Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.
Attention Deficit Disorder with Hyperactivity ; drug therapy ; Biomedical Research ; Child ; Clinical Studies as Topic ; Data Collection ; Drugs, Chinese Herbal ; therapeutic use ; Humans

Objective: To evaluate the clinical efficacy and safety of Fuganlin Oral Liquid in treatment of acute upper respiatory infection (AURI) in pratical application. Methods: A multi-centered observational study was conducted. Total 2124 patients were administrated with Fuganlin Oral Liquid for one week, and observed the cure rate and the occurrence rate of complications in different levels, and the safety was evaluated. Results: The total cure rate was 95.12%, and there was no significant difference on it among different dosage and diagnosis groups, while patients (younger than one year old) took Fuganlin Oral Liquid alone had higher cure rate. The occurrence rate of complications was 0.24%, and there was no statistical difference among different dosage, age, and diagnosis groups, while patient took Fuganlin Oral Liquid alone had lower rate than combination therapy. The rateS of adverse events and adverse reaction were 1.37% and 1.04%, there was statistical difference except in different dosage groups. Conclusion: Fuganlin Oral Liquid has high cure rate and low complication rate. It has a good clinical efficacy, especially in young age groups. The efficacy of Qi deficiency group and wind heat syndrome group, even the disease diagnosis group was similar. A few clinical adverse events and adverse reaction was founded, high dosage group was as safe as the low dosage group. Above all, Fuganlin Oral Liquid has widely applied prospect in clinical practice.

Cutaneous Fistula ; Digestive System Abnormalities ; therapy ; Endoscopy, Gastrointestinal ; methods ; Female ; Humans ; Infant ; Treatment Outcome

OBJECTIVETo investigate the effect of propofol on brain regions at different sedation levels and the association between changes in brain region activity and loss of consciousness using blood oxygen level-dependent functional magnetic resonance imaging (BOLD-fMRI) and bispectral index (BIS) monitoring.

METHODSForty-eight participants were enrolled at Peking Union Medical College Hospital from October 2011 to March 2012 and randomly assigned to a mild or a deep sedation group using computer- generated random numbers. Preliminary tests were performed a week prior to scanning to determine target effect site concentrations based on BIS and concomitant Observer's Assessment of Alertness/Sedation scores while under propofol. Within one week of the preliminary tests where propofol dose-response was established, BOLD-fMRI was conducted to examine brain activation with the subject awake, and with propofol infusion at the sedation level.

RESULTSMild propofol sedation inhibited left inferior parietal lobe activation. Deep sedation inhibited activation of the left insula, left superior temporal gyrus, and right middle temporal gyrus. Compared with mild sedation, deep propofol sedation inhibited activation of the left thalamus, precentral gyrus, anterior cingulate, and right basal nuclei.

CONCLUSIONMild and deep propofol sedation are associated with inhibition of different brain regions, possibly explaining differences in the respective loss of consciousness processes.

Adult ; Brain ; drug effects ; Consciousness Monitors ; Deep Sedation ; Dose-Response Relationship, Drug ; Humans ; Hypnotics and Sedatives ; pharmacology ; Male ; Propofol ; pharmacology

Objective: To evaluate the efficacy and safety of Qingfei Xiaoyan Pill (QXP) in the treatment of lung phlegm heat syndrome in children with acute bronchitis. Methods: Stratified random, open, parallel-group controlled, and multi-center clinical studies were applied. Totally 96 patients suffering from Xiao'er acute bronchitis were randomly divided into treatment group and the control group according to 2:1 ratio. The patients in treatment group were given QXP for application while the patients in control group were given Xiaoer Feire Kechuan Oral Liquid for application, 5 d in total. Results: The curative rates of treatment and control groups in disease efficacy were 76.92% and 50.00%, and the curative rates of both groups in traditional Chinese medicine syndrome effect were 78.85% and 60.76%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P < 0.05). Except ropy sputum, compared with same group before treatment, there were no significant differences between the two groups in single syndrome curative effect (P > 0.05). Conclusion: QXP has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety and is better than Xiaoer Feire Kechuan Oral Liquid.

Brain Stem/pathology* ; Death, Sudden/etiology* ; Fatal Outcome ; Humans ; Intracranial Hemorrhages/mortality* ; Leukemia/pathology*

Apoptosis is necessary for the development and maturation of Leydig cells. However, increased apoptosis results the decline of testosterone production, which may increase germ cell apoptosis and the possibility of infertility. There are several aspects contributing to Leydig cell apoptosis such as ethane dimethanesulphonate (EDS), glucocorticoid, developmental stage and some hormones including FSH, LH/hCG and testosterone. A number of genes are involved in the regulation of Leydig cells apoptosis. It was reported that SCF/c-kit, Bcl-2 and Bcl-xl inhibited the apoptosis while caspase-3, Fas, Bax and clusterine stimulated it.
Animals ; Apoptosis ; Caspase 3 ; Caspases ; physiology ; Humans ; Leydig Cells ; cytology ; Male ; Proto-Oncogene Proteins c-bcl-2 ; physiology ; Stem Cell Factor ; physiology ; bcl-X Protein

Functional abdominal pain is one of the most common problems in functional gastrointestinal disorders,and it's also one of the diseases benefit most from traditional Chinese medicine (TCM) treatment.This paper illustrates some key considerations on the study design of traditional Chinese medicine intended for the treatment of FAP based on the latest treatment and evaluation guidelines,technical guidance,professional authority works as well as the latest clinical studies,and combined with experience of clinical trial design.It hopes to offer helps for research designers in this genera.

Extracting and encoding rhythmic information is very important for brain functions, as it is the foundation of speech recognition,music appreciation and rhythmic movement et al.However,our knowledge of how the neural system processes rhythm information of external inputs remains limited. In the present paper,we review a neural network model of the scale-free topology can serve as an efficient way to encode rhythm information. In the model, neurons are connected by either electrical synapses or chemical synapses with strengths decreasing with the connectivity of neurons, so that hub neurons are difficult to activate. To encode rhythm information, hub neurons trigger synchronous firing across the network, while loops formed by low-degree neurons determine the rhythm of synchronous firing. This model successfully reproduces the long-period synchronous firing observed in experimental data, and indicates that the neural system can encode temporal information via local dynamics in a distributed way.This review aims to elaborate and summarize the mechanism by which neurons encode rhythmic information.

AIMTo study the pharmacokinetics of genistein in Beagle dogs.

METHODSGenistein, suspended in 0.5% CMC-Na solution, was orally administered to Beagle dogs at the dose of 5.34 mg.kg-1. At various time intervals, 1.5 mL of blood was drawn from the vein of dogs in their front legs. At the same time, urine and feces were collected. After the collection, the feces were homogenized with physiological saline (to 1 g feces, 10 mL physiological saline were added). The genistein in plasma, urine and homogenized feces was extracted twice by vortexing with 2.0 mL mixture of methyl tert-butyl ether and pentane (8:2). The organic phase was transferred into tubes and evaporated in ventilation cabinet. The residue was dissolved in 50 microL of methanol and 20 microL of the solution was drawn and detected by high-performance liquid chromatography. The pharmacokinetic parameter was calculated by 3P97 software.

RESULTSThe plasma concentration-time curve was fitted to a one-open-compartment model. The peak time was 0.29 h, and the elimination half-life was 0.52 h. After genistein was administered, 10.79% of genistein were excreted from urine and 21.55% from feces within 24 h. It was also found that 13.00% genistein were excreted from urine and 52.46% from feces within 60 h.

CONCLUSIONIt showed that the speed of absorption and elimination of genistein was high in Beagle dog, and genistein was mainly excreted in the form of parent compound in urine and feces.

Animals ; Anticarcinogenic Agents ; blood ; pharmacokinetics ; urine ; Area Under Curve ; Chromatography, High Pressure Liquid ; Dogs ; Feces ; chemistry ; Genistein ; blood ; pharmacokinetics ; urine