中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2008年
12期
1012-1016
,共5页
伊曲康唑疗效和安全性评估ICU协作组
伊麯康唑療效和安全性評估ICU協作組
이곡강서료효화안전성평고ICU협작조
伊曲康唑%真菌病%重症监护病房%治疗%安全
伊麯康唑%真菌病%重癥鑑護病房%治療%安全
이곡강서%진균병%중증감호병방%치료%안전
Itraconazole%Mycoses%Intensive care unit%Therapy%Safety
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周后明显升至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90.0%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.
目的 評價伊麯康唑靜脈口服序貫治療ICU侵襲性真菌感染的療效與安全性.方法 採用多中心、開放試驗設計,選擇ICU侵襲性真菌感染患者,用伊麯康唑靜脈口服序貫治療.觀察用藥1、2,4、6週的臨床有效率和真菌清除率.結果 159例患者納入本研究,其中擬診58例,臨床診斷81例,確診20例.療效分析顯示,治療1週臨床有效率為35.2%,2週後明顯升至73.6%.治療第2週,擬診病例和臨床診斷病例的臨床有效率分彆為72.9%和72.2%,確診病例的臨床有效率為78.9%.治療1週真菌清除率為40.9%,2週和4週後分彆為75.9%和92.9%.治療第2週,擬診病例和臨床診斷病例的真菌清除率分彆為90.0%和64.6%,確診病例的真菌清除率為84.2%.綜閤療效分析顯示,治療1週的有效率為44.1%,4週後達92.9%～100.0%.與藥物有關的不良反應髮生率為1.3%(2/159),未見嚴重不良反應.結論 伊麯康唑靜脈口服序貫治療ICU侵襲性真菌感染,可穫得較好的臨床療效.
목적 평개이곡강서정맥구복서관치료ICU침습성진균감염적료효여안전성.방법 채용다중심、개방시험설계,선택ICU침습성진균감염환자,용이곡강서정맥구복서관치료.관찰용약1、2,4、6주적림상유효솔화진균청제솔.결과 159례환자납입본연구,기중의진58례,림상진단81례,학진20례.료효분석현시,치료1주림상유효솔위35.2%,2주후명현승지73.6%.치료제2주,의진병례화림상진단병례적림상유효솔분별위72.9%화72.2%,학진병례적림상유효솔위78.9%.치료1주진균청제솔위40.9%,2주화4주후분별위75.9%화92.9%.치료제2주,의진병례화림상진단병례적진균청제솔분별위90.0%화64.6%,학진병례적진균청제솔위84.2%.종합료효분석현시,치료1주적유효솔위44.1%,4주후체92.9%～100.0%.여약물유관적불량반응발생솔위1.3%(2/159),미견엄중불량반응.결론 이곡강서정맥구복서관치료ICU침습성진균감염,가획득교호적림상료효.
Objective To investigate the therapeutic efficacy and safety of itraconazole injection/ oral sequential therapy on invasive fungal infection(IFI)in ICU.Methods In this muhicenter,post marketing.open-label study,ICU patients who have met the inclusion IFI criteria will be enrolled in this study.Itraconazole intravenous injection is admministered 200 mg twice a day in day 1-2.then 200 mg once a day at least for 5 days.and maintenance itraconazole oral solution as sequential therapy,itrsconazole oral solution 200 mg twice a day sequential therapy lasts for 2 weeks.Clinical effiacy 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.ConclusionsItraconazole injection/oral sequential therapy is an effective and safe antibiotic for the treatment of IFI in ICU.
