泊沙康唑预防侵袭性真菌感染有效性及安全性的荟萃分析

Efficacy and safety of posaconazole in prophylaxis of invasive fungal infections:a meta-analysis

目的 系统评价泊沙康唑预防侵袭性真菌感染（IFI）的有效性和安全性。方法 通过计算机检索Pubmed、EMbase、Cochrane library、CNKI、VIP、CBM等数据库,收集截止到2014年7月国内外已公开发表的泊沙康唑预防IFI的随机对照试验及半随机对照试验。由2名研究者对收集到的文献按照纳入和排除标准进行独立筛选、提取和进行质量评价,采用RevMan 5.3软件对最终的纳入文献进行统计分析。比较泊沙康唑与其他抗真菌药预防IFI的有效性和安全性。结果 共纳入5项研究,共计1 644例患者,其中,泊沙康唑组832例,对照组812例。荟萃分析结果提示：泊沙康唑预防IFI的有效性优于两性霉素B（OR=0.17,95%CI：0.05-0.60,P=0.006）,差异有统计学意义;在安全性方面,两组发热的发生率差异无统计学意义（OR=1.71,95%CI：0.64-4.61,P=0.29）;泊沙康唑预防IFI的有效性优于伊曲康唑（OR=0.17,95%CI：0.06-0.50,P=0.001）,差异有统计学意义,安全性方面,两项研究均显示两组不良反应发生率差异无统计学意义（OR=1.87,95%CI：0.42-8.24,P=0.41）、（OR=0.64,95%CI：0.11-3.61,P=0.62）;泊沙康唑预防IFI的有效性优于氟康唑（OR=0.41,95%CI：0.27-0.63,P〈0.0001）,差异有统计学意义,其中,2项研究表明泊沙康唑组不良反应发生率高于氟康唑组（OR=3.93,95%CI：1.32-11.72,P=0.01）、（OR=2.11,95%CI：1.12-3.98,P=0.02）,差异有统计学意义,一项研究表明两组不良反应发生率差异无统计学意义（OR=0.88,95%CI：0.63-1.23,P=0.46）。结论 泊沙康唑预防IFI的有效性优于两性霉素B、伊曲康唑和氟康唑,且安全性好,具有良好的临床应用前景。

Objective To systematically review the efficacy and safety of posaconazole in the prophylaxis of invasive fungal infections （IFI）. Methods PubMed, EMbase, Cochrane Library, CNKI, VIP, and CBM databases were searched to identify the randomized and quasi-randomized controlled trials of posaconazole in prophylaxis of invasive fungal infections up to July 2014. Two reviewers screened, extracted data and evaluated study quality independently according to the inclusion and exclusion criteria. Review Manager（version 5. 3） software was used to analyze the data. Results A total of 5 studies （n = 1 644） were included finally, including 832 cases in posaconazole group and 812 in control group. Meta-analysis showed that posaconazole is better than amphotericin B in preventing the incidence of IFI （OR = O. 17, 95% CI ： 0. 05-0. 60, P = 0. 006）. There was no significant difference in the incidence of fever between posaconazole and amphotericin B （OR = 1.71, 95% CI： O. 64-4. 61, P = 0. 29）. Posaconazole is better than itraconazole in preventing the incidence of IFI （OR = 0. 17, 95% CI ： 0. 06-0. 50, P = 0. 001）. One study showed non-significant higher incidence of adverse reactions in posaconazole group than in itraconazole group （OR = 1.87, 95%CI ： 0.42-8.24, P = 0.41）. Another study reported non-significant lower incidence of fever in posaconazole group than in itraconazole group （OR = 0.64, 95% CI： 0. 11-3. 61, P = 0. 62）. Posaconazole is better than fluconazole in preventing the incidence of IFI （OR=0.41, 95%CI ： 0. 27-0. 63, P〈0. 000 1）. Two studies showed higher incidence of adverse reactions in posaconazole group than in fluconazole group （OR = 3. 93, 95% CI ： 1.32-11.72, P = 0. 01 ） and （OR = 2. 11, 95%CI ： 1.12 3.98, P = 0. 02）. One study showed non-significant lower incidence of adverse reactions in posaconazole group than in control group （OR = 0. 88, 95% CI ： 0. 63-1. 23, P = 0. 46）. Conclusions Posaconazole is better than amphotericin B, itraconazole and fluconazole in preventing the incidence of IFI associated with better safety profile.