伊曲康唑静脉口服序贯治疗ICU侵袭性真菌感染的疗效与安全性

Clinical efficacy and safety of itraconazole injection/oral solution sequential therapy for treatment of invasive fungal infection in intensive care unit

目的评价伊曲康唑静脉口服序贯治疗ICU侵袭性真菌感染的疗效与安全性。方法采用多中心、开放试验设计，选择ICU侵袭性真菌感染患者，用伊曲康唑静脉口服序贯治疗。观察用药1、2、4、6周的临床有效率和真菌清除率。结果159例患者纳入本研究，其中拟诊58例，临床诊断81例，确诊20例。疗效分析显示，治疗1周临床有效率为35．2％，2周后明砂升至73．6％。治疗第2周，拟诊病例和临床诊断病例的临床有效率分别为72．9％和72．2％，确诊病例的临床有效率为78．9％。治疗1周真菌清除率为40．9％，2周和4周后分别为75．9％和92．9％。治疗第2周，拟诊病例和临床诊断病例的真菌清除率分别为90．O％和64．6％，确诊病例的真菌清除率为84．2％。综合疗效分析显示，治疗1周的有效率为44．1％，4周后达92．9％－100．0％。与药物有关的不良反应发生率为1．3％（2／159），未见严重不良反应。结论伊曲康唑静脉口服序贯治疗ICU侵袭性真菌感染，可获得较好的临床疗效。

Objective To investigate the therapeutic efficacy and safety of itraconazole injection/ oral sequential therapy on invasive fungal infection （IFI） in ICU. Methods In this multicenter, postmarketing, open-label study, ICU patients who have met the inclusion IFI criteria will be enrolled in this study. Itraeonazole intravenous injection is administered 200 mg twice a day in day 1-2, then 200 nag once a day at least for 5 days, and maintenance itraconazole oral solution as sequential therapy, itraconazole oral solution 200 mg twice a day sequential therapy lasts for 2 weeks. Clinical efficacy and adverse reaction were record. Results A total of 159 patients were enrolled and completed this trial. （ 1 ） At the end of first week, total clinical cure rate was 35.2% , and increased to 73.6% after the second week. Clinical cure rate were 72. 9% and 72. 2% in possible and probable IFI patients, and 78.9% in proven IFI patients at the end of second week. （2） At the end of first week, total fungal clearance was 40. 9% , and increased to 75. 9% and 92. 9% at the end of second and fourth week. Fungal clearance were 90. 0% and 64. 6% in possible and probable IFI patients, and 84. 2% in proven IFI patients at the end of second week respectively. （ 3 ） Combined clinical cure rate and fungal clearance, the total clinic efficacy was 44. 1% at the end of first week, and increased to 92. 9% and 100. 0% at the end of second and fourth week. （4）No severe adverse reaction was found. Conclusions Itraconazole injection/oral sequential therapy is an effective and safe antibiotic for the treatment of IFI in ICU.