摘要
目的评价泊沙康唑预防性抗真菌的疗效与安全性。方法检索中国知网中国期刊全文数据库、维普数据库、中国生物医学文献数据库、万方医学数据库、PubMed、CochraneLibrary、Embase、OVID、WebofScience（建库至2014年3月），收集泊沙康唑与安慰剂或其他抗真菌药物比较预防真菌感染并以侵袭性真菌感染发生率、病死率和不良反应发生率中任何一项作为研究终点的随机对照试验（RCT），提取相关数据并应用RevMan5．1软件进行Meta分析，结果以比值比（OR）以及95％置信区间（c，）表示。结果共纳入6项RCT，其中4项为泊沙康唑与1种其他抗真菌药比较，2项RCT为泊沙康唑与2种其他抗真菌药比较，试验组患者共1410例，对照组929例。Meta分析结果显示，试验组侵袭性真菌感染发生率低于对照组，差异有统计学意义（OR=0．37，95％CI：0．27—0．50，P〈0．00001）。与不同对照药物比较的结果显示，试验组侵袭性真菌感染发生率低于氟康唑对照组（OR=0．42，95％CI：0．28—0．64，P〈0．0001）和伊曲康唑对照组（OR：0．33，95％CI：0．21—0．53，P〈0．00001）；与伏立康唑对照组和两性霉素B脂质体对照组差异均无统计学意义（OR=0．13，95％CI：0．01—2．67，P=0．19；OR=0．11，95％CI：0．01—2．34，P=0．16）。试验组侵袭性霉菌感染发生率低于氟康唑对照组（OR=0．25，95％CI：0．12～0．51，P〈0．00001），与伊曲康唑对照组差异无统计学意义（OR=0．10，95％CI：0．01～1．59，P=0．10）。试验组侵袭性念珠菌感染发生率与氟康唑、伊曲康唑对照组比较差异均无统计学意义（P：0．91；P=0．33）。试验组全因病死率低于对照组，差异有统计学意义（OR=0．64，95％CI：0．49～0．82，P=0．0005）。试验组不良反应发生率低于对照组，差异有统计学意义（OR=0．81，95％CI：0．66—0．99，P=0．04），但亚组分析结果显示试验组与氟康唑、伊曲康唑、伏立康唑和两性霉素B脂质体对照组比较，差异均无统计学意义（均P〉0．05）。考虑可能存在发表偏倚。结论泊沙康唑预防侵袭性真菌感染的疗效优于非泊沙康唑类药物，安全性与非泊沙康唑类药物相似。
Objective To evaluate the effectiveness and safety of posaconazole in antifungal prophylaxis. Methods CNKI, VIP, CBM, Wangfang Database, PubMed, Cochrane Library, Embase, OVID, and Web of Science from the inception to March 2014 were searched. The randomized controlled trials （RCT） which compared posaconazole with placebo or other antifungal drugs in antifungal prophylaxis and the endpoint was the incidences of invasive fungal infection （ IFI ） , all-cause mortality, or adverse reactions were collected. The related information was selected and RevMan 5. 1 software of Cochrane Collaboration was used for statistical analysis. The results were expressed as odds ratios （OR） and its corresponding 95% confidence intervals （CI）. Results A total of 6 RCTs were enrolled into the study. Of them, 4 RCTs were comparison of posaconazole with one other antifungal drug, and 2 RCTs were comparison of posaconazole with two kinds of other antifungal drugs. There were 1 410 cases in the experimental group and 929 cases in the control group. The results of Meta-analysis showed that the incidence of IFI in the experimental group was lower than that in the control group （ OR = 0.37, 95% CI： 0. 27-0.50, P 〈 0. 000 01 ）. The results of comparison of posaconazole with other antifungal drugs showed that the incidence of invasive fungal infections in the experimental group were lower than those in the flneonazol group （ OR = 0.42, 95% CI： 0. 28-0.64, P 〈 0.000 1 ） and the itraconazole group （ OR = 0.33, 95% CI： 0. 21-0. 53,P〈 0. 000 01 ）. There were no statistical significant differences in incidence of invasive fungal infections between the experimental group and the control groups of vorieonazole and amphotericin B （OR =0.13, 95% CI： 0.01-2.67, P=0.19; OR=0. 11,95% CI： 0.01-2.34, P=0.16）. The incidence of invasive mold infection in the experimental group was lower than that in the fluconazole group （ OR =0.25, 95% CI： 0. 12-0.51, P =0.000 1 ） . There was no statistical significant difference in incidence of invasive mold infection between the experimental group and the itraeonazole group （ OR = 0. 10, 95% CI： 0. 01-1.59, P = 0.10）. There were no statistical significant differences in incidence of invasive candida infection between the experimental group and the control groups of fluconazol and itraconazole （P = 0.91, P = 0.33 ）. The all-canse mortality in the experimental group was lower than that in the control group （ OR =0.64, 95% CI： 0. 49-0.82, P = 0. 000 5 ）. The incidence of adverse reactions in the experimental group was lower than that in the control group （OR = 0.81,95% CI： 0. 66-0.99, P = 0.04） ; but the result of subgroup analysis showed that there were no statistical significant difference in the incidence of adverse reactions between the experimental group and the control groups such as fluconazol, itracanazole, voriconazole, and amphotericin B liposomes （ all P 〉 0.05 ）. It was considered that publication bias existed in abovementioned 6 RCTs. Conclusion The effectiveness of posaconazole in antifungal prophylaxis is better than those in the non-posaeonazole drugs and the safety of posaconazole is similar to the non-posaconazole drugs.
出处
《药物不良反应杂志》
CSCD
2015年第4期268-274,共7页
Adverse Drug Reactions Journal
作者简介
通信作者：卢来春，Email：lulaicq@163．com
