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在接受造血干细胞移植的中性粒细胞减少患者中,使用米卡芬净与氟康唑进行抗真菌预防的比较。

Use of micafungin versus fluconazole for antifungal prophylaxis in neutropenic patients receiving hematopoietic stem cell transplantation.

作者信息

Hiramatsu Yasushi, Maeda Yoshinobu, Fujii Nobuharu, Saito Takashi, Nawa Yuichiro, Hara Masamichi, Yano Tomofumi, Asakura Shoji, Sunami Kazutaka, Tabayashi Takayuki, Miyata Akira, Matsuoka Ken-Ichi, Shinagawa Katsuji, Ikeda Kazuma, Matsuo Keitaro, Tanimoto Mitsune

机构信息

Department of Hematology, Oncology, and Respiratory Medicine, Okayama University Graduate School of Medicine, Okayama, Japan.

Department of Infection Control and Prevention, Kyoto University Hospital, Kyoto, Japan.

出版信息

Int J Hematol. 2008 Dec;88(5):588-595. doi: 10.1007/s12185-008-0196-y. Epub 2008 Nov 29.

Abstract

A prospective randomized clinical trial assessed the efficacy and tolerance of micafungin compared with that of standard fluconazole treatment in patients undergoing hematopoietic stem cell transplantation (HSCT). Adult patients (n = 106) were randomly assigned to receive prophylaxis with either micafungin 150 mg (n = 52), or fluconazole 400 mg (n = 52). Success was defined as the absence of suspected, proven, or probable invasive fungal infection (IFI) through the end of therapy and the absence of proven or probable IFI through the end of the 4-week period following treatment. The overall efficacy of micafungin was comparable to that of fluconazole (94 vs. 88%; difference 6.0%; 95% confidence interval, -5.4 to +17.4%; P = 0.295). A total of 2 (4.0%) of 50 patients in the micafungin arm and 6 (12.0%) of 50 patients in the fluconazole arm received empirical antifungal therapy (P = 0.06). Micafungin treatment did not result in increasing adverse effects and had a safe profile as fluconazole in neutropenic patients. This randomized trial indicates that the efficacy and tolerance of micafungin 150 mg was comparable to that of fluconazole 400 mg, suggesting that micafungin at 150 mg daily represents a valuable new treatment option for antifungal prophylaxis in HSCT recipients.

摘要

一项前瞻性随机临床试验评估了米卡芬净与标准氟康唑治疗对接受造血干细胞移植(HSCT)患者的疗效和耐受性。成年患者(n = 106)被随机分配接受以下预防性治疗:米卡芬净150 mg(n = 52)或氟康唑400 mg(n = 52)。成功定义为治疗结束时无疑似、确诊或可能的侵袭性真菌感染(IFI),且治疗后4周结束时无确诊或可能的IFI。米卡芬净的总体疗效与氟康唑相当(94%对88%;差异6.0%;95%置信区间,-5.4至+17.4%;P = 0.295)。米卡芬净组50例患者中有2例(4.0%),氟康唑组50例患者中有6例(12.0%)接受了经验性抗真菌治疗(P = 0.06)。米卡芬净治疗未导致不良反应增加,在中性粒细胞减少患者中与氟康唑具有相同的安全性。这项随机试验表明,150 mg米卡芬净的疗效和耐受性与400 mg氟康唑相当,这表明每日150 mg米卡芬净是HSCT受者抗真菌预防的一种有价值的新治疗选择。

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