伊曲康唑序贯治疗25例深部真菌感染的临床研究

目的评价伊曲康唑序贯治疗深部真菌感染的疗效和安全性。方法采用开放、随机、非对照试验。注射用伊曲康唑的起始剂量为200 mg,静脉滴注,每12小时1次,第3天开始剂量为200mg,静脉滴注,每天1次,静脉制剂总疗程为2周,继之伊曲康唑胶囊口服,200 mg/次,每12小时1次,疗程2～4周。结果共入选呼吸道感染、血流感染等深部真菌感染患者25例,其中包括确诊(proven)病例12例,拟诊(probable)病例11例,疑似(possible)病例2例。可进行疗效评价的22例患者中,痊愈11例,显效4例,进步2例,无效5例,有效率68.2%(15/22),痊愈率50.0%(11/22)。共获病原真菌24株,其中念珠菌属22株,曲霉及组织胞浆菌各1株。治疗后清除18株,真菌清除率为75.0%(18/24)。应用伊曲康唑治疗25例患者中,发生临床不良事件与药物可能有关者3例,主要包括药物热、胸闷、心悸,食欲下降等。实验室异常与药物可能有关者4例,主要为丙氨酸转移酶及天冬氨酸转移酶的轻度升高,1例患者出现血肌酐、尿素氮值升高及溶血。除1例外,不良反应多数属轻度,患者可耐受。结论伊曲康唑序贯治疗深部真菌感染获良好疗效,多数患者耐受性良好。

A clinical trial of intravenous itraconazole followed by itraconazole capsule in the treatment of 25 cases of systemic fungal infection

Objective To evaluate the efficacy and safety of intravenous itraconazole followed by itraconazole capsule.Methods An open-label,randomized,non-controlled study was conducted.Itraconazole was administered intravenously at a dose of 200 mg,q12h for the first 2 days,then once daily from the 3rd to the 14th day and followed by itraconazole capsule,200 mg,q12h for 2 to 4 weeks.Results A total of 25 patients were enrolled in the study,including 12 documented cases of invasive fungal in- fection,11 probable cases and 2 possible cases.Twenty-two patients were eligible for clinical efficacy analysis,of which 11 were cured,4 significant improved,2 improved and 5 failed.The effective rate was 68.2%(15/22),and the cure rate was 50.0%(11/22).Twenty-four strains of fungus were obtained,including 22 strains of Candida spp.and one each of Aspergil- lus and Histoplasma capsulatum.Eighteen strains of fungus were eradicated after itraconazole treatment.The eradication rate was 75.0%(18/24).In the 25 cases who received at least one dose of intravenous itraconazole,itraconazole-related or proba- bly-related clinical adverse event was reported in 3 patients,including drug fever,chest discomfort,palpitation and decreased appetite,Itraconazole-related or probably-related laboratory abnormality was reported in 4 cases.AST or ALT elevation was the most common laboratory abnormality.One patient was found to have increased blood creatinine,BUN and hemolysis.Most adverse effects were mild and tolerable except one serious adverse effect.Conclusions Intravenous itraconazole followed by itraconazole capsule therapy has good efficacy in the treatment of systematic fungal infection.The regimen is well-tolerated in most patients.