【摘 要】
：
Objective: To investigate the time-dose-response relationship of benvitimod cream after topical administration in patients with mild and moderate psoriasis vulgaris for dosage regimen exploring.Method
【机 构】
：
Department of Pharmacy, Peking University People's Hospital Beijing, China;Department of Pharmacy A
【出 处】
：
第五届定量药理学与新药评价国际会议
论文部分内容阅读
Objective: To investigate the time-dose-response relationship of benvitimod cream after topical administration in patients with mild and moderate psoriasis vulgaris for dosage regimen exploring.Methods: Thirty-six patients with mild and moderate psoriasis vulgaris were randomly assigned to receive 0.5%, 1.0%, 1.5%, and 0% (placebo) benvitimod cream of 30 g/1.7 m2 twice daily for six weeks.The primary efficacy outcome was the proportion of patients achieving more than 75% change of the psoriasis area and severity index (PASI 75) from baseline.A longitudinal Emax model was established by the NONMEM method,and then applied to try to find an appropriate dose for following trials.Results: In the final time-dose-response model, the primary outcome at week 6 of PASI 75 of the 0.5%, 1.0%, and 1.5% benvitimod cream was 31%, 63%, and 75%, respectively, demonstrating that the 1.0 % benvitimod cream was an appropriate dose for the next trial.The time parameters of ET50 and ET90 were 15 and 69 days for 1.0 % benvitimod cream, indicating that the maximum efficacy of PASI change rate was obtained at approximately week 10.The accuracy of PASI change rate by extrapolation prediction was limited at Week 10, so the treatment period should be longer in future trials.Conclusions: The established dose-response model could well describe the relationship between PASI change rate and doses of benvitimod cream in patients with mild and moderate psoriasis vulgaris.This modeling approach may help choose 1.0% benvitimod cream twice daily as a dosage regimen in following clinical trials.
其他文献
目的 了解山东省中毒救治医疗机构突发中毒急救现状，为制定中毒控制策略和建设规划方案提供依据.方法 采用多层整群抽样的方法，选取山东省17个地市中毒救治医疗机构为调查对象，采用问卷方式调查，建立数据库，运用SPSS 18.0进行统计学分析.结果 不同经济水平地区医疗机构药物储备、中毒救治能力及中毒救治人员年龄、学历、职称有显著性差异，突发中毒应急培训、演练不足.结论 不同经济水平地区急救能力存在显著
目的 揭示影响农村生活饮用水安全的风险因素，为农村生活饮用水安全风险预警和控制提供依据。方法 资料来源于山东省威海市2014年水质监测结果和1588家农村集中供水单位的卫生学调查情况；运用风险矩阵的管理理论，识别和衡量各类潜在风险发生的概率及其影响等级，进一步用Borda序值法对风险因素进行排序。结果 本研究共识别出农村饮水安全的风险因素23项，其中影响水质卫生的风险因素15项，供水单位存在的风险
目的 对急诊医生工作满意度及其影响因素进行分析.方法 采用课题组自行设计的《医生工作满意度量表》作为测量工具，对4个省的155名急诊医生进行调查.通过多元线性回归分析识别急诊医生工作满意度的影响因素，并运用因素重要性推到象限图识别影响急诊医生工作满意度的关键因素.结果 急诊医生的总体工作满意度为3.22±1.00分，多元线性回归分析共识别出对医院的认可度、物质回报、组织管理、医患互动、与同事的合作
前言临床许多疾病通过血液传播,如病毒性肝炎、梅毒、艾滋病,且国内外由于输血、手术等造成传染性疾病感染的案例不在少数,准确的结果是对病人和医生的有力保障.因此,术前筛查尤为重要.
Objectives: The objective of this study was to estimate the population pharmacokinetics (PopPK) of voriconazole by using Nonlinear Mixed Effect Model, to identify the factors influencing the pharmacok
Neurosurgical procedures may damage the blood-brain barrier to allow morevancomycin distribution into the cerebrospinal fluid (CSF) from blood after intravenous administration.However, a large inter-s
Background: Cefoperazone/sulbactam (CPZ/SUL) is a beta-lactam and beta lactamase inhibitor combination for the treatment of respiratory tract infection.The aim of this study was to develop population
Aims: The purposes of this study were to establish population pharmacokinetic-pharmacodynamic (PopPK-PD) models of S-and R-warfarin in heart valvular replacement (HVR) patients and to provide suggesti
Therapeutic monoclonal antibodies (mAbs) represent a growing segment of the development pipeline in the pharmaceutical industry.Physiologically based pharmacokinetic (PBPK) modeling has been extensive
Background and Aim: Hepatic enzyme CYP2D6 plays an important role in metabolizing many drugs and its genetic polymorphism results in significant individual therapeutic difference.Estimating the phenot