伊曲康唑注射液治疗ICU侵袭性真菌感染的疗效与安全性

The clinical efficacy and safety of itraconazole injection in treatment of invasive fungal infection in intensive care unit Collaborative Research Group of ltraconazole in Intensive Care Unit

目的 评价伊曲康唑注射液治疗ICU侵袭性真菌感染（IFI）的疗效与安全性.方法 采用多中心、开放前瞻性研究,选1CU内IFI患者,应用伊曲康唑静脉注射液治疗,观察用药第7天及用药结束后的临床有效性、真菌清除率及安全性.结果 共33家医院495例患者纳入本研究.临床诊断289例（62.02%,289/466）,拟诊143例（30.69%,143/466）,确诊34例（7.29%,34/466）.最常见的感染部位为肺（86.51%）,其次为泌尿系和血液（各占4.07%）.真菌种类以念珠菌最多见（82.66%）,其次为曲霉菌（14.63%）.与真菌感染相关因素中,最多见的是广谱抗生素应用（70.47%）,其次分别为病情危重（69.45%）和长期住院（62.12%）等.临床疗效分析显示,治疗第7天临床有效率为53.91%,治疗结束后升至78.53%.治疗第7天真菌清除率为58.62%,治疗结束后升至86.27%.不良事件发生率为8.48%,其中与药物相关的不良事件发生率为6.87%.不良事件中最多见的是消化道症状（17/495,3.53%）.结论 伊曲康唑注射液治疗ICU内IFI具有较好的临床疗效及安全性.

Objective To investigate the efficacy and safety of itraconazole injection for the treatment of invasive fungal infection （IFI） in ICU. Methods In this multicenter, prospective open-label study, ICU patients who had met the IFI inclusion criteria were enrolled. Itraconazole intravenous injection was administered 200 mg twice daily. Clinical efficacy and adverse events were recorded. Results A total of 495 patients from 33 centers were enrolled with 62. 02% clinical diagnosis, 30. 69% probable diagnosis and 7.29% confirmed diagnosis. The infection sites were mostly from the lung （86. 51% ） and the urinary tract and bloodstream stood for the second place （4. 07% ）. Of all the infections, 82. 66% were candida wheras 14. 63% were aspergillus. Broad-spectrum antibiotics usage, severe illness and long-term hospitalization were the most common risk factors for IFI （70. 47% , 69.45% and 62. 12% respectively）. The clinical cure rate was 53.91% at day 7 and increased to 78.53% at the end of treatment. Total fungal clearance increased from 58.62% at day 7 to 86. 27% at the end of treatment. The rate of total adverse event was 8.48% with 6. 87% drug-related. Conclusion Itraeonazo]c injection was an effective and safe drug for the treatment of IFI in ICU.