Early enteral nutrition supplemented with probiotics improved the clinical outcomesin patients with severe head injury： protocol for a meta-analysis of randomizedcontrolled trials

Objective： The aim of this systematic review of randomized controlled trials （RCTs） is to determine the effects of earlyenteral nutrition supplemented with probiotics on clinical outcomes in patients with SHI.Methods and analysis： A systematic search will be carried out in PubMed, Cochrane Central Register of ControlledTrials （CENTRAL）, China National Knowledge Infrastructure （CNKI）, WanFang database, and Chinese BiomedicalLiterature （CBM） in order to identify the randomized controlled trials （RCTs） investigated the potential of early enteralnutrition supplemented with probiotics on patients with severe head injury, as well as we will also manually check thebibliographies of eligible studies and topic-related reviews. We will assign two investigators to independently search allpotential citations, extracted data, and appraised risk of bias accordingly, and then STATA software version 12.0 will beused to statistically analyze all data.Ethics and dissemination： The ethics approval and patient written informed consent will not be required because allanalyses in the present study will be performed based on data from published studies. We will submit our systematicreview to a peer-reviewed scientific journal for publication.

Study Design and Implementation for Population Pharmacokinetics of Chinese Medicine：An Expert Consensus

Although many population pharmacokinetics（PPK） researches have been conducted on chemical drugs,few have been in the field of Chinese medicine（CM）.Each ingredient in CMs possesses different pharmacokinetic characteristics,therefore,it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations.To develop an expert consensus on study design and implementation for PPK of CM,in August 2013,6 experts in the field of PPK,CMs pharmacology,and statistics discussed problems on the PPK research protocol of CMs,and a consensus was reached.The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected.The compositions with definite therapeutic effects were selected as indices,and specific time points and sample sizes were designed according to standard PPK design methods.Target components were tested through various chromatography methods.Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs（which assists in reasonable adjustments on clinical dosage）.This consensus specifies the study design and implementation process of PPK.It provides guidance for the following：post-marketing clinical studies,in vivo investigations related to the metabolism in different populations,and development and clinical adjustment of dosages of CMs.