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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Itraconazole oral solution for primary prophylaxis of fungal infections in patients with hematological malignancy and profound neutropenia: a randomized, double-blind, double-placebo, multicenter trial comparing itraconazole and amphotericin B.
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Itraconazole oral solution for primary prophylaxis of fungal infections in patients with hematological malignancy and profound neutropenia: a randomized, double-blind, double-placebo, multicenter trial comparing itraconazole and amphotericin B.

机译：伊曲康唑口服液用于预防血液系统恶性肿瘤和严重中性粒细胞减少症患者的真菌感染：一项比较伊曲康唑和两性霉素B的随机，双盲，双安慰剂，多中心试验。

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Systemic and superficial fungal infections are a major problem among immunocompromised patients with hematological malignancy. A double-blind, double-placebo, randomized, multicenter trial was performed to compare the efficacy and safety of itraconazole oral solution (2.5 mg/kg of body weight twice a day) with amphotericin B capsules (500 mg orally four times a day) for prophylaxis of systemic and superficial fungal infection. Prophylactic treatment was initiated on the first day of chemotherapy and was continued until the end of the neutropenic period (>0.5 x 10(9) neutrophils/liter) or up to a maximum of 3 days following the end of neutropenia, unless a systemic fungal infection was documented or suspected. The maximum treatment duration was 56 days. In the intent-to-treat population, invasive aspergillosis was noted in 5 (1.8%) of the 281 patients assigned to itraconazole oral solution and in 9 (3.3%) of the 276 patients assigned to oral amphotericin B; of these, 1 and 4 patients died, respectively. Proven systemic fungal infection (including invasive aspergillosis) occurred in 8 patients (2.8%) who received itraconazole, compared with 13 (4.7%) who received oral amphotericin B. Itraconazole significantly reduced the incidence of superficial fungal infections as compared to oral amphotericin B (2 [1%] versus 13 [5%]; P = 0.004). Although the incidences of suspected fungal infection (including fever of unknown origin) were not different between the groups, fewer patients were administered intravenous systemic antifungals (mainly intravenous amphotericin B) in the group receiving itraconazole than in the group receiving oral amphotericin B (114 [41%] versus 132 [48%]; P = 0.066). Adequate plasma itraconazole levels were achieved in about 80% of the patients from 1 week after the start of treatment. In both groups, the trial medication was safe and well tolerated. Prophylactic administration of itraconazole oral solution significantly reduces superficial fungal infection in patients with hematological malignancies and neutropenia. The incidence of proven systemic fungal infections, the number of deaths due to deep fungal infections, and the use of systemic antifungals tended to be lower in the itraconazole-treated group than in the amphotericin B-treated group, without statistical significance. Itraconazole oral solution is a broad-spectrum systemic antifungal agent with prophylactic activity in neutropenic patients, especially for those at high risk of prolonged neutropenia.
机译：在患有血液恶性肿瘤的免疫功能低下的患者中，全身和浅表真菌感染是一个主要问题。进行了一项双盲，双安慰剂，随机，多中心试验，以比较伊曲康唑口服溶液（2.5 mg / kg体重，每天两次）与两性霉素B胶囊（500 mg，每天四次，口服）的疗效和安全性。用于预防全身和浅表真菌感染。预防治疗在化疗的第一天开始，并且一直持续到中性粒细胞减少期结束（> 0.5 x 10（9）中性粒细胞/升）或中性粒细胞减少症结束后最多3天，除非全身性真菌记录或怀疑感染。最大治疗时间为56天。在意向性治疗人群中，在伊曲康唑口服溶液治疗的281例患者中，有5（1.8％）名侵入性曲霉病，在276名口服两性霉素B的患者中有9名（3.3％）;其中，有1例和4例患者死亡。经证实的全身性真菌感染（包括侵袭性曲霉病）发生在接受伊曲康唑的8例患者（2.8％）中，而口服两性霉素B的13例（4.7％）发生。与口服两性霉素B相比，伊曲康唑显着降低了浅表真菌感染的发生率（ 2 [1％]与13 [5％]; P = 0.004）。尽管两组之间可疑的真菌感染（包括不明原因的发烧）的发生率没有差异，但接受伊曲康唑的组接受静脉内系统性抗真菌药（主要是静脉注射两性霉素B）的患者少于口服两性霉素B的患者（114 [114 [ 41％对132 [48％]; P = 0.066）。从治疗开始1周后，约80％的患者血浆伊曲康唑水平达到适当水平。在两组中，试验药物都是安全的并且耐受性良好。预防性给予伊曲康唑口服溶液可显着减少血液系统恶性肿瘤和中性粒细胞减少症患者的浅表真菌感染。伊曲康唑治疗组的经证实的全身性真菌感染的发生率，深部真菌感染导致的死亡数和全身性抗真菌剂的使用趋于低于两性霉素B治疗组，但无统计学意义。伊曲康唑口服溶液是一种广谱的全身性抗真菌药，对中性粒细胞减少症患者具有预防作用，尤其是对于那些具有长期中性粒细胞减少症高风险的患者。

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