伊曲康唑静脉注射液/口服液序贯治疗血液系统疾病患者侵袭性真菌感染

摘要

目的 观察伊曲康唑静脉注射液/口服液序贯治疗血液系统疾病患者侵袭性真菌感染(IFI)的疗效及安全性.方法 所有血液系统疾病住院患者,符合IFI的诊断标准,后者类型包括确诊IFI、临床诊断IFI、拟诊IFI.本研究为开放研究,疗程为4～6周,分静脉给药阶段和口服给药阶段.静脉给药共14d,最初2d剂量为400mg/d,分两次给药,给药间隔12h;其后12d,剂量为200ms/d,1次/d.静脉用药结束后,继续给受试者序贯伊曲康唑口服液维持治疗,推荐剂量400mg/d,分两次给药(200 mg,2次/d),共用2～4周.根据受试者的病情决定每1～2周进行疗效与安伞性评价.结果 227例入组患者治疗结束后有效率为75.33%,其巾痊愈率达47.14%;227例患者治疗后205例退热(90.3%),中位退热时间5 d(2～20 d);可评价的186例患者,真菌学清除率为69.89%.发生与药物相关的不良事件11例,无与药物相关的严重不良事件发生.结论 伊曲康唑静脉注射液/口服液序贯治疗血液系统疾病患者IFI的疗效可靠,应用安全.%Objective We performed this study to investigate the efficacy and safety of sequential jntravenous and oral itraconazole in the treatment of invasive fungal infection(IFI)in the patients with hematological diseases.Methods AII the patients fit for the diagnostic criteria of IFI(proven diagnosis.probable diagnosis and possible diagnosis)with hematological diseases were entered into this studv.The trial Was designed as an open labeled,multi-centered study.with the total treatment duration of 4-6 weeks including intravenous and oral period.Intravenous itraconazole was given at the dose of 200 rag.twice a day in the first two days,and adjusted to 200 mg/d for subsequent 12 days.Sequential oral itraconazole was given at the dose of 200 mg,twice a day,for 2-4 weeks for maintenance therapy.Efficacy and safety evaluation was performed every 1-2 weeks according to the physician's decision.Results Two hundred and twenty seven patients were enrolled into this study.The overall response rate was 75.33%and the cure rate was 47.14%.Two hundred and five patients(205/227.90.3%)defervesced after a median of 5 days (2-20 days).One hundred and eishty six patients were applicable for microbiological evaluation.among them.69.89%responded to the treatment.Eleven treatment-related adverse events occurred during the study and none of them were severe adverse events.Conclusion Sequential intravenous and oral itraconazole therapy was effective for IFI and tolerated well in patients with hematological diseages.