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 investigate the prevalence rate of healthcare-associated infection(HAI)in a hospital,so as to provide reference for making HAI control measures.Methods The cross-sectional survey on HAI was carried out among all hospitalized patients on May 26,2010,December 12,2012 and December 4,2013,respectively,sur-veyed data were analyzed.Results The prevalence rate was 6.66%(n =116),6.67%(n =113)and 6.33%(n =120)in 2010,2012 and 2013 respectively,and case rate was 7.29%(n=127),7.38%(n=125)and 6.97%(n=132) respectively,intensive care unit(ICU )had the highest infection rate,internal medicine ICU was up to 71 .43%. The main infection site was lower respiratory tract(44.53%),followed by surgical site infection (9.11 %)and uri-nary tract infection (9.11 %).The isolation rate of gram-negative bacteria,gram-positive bacteria and fungi was 60.81 %,20.38% and 18.81 % respectively.Usage rate of antimicrobial agents in three years was 32.95%, 29.87% and 25.59% respectively (χ2 = 13.16,P <0.01 ).Conclusion Prevalence rate of HAI in this hospital is high ,the main pathogen is gram-negative bacteria,the main infection site is lower respiratory tract ,antimicrobial use decreased year by year.Monitor on high risk departments,main sites and pathogens should be intensified.

[Summary] An analysis of clinical data was performed in 6 patients diagnosed as adefovir dipivoxil (ADV)-induced nephropathy in recent 14 months.The results showed that all of six patients suffered from pain over multiple joints after taking ADV 10-20 mg/d for 2-3 years,along with hypophosphatemia,hypouricemia,and raised osteogenesis index.One case had increased serum creatinine,5 cases had hypokalemia,renal glycosuria,and4 cases had albuminuria.Imageological examination showed osteoporosis,osteomalacia,and pseudo fracture.After discontinuance of ADV treatment,joint pain was obviously relieved within 3-6 weeks,blood uric acid level returned to normal within 1-2.5 months,and renal glycosuria and albuminuria disappeared by 1-2 months.The results suggest that after taking ADV for more than two years,attention should be paid to the nephropathy induced by ADV and regular monitoring of renal function,blood electrolyte,and urine should be mandatory.Hypouricemia is a reliable index of diagnosis and treatment in this event.

OBJECTIVETo study the main mechanisms of Aitongxiao Recipe (ATXR) for anti-tumor at the molecular level, and to clarify different efficient drugs' roles in anti-tumor, thus in-depth explaining the objectivity and substance of "cancer toxic" theory.

METHODSWalker-256 tumor strain was used for Wistar rat transplanted liver cancer modeling. After successful modeling rats were randomly divided into 5 groups, i. e., the ATXP group, the qi regulating and blood circulating group (as the assembled I group), the heat clearing and detoxification group (as the assembled II group), the body resistance strengthening and cultivating group (as the assembled III group), and the model group, 10 in each group. Corresponding medication was given to rats in each group for 14 successive days. Finally rats were sacrificed and the tumor mass was taken out. The apoptosis rate and the cell cycle of tumor cells were detected by flow cytometry Annexin V/PI. The protein and mRNA expressions of Bcl-2 and survivin were detected using immunohistochemistry and real-time fluorescent quantitative PCR.

RESULTS(1) The apoptosis of hepatoma carcinoma cells could be obviously promoted in the ATXP group. The cell cycle could also be affected, making major cells arrest at G0/G1 phase. The proliferation of hepatoma carcinoma cells was effectively prevented. The efficacy in the assembled II group was in line with that in the ATXP group with no statistical difference (P>0.05). It was also effective in the assembled III group, but its efficacy was not as good as that in the former two groups, showing statistical difference (P<0.01). (2) ATXP could obviously down-regulate the protein and mRNA expressions of Bcl-2 and survivin in hepatoma carcinoma cells. Drugs for heat clearing and detoxification showed significant effects on down-regulating the protein and mRNA expressions of Bcl-2 and survivin in hepatoma carcinoma cells. Their effects were similar to that of ATXP (P>0.05). The effects of drugs for body resistance strengthening and cultivating were not as good as the former two, showing statistical difference (P<0.01). Drugs for blood circulating and stasis removing could up-regulate the protein and mRNA expressions of Bcl-2 and survivin to some extent.

CONCLUSIONS(1) ATXP could increase the apoptosis ratio of hepatoma carcinoma cells obviously through down-regulating the protein and mRNA expressions of Bcl-2 and survivin, thus inhibiting their proliferation. (2) Drugs for heat clearing and detoxification played the most important roles in ATXP. The evil heat and dampness (damp-heat insidious pathogen) is the most fundamental carcinogenic factors. The insufficiency of vital qi is also one of the pathogenic factors. The mechanisms of phlegm, stasis, and other pathological products are not clear and await further studies.

Animals ; Apoptosis ; Carcinoma 256, Walker ; metabolism ; Carcinoma, Hepatocellular ; metabolism ; pathology ; Cell Cycle ; Cell Line, Tumor ; Drugs, Chinese Herbal ; pharmacology ; Liver Neoplasms ; metabolism ; pathology ; Male ; Microtubule-Associated Proteins ; metabolism ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Rats ; Rats, Wistar

Female ; Humans ; Infant, Newborn ; Maple Syrup Urine Disease ; diagnosis ; therapy