IR@PKUHSC  > 北京大学第二临床医学院
学科主题临床医学
Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study
Shen, Yang1; Huang, Xiao-Jun2; Wang, Jian-Xiang3,4,5; Jin, Jie6; Hu, Jian-Da7; Yu, Kang8; Wu, De-Pei9; Wang, Shu-Jie10; Yu, Li11; Chen, Xie-Qun12; Liu, Ting13; Liang, Ying-Ming14; Chen, Fang-Ping15; Li, Yan16; Shen, Zhi-Xiang1
关键词posaconazole prophylaxis invasive fungal infection
刊名INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
2013-09-01
DOI10.5414/CP201880
51期:9页:738-745
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
资助者Merck Research Institute ; Shanghai Municipal Commission for Science and Technology ; Merck Research Institute ; Shanghai Municipal Commission for Science and Technology
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]LIPOSOMAL AMPHOTERICIN-B ; MYCOSES STUDY-GROUP ; EMPIRICAL THERAPY ; EUROPEAN-ORGANIZATION ; ANTIFUNGAL PROPHYLAXIS ; CANCER-PATIENTS ; ASPERGILLOSIS ; NEUTROPENIA ; SURVEILLANCE ; ITRACONAZOLE
英文摘要

Background: Invasive fungal infection (IFI) is common in neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MD S). Posaconazole is a broad-spectrum triazole antifungal drug with efficacy in prevention of IFI; however, it has not been previously studied as prophylaxis in a Chinese population. Methods: This multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia. Prophylaxis with posaconazole or fiuconazole was administered for a maximum of 12 weeks, or until patients recovered from neutropenia and achieved complete remission or an IFI occurred. The primary endpoint was incidence of proven, probable, or possible IFI during treatment. Clinical failure rate, all-cause mortality and time to first systemic antifungal treatment were secondary endpoints. Results: Patients were randomized to receive posaconazole (n = 129) or fluconazole (n= 123); 117 patients in each group were included in the statistical analysis. The incidence of proven, probable or possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (p = 0.0114). The clinical failure rate was numerically lower in the posaconazole group (37/117 (31.6%; 95%CI: 23.3 - 40.9)) than in the fiuconazole group (49/117 (41.88%; 95% CI: 32.8 - 51.4)) (p = 0.168). Patients receiving posaconazole had a later onset of first systematic antifungal treatment than those receiving fluconazole (p = 0.0139). The most common important adverse events were liver function abnormalities (11 patients (8.8%) on posaconazole and 6 (5.0%) on fluconazole (p = 0.221)). Conclusions: Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic Chinese patients and is well tolerated during long-term use (ClinicalTrials.gov number, NCT00811928).

语种英语
所属项目编号10411965600
资助者Merck Research Institute ; Shanghai Municipal Commission for Science and Technology ; Merck Research Institute ; Shanghai Municipal Commission for Science and Technology
WOS记录号WOS:000324607500006
引用统计
被引频次:13[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/400002259/58384
专题北京大学第二临床医学院
作者单位1.Xijing Hosp, Xian, Shaanxi, Peoples R China
2.Huaxi Hosp, Chengdu, Sichuan Provinc, Peoples R China
3.Tangdu Hosp, Xian, Shaanxi, Peoples R China
4.Xiangya Hosp, Changsha, Hunan, Peoples R China
5.Beijing Univ, People Hosp, Beijing 100871, Peoples R China
6.Fujian Med Univ, Union Hosp, Fuzhou, Fujian, Peoples R China
7.Wenzhou Med Coll, Wenzhou, Zhejiang, Peoples R China
8.Gen Hosp Chinese Peoples Liberat Army, Beijing, Peoples R China
9.Shanghai Jiao Tong Univ, Sch Med, Rui Jin Hosp, Shanghai 200030, Peoples R China
10.Chinese Acad Med Sci, Inst Hematol, Tianjin, Peoples R China
11.Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China
12.Peking Union Med Coll, Tianjin, Peoples R China
13.Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
14.Suzhou Univ, Affiliated Hosp 1, Suzhou 215006, Jiangsu, Peoples R China
15.Beijing Union Med Coll Hosp, Beijing, Peoples R China
16.China Med Univ, Affiliated Hosp 1, Shenyang, Liaoning Provin, Peoples R China
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GB/T 7714
Shen, Yang,Huang, Xiao-Jun,Wang, Jian-Xiang,et al. Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study[J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,2013,51(9):738-745.
APA Shen, Yang.,Huang, Xiao-Jun.,Wang, Jian-Xiang.,Jin, Jie.,Hu, Jian-Da.,...&Shen, Zhi-Xiang.(2013).Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study.INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,51(9),738-745.
MLA Shen, Yang,et al."Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study".INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 51.9(2013):738-745.
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