目的:对卡泊芬净与伏立康唑在中性粒细胞缺乏伴发热(以下简称"粒缺发热")患者中初始经验性抗真菌治疗的方案进行经济学评价。方法:基于两项关于卡泊芬净与伏立康唑初始经验性抗真菌治疗粒缺发热的国际多中心临床试验,结合国...目的:对卡泊芬净与伏立康唑在中性粒细胞缺乏伴发热(以下简称"粒缺发热")患者中初始经验性抗真菌治疗的方案进行经济学评价。方法:基于两项关于卡泊芬净与伏立康唑初始经验性抗真菌治疗粒缺发热的国际多中心临床试验,结合国内临床专家对疾病治疗过程中药物选择方面的意见,构建决策树模型,运用Tree Age Pro 2011软件分析卡泊芬净与伏立康唑作为初始经验性抗真菌药物分别治疗10 d的成本效果。结果:卡泊芬净组患者的直接医疗费用低于伏立康唑组(52 826.71元vs.58 246.70元),治疗成功率和患者生存率均高于伏立康唑组(分别为33.95%vs.25.63%、92.36%vs.91.87%)。无论是以治疗成功率还是以患者生存率为效果指标,卡泊芬净组的成本-效果比均小于伏立康唑组,且增量成本-效果比和敏感度分析结果均证实了此结果。结论:对粒缺发热患者进行初始经验性抗真菌治疗,卡泊芬净比伏立康唑更具有成本效果优势。展开更多
Background Invasive fungal infection （IFI） is a common and fatal complication in neutropenic patients with hematological malignancy. Empirical antifungal therapy is widely used in practice due to the difficulty of p...Background Invasive fungal infection （IFI） is a common and fatal complication in neutropenic patients with hematological malignancy. Empirical antifungal therapy is widely used in practice due to the difficulty of pathogens determination and illness of the hosts. The aim of this study was to evaluate the efficacy and safety of itraconazole as empirical antifungal therapy for persistent fever in neutropenic patients with hematologic malignancies. Methods Two hundred and seventy-four patients with hematologic malignancies who had suspected fungal infections were enrolled in 18 centers across China between April 2008 and April 2009. Empirical antifungal therapy with intravenous itraconazole 200 mg twice daily was given for the first two days, followed by 200 mg once daily for the next 12 days. Oral itraconazole solution was sequential for follow-up therapy if necessary. Five composite end points were evaluated for the response, which was more restrictive and adopted for the first time in such study in China. Results The intent-to-treat analysis included data from 274 patients （full analysis set, FAS）, of whom 248 were included as the per-protocol population （PPS）. As the composite end point of five indices was concerned, the overall response rate was 43.4%. Seperately, defervescence was achieved in 90% of patients in which 55.5% occured during neutropenia. The mean time to defervescence was 2.71 days. Absence of breakthrough IFI during drug administration or within the first 7 days after study completion was observed in 71.5% of patients. Fifty-five point five percent patients with IFI at baseline was successfully treated. Ninety point five percent patients survived for at least 7 days after completing the study. PPS analysis revealed that the duration of neutropenia 〉10 days was a statistically significant negative predictor for the response. The withdrawal rate due to drug-related toxicity or lack of efficacy was 11.0%. The incidence of adverse events was 22.6%, in which 11.6% was study drug related.展开更多
文摘目的:对卡泊芬净与伏立康唑在中性粒细胞缺乏伴发热(以下简称"粒缺发热")患者中初始经验性抗真菌治疗的方案进行经济学评价。方法:基于两项关于卡泊芬净与伏立康唑初始经验性抗真菌治疗粒缺发热的国际多中心临床试验,结合国内临床专家对疾病治疗过程中药物选择方面的意见,构建决策树模型,运用Tree Age Pro 2011软件分析卡泊芬净与伏立康唑作为初始经验性抗真菌药物分别治疗10 d的成本效果。结果:卡泊芬净组患者的直接医疗费用低于伏立康唑组(52 826.71元vs.58 246.70元),治疗成功率和患者生存率均高于伏立康唑组(分别为33.95%vs.25.63%、92.36%vs.91.87%)。无论是以治疗成功率还是以患者生存率为效果指标,卡泊芬净组的成本-效果比均小于伏立康唑组,且增量成本-效果比和敏感度分析结果均证实了此结果。结论:对粒缺发热患者进行初始经验性抗真菌治疗,卡泊芬净比伏立康唑更具有成本效果优势。
文摘Background Invasive fungal infection （IFI） is a common and fatal complication in neutropenic patients with hematological malignancy. Empirical antifungal therapy is widely used in practice due to the difficulty of pathogens determination and illness of the hosts. The aim of this study was to evaluate the efficacy and safety of itraconazole as empirical antifungal therapy for persistent fever in neutropenic patients with hematologic malignancies. Methods Two hundred and seventy-four patients with hematologic malignancies who had suspected fungal infections were enrolled in 18 centers across China between April 2008 and April 2009. Empirical antifungal therapy with intravenous itraconazole 200 mg twice daily was given for the first two days, followed by 200 mg once daily for the next 12 days. Oral itraconazole solution was sequential for follow-up therapy if necessary. Five composite end points were evaluated for the response, which was more restrictive and adopted for the first time in such study in China. Results The intent-to-treat analysis included data from 274 patients （full analysis set, FAS）, of whom 248 were included as the per-protocol population （PPS）. As the composite end point of five indices was concerned, the overall response rate was 43.4%. Seperately, defervescence was achieved in 90% of patients in which 55.5% occured during neutropenia. The mean time to defervescence was 2.71 days. Absence of breakthrough IFI during drug administration or within the first 7 days after study completion was observed in 71.5% of patients. Fifty-five point five percent patients with IFI at baseline was successfully treated. Ninety point five percent patients survived for at least 7 days after completing the study. PPS analysis revealed that the duration of neutropenia 〉10 days was a statistically significant negative predictor for the response. The withdrawal rate due to drug-related toxicity or lack of efficacy was 11.0%. The incidence of adverse events was 22.6%, in which 11.6% was study drug related.
