与性别因素相关的莫达非尼药动学特征的Meta分析  

A Meta-analysis of modafinil pharmacokinetics and gender

作　　者：李亚东[1] 王天笑[1] 洪宗元[1] 

机构地区：[1]皖南医学院定量药理研究所,药理学教研室

出　　处：《中国临床药理学与治疗学》2014年第6期651-655,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金面上项目(81171255);教育部科学技术研究重点项目(208058)

摘　　要：目的:评价莫达非尼在人体内药动学特征是否具有性别差异,制定合理的临床给药方案。方法:检索Pubmed、Medline、Ovid、springer link、CNKI、VIP、CBM等数据库,选取自1994年1月至2013年2月间发表的有关莫达非尼(单剂量口服给药)在人体内药动学研究方面的文献,按系统评价方法进行筛选,用Revman 5.0软件对药物消除半衰期(t1/2β)、曲线下面积(AUC0-∞)和血药浓度达峰时间(tmax)三个药动学参数进行Meta分析。结果:共纳入8篇文献,含样本207例。Meta分析结果显示,与男性相比,女性的t1/2β明显缩短(均数差为1.13,95%CI=0.31~1.96,P=0.007),AUC0-∞则显著增大(均数差为-6.37,95%CI=-9.20^-3.53,P<0.0001);而tmax无明显性别差异(均数差为-0.11,95%CI=-0.32~0.10。P=0.32)。结论:莫达非尼在人体内的t1/2β与AUC0-∞等药动学参数存在性别差异,这为制定合理的临床给药方案提供了药动学参考。AIM： Modafinil is a potent wake- promoting compound with low abuse potential used in the treatment of narcolepsy and day time sleepiness. This paper was to evaluate the difference of modafinil pharmaeokinetics between females and males for developing more reasona- ble clinical dosing regimens. METHODS. A systematic review and Meta-analysis of pharmacokinetic studies that administered a single oral dose of modafinil were performed. Pharmacokinetic parameters of modafinil were from 8 papers selected from Pubmed, Medline, Ovid, springer link, CNKI, VIP and CBM etc. databases for January of 1994 to February of 2013. The three pharmacokinetics parameters, tl/2β, AUC0-∞, Tmax were analysised using Revman 5. 0 software. RESULTS. Pooled analysis （n = 207） dem- onstrated that the elimination half-life （t1/2β） ofmodafinil in females was shorter than that in males （Mean difference = 1.13,95X CI= 0.31 -1.96,P=0.007）, while the area under the concentration-time curve （AUC0-∞） in females was increased significantly, compared with that in males （Mean difference =-6.37, 95% CI = -9.20--3.53, P〈0.0001）. However, the peak plasma modafinil concentration （tmax） was no difference between females and males （Mean difference=-0.11,95G CI=-0. 32-0.10, P =0.32）. CONCLUSION. This study indicates a marked effect of gender factor on modafinil pharmacokinetics, which provides a reference for reasonable administration in clinic.

关 键 词：莫达非尼 药动学 META分析 性别因素 

分 类 号：R969.2[医药卫生—药理学]