Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation
Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation
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DOI：
10.1086/422312
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发表时间：
2004-11-15
影响因子：
11.8
通讯作者：
Walsh, TJ
中科院分区：
文献类型：
--
作者：
van Burik, JAH;Ratanatharathorn, V;Walsh, TJ
我们假设，棘白菌素米卡芬净的化学预防将是一种有效的药物，在中性粒细胞减少症患者接受造血干细胞移植（HSCT）的抗真菌预防。因此，我们进行了一项随机、双盲、多机构、比较性III期试验，涉及882名成人和儿童患者，每日一次给予50 mg米卡芬净（体重< 50 kg的患者为1 mg/kg）和400 mg氟康唑（体重< 50 kg的患者为8 mg/kg）。成功定义为治疗结束时没有疑似、证实或可能的侵袭性真菌感染（IFI），以及治疗后4周结束时没有证实或可能的IFI。在HSCT后的血小板减少期，米卡芬净作为抗真菌预防性治疗的总体疗效上级优于氟康唑（米卡芬净组为80.0%，氟康唑组为73.5%[差异为6.5%]; 95%置信区间为0.9% - 12%; P = .03）。这项随机试验证明了棘白菌素对血小板减少症患者进行抗真菌预防的有效性。
We hypothesized that chemoprophylaxis with the echinocandin micafungin would be an effective agent for antifungal prophylaxis during neutropenia in patients undergoing hematopoietic stem cell transplantation (HSCT). We therefore conducted a randomized, double-blind, multi-institutional, comparative phase III trial, involving 882 adult and pediatric patients, of 50 mg of micafungin (1 mg/kg for patients weighing < 50 kg) and 400 mg of fluconazole (8 mg/kg for patients weighing < 50 kg) administered once per day. Success was defined as the absence of suspected, proven, or probable invasive fungal infection (IFI) through the end of therapy and as the absence of proven or probable IFI through the end of the 4-week period after treatment. The overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after HSCT (80.0% in the micafungin arm vs. 73.5% in the fluconazole arm [difference, 6.5%]; 95% confidence interval, 0.9% - 12%; P = .03). This randomized trial demonstrates the efficacy of an echinocandin for antifungal prophylaxis in neutropenic patients.