PHASE II TRIAL OF AMPHOTERICIN B FOR FLUCONAZOLE RESISTANT ORAL CANDIDIASIS

这是一项评估疗效的开放标签多中心临床试验。 两性霉素B口服混悬剂治疗慢性萎缩性胃炎的临床观察 耐氟康唑口腔念珠菌病。 受试者将用5毫升两性霉素B口服混悬液4 每天一次，持续14或28天。14天后有反应的受试者 将转移到维护阶段，在该阶段，他们将成为 14天后无完全反应将继续诱导治疗14 再多几天。第28天的完全响应者将被转移到 研究的维护阶段，而第14天和第28天以及 第28天的非完全响应者和第28天的非完全响应者将 停止学习。然后，受试者将在他/她的诊所接受治疗 医生的自由裁量权。第14天和第28天的应答者将集中到 一组用于最终分析，并将用于确定疗效 两性霉素口服液。

This is an open label multicenter clinical trial assessing the efficacy and toxicity of amphotericin B oral suspension in the treatment of fluconazole-resistant oral candidiasis. Subjects will be treated with 5ml of amphotericin B oral suspension four times daily for 14 or 28 days. The subjects that respond after 14 days will be transferred to maintenance phase, where they will be subjects that do not fully respond after 14 days will continue induction therapy 14 more days. Full responders at day 28 will be transferred to the maintenance phase of the study, while failures from days 14 and 28 and non-full responders from day 28 and non-full responders from day 28 will be discontinued from study. The subject would then be treated at his/her physician's discretion. Responders from day 14 and 28 will be pooled into one group for final analysis, and will be used to determine the efficacy of amphotericin oral solution.