【摘要】 目的评价并对比恶性血液病患者应用泊沙康唑与伊曲康唑预防侵袭性真菌病(IFD)的效果和安全性。方法采用前瞻性随机对照研究,具有高危真菌感染因素的恶性血液病患者分为两组,泊沙康唑组予泊沙康唑200 mg,po,tid;伊曲康唑组予伊曲康唑200 mg,po,bid。两组均服药持续至粒细胞缺乏恢复或需要更换抗真菌药物。观察两组预防效果以及安全性。结果共有55例患者完成研究,泊沙康唑组25例,伊曲康唑组30例。泊沙康唑组和伊曲康唑组出现IFD的比例分别为4%(1/25)和23%(8/30),组间有显著差异(P<0.05);泊沙康唑组换用一线抗真菌治疗的比例低于伊曲康唑组(20%vs.47%,P<0.05),且无真菌感染事件生存率明显高于伊曲康唑组(80%vs.63%,P<0.05)。两组不良反应均较少。结论对于具有高危真菌感染因素的恶性血液病患者,与伊曲康唑相比,泊沙康唑可以更加有效地预防IFD的发生,且具有良好的安全性。更多还原

【Abstract】 AIM To compare the efficacy and safety of posaconazole with itraconazole for prophylaxis of invasive fungal infection( IFD) in patients with hematologic malignancy. METHODS The patients with hematologic malignancy and high risk of developing IFD were enrolled into this prospective randomized control trial. The patients in the posaconazole group received posaconazole(200 mg, po, tid), and the patients in the itraconazole received itraconazole( 200 mg, po, bid). The treatment was continued until the recovery of neutropenia or adjustment of antifungal therapy if needed. Efficacy and safety of the prophylaxis therapy in both groups were observed. RESULTS Fifty- five patients(25 patients in the posaconazole group and 30 patients in the itraconazole group) completed the trial. For the probable/proven IFD patients, 4%(1/25) of the patients in the posaconazole group developed IFD and 23%(8/30) in the itraconazole group(P < 0.05). The frequency of frontline antifungal therapy in the posaconazole group was significantly less than that in the itraconazole group(20% vs. 47%, P < 0.05), and the patients in the posaconazole group had better fungus- free survival(80%vs. 63%, P < 0.05). Adverse reactions rates of the two groups were mild. CONCLUSION Posaconazole is more effective for prophylaxis against IFD than itraconazole in patients with hematologic malignancy who receive chemotherapy or bone marrow transplantation and it also has satisfactory safety.更多还原