【摘要】：目的對使用伏立康唑的患者進(jìn)行治療藥物監(jiān)測的有效性和安全性進(jìn)行評(píng)價(jià)。方法系統(tǒng)檢索Pub Med、Em Base、Cochrane Library、Clinicaltrials.gov、CNKI、萬方和CBM數(shù)據(jù)庫,檢索日期截至2016年1月26日。納入比較伏立康唑進(jìn)行治療藥物監(jiān)測與不進(jìn)行治療藥物監(jiān)測患者的隨機(jī)對照試驗(yàn)或觀察性研究,結(jié)局指標(biāo)包括真菌感染相關(guān)病死率、治療有效率、不良事件發(fā)生率、因不良事件停藥發(fā)生率、肝毒性發(fā)生率、神經(jīng)毒性發(fā)生率和視覺障礙發(fā)生率。兩位研究者獨(dú)立提取數(shù)據(jù)和進(jìn)行質(zhì)量評(píng)價(jià),必要時(shí)采用薈萃分析對數(shù)據(jù)進(jìn)行定量分析。結(jié)果共納入1篇隨機(jī)對照試驗(yàn)和1篇回顧性隊(duì)列研究,共計(jì)169名患者,研究對象分別為成人和兒童,研究總體質(zhì)量較高。對于有效性,沒有研究報(bào)道真菌感染相關(guān)病死率。治療藥物監(jiān)測能提高成人(RR=1.38,95%CI:1.00~1.90,P0.05)和兒童(RR=3.15,95%CI:0.80~12.42,P0.05)患者治療有效率,但兒童患者差異無統(tǒng)計(jì)學(xué)意義;對于安全性,相比于非治療藥物監(jiān)測組,成人患者治療藥物監(jiān)測組有顯著更低的因不良事件而停藥的發(fā)生率(RR=0.21,95%CI:0.05~0.95,P0.05);兒童患者治療藥物監(jiān)測組有顯著更高的不良事件發(fā)生率(RR=1.71,95%CI 1.08-2.71,P0.05),該結(jié)果可能與治療藥物監(jiān)測組療程更長有關(guān)。其余安全性指標(biāo)差異均無統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論伏立康唑治療藥物監(jiān)測雖然從藥代動(dòng)力學(xué)理論上能使患者獲益,但仍需更多高質(zhì)量的臨床研究證實(shí)。
[Abstract]:Objective to evaluate the efficacy and safety of therapeutic drug monitoring in patients with Volconazole. Methods Pub Med,Em Base,Cochrane Library,Clinicaltrials.gov,CNKI, Wanfang and CBM databases were searched systematically, and the retrieval date was as of January 26, 2016. A randomized controlled trial or an observational study was conducted to compare the efficacy of voriconazole in the treatment of patients with or without drug monitoring. The outcome indicators included fungal infection-related mortality, effective treatment rate, and incidence of adverse events. The incidence of drug withdrawal, hepatotoxicity, neurotoxicity and visual impairment due to adverse events. The two researchers independently extracted data and evaluated their quality and, if necessary, quantitatively analyzed the data by meta-analysis. Results one randomized controlled trial and one retrospective cohort study were conducted in 169 patients. The subjects were adults and children. The overall quality of the study was high. For effectiveness, no studies have been reported on fungal infection-related mortality. Therapeutic drug monitoring could improve the effective rate of treatment in patients with RR=1.38,95%CI:1.00~1.90,P0.05 and RR=3.15,95%CI:0.80~12.42,P0.05, but there was no significant difference between them. For safety, the incidence of drug withdrawal due to adverse events (RR=0.21,95%CI:0.05~0.95,P0.05) was significantly lower in adult patients than in non-therapeutic drug monitoring groups. The incidence of adverse events in the treatment drug monitoring group was significantly higher (RR=1.71,95%CI 1.08-2.71 P 0.05), which may be related to the longer course of treatment in the drug monitoring group. There was no significant difference in other safety indexes (P0.05). Conclusion although the pharmacokinetic monitoring of Volconazole can benefit patients more high quality clinical studies are needed.
【作者單位】： 北京大學(xué)第三醫(yī)院藥劑科;北京大學(xué)藥學(xué)院藥事管理與臨床藥學(xué)系;
【分類號(hào)】：R978.5

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