Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia
Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia
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DOI：
10.1128/aac.48.6.2021-2024.2004
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发表时间：
2004-06-01
影响因子：
4.9
通讯作者：
Henkel, T
中科院分区：
文献类型：
--
作者：
Krause, DS;Reinhardt, J;Henkel, T
本研究评估了阿尼芬净（一种新型棘白菌素）在侵袭性念珠菌病（包括念珠菌血症）患者中的安全性和有效性。总共 123 名符合条件的患者被随机接受三种静脉注射方案中的一种，即 50、75 或 100 mg 每日一次。治疗持续两周直至体征和症状消退或改善。主要疗效标准是治疗结束 (EOT) 后 2 周、随访 (FU) 时可评估人群的总体缓解率（即临床和微生物学成功）。一百二十 (120) 名患者接受了至少一剂阿尼芬净； 68 个可评估。不良事件和实验室数据的审查表明安全参数没有剂量反应。非白色念珠菌属念珠菌种约占所有分离株的一半。 50、75 和 100 mg 组的 EOT 成功率分别为 84%、90% 和 89%。在 FU，成功率分别为 72%、85% 和 83%。阿尼芬净治疗侵袭性念珠菌病和念珠菌血症的 3 期研究是必要的。
This study evaluated the safety and efficacy of anidulafungin, a novel echinocandin, in patients with invasive candidiasis, including candidemia. A total of 123 eligible patients were randomized to one of three intravenous regimens, 50, 75, or 100 mg once daily. Treatment continued for 2 weeks beyond resolution or improvement of signs and symptoms. The primary efficacy criterion was a successful global response rate (i.e., clinical and microbiological success) in the evaluable population at the follow-up (FU) visit, 2 weeks after end of therapy (EOT). One hundred twenty (120) patients received at least one dose of anidulafungin; 68 were evaluable. Review of adverse events and laboratory data indicated no dose response for safety parameters. Non-albicans Candida species accounted for approximately one-half of all isolates. Success rates at EOT were 84, 90, and 89% in the 50-, 75-, and 100-mg groups, respectively. At FU, the success rates were 72, 85, and 83%. Phase 3 studies of anidulafungin for the treatment of invasive candidiasis and candidemia are warranted.