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Placebo effect model in asthma clinical studies: longitudinal meta-analysis of forced expiratory volume in 1 second
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
2012-08-01
DOI10.1007/s00228-012-1245-2
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
WOS记录号WOS:000306426800004
引用统计
被引频次:11[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/54947
专题北京大学药学院_药剂学系
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
推荐引用方式
GB/T 7714
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.
APA Wang, Xipei.,Shang, Dewei.,Ribbing, Jakob.,Ren, Yupeng.,Deng, Chenhui.,...&Lu, Wei.(2012).Placebo effect model in asthma clinical studies: longitudinal meta-analysis of forced expiratory volume in 1 second.EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY,68(8),1157-1166.
MLA Wang, Xipei,et al."Placebo effect model in asthma clinical studies: longitudinal meta-analysis of forced expiratory volume in 1 second".EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY 68.8(2012):1157-1166.
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