伏立康唑预防侵袭性真菌感染有效性及安全性的荟萃分析

摘要

目的 系统评价伏立康唑在预防侵袭性真菌感染(invasive fungal infections,IFI)中的有效性及安全性.方法 计算机检索PubMed、Cochrane Library、EMbase、CNKI、CBM、VIP数据库,收集伏立康唑预防深部真菌感染的随机对照试验,检索时间从建库至2011年12月.由2位研究者按照纳入标准独立筛选文献、提取资料和评价质量后,采取RevMan 5.0软件进行荟萃分析.结果 共纳入4个研究,1288例患者.荟萃分析结果提示:伏立康唑、两性霉素B两组预防失败率的差异无统计学意义[OR=0.75,95％CI(0.32～1.77),P=0.52],伏立康唑组严重不良反应率低于两性霉素B组,差异有统计学意义[OR=0.15,95％(0.04～0.55),P=0.005]；伏立康唑、氟康唑两组IFI发生率[OR=0.62,95 ％CI(0.35～1.09),P=0.09]、视觉异常发生率[OR=1.14,95％CI(0.59～2.18),P=0.07]的差异均无统计学意义；伏立康唑预防成功率高于伊曲康唑组[OR=1.96,95％CI(1.35～2.84),P=0.0004]、不良反应发生率低于伊曲康唑组[OR=0.54,95％CI(0.37～0.78),P=0.001],差异均有统计学意义,而两组不良反应致用药终止发生率的差异无统计学意义[OR=2.05,95％CI(0.74～5.72),P=0.017].结论 伏立康唑在预防IFI中表现出高效低毒性临床特点,近年来临床应用越来越受青睐,其价值有待时间的进一步考验.%Objective To systematically review the efficacy and safety of voriconazole in the prophylaxis of invasive fungal infections. Methods The PubMed, Cochrane Library, Embase, CNKI, CBM, VIP databases were searched for an interval from outset of each database through December 2011 to find out the randomized controlled trial of voriconazole in prophylaxis of deep fungal infections. Two reviewers independently assessed the quality of the included studies and extracted relevant data. The Review Manager (version 5.0) software was used to analyze the data. Results A total of 4 studies involving 1 288 patients were included. Meta-analysis showed that there was not significant difference between voriconazole and amphotericin B in terms of prophylaxis failure rate [OR = 0. 75, 95% CI (0.32-1.77), P = 0. 52], incidence of IFI [OR = 0.62, 95% CI (0.35-1.09), P = 0.09] and incidence of paropsis [OR = 1. 14, 95% CI (0.59-2. 18), P = 0. 07]. The incidence of adverse effects was significantly lower in voriconazole-treated patients than in amphotericin B-treated patients [OR = 0. 15, 95% CI(0. 04-0. 55) , P = 0. 005] and itraconazole-treated patients [OR = 0. 54, 95%CI(0. 37-0. 78), P = 0. 001]. The rate of successful prophylaxis in voriconazole-treated patients was significantly higher than in the itraconazole group [OR = 1. 96, 95% CI (1. 35-2. 84) , P = 0. 0004]. The incidence of the adverse events leading to discontinuation of treatment was similar between voriconazole and itraconazole [OR = 2.05, 95% CI (0. 74-5. 72), P - 0. 017]. Conclusions As a highly effective and low toxic antifungal agent, voriconazole is usually used for prophylaxis of invasive fungal infections. Its real value in this situation remains to be confirmed.