伏立康唑胶囊预防初诊急性髓系白血病患者侵袭性曲霉菌感染的临床研究  

Clinical trial of voriconazole in primary prophylaxis of invasive aspergillosis in patients with newly diagnosed acute myeloid leukemia

作　　者：赵金涛[1] 方志鸿[1] 王思力[1] 苏蕊[1] 黄耘[1] 李志锋[1] 谢泗停[1] 林志娟[1] 王凌燕[2] 

机构地区：[1]厦门大学附属第一医院血液科,福建厦门361021 [2]福建医科大学附属协和医院血液科,福州350009

出　　处：《中国临床药理学杂志》2016年第22期2108-2110,2116,共4页The Chinese Journal of Clinical Pharmacology

基　　金：2015年福建省卫生计生委青年科研课题基金资助项目(2015-1-39)

摘　　要：目的观察伏立康唑在初诊急性髓系白血病(AML)诱导缓解治疗中侵袭性曲霉菌感染一级预防的有效性及安全性。方法初诊急性髓系白血病诱导缓解治疗的96例患者分为试验组66例和对照组30例。试验组患者口服伏立康唑胶囊预防真菌感染,首日为负荷剂量6 mg·kg^(-1),每日2次。次日起维持剂量200 mg,每日2次;对照组患者未进行真菌感染预防。观察2组患者真菌感染的发生率,分析预防用药的有效性和安全性。结果应用伏立康唑胶囊进行真菌感染的一级预防,未发现严重的药物不良反应发生。试验组患者在诱导缓解治疗中侵袭性曲霉菌(IA)感染发生率为0.02%(1/66例),对照组侵袭性曲霉菌感染的发生率为13.33%(4/30例,P<0.05)。结论伏立康唑胶囊能有效降低初诊急性髓系白血病患者的侵袭性曲霉菌感染的发生率。Objective To evaluate the efficacy and safety of primary prophylaxis of invasive aspergillosis （IA） in patients with acute myeloid leukemia（AML）. Methods A total of 96 newly diagnosed AML pa- tients who enrolled in our hospital were involved in this research. Patients were divided into two groups, 66 patients in treatment group and the rest in control group. Primary prophylaxis with voriconazole was performed in the treatment group after the induction therapy or when the neutrophils counts less than 0. 5 ×10^9/L. There was no antifungal prophylaxis in the control group. On the basis of incidence of IA in each group, the efficacy of prophylaxis and the adverse reactions were summarized and analyzed. Results No serious adverse reactions were found during the primary an- tifungal prophylaxis with voriconazole. The incidence of proven or proba- ble IA in control group was 13.33% （4/30）, while the treatment group was 0. 02% （ 1/66, P 〈 0. 05）. Conclusion Voriconazole capsules can effectively reduce the incidence of invasive aspergillosis in newly diag- nosed acute myeloid leukemia patients.

关 键 词：伏立康唑 急性髓系白血病 侵袭性曲霉菌感染 

分 类 号：R978.1[医药卫生—药品]