泊沙康唑一级预防造血干细胞移植患者侵袭性真菌病的效果及安全性评估

Efficacy and Safety of Posaconazoleon for Primary Antifungal Prophylaxis against Invasive Fungal Disease in Patients with Stem Cell Transplantation

目的:观察泊沙康唑用于造血干细胞移植(allo-HSCT)中一级预防侵袭性真菌病(IFD)的效果及安全性。方法:45例allo-HSCT无IFD的患者从预处理开始应用泊沙康唑,直至患者的中性粒细胞恢复至0.5×10~9/L以上为止,35例以米卡芬净预防IFD患者为对照(对照组),分析2组间IFD易感因素有无差异,比较2组IFD发生率及药物不良反应的差异。结果:移植后100 d内共有13例(16%)发生IFD,其中5例(38%)死亡,而67例未发生IFD患者中10例(15%)死亡,2组间总生存率差异有统计学意义(P=0.027)。45例泊沙康唑一级预防组中发生IFD者4例(9%),对照组中35例患者发生IFD 9例(26%),2组IFD发生率差异有统计学意义(P=0.043)。在IFD风险因素评估和不良反应评估方面,2组之间无统计学差异(P>0.05)。结论:应用泊沙康唑对allo-HSCT患者行IFD的一级预防的效果明显优于米卡芬净,且患者对治疗的耐受性良好。

Objective： To investigate the efficacy and clinical safety of posaconazoleon primary antifungal prophylaxis against invasive fungal disease （IFD） in patients with stem cell transplantation. Methods： At the start from preconditioning regimen, 45 patients without IFD were administered with posaconazoleon until neutrophils greater than 0. 5 x 109/L, 35 patients treated with micafungin were enrolled in control group. The incidence, risk factors of IFD and side effects of medicines were evaluated. Results： Of the total 80 patients, 13 （16%） had IFD within I00 days after allo-HSCT. The overall survival was significantly different between patients with or without IFD by Kaplan-Meier survival curve analysis （P 〈 0.05 ）. Out of the 45 cases in posaconazoleon group, IFD occurred in 4 cases （9%）. In contrast, the incidence of IFD in control group was 26% （9 out of 35 ） （P 〈 0.05 ）. The risk factors of IFD and side effects were not significantly different between 2 groups （ P 〉 0.05 ）. Conclusion ： The primary prevention efficancy of IFD by posaconazoleon after allo-HSCT is much better than that of micafungin with well tolerability and satisfactory efficacy.