International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia
International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia
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米卡芬净单药及联合治疗新诊断和难治性念珠菌血症的国际、开放标签、非比较临床试验
DOI：
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发表时间：
2005
影响因子：
4.5
通讯作者：
D. Buell
中科院分区：
文献类型：
--
作者：
L. Ostrosky;D. Kontoyiannis;J. Raffalli;K. Mullane;J. Vázquez;E. Anaissie;J. Lipton;P. Jacobs;J. H. V. Rensburg;J. Rex;J. Rex;W. Lau;D. Facklam;D. Buell
念珠菌属是血液感染的第四大原因，非白色念珠菌物种的重要性日益增加。米卡芬净是一种新型棘白菌素类抗真菌药物，具有优异的体外抗念珠菌活性。患有新发或难治性念珠菌血症的儿科、新生儿和成人患者被纳入这项开放标签、非比较性国际研究。对于白色念珠菌感染，米卡芬净的初始剂量为 50 mg/d（对于 <40 kg 的患者为 1 mg/kg），对于其他物种引起的感染为 100 mg/d（对于 <40 kg 的患者为 2 mg/kg）。允许剂量递增。最长治疗时间为 42 天。共有 126 名患者可进行评估（接受至少五剂米卡芬净）。总体而言，83.3% 的患者取得了成功（完全或部分缓解）。治疗最常见念珠菌属引起的感染的成功率。白色念珠菌占85.1%，光滑念珠菌占93.8%，近平滑念珠菌占86.4%，热带念珠菌占83.3%。与米卡芬净相关的严重不良事件并不常见。米卡芬净有望成为一种安全有效的药物，用于治疗新诊断和难治性念珠菌血症病例。大规模、随机、对照试验是必要的。
Candida spp. are the fourth leading cause of bloodstream infections, and non-albicans species are increasing in importance. Micafungin is a new echinocandin antifungal agent with excellent in vitro activity against Candida spp. Pediatric, neonatal, and adult patients with new or refractory candidemia were enrolled into this open-label, noncomparative, international study. The initial dose of micafungin was 50 mg/d (1 mg/kg for patients <40 kg) for infections due to C. albicans and 100 mg/d (2 mg/kg for patients <40 kg) for infections due to other species. Dose escalation was allowed. Maximum length of therapy was 42 days. A total of 126 patients were evaluable (received at least five doses of micafungin). Success (complete or partial response) was seen in 83.3% patients overall. Success rates for treatment of infections caused by the most common Candida spp. were as follows: C. albicans 85.1%, C. glabrata 93.8%, C. parapsilosis 86.4%, and C. tropicalis 83.3%. Serious adverse events related to micafungin were uncommon. Micafungin shows promise as a safe and effective agent for the treatment of newly diagnosed and refractory cases of candidemia. Large-scale, randomized, controlled trials are warranted.
影响因子：
11.8
作者：
van Burik, JAH;Ratanatharathorn, V;Walsh, TJ
通讯作者：
Walsh, TJ
影响因子：
158.5
作者：
Walsh, TJ;Pappas, P;Lee, J
通讯作者：
Lee, J
影响因子：
11.8
作者：
Perfect, JR;Marr, KA;Johnson, E
通讯作者：
Johnson, E