Recommended Citation
GB/T 7714
Cheng Shu,Zhou Jian-feng,Zou Ping,et al. Efficacy and safety of itraconazole as empirical antifungal therapy in febrile neutropenic patients with hematologic malignancies: an open-lable, multicenter, observational trial in a Chinese cohort[J]. CHINESE MEDICAL JOURNAL,2011,124(22):3670-3675.
APA Cheng Shu,Zhou Jian-feng,Zou Ping,Huang Xiao-jun,Jin Jie,&Shen Zhi-xiang.(2011).Efficacy and safety of itraconazole as empirical antifungal therapy in febrile neutropenic patients with hematologic malignancies: an open-lable, multicenter, observational trial in a Chinese cohort.CHINESE MEDICAL JOURNAL,124(22),3670-3675.
MLA Cheng Shu,et al."Efficacy and safety of itraconazole as empirical antifungal therapy in febrile neutropenic patients with hematologic malignancies: an open-lable, multicenter, observational trial in a Chinese cohort".CHINESE MEDICAL JOURNAL 124.22(2011):3670-3675.
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