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首页> 外文期刊>The New England journal of medicine >Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia.
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Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia.

机译：卡泊芬净与脂质体两性霉素B用于持续发烧和中性粒细胞减少症患者的经验性抗真菌治疗。

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BACKGROUND: Patients with persistent fever and neutropenia often receive empirical therapy with conventional or liposomal amphotericin B for the prevention and early treatment of invasive fungal infections. Caspofungin, a member of the new echinocandin class of compounds, may be an effective alternative that is better tolerated than amphotericin B. METHODS: In this randomized, double-blind, multinational trial, we assessed the efficacy and safety of caspofungin as compared with liposomal amphotericin B as empirical antifungal therapy. At study entry, patients were stratified according to risk and according to whether they had previously received antifungal prophylaxis. A successful outcome was defined as the fulfillment of all components of a five-part composite end point. RESULTS: Efficacy was evaluated in 1095 patients (556 receiving caspofungin and 539 receiving liposomal amphotericin B). After adjustment for strata, the overall success rates were 33.9 percent for caspofungin and 33.7 percent for liposomal amphotericin B (95.2 percent confidence interval for the difference, -5.6 to 6.0 percent), fulfilling statistical criteria for the noninferiority of caspofungin. Among patients with baseline fungal infections, a higher proportion of those treated with caspofungin had a successful outcome (51.9 percent vs. 25.9 percent, P=0.04). The proportion of patients who survived at least seven days after therapy was greater in the caspofungin group (92.6 percent vs. 89.2 percent, P=0.05). Premature study discontinuation occurred less often in the caspofungin group than in the amphotericin B group (10.3 percent vs. 14.5 percent, P=0.03). The rates of breakthrough fungal infections and resolution of fever during neutropenia were similar in the two groups. Fewer patients who received caspofungin sustained a nephrotoxic effect (2.6 percent vs. 11.5 percent, P<0.001), an infusion-related event (35.1 percent vs. 51.6 percent, P<0.001), or a drug-related adverse event or discontinued therapy because of drug-related adverse events. CONCLUSIONS: Caspofungin is as effective as and generally better tolerated than liposomal amphotericin B when given as empirical antifungal therapy in patients with persistent fever and neutropenia.
机译：背景：持续发烧和中性粒细胞减少的患者经常接受常规或脂质体两性霉素B的经验疗法，以预防和早期治疗侵袭性真菌感染。卡泊芬净是新型棘球菌素类化合物的成员，可能是比两性霉素B耐受性更好的有效替代品。方法：在这项随机，双盲，多国试验中，我们评估了卡泊芬净与脂质体相比的疗效和安全性两性霉素B作为经验性抗真菌治疗。在研究开始时，根据风险和以前是否接受过抗真菌药物对患者进行了分层。成功的成果定义为完成了一个由五部分组成的复合终点的所有组成部分。结果：对1095例患者进行了疗效评估（556例接受卡泊芬净，539例接受脂质体两性霉素B）。调整地层后，卡泊芬净的整体成功率为33.9％，两性霉素B脂质体的总成功率为33.7％（差异的置信区间为95.2％，-5.6％至6.0％），满足卡泊芬净非劣效的统计标准。在基线真菌感染的患者中，接受卡泊芬净治疗的患者中成功率较高（51.9％比25.9％，P = 0.04）。卡泊芬净组中在治疗后至少存活7天的患者比例更高（分别为92.6％和89.2％，P = 0.05）。卡泊芬净组中的早产研究中断发生率比两性霉素B组低（10.3％对14.5％，P = 0.03）。两组中突破性真菌感染的发生率和中性粒细胞减少症的发烧消退率相似。接受卡泊芬净治疗的患者较少发生肾毒性（2.6％vs. 11.5％，P <0.001），输注相关事件（35.1％vs. 51.6％，P <0.001）或药物相关不良事件或中止治疗因为药物相关的不良事件。结论：对于持续发烧和中性粒细胞减少的患者，经验性抗真菌治疗给予卡泊芬净的效果与脂质体两性霉素B相同，并且通常耐受性更好。

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