Current Status of Pediatric Labeling in China and the Near Future Efforts Needed for the Country

Background: Children are recognized as therapeutic orphan in many parts of the world, one expression of this is the lack of adequate pediatric labeling information. Some researches have been done to investigate the pediatric labeling condition in the U.S. and other countries, but no national studies had been carried out in China. This survey was conducted aiming to inquire the current situation of pediatric labeling in China.Methods: We investigated 6020 child-applied medicines from 15 representative Chinese hospitals, and analyzed the information according to the dosage forms, therapeutic category, and label information integrity.Results: Among all these medicines, only 238 (3.95%) are pediatric products, the rest are adult formulations with an extended use in children. The major pediatric formulations were injection (45.95%), tablet (23.69%) and capsule (4.93%), respectively. Alimentary tract/ metabolism medicine (24.70%) and infections medicines (20.60%) had the most species . In prescription drugs, only 210 of 5187 (4%) medicines had adequate pediatric labeling information. The main cause of this deficiency was lack of evidence derived from pediatric clinical trials. Conclusion: The dilemma of therapeutic orphan requires significant attention. Inadequate labeling information and lack of pediatric clinical trials were two prominent issues in China. It calls for more efforts from pharmaceutical industries, regulatory agencies, and legislature in China to collaborate and find solution to improve the situation.<br/

Space distribution of EEG responses to hanoi-moving visual and auditory stimulation with Fourier Independent Component Analysis

Background and objective: The relationship between EEG source signals and action-related visual and auditory stimulation is still not well understood. The objective of this study was to identify EEG source signals and their associated action-related visual and auditory responses, especially independent components of EEG.Methods: A hand-moving-Hanoi video paradigm was used to study neural correlates of the action-related visual and auditory information processing determined by mu rhythm (8-12 Hz) in 16 healthy young subjects. Independent component analysis (ICA) was applied to identify separate EEG sources, and further computed in the frequency domain by applying-Fourier transform ICA (F-ICA).Results: F-ICA found more sensory stimuli-related independent components located within the sensorimotor region than ICA did. The total number of independent components of interest from F-ICA was 768, twice that of 384 from traditional time-domain ICA (p0.05).Conclusions: These results support the hypothesis that mu rhythm was sensitive to detection of the cognitive expression, which could be reflected by the function in the parietal lobe sensory-motor region. The results of this study could potentially be applied into early diagnosis for those with visual and hearing impairments in the future

Inflammatory Stress Potentiates Emodin-Induced Liver Injury in Rats

Herbal medicines containing emodin, widely used for the treatment of hepatitis in clinic, have been reported with hepatotoxicity in individuals. A modest inflammatory stress potentiating liver injury has been linked to the idiosyncratic drug-induced liver injury (IDILI). In this study, we investigated the hypothesis that lipopolysaccharide (LPS) interacts with emodin could synergize to cause liver injury in rats. Emodin (ranging from 20, 40 to 80 mg/kg), which is in the range of liver protection, was administered to rats, before LPS (2.8 mg/kg) or saline vehicle treatment. The biochemical tests showed that non-toxic dosage of LPS coupled with emodin caused significant increases of plasma ALT and AST activities as compared to emodin alone treated groups (P<0.05). In addition, with LPS or emodin alone could not induce any changes in ALT and AST activity, as compared with the control group (0.5% CMC-Na treatment). Meanwhile, the plasma proinflammatory cytokines, TNF-α, IL-1β, and IL-6 increased significantly in the emodin/LPS groups compared to either emodin groups or the LPS (P<0.05). Histological analysis showed that liver damage was only found in emodin/LPS cotreatmented rat livers samples. These results indicate that non-toxic dosage of LPS potentiates the hepatotoxicity of emodin. This discovery raises the possibility that emodin and herbal medicines containing it may induce liver injury in the inflammatory stress even in their therapeutic dosages