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学科主题: 临床医学
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Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study
作者: 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
发表日期: 2013-09-01
DOI: 10.5414/CP201880
卷: 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
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
项目资助者: Merck Research Institute ; Shanghai Municipal Commission for Science and Technology
WOS记录号: WOS:000324607500006
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/58384
Appears in Collections:北京大学第二临床医学院_期刊论文

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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

Recommended Citation:
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.
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