Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.

Objective To study the screening value of color doppler flow imaging (CDFI) for gastroesophageal reflux(GER).Methods Through the window of left lobe liver, the abdominal esophageal length,the phenomenon of GER and the frequency of GER were detected by CDFI in 55 children with GER and 55 control group.Results Abdominal esophagus was identified by CDFI in every children. The abdominal esophageal length was shorter in refluxers than that in control group. A significant correlation was found between its length and the age of control group.To diagnose GER with CDFI ,its accuracy was 98.18%,and its specificity was 76.36%.Conclusions Visualization and measurements of the abdominal esophagus are readily achieved with CDFI in children.Abdominal esophageal length is shorter in refluxers than that in control group. CDFI is a rapid method of screening GER.

Objective To study whether gastric liquid emptying is delayed in children with gastroesophageal reflux and its clinical significance. Methods At different times after meal, the gastric antral diameters were measured by real - time ultrasonography in 55 children with gastroesophageal reflux and 55 controls. Results At 20 min,60 min after meal , there was a significant difference in gastric emptying rate between case groups and control groups, respectively(P

ObjectiveTo investigate the diagnoses of somatic diseases of inpatients with psychosis and hospitalized more then 2 years.MethodsThe material of all 350 inpatients were investigated and analyzed.ResultsThe first three psychiatric diagnoses were schizophrenia (61.32%), Alzheimer's disease (15.26%), mood disorder (4.74%). The first three diagnoses of accompanying somatic diseases were heart disease (8.68%), diabetes mellitus (8.42%), and hypertension (4.47%).ConclusionWith the changes of social environment, the disease pedigree of inpatients with psychosis changes, senile patients become more and more, and the incidence of concurrent somatic diseases gradually increases.

The role of interleukin-17 (IL-17) in autoimmune hepatitis (AIH) was investigated. A mouse model of experimental autoimmune hepatitis was established, and the syngeneic S-100 antigen emulsified in complete Freud's adjuvant was injected intraperitoneally into adult male C57BL/6 mice. The IL-17 expression in serum and the livers of the mice models was detected by using ELISA and immunohistochemistry, respectively. IL-17 neutralizing antibody was used to study the biological effect of IL-17 in the experimental AIH. IL-17 neutralizing antibody in vivo administration alleviated the hepatic inflammation and ALT level in the AIH model. IL-17 in the peripheral blood mononuclear cells (PBMC) of AIH patients was measured by using real-time PCR method. The results showed that IL-17 level was significantly up-regulated in AIH patients and mice models. It was concluded that IL-17 contributed to the development of AIH and might be a potential therapeutic target of AIH.

BackgroundDry eye is a multi-factorial-induced tear film and ocular surface disorder.Immunoinflammation plays a key role in the pathogenesis of dry eye.As inhibitor of the cyclo-oxygenase pathway,nonsteroidal anti-inflammatory drugs play an anti-inflammatory and anti-hypersensitivity role,and it can be a potential treatment for dry eyes.ObjectiveThis study was to investigate the effectiveness of nonsteroidal anti-inflammatory drugs (0.1％topical pranoprofen) on moderate to severe dry eyes and its mechanism.MethodsThis was a small sample of randomized controlled clinical trial.Thirty right eyes of 30 patients with moderate to severe dry eyes were included in the study according to the diagnosis criteria and randomized into two groups.The patients of the trial group received topical administration of 0.1％ pranoprofen plus 0.1％ sodium hyaluronate,and those of the control group received the topical 0.1％ sodium hyaluronate only.Ocular surface inflammation index scores (OSDI) and ocular surface fluorescine staining (OSS) scores were measured under the slit lamp,and tear film break-up time (BUT),Schirmer Ⅰ test values were evaluated.The expression of human leucocyte antigen-DR (HLA-DR) and CD11b in conjunctiva epithelial cells were detected by impression cytology and flow cytometry (FCM).All the indexes were compared between the two groups before and after treatment.Informed consent was obtained from all patients.ResultsThere were no significant differences in terms of age and gender and their baseline values between the trial group and control group (t=0.412,P=0.684;x2=0.240,P=0.624),and so were all the indexes (P＞0.05).Compared with the control group,the OSDI,OSS scores and cells positive for HLA-DR were lowered but the BUT was delayed in the trial group on day 15 ( t=2.43,P=0.03;t=2.83,P=0.01;t=3.29,P=0.00;t=3.23,P=0.00 ).No significant differences were found in the Schirmer Ⅰ test value and CD11b expression between these two groups (t=0.17,P=0.87;t=0.28,P=0.79).The OSDI,OSS scores and BUT were significantly improved,and the number of cells positive for HLA-DR were reduced 15 days after administration of drugs in comparison with before treatment in the trial group ( t =12.30,10.70,6.10,7.92,P =0.00 ).However,there were no comparable alteration seen in these indexes before and after the usage of drugs in the control group ( P＞0.05).Positive correlations were found in HLADR expression with OSDI and OSS ( r =0.601,P =0.018 ; r =0.586,P =0.022 ) and a negative correlation in HLADR expression with BUT (r=-0.697,P=0.004) on day 15 in the trial group.ConclusionsTopical usage of 0.1％ pranoprofen is beneficial for remitting the ocular signs and symptoms in moderate to severe dry eyes.This study illustrates that topical usage of 0.1％ pranoprofen can down-regulate the expression of inflammatory markers in conjunctival epithelial cells.

Objective To study expressions of heme oxygenase-1 mRNA and protein in rat hippocampus after hypoxic-ischemia brain damage(HIBD) as well as the relationship with apoptosis in brain.Methods Seven-day-old SD rats were randomly divided into hypoxic-ischemia brain damage group and sham control group.Expressions of HO-1 protein and mRNA as welll as the relationship with apoptosis after HIBD in neonatal rat were determined by immunohisochemistry and in situs hybridizaion as well as terminal deoxynucleotidy transferase mediated UTP-biotin nick end labeling(TUNEL).Results 1.In the right hippocampus,expression of HO-1 gene increased sharply at 4 h (P

Objective To study changes of phosphorylated cyclic adenosine monophosphate(c-AMP) response element binding protein in hippocampus(CA1) of neonatal rats after cerebral hypoxic-ischemia(HI)and effects of gangliosides (GM1)on the p-CREB.Methods An animal model of neonatal hypoxic-ischemia brain damage was established. Changes of p-CREB in hippocampal CA1 was detected with immunohistochemical methods.Results The p-CREB levels in the CA1 of HI and GM1 groups increased transiently and then decreased quickly, but there was no significant difference between HI and GM1 group.Conclusion The p-CREB levels in the CA1 of HI group increase transiently and then decrease quickly after HI ;GM1 has little effect on p-CREB in the CA1 after HI.

Objective Pueraria extract puerarin,HPLC assay puerarin extract and compare different doses of correlation with the hang-over effect of puerarin evaluate different doses of puerarin liver hangover effect. Methods Extracted under optimal conditions obtained in the previous experiment puerarin spare,HPLC method for qualitative and quantitative detection of alcohol extract of kudzu root ( PRE) ,the male Kunming mice were randomly divided into control group,positive control group and puerarin group,each group of 10. Give mice fed pueraria extract,30 min after administration of liquor,drunk mice sobering observation time and the determination of mouse liver ADH,GOT,GPT con-tent in order to investigate the effect of puerarin on drunken mice. Results HPLC fraction was measured at 8 times the volume of 70% etha-nol,60 ℃ constant temperature water bath shaker at 30 min for optimal extraction conditions puerarin extraction. Compared with the positive control groups:low,medium and high doses of alcohol extract of pueraria can significantly shorten the time to sober up drunken mice,the dose of PRE could effectively inhibit the absorption of alcohol,reduce liver tissue ADH,GOT,GPT,the effects of high doses of PRE absorption of alcohol was small. Conclusion HPLC method capable of puerarin extract the qualitative and quantitative determination of puerarin on liver injury caused by acute alcoholism a protective regulatory role,and the hangover effect of puerarin dose showed a good positive correlation.

Objective To retrospectively analyze the prognostic factors for locoregionally recurrent early?stage extranodal nasal?type natural killer/T?cell lymphoma ( NKTCL) . Methods A total of 56 patients with early?stage extranodal nasal?type NKTCL, who had locoregional recurrence after initial treatment and then received salvage treatment from 1995 to 2014, were enrolled as subjects. The effects of salvage treatment on the overall survival ( OS) rate were analyzed after initial treatment and recurrence. Univariate and multivariate prognostic analyses were performed on the OS rate after recurrence. Results The median follow?up time was 35. 9 months after initial treatment and 14. 8 months after recurrence. The 3?year OS rate was 73% after initial treatment and 58% after recurrence. Compared with chemotherapy alone, radiotherapy?containing salvage treatment significantly improved the OS rates after initial treatment and recurrence ( P=0. 040, 0. 009 ) , and re?irradiation also significantly improved the OS rates after initial treatment and recurrence (P=0. 018, 0. 019). Most (84%) of the acute and late adverse reactions after re?irradiation were grade 1?2 ones. The univariate and multivariate analyses showed that the Karnofsky Performance Status score, radiotherapy in initial treatment, and radiotherapy in salvage treatment were influencing factors for the OS rate after recurrence. Conclusions Radiotherapy achieves improved survival and tolerable toxicities, making it indispensable in the treatment of locoregionally recurrent extranodal nasal?type NKTCL.