摘要
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.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2008年第12期1012-1016,共5页
Chinese Journal of Internal Medicine