L 743,872 VS AMPHOTERICIN B IN FLUCONAZOLE UNRESPONSIVE CANDIDIASIS

这是一项双盲随机对照研究，旨在评价新药L-743,872与两性霉素B治疗氟康唑敏感的口咽和食道念珠菌病的安全性、耐受性和疗效。患者将被随机分配到L-743,872，35 mg/天，50 mg/天和70 mg/天，或两性霉素B 0.5 mg/kg天。所有患者将接受：(1)L-743,872加安慰剂给两性霉素B或(2)两性霉素B加安慰剂给L-743,872。L-743,872或与之匹配的安慰剂将在1小时内每日单次静脉滴注。然后是两性霉素B或匹配的安慰剂，每日单次静脉滴注，持续2小时。在第一天，将在第一次治疗剂量两性霉素B安慰剂之前给予测试剂量(1毫克)的两性霉素B/两性霉素B安慰剂，以确定在随后的剂量之前是否需要用药。

This is a double-blind, randomized, comparative study to evaluate the safety, tolerability, and efficacy of L-743,872, a new echinocandin antifungal, versus amphotericin B in the treatment of fluconazole- unresponsive oropharyngeal and esophageal candidiasis. Patients will be randomized to doses of L-743,872 of 35 mg/day, 50 mg/day, and 70 mg/day or amphotericin B at 0.5 mg/kg day. All patients will receive either: (1) L-743,872 and placebo to amphotericin B or (2) amphotericin B and placebo to L-743,872. L-743,872 or matching placebo will be given intravenously as a single daily dose infused over a 1 hour period. This will be followed by amphotericin B or matching placebo given intravenously as a single daily dose infused over a 2 hour period. On Day 1, a test dose (1 mg) of amphotericin B/amphotericin B placebo will be given prior to the first therapeutic dose of amphotericin B placebo to determine the need for premedication prior to subsequent doses.