OBJECTIVE:To provide reference for the construction and management of hospital clinical drug trial institution. METHODS: The practice of our hospital in the construction and management of hospital clinical drug trial institution in accordance with the Good Clinical Practice and the Trial Provisions for Drug Clinical Trial Institution Qualification was summarized. RESULTS: Hospital attached great importance by taking effective measures,strengthening the construction of software and hardware and emphasizing reforming was the key to pass the qualification confirmation,and the key points in the management are to tighten control on the clinical trial process and establish complete management regulations. CONCLUSION: The construction and management of hospital clinical drug trial institution is conducive to the improvement of clinical trial level and it serves as a scientific,accurate and reliable basis for the evaluation and marketing approval of new drugs.

Objective To determine whether Nutritional Risk Screening 2002 (NRS2002) of admission independently predicts outcome of non-invasive positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients during hypercapnic respiratory failure.Methods Patients with COPD presenting with hypercapnic respiratory failure at Sichuan University Hospital between December 2010 and May 2012 and receiving NIPPV were studied prospectively.NRS2002 was measured before NIV administration.233 patients met the inclusion criteria,with NIPPV failed in 71 cases and succeed in 162 cases.The patients were followed up till they were discharged.Results After multivariate Logistic regression,the items such as baseline PaCO2,NRS2002 score could predicted 76.4％ of the failure outcome.The area under the curve was 0.767.The positive predictive value was 35.23％.The negative predictive value was 84.21％.Conclusions We can predict the risk failure of NIPPV in patients with COPD and hypercapnic respiratory failure with NRS2002 score and baseline PaCO2,and adjust the treatment project according to the evaluation result.NRS2002 supply non-invasive and portable method for predicting the failure of NIPPV.

ObjectiveTo evaluate the value of optical coherence tomography (OCT) in the diagnosis and therapy of epiretinal membrane (EM) in the macular.MethodsForty-nine cases (61 eyes) of EM patients were examined with OCT before and after operation.ResultsThe EM in the macular revealed a high reflex belt in the surface of the retina. The thickness of the reflex belt were different. With some patients, the belt adhered to the inner layer of the retina and with most patients, the belt was separated from the retina. Shallow foveolar and increased thickness of the retina ccould usually been seen. Part cases complicated with false macular hole, laminar hole, cystoid macular edema or detachment of the neuroepithelium. After operation, the reflex belt disappeared. The damage of the macular neruoepithelium and macular edema remained in part cases.ConclusionOCT can objectively reveal the EM and the change of the retina structure after operation.

This study was aimed to explore the effect of heat-nature Chinese herbs of Pepper and Piper longum on hepatic energy metabolism of rats in order to research the impact of ratˊs physical activities with heat-nature Chinese herbs and establish the research foundation of Chinese herbal medicine nature . A total of 30 rats were randomly divided into three groups . Saline was given in the control group . Pepper water extract was given in the Pepper group . And Piper longum water extract was given in the Piper longum group . The administration dosage was 10 ml/kg intragastrically for 30 days . Changes of hepatic energy metabolism related enzymes were determined . The results showed that compared with the control group , Ca2+-ATPase , Ca2+-Mg2+-ATPase , and LDH enzyme of the Pepper group and Piper longum group were significantly increased . And the hepatic glycogen content was significantly reduced . It can obviously increase energy intake , digestible energy and metabolizable energy per body weight in rats . There was no statistical significance between the Pepper group and Piper longum group . It was concluded that the heat-nature Chinese herbs of Pepper and Piper longum can promote the decomposition of hepatic glycogen , increase the activity of LDH enzyme , Ca2+-ATPase , Ca2+-Mg2+-ATPase . It increases the consumption of ATPase in order to increase energy intake , digestible ener-gy and metabolizable energy per body weight in rats and promote the hepatic energy metabolism .

Objective To investigate the accuracy of functional magnetic resonance imaging(fMRI) and contrast-enhanced ultrasound on evaluation of the breast cancer patients after neoadjuvant chemotherapy.Methods Forty-eight patients with breast cancer who were confirmed by biopsy,undergoing 4 cycles weekly dose-concentrated programs (wPC) neoadjuvant chemotherapy,evaluated the efficacy by fMRI and contrastenhanced ultrasound.Results In pathology,complete remission was 12 cases (25.0％,12/48),non remission was 13 cases (27.1％,13/48).In contrast-enhanced ultrasound,complete remission was 20 cases (41.7％,20/48),non remission was 10 cases (20.8％,10/48).In fMRI,complete remission was 17 cases (35.4％,17/48),non remission was 11 cases (22.9％,11/48).The P values more than 0.05 showed no statistically significant among three methods,the Kappa test showed that fMRI were superior to contrastenhanced ultrasound on evaluating the efficacy of neoadjuvant chemotherapy.Conclusions fMRI and contrast-enhanced ultrasound can be used in evaluating the efficacy of neoadjuvant chemotherapy,however,the data shows fMRI is superior to contrast-enhanced ultrasound.Contrast-enhanced ultrasound must be as the supplementary method.

Objective To Analyze the development tendency and major influential factors of the resource and service of traditional medicine (TM) by contrasting the statistical data between China and India.Methods The research data came from the governmental statistical date of traditional medicine.The main statistical indicators included:number of TM hospitals,number of beds in TM institutions,number of health personnel of TM,number of visits and inpatients of TM institutions.A contrastive analysis was given based on these data over the period of 2008-2012.Results In 2012,the number of traditional Chinese medicine (TCM) hospital per ten million populations was 25.1,the number of Traditional Indian Medicine (TIM) hospital per ten million populations was 25.9; the number of beds in TCM institutions per ten thousand populations was 4.5,the number of beds in TIM institutions per ten thousand populations was 0.5; the number of TCM physicians and physician assistants per ten thousand populations was 2.6,the number of TIM physicians and physician assistants per ten thousand populations was 5.9.In 2012,the numbers of visits and inpatients of governmental public TCM hospitals were 426.671 million and 16.882 million; the numbers of visits and inpatients of governmental public TIM hospitals were 73.445 million and 0.947 million.Conclusion There was no significant difference in the number of TM hospitals per ten million populations between China and India.China had obviously advantages in the number of beds in TM institutions,number of visits and inpatients of TM institution.India had obviously advantages in the number of TM health personnel.

Objective To investigate the accuracy of prognosis risk assessment and clinical applicability of Rockall (RS) and Blatchford scoring system (BRS) for acute nonvariceal upper gastrointestinal bleeding (ANVUGIB). Methods From January 2009 to December 2009, the clinical date 195 ANVUGIB patients who met the standards with complete information and treated in The First Affiliated Hospital of Anhui Medical University were recorded. Each patient's scores of RS and BRS were calculated for risk stratification. Patients were followed up for 30 days after discharged.Death or the prognosis of disease in 30 days after discharged was considered as clinical study endpoints.Checked prognostic capacity of these two scoring system. Results In the 195 patients, there were 150 years, mean age was 53.97±18.34 years. 90 patients' age was over sixty (elderly group), 105 less than sixty (non-elderly group). 182 patients survived (93.3%), while 13 dead (6.7%). In survival patients, 11were re-bleeding (5.6 %). Mortality ( 12.2 %, 11/90), the percentage of patients with comorbidities (43.3%, 39/90) and taking aspirin (24. 4%, 22/90) were higher in elderly patients than non-elderly patients (1.9%, 2/105; 16.2%, 17/105; 11.4%, 12/105 respectively)(P＜0.05).The AUC of RS in predicting risk of death was 0.742 (P=0.004) and re-bleeding was 0.469 (P=0.101). For BRS score system, the AUC of predicting risk of death was 0. 493 (P= 0. 067)and rebleeding was 0.341(P=0.092). The RS score was positively correlated with length of hospital stay,however there was no statistically significant between BRS score and length of hospital stay.Conclusion RS score system was good at predicting the risk of death, and the score was positively correlated with length of hospital stay. While it was poor in predicting the risk of re-bleeding. BRS performed poorly in predicting the risk of both death and re-bleeding, so it was not suitable for predicting the risk of hospitalized patients.

Objective To study the effects of glycosaminoglycan extracted from Pinctada martensii on the proliferation, differentiation and mineralization of newborn rat calvarium osteoblast in vitro. Methods MTT, PNPP and ARS methods were used to measure the cell proliferation, activity of ALP and the function of mineral nodes formation of osteoblasts cultured in vitro. Results Glycosaminoglycan at concentration of 0.008～0.5g?L -1 inhibited mildly the proliferation of osteoblast cells, however, this range of concentrations of glycosaminoglycan markedly increased the ALP activity and stimulated mineral node bone formation in osteoblast. Conclusion Glycosaminoglycan extracted from the Pinctada martensii showed stimulating effects on the differentiation and mineralization of newborn rat calvarium osteoblast in vitro, but the stimulating effect on cells proliferation was not observed.

Objective To study the effect of Tongxinluo capsule on vascular endothelial injure in patients with diabetes mellitus.Methods 60 patients with diabetes mellitus were randomly divided into common group and Tongxinluo group.The former was treated with insulin or oral hypoglycemic agents,the latter was added with Tongxinluo capsule oral based on aforesaid therapy.Plasma von Willebrand Factor(vWF)and superoxide dismutase(SOD)were measured before and after treatment.Results After treated with Tongxinluo,The plasma level of vWF was lower than that of common(P<0.01),as well as the level of lipid(P<0.01),while the plasma level of SOD was higher(P<0.01).Conclusion Tongxinluo can protect the of vascular endothelial cells from diabetes mellitus,that may play a role in prevention of the complication.

Objective:To screen the time points of high survival rate and efferocytosis dysfunction of rat alveolar macrophages stimulated by cigarette smoke extract (CSE), establish an in vitro model of alveolar macrophage efferocytosis function, and study chronic respiratory diseases with chronic inflammatory reaction as the main pathological changes. Methods:① Time point screening experiment: rat alveolar macrophages (NR8383 cells) were cultured in vitro, and the cells in logarithmic growth phase were divided into blank control group (100 μL complete medium) and 5% CSE group (90 μL complete medium + 10 μL 100% CSE). Alma blue method was used to detect the effect of 5% CSE on the activity of NR8383 cells at 6, 12, 24 and 48 hours. ② Apoptosis induction experiment: rat type Ⅱ alveolar epithelial cells (RLE-6TN cells) were cultured in vitro as phagocytic target cells of NR8383 cells, and the cells in logarithmic growth phase were divided into blank control group and 10, 30 and 60 minutes groups after ultraviolet exposure (apoptosis was induced by 30 000 μJ/cm 2 ultraviolet irradiation for 15 minutes). Flow cytometry was used to detect the apoptosis rate of RLE-6TN cells cultured for 10, 30 and 60 minutes after ultraviolet exposure. ③ Cell efferocytosis experiment: NR8383 cells in logarithmic phase were divided into blank control group and 5% CSE group. Two hours before NR8383 cells were stimulated by CSE for 6, 12 and 24 hours, RLE-6TN cells were exposed to ultraviolet to induce apoptosis, and the RLE-6TN cell suspension was added to NR8383 cells (the ratio of RLE-6TN cells to NR8383 cells was 5∶1). Flow cytometry was used to detect the efferocytosis rate of NR8383 cells to RLE-6TN cells at different time points treated with 5% CSE. Results:① Compared with the blank control group, the activity of NR8383 cells significantly decreased after treatment with 5% CSE for 48 hours [cell reduction rate: (68.5±4.1)% vs. (73.6±2.3)%, P < 0.05]. However, there were no significant differences when the activities of NR8383 cells treated with 5% CSE for 6, 12 and 24 hours were compared with the blank control group, so these three time points were selected for the subsequent establishment of alveolar macrophage cell efferocytosis dysfunction in vitro model experiment. ② Compared with the blank control group, the apoptosis rate of RLE-6TN cells significantly increased at 10, 30 and 60 minutes after ultraviolet exposure [(66.87±8.63)%, (85.51±2.39)%, (96.13±2.74)% vs. (9.13±3.17)%, all P < 0.01] in a time-dependent manner. Considering that it taked about 50 minutes for RLE-6TN cells to be labeled with PKH26 membrane labeling probe, 10 minutes after ultraviolet exposure was selected to label RLE-6TN cells. ③ Compared with the blank control group, the efferocytosis function of NR8383 cells was significantly decreased after treatment with 5% CSE for 12 hours [cell efferocytosis rate: (33.64±1.30)% vs. (44.02±2.71)%, P < 0.01], but there was no significant effect on the efferocytosis function of NR8383 cells at 6 hours and 24 hours. Conclusions:CSE can induce alveolar macrophage cell efferocytosis dysfunction. Based on the test results of the effect of 5% CSE on NR8383 cell activity and cell efferocytosis function, 12 hours with high survival rate and weak efferocytosis effect of NR8383 cells can be selected as the in vitro model condition of alveolar macrophage cell efferocytosis dysfunction.