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Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Micafungin versus Itraconazole for Prophylaxis of Invasive Fungal Infections in Patients undergoing Hematopoietic Stem Cell Transplant
Huang, Xiaojun1; Chen, Huan; Han, Mingzhe2,3,4; Zou, Ping5; Wu, Depei6; Lai, Yongrong7; Huang, He8; Chen, Xiequn9; Liu, Ting10; Zhu, Huanling10; Wang, Jianmin11; Hui, Jianda12
关键词Micafungin Itraconazole Prevention of invasive fungal infection Antifungal prophylaxis Hematopoietic stem cell transplant
刊名BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
2012-10-01
DOI10.1016/j.bbmt.2012.03.014
18期:10页:1509-1516
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Hematology ; Immunology ; Transplantation
资助者Astellas Pharma China, Inc. ; Astellas Pharma China, Inc.
研究领域[WOS]Hematology ; Immunology ; Transplantation
关键词[WOS]ANTIFUNGAL PROPHYLAXIS ; NEUTROPENIC PATIENTS ; FLUCONAZOLE ; RECIPIENTS ; METAANALYSIS ; CHEMOTHERAPY ; MALIGNANCIES
英文摘要

This multicenter, randomized, open-label phase III study compared the efficacy and safety of micafungin and itraconazole in prophylaxis of invasive fungal infections in neutropenic patients undergoing hematopoietic stem cell transplants in China. Micafungin (50 mg/day i.v.) or itraconazole (5 mg/kg/day p.o.) was administered for <= 42 days. The primary endpoint, treatment success, was defined as no proven, probable, or suspected invasive fungal infection through therapy and the absence of proven or probable invasive fungal infection through the end of 4 weeks after therapy. Noninferiority of micafungin against itraconazole was established if the lower boundary of the 95% confidence interval (CI) was >10%. Of 287 patients, 283 were evaluable for efficacy (136 for micafungin, 147 for itraconazole, intent-to-treat population). Treatment success was documented in 92.6% (126 of 136) of micafungin-treated patients and 94.6% (139 of 147) of itraconazole-treated patients (95% CI, -7.562% to 3.482%; P = .48), indicating noninferiority of micafungin against itraconazole. Results were similar for patients treated per protocol. Whereas the rates of proven or probable invasive fungal infection were numerically higher with micafungin than itraconazole at 4.4% (6 of 136) and 1.4% (2 of 147), rates of suspected invasive fungal infection were similar at 5.9% (8 of 136) and 7.5% (11 of 147), respectively. More patients treated with micafungin than itraconazole completed the study (82.9% versus 67.3%, respectively). Significant differences in incidence of withdrawal due to an adverse event (4.4% versus 21.1%) and drug-related adverse events (8% versus 26.5%) were shown between micafungin and itraconazole (P = .00, chi-square test). Micafungin was as effective as itraconazole in preventing invasive fungal infections in patients with neutropenia. In comparison to itraconazole, treatment tolerance was much better with micafungin. Biol Blood Marrow Transplant 18: 1509-1516 (2012) (C) 2012 American Society for Blood and Marrow Transplantation

语种英语
资助者Astellas Pharma China, Inc. ; Astellas Pharma China, Inc.
WOS记录号WOS:000309314100007
引用统计
被引频次:23[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67724
专题北京大学第二临床医学院_血液科
作者单位1.Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China
2.Peking Univ, Peoples Hosp, Beijing Key Lab HSCT, Inst Hematol, Beijing 100044, Peoples R China
3.CAMS, Inst Hematol, Tianjin, Peoples R China
4.CAMS, Blood Dis Hosp, Tianjin, Peoples R China
5.PUMC, Tianjin, Peoples R China
6.Huazhong Univ Sci & Technol, Tongji Med Coll, Affiliated Union Hosp, Beijing, Peoples R China
7.Guangxi Med Univ, Affiliated Hosp 1, Nanning, Peoples R China
8.Zhejiang Univ, Sch Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
9.Fourth Mil Med Univ, Xijing Hosp, Xian 710032, ShaanXi, Peoples R China
10.W China Univ Med Sci, Affiliated Hosp 1, Guangzhou, Guangdong, Peoples R China
11.Second Mil Med Univ, Changhai Hosp, Shanghai, Peoples R China
12.Fujian Med Univ, Affiliated Union Hosp, Fuzhou, Peoples R China
推荐引用方式
GB/T 7714
Huang, Xiaojun,Chen, Huan,Han, Mingzhe,et al. Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Micafungin versus Itraconazole for Prophylaxis of Invasive Fungal Infections in Patients undergoing Hematopoietic Stem Cell Transplant[J]. BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION,2012,18(10):1509-1516.
APA Huang, Xiaojun.,Chen, Huan.,Han, Mingzhe.,Zou, Ping.,Wu, Depei.,...&Hui, Jianda.(2012).Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Micafungin versus Itraconazole for Prophylaxis of Invasive Fungal Infections in Patients undergoing Hematopoietic Stem Cell Transplant.BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION,18(10),1509-1516.
MLA Huang, Xiaojun,et al."Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Micafungin versus Itraconazole for Prophylaxis of Invasive Fungal Infections in Patients undergoing Hematopoietic Stem Cell Transplant".BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION 18.10(2012):1509-1516.
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