泊沙康唑预防侵袭性真菌感染的 Meta 分析

摘要

目的：评价泊沙康唑预防侵袭性真菌感染的疗效及安全性。方法采用系统评价方法,通过检索数据库PUBMED、Medline、Embase、Cochrane Library、中国生物医学文献数据库、中国知网、中国维普以及会议论文集等截止至2014年12月所有关于泊沙康唑预防侵袭性真菌感染的随机对照临床试验,同时追查相关参考文献。并逐个进行质量评价和资料提取,运用 Review Manager 5.2及 Stata 12.0软件进行 Meta 分析。结果共纳入4项研究,共1487例患者。Meta分析结果提示,泊沙康唑与对照组药物相比,能有效降低侵袭性真菌感染(invasive fungal infection,IFI)发生率[RR=0.41,95%CI (0.27,0.63),P <0.00001],尤其在预防侵袭性曲霉菌感染方面,其疗效优于氟康唑(P <0.0001)；预防 IFI 相关死亡的疗效优于对照组[RR=0.32,95%CI (0.15,0.67),P =0.002<0.05]。而不良反应发生率、因不良反应中止治疗发生率、全因死亡率两组间并无统计学差异(P >0.05)。亚组分析显示,泊沙康唑与氟康唑相比,两组间不良反应发生率及侵袭性念珠菌感染发生率均无统计学差异(P >0.05)。结论泊沙康唑可作为两性霉素 B 脂复合物、氟康唑、伊曲康唑等预防侵袭性真菌感染的良好替代药物,能更有效地预防真菌感染,减少 IFI 相关死亡率,而且不增加不良反应发生的风险。%Objective To assess the efficacy and safety of posaconazole for prophylaxis of invasive fungal infections.Meth-ods Databases such as PUBMED,Medline,Embase,Cochrane Library,SinoMed,CNKI,VIP Information and conference proceedings were searched for relevant randomized controlled trials (RCTs)about posaconazole for prophylaxis of invasive fungal infections.The cut-off time is December 2014.And reference of the included articles were also manually searched.Quali-ty of included studies were assessed and data of which were extracted.Both Review Manager 5.2 and Stata 12.0 software were used.Results Four RCTs which included 1 476 patients met the search criteria were assessed.Meta analysis results:the posaconazole group significantly reduced:the IFI rate[RR=0.41,95%CI (0.27,0.63),P <0.000 01],especially in prophylaxis for invasive aspergillosis (posaconazole vs fluconazole,P <0.000 1);and mortality from IFI[RR=0.32,95%CI (0.1 5,0.67), P =0.002<0.05].However,no significant differences were observed in adverse reactions,therapy discontinued because of ad-verse reactions,all-cause mortality rate between posaconazole and controlled groups (P >0.05).For subgroup analysis,there was no significant difference in both the rates of adverse reactions and invasive candidiasis infection between posaconazole and fluconazole (P >0.05).Conclusion Posaconazole can be used as a good alternative of amphotericin B lipid complex,flucon-azole or itraconazole for prophylaxis of invasive fungal infections.Posaconazole significantly improves the effect of prophylaxis and decreases IFI associated mortality but with no risk of increase in adverse events.