北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学药学院  > 药剂学系  > 期刊论文
学科主题: 药学
题名:
Placebo effect model in asthma clinical studies: longitudinal meta-analysis of forced expiratory volume in 1 second
作者: Wang, Xipei1,2; Shang, Dewei3; Ribbing, Jakob4,5; Ren, Yupeng2; Deng, Chenhui2; Zhou, Tianyan1,2; Guo, Feng6; Lu, Wei1,2
关键词: Asthma ; Placebo effect ; Longitudinal ; Meta-analysis ; FEV1
刊名: EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
发表日期: 2012-08-01
DOI: 10.1007/s00228-012-1245-2
卷: 68, 期:8, 页:1157-1166
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Pharmacology & Pharmacy
研究领域[WOS]: Pharmacology & Pharmacy
关键词[WOS]: LEUKOTRIENE-RECEPTOR ANTAGONIST ; MODERATE PERSISTENT ASTHMA ; POPULATION PHARMACOKINETIC METAANALYSIS ; CONTROLLED-TRIAL ; 5-LIPOXYGENASE INHIBITOR ; TRIAMCINOLONE ACETONIDE ; INHALED BECLOMETHASONE ; HEALTHY-VOLUNTEERS ; POWDER INHALER ; DOUBLE-BLIND
英文摘要:

Our objective was to describe the time course of the placebo effect in asthma and quantitatively investigate the affective factors of the placebo effect for the placebo response simulation during the asthma clinical study design.

We conducted a systemic search of public data sources for the study-level forced expiratory volume in 1 second (FEV1) to build the placebo effect model for studies by oral or inhaled administrations simultaneously. The administration routes, types of inhalation device, mean patient age, mean male proportion, baseline FEV1, disease severity, year of publication, inhaled corticosteroid status during the treatment, and dropout rate were tested as covariates.

There are 34 literature sources containing 178 mean values for FEV1 presenting the individual observations from about 3,703 patients. The exponential models adequately described the time course of placebo effect with the typical value of the maximum placebo effect (P-max) of 0.060 L. Dropout rate incorporated in the residual error model and the disease severity (mild to moderate and moderate to severe) at baseline were covariates that remained in the final model.

The placebo effect is adequately described by an exponential model over time. By incorporating the dropout rate in the residual error model, the estimation precision was improved. The model could predict the placebo response profile in mild to severe asthmatic patients for the asthma clinical study design and could also be a structure model of the placebo effect for the pure drug effect evaluation in the asthma clinical trials.

语种: 英语
所属项目编号: 2009ZX09301-010
项目资助者: Ministry of Science and Technology of the People&prime ; s Republic of China (Peking University New Drug Research &amp ; Development Platform)
WOS记录号: WOS:000306426800004
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54947
Appears in Collections:北京大学药学院_药剂学系_期刊论文

Files in This Item:

There are no files associated with this item.


作者单位: 1.Peking Univ, State Key Lab Nat & Biomimet Drugs, Beijing 100191, Peoples R China
2.Peking Univ, Sch Pharmaceut Sci, Dept Pharmaceut, Beijing 100191, Peoples R China
3.Capital Med Univ, Beijing Anding Hosp, Lab Clin Psychopharmacol, Beijing 100088, Peoples R China
4.Pfizer Global Res & Dev, Clin Pharmacol, Pharmacometr, S-19190 Sollentuna, Sweden
5.Pfizer Global Res & Dev, Clin Pharmacol, Pharmacometr, Sandwich, Kent, England
6.Pfizer China Res & Dev Ctr, Asia Clin Pharmacol & Pharmacometr, Shanghai 201203, Peoples R China

Recommended Citation:
Wang, Xipei,Shang, Dewei,Ribbing, Jakob,et al. Placebo effect model in asthma clinical studies: longitudinal meta-analysis of forced expiratory volume in 1 second[J]. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY,2012,68(8):1157-1166.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[Wang, Xipei]'s Articles
[Shang, Dewei]'s Articles
[Ribbing, Jakob]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[Wang, Xipei]‘s Articles
[Shang, Dewei]‘s Articles
[Ribbing, Jakob]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2017  北京大学医学部 - Feedback
Powered by CSpace