泊沙康唑初级预防急性髓系白血病诱导化疗后发生侵袭性真菌病的临床评估

目的观察泊沙康唑口服悬液初级预防急性髓系白血病(AML)患者诱导化疗后发生侵袭性真菌病(IFD)的疗效及毒副反应。方法收集2016年5月至2018年5月宁波市鄞州人民医院血液科收治的所有符合入选和排除标准的初诊AML患者206例(除外急性早幼粒细胞白血病、入院后接受静脉抗真菌或诱导化疗前1个月发生IFD、合并重要脏器功能不全、年龄>65岁),其中诱导化疗期间使用泊沙康唑口服悬液进行初级预防IFD的患者47例(泊沙康唑组),使用伏立康唑片进行初级预防IFD的患者61例(伏立康唑组),未进行初级预防IFD的患者98例(对照组)。对各组临床资料进行回顾性分析,比较3组诱导化疗期间IFD的发生率及泊沙康唑口服悬液、伏立康唑片的药物安全性。结果(1)泊沙康唑组出现5例(10.6%)IFD,均为拟诊病例;伏立康唑组出现11例(18.0%)IFD,其中拟诊7例,临床诊断3例,确诊1例;对照组出现35例(35.7%)IFD,其中拟诊19例,临床诊断11例,确诊5例。泊沙康唑组和伏立康唑组IFD的发生率均明显低于对照组(P值均<0.05)。泊沙康唑组IFD的发生率低于伏立康唑组,但差异无统计学意义(P>0.05)。(2)泊沙康唑组不良事件发生率明显低于伏立康唑组12.8%(6/47)比32.8%(20/61),P<0.05]。结论(1)AML诱导化疗期间使用泊沙康唑口服悬液或伏立康唑片进行初级预防,可以明显减少IFD的发生率;(2)AML诱导化疗期间使用泊沙康唑口服悬液和伏立康唑片进行初级预防IFD的疗效相当,但泊沙康唑口服悬液安全性更好。

Breakthrough of invasive fungal disease with posaconazole as primary prophylaxis after induction chemotherapy for acute myeloid leukemia

Objective To investigate the breakthrough incidence of invasive fungal disease(IFD)and side effects of posaconazole as primary prophylaxis during induction chemotherapy for acute myeloid leukemia(AML).Methods A total of 206 newly diagnosed AML patients admitted to our department during January 2016 and December 2018 were enrolled in the study.Exclusive criteria were as followings including patients diagnosed as acute promyelocytic leukemia;those who received intravenous antifungal therapy after admission or had history of IFD one month before induction chemotherapy,or those with functional insufficiency of vital organs and those older than 65.Forty-seven patients received posaconazole(posaconazole group),61 cases received voriconazole(voriconazole group)and 98 cases did not receive any prophylaxis(control group)during induction chemotherapy.Prophylactic efficacy and safety between posaconazole and voriconazole were compared.Results During induction chemotherapy,five possible cases of IFD occurred in posaconazole group(10.6%);while 11 cases(18.0%)were in voriconazole group including 7 possible,3 probable and 1 proven.Thirty-five cases(35.7%)in control group were diagnosed as IFD including 19 possible,11 probable and 5 proven ones.The incidences of IFD in posaconazole and voriconazole group were significantly lower than that in control group(P<0.05).The difference of posaconazole group and voriconazole group was not significant(P>0.05).The reported adverse events in posaconazole group were significantly lower than those in voriconazole group12.8%(6/47)vs.32.8%(20/61),P<0.05].Conclusions Posaconazole and voriconazole decrease IFD as primary prophylaxis during induction chemotherapy in patients with AML.The prophylactic effect of IFD with posaconazole is similar as voriconazole,but posaconazole shows better safety.