Infection and inflammatory response can induce the brain damage in neonate,but the mechanism involved in it has not been elucidated completely.Proposed mechanisms include inflammatory response,cytokine and free radical-mediated injury,and excitatory amino acids-induced injury.The activation of microglia and selective vulnerability of immature oligodendrocyte play an important role in the whole process.Recent researches show that the fetal inflammatory response and complex gene regulation are also involved in the infection-induced brain damage.

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

Animals ; Animals, Newborn ; Brain ; blood supply ; drug effects ; metabolism ; Female ; Hypoxia-Ischemia, Brain ; physiopathology ; Immunohistochemistry ; Lipopolysaccharides ; toxicity ; Male ; Models, Animal ; Random Allocation ; Rats ; Rats, Wistar ; Tumor Necrosis Factor-alpha ; analysis

Objective To investigate quantitatively the thermal sensation characteristics of the patients with facial palsy and the value of quantitative thermal test (QTT) in prognostication.Methods The QTT threshold of the fore ear and cheek of 30 patients with peripheral facial palsy was tested,their facial nerve conduction velocity was measured,and House-Brackmann facial nerve grading system was used to estimate facial nerve function at 2～3 weeks,a month,two months and half a year post onset.Results It was found that 12 out of 30 patients had abnor- mal QTT threshold value;the majority of them suffered from herpes virus and diabetes.In those with abnormal QTT, 8 were with diabetes mellitus (account for 66.7%),3 with partial shingles (account for 25%),and 1 with positive serum virus infection (account for 8.3%).Those with normal QTT were significantly different from those with abnor- mal QTT,with regard to the House-Brackmann rating scores after 2 and 6 months post onset (P

Treatment of clunial nerve entrapment syndrome with needle knife has the advantages of quick efficacy and easy application. However, because of the surgeons' lack of knowledge of the disease and the operation of different proficiency, there are differences in the treatment effects. This article introduced the guidance principle of"staging, segmenting and layering", which can improve the efficacy during treatment and be beneficial to the clinical application of all levels of clinical doctors.

Candida shehatae xyl1 gene and Pichia stipitis xyl2 gene were amplified by PCR and the xyl1 and xyl2 were both placed under the promoter GAL of vector pYES2 to produce the recombinant expression vector pYES2-P12. Subsequently the pYES2-P12 vector was transformed into S. cerevisiae YS58 by LiAc to produce the recombinant yeast YSS8-12. It was indicate that the recombinant yeast YSS8-12 could converse xylose to ethanol with the xylose consumption rate of 81. 3%.

Objective To evaluate the neuroprotective effect and safety of neonatal hypoxic-ischemic encephalopathy(HIE)treated with recombinant human erythropoietin(rhEPO).Methods Fifty-three neonates with HIE were randomly divided into rhEPO treated group(n=29) with the dosage of 300 U/(kg?time),three times a week for 2 weeks and control group(n=24)without rhEPO.All supportive measures were same between 2 groups.Neurological scoring was evaluated at d3,d5 and d7 Neonatal behavioral neurological assessment(NBNA) was evaluated at d7,d14 and d28.The neurodevelopment quote was evaluated at age of 3 and 6 months.Blood pressure,liver and renal function,blood electrolytes and blood hemoglobin,platelet and reticular red blood cell count were monitored before and after treatment in all infants.Results The neurological scoring between two groups had no difference at d3.The significant difference was found at d7(P0.05).Conclusions Teraphy with rhEPO on neonatal HIE infants can promote neurological recovery,and there is no serious side effect with rhEPO treatment.

Objective To investigate the effects of Pulmicort Respules on the airway resistance and airway remodeling in rats with allergic asthma. Methods Thirty-two SD rats were randomly divided into blank control group,asthma model group,Pulmicort Respules group and normal saline control group,with 8 rats in each group.On the 14th day of allergization,rats were challenged by ovalbumin inhalation and were treated correspondingly.On the 28th day,airway resistance was determined,HE staining was conducted in lung tissues of each group,and airway remodeling related parameters were also measured. Results The airway resistance of Pulmicort Respules group was significant lower than that of blank control group,asthma model group and normal saline control group(P

Humans ; Job Satisfaction ; Occupational Health ; Reward ; Stress, Psychological ; physiopathology ; Surveys and Questionnaires ; Workload

Objective To evaluate the clinical effect and safety of L-carnitine and coenzyme Q10 on the treatment of chronic heart failure. Methods One hundred ninety-six patients with chronic heart failure cardiacⅢ-Ⅳlevel were paired by age and gender, and each pair were randomly divided into experimental group and the control group, every group has 98 patients.The control group was treated with metoprolol 100 mg, bid +chlorine 50 mg qd +spironolactone 40 mg bid conventional heart failure treatment.The experimental group was added with L-carni-tine (20 mg? kg -1 ,bid) and coenzyme Q10 (10 mg tid) on the basis of conventional treatment. After treatment, the improvement of cardiac function and incidence of adverse drug reactions between the two groups were compared. Results The total effective rate of treatment group (89.80%) is significantly higher than that in control group 63.27%(P<0.05).After treatment, the C reactive protein content and the brain natriuretic peptide ( BNP) level of experimental group were signifi-cantly lower than those in control group ( P<0.05).6 min walking dis-tance of patients in experimental group is longer than that in control group.The left ventricular ejection fraction ( LVEF) of treatment group was significantly higher than that in control group and the left ventricular diastolic diameter ( LVEDD) and left ventricular end systolic diameter ( LVESD) significantly lower than those of control group.The adverse reactions between the two groups have no significant difference (P>0.05).Conclusion L-carnitine combined coenzyme Q10 can significantly improve the treatment effect of severe chronic heart failure without increasing of the incidence of adverse drug reactions.