Yuan Wei, Ren Jinhai, Guo Xiaonan, Guo Xiaoling, Cai Shengxin
Department of Haematology, Pingan Affiliated Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).
Department of Haematology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).
Med Sci Monit. 2016 Nov 7;22:4226-4232. doi: 10.12659/msm.897596.
BACKGROUND The aim of this study was to evaluate the efficiency, adverse effects, and pharmacoeconomic impact of empirical and preemptive antifungal therapy for febrile neutropenic hematological malignancy patients in China. MATERIAL AND METHODS Patients with febrile neutropenia during hematological malignancy were randomly divided into an empirical group and a preemptive group. The preemptive antifungal treatment was initiated if patient status was confirmed by clinical manifestation, imaging diagnosis, 1-3-β-D glucan(G) testing, and galactomannan (GM) test. The treatment was ended 2 weeks later if the patient was recovered from neutropenia. Voriconazole was used as the first-line medicine. All patients received intravenous administration of voriconazole every 12 h, with an initiating dose of 400 mg, then the dose was reduced to 200 mg. RESULTS The overall survival rate was 97.1% and 94.6% in the empirical group and preemptive group, respectively, with no significant difference observed (χ²=1.051, P=0.305). However, the occurrence rate of invasive fungal disease (IFD) in the preemptive group was 9.2% vs. 2.2% in the empirical group. Moreover, the mortality rate due to IFD was 0.7% and 2.3% for the empirical group and preemptive group, respectively. The average duration and cost of preemptive antifungal therapy were 13.8±4.7 days and 8379.00±2253.00 RMB, respectively, which were lower than for empirical therapy. However, no significant differences were observed for incidence of adverse effects and hospital stay between the 2 groups. CONCLUSIONS Preemptive antifungal therapy for patients with febrile neutropenic hematological malignancy demonstrated a similar survival rate as with empirical therapy but is economically favorable in a Chinese population.
背景 本研究旨在评估中国发热性中性粒细胞减少的血液系统恶性肿瘤患者经验性和抢先性抗真菌治疗的疗效、不良反应及药物经济学影响。
材料与方法 将血液系统恶性肿瘤期间出现发热性中性粒细胞减少的患者随机分为经验性治疗组和抢先性治疗组。如果通过临床表现、影像学诊断、1-3-β-D葡聚糖(G)检测和半乳甘露聚糖(GM)检测确诊患者病情,则开始抢先性抗真菌治疗。如果患者从中性粒细胞减少症中康复,则在2周后结束治疗。伏立康唑用作一线药物。所有患者每12小时静脉注射一次伏立康唑,起始剂量为400mg,然后剂量减至200mg。
结果 经验性治疗组和抢先性治疗组的总生存率分别为97.1%和94.6%,差异无统计学意义(χ²=1.051,P=0.305)。然而,抢先性治疗组侵袭性真菌病(IFD)的发生率为9.2%,而经验性治疗组为2.2%。此外,经验性治疗组和抢先性治疗组因IFD导致的死亡率分别为0.7%和2.3%。抢先性抗真菌治疗的平均持续时间和费用分别为13.8±4.7天和8379.00±2253.00元,均低于经验性治疗。然而,两组之间不良反应发生率和住院时间差异无统计学意义。
结论 对于发热性中性粒细胞减少的血液系统恶性肿瘤患者,抢先性抗真菌治疗的生存率与经验性治疗相似,但在中国人群中具有经济优势。