The pediatric population is different from adults in their physi-ological function and tissues structure, and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole coun-try.However, the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for chil-dren for a while.Accordingly, Chinese Food and Drug Administration ( CFDA) issues the guidance for clinical investigation of medicinal prod-ucts in the pediatric population, which ensure the clinical trials are more scientific and ethic. This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.

The pediatric population is different from adults in their dis-ease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use, and is helpful to promote the health of children.Howev-er, considering the specificity of children, it is changeable to conduct the drug clinic trials, especially for the study protocol design.Accordingly, CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population, which ensure the clinical trials are more sci-entific and ethic.This paper means to interpret the guidance and there-fore to help the development of clinical trials in pediatric population.

Objective The aim of the study was to investigate the epidemic situation,clinical symptom,diagnosis and epidemiological characteristics of human Fasciola gigantica infection in Dali,Yunnan province.It will also provide a scientific basis for fasciolosis control and prevention.Methods Epidemic data were collected and patient's clinical signs and symptoms were studied.Serum soluble antigen of Fasciola gigantica of patients and part of family members and health people in the same village was detected using enzyme-linked immunosorbent assay (ELISA) and the eggs of Fasciola gigantica in stool were observed under microscope.Sequencing and PCR amplification of Fasciola gigantica eggs had been done.Sequencing results were analyzed using basic local alignment search tool (BLAST) program of the U.S.National Center for Biotechnology Information (NCBI) and the similarity of the two in the sequence of nucleic acid was compared.Furthermore,patients were experimentally given orally therapeutic doses of Triclabendazole 10 mg·kg-1·d-1 daily for 2 days,and kept in the hospital for observation for one week.Moreover,host and vector were investigated in the surrounding ditches of Dali prefecture and Limnaea peregra snail samples were collected.All the snails were squashed by glass sheet in order to detect the cercarie.Cow dung and sheep manure was collected in the Limnaea peregra distribution environment,and the eggs in the feces were checked by microscope after washing and precipitation.Results All the 26 patients had a continued hyperpyrexia with distinct alimentary system symptoms of nausea,vomiting,stomachache,abdominal distension as well as hepatomegaly,sensitive to percussion,different levels of liver damage detected by CT.All the patients had an eaten history of raw Herba Houttuyniae and other aquatic plants,and the course of the disease was similar,with the same epidemiological characteristics.ELISA detection was used in the 26 patients,family members and other healthy population,the results of all the 26 patients were positive(100.0％,26/26) ; the positive rates of the 57 family members and other health people of the same village were 31.6％ (18/57) and 17.1％ (6/35),respectively.The results of sequencing and BLAST program showed that the pathogen was Fasciola gigantica with the similarity between 99％-100％.PCR amplification also confirmed that the eggs were Fasciola gigantica eggs with an approximately 1000 bp band on agarose gel.After treatment with Triclabendazole,body temperature of the patients dropped to normal and symptoms improved markedly.Moreover,329 Limnaea peregra snails were collected including 5 ones with redia and one-tailed cercariae which were preliminary identified as the larva of Fasciola gigantica.There were also eggs of Fasciola gigantica detected in one stool of cattle and one of goat.Conclusions Eating raw food is the leading cause of the onset of the disease.Triclabendazole is the drug of choice to treat Fasciolasis.Health education should be strengthened by government and disease prevention and control departments in order to make the local residents to understand the potential hazard of eating raw aquatic vegetable and drinking unboiled water,which is the key to prevent the occurrence of the disease.

PURPOSETo investigate the prevalence and diagnosis rate of intra-abdominal hypertension (IAH) in a mixed-population intensive care unit (ICU), and to investigate the knowledge of ICU staff regarding the guidelines published by the World Society of Abdominal Compartment Syndrome (WSACS) in 2013.

METHODSA one-day cross-sectional study based on the WSACS 2013 guidelines was conducted in the general ICU of a tertiary teaching hospital in Chongqing, China. The included patients were divided into intravesical pressure (IVP) measured group and IVP unmeasured group. The epidemiologic data were recorded, and potential IAH risk factors (RFs) were collected based on the guidelines. IVP measurements were conducted by investigators every 4 h and the result was compared to that measured by the ICU staff to evaluate the diagnosis rate. Besides, a questionnaire was used to investigate the understanding of the guidelines among ICU staff.

RESULTSThirty-two patients were included, 14 in the IVP measured group and 18 in the IVP unmeasured group. The prevalence of IAH during the survey was 15.63% (5/32), 35.71% (5/14) in IVP measured group. Only one case of IAH had been diagnosed by the ICU physician and the diagnosis rate was as low as 20.00%. Logistic regression analysis showed that sequential organ failure assessment (SOFA) score was an independent RF for IAH (OR: 1.532, 95% CI: 1.029-2.282, p=0.036. Fourteen doctors and 5 nurses were investigated and the response rate was 67.86%. The average scores of the doctors and nurses were 27.14±20.16 and 16.00±8.94 respectively. None of them had studied the WSACS 2013 guidelines thoroughly.

CONCLUSIONPatients with a higher SOFA score has a higher incidence of IAH. The IAH prevalence in 14 ICU patients with indwelling catheter was 35.71%. Strengthening the wide and rational use of WSACS guideline is important to improve the diagnosis of IAH.

Aged ; China ; epidemiology ; Critical Illness ; epidemiology ; Cross-Sectional Studies ; Female ; Humans ; Intensive Care Units ; Intra-Abdominal Hypertension ; diagnosis ; epidemiology ; Male ; Middle Aged ; Prevalence ; Risk Factors ; Severity of Illness Index ; Surveys and Questionnaires