Hôpital Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Eur J Clin Microbiol Infect Dis. 2012 Jun;31(6):1173-9. doi: 10.1007/s10096-011-1425-5. Epub 2011 Oct 5.
The purpose of this study was to evaluate efficacy and safety of voriconazole in patients with acute invasive aspergillosis (IA) in a real-life, clinical setting. This was a multicenter observational study in adult patients treated with voriconazole for invasive mycosis. The study evaluated clinical response, mortality, use of other licensed antifungal therapy (OLAT), and treatment duration. This sub-analysis evaluated treatment and outcome data specifically from adult patients with proven/probable IA, while safety data were assessed in patients with proven/probable/possible IA. Of the 141 patients enrolled, 113 were adults with proven/probable IA and six had possible IA. Voriconazole treatment duration ranged from 1 to 183 days (median, 49.5 days). Voriconazole was used exclusively in 64% (72/113) of patients and in combination/sequentially with OLAT in 36%. Overall successful treatment response was 50% (57/113 patients). Twelve percent (14/113) of patients were switched to OLAT, either because of insufficient response (four patients) or for safety reasons (10 patients). Overall and attributable (entirely or partially due to fungal infection) mortality rates were 52% (59/113) and 17%, respectively. Treatment-related adverse events were reported for 18% (22/119) of patients. This observational study confirms the results of previous clinical trials demonstrating voriconazole as an effective and safe agent for treatment of confirmed acute IA.
本研究旨在评估伏立康唑在真实临床环境中治疗急性侵袭性曲霉病(IA)患者的疗效和安全性。这是一项多中心观察性研究,纳入了接受伏立康唑治疗侵袭性真菌感染的成年患者。该研究评估了临床反应、死亡率、其他已批准的抗真菌治疗(OLAT)的应用以及治疗持续时间。本亚分析专门评估了确诊/疑似 IA 成年患者的治疗和结局数据,而安全性数据则在确诊/疑似/可能 IA 患者中进行评估。在纳入的 141 例患者中,113 例为确诊/疑似 IA 的成年患者,6 例为可能 IA。伏立康唑的治疗持续时间为 1-183 天(中位数 49.5 天)。64%(72/113)的患者单独使用伏立康唑,36%的患者联合/序贯使用 OLAT。总体治疗反应成功率为 50%(57/113 例患者)。12%(14/113)的患者因疗效不佳(4 例)或因安全性原因(10 例)改用 OLAT。总体和归因(完全或部分归因于真菌感染)死亡率分别为 52%(59/113)和 17%。18%(22/119)的患者报告了与治疗相关的不良事件。这项观察性研究证实了先前临床试验的结果,表明伏立康唑是治疗确诊急性 IA 的有效且安全的药物。