Objective To observe the mild chronic obstructive pulmonary disease (COPD) patients′oropharyngeal flora distri‐bution state ,discuss the illness development and prevention measure of COPD patients with oropharyngeal flora disorder .Methods 124 cases of mild COPD patients from the medical center were enrolled in the study to do bacterial culture of swabs ,and 100 cases of healthy subjects were recruited at the same time to do bacterial culture of swabs as control group .The oropharyngeal bacteria distribution state was observed .Results The number of species and detection rates of main pathogenic bacteria and conditional pathogenic bacteria in COPD patients was higher than healthy subjects .In mild COPD patients ,the patients with abnormal oropha‐ryngeal bacteria isolates≥3 ,accounted for 29 .0% (36/124) which was significantly higher than that in control group(8 .0% ,8/100) and the difference was statistically significant(P< 0 .05) .Conclusion Because of immune factors and bad living habits such as smoking ,which could lead to the disorder of body′s normal flora ,infection and make the illness developed .Monitoring of oropharyn‐geal flora distribution state ,and taking active measures to prevent and control it had clinical significance in the prevention of infec‐tion and the development of mild COPD .

OBJECTIVE: To evaluate the use of Xingnaojing Injection in medical insurance inpatients in Beijing city so as to provide reference for rational drug use and medical insurance billing.METHODS: Inpatient cases using Xingnaojing Injection in 5 Beijing hospitals of different levels were randomly sampled from the 2004 Beijing Medical Insurance Database,and analyzed in terms of indication, dosage, treatment course and ADR.RESULTS: A total of 676 cases were sampled with more than 25 kinds of indications,and among the top 10 indications, 18.0% were inconsistent with the instruction,and 17.5% were in lack of evidence support such as randomized controlled trials.Individual dose of Xingnaojing Injection was(27.9?9.0)mL, which was higher than the usual dose described by the instructions and clinical trials.The mean treatment course of Xingnaojing Injeciton was 14.6 days,with 20.9% exceeding 20 days.Drugs used in combination with Xingnaojing Injection included anti - thrombosis agents( 13.3% ) and traditional Chinese medicines with the action of promoting blood circulation and removing blood stasis (12.7%) .CONCLUSION: The use of Xingnaojing injection in medical insurance patients was not consistant with the instruction or evidence supported by clinical trials.

OBJECTIVE:To promote rational use of Xingnaojing (XNJ) injection in medical insurance patients.METHODS:Clinical trials on indications of XNJ were searched systematically,and clinical evidence that XNJ was applied for different indications were collected and classified.A questionnaire survey was carried out in 20 medical institutions to find out the doctors' attitude and prescribing practice relating to indications,application indications,usage and dosage,timing of application and drug combination of XNJ.The results of above 2 kinds of studies were provided to a group of experts to reach consensus about guideline of XNJ.RESULTS:Guidelines of XNJ,which contained the application indications,timing of medication,dosage,treatment course and drug combination,were developed.The strength and degree of evidence were labeled for each items of recommendation.CONCLUSION:For drugs with low-quality clinical evidence,guideline should be developed according to experts' consensus which is based on evidence-based medicine.

【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.

[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.

Objective To evaluate the effect of recombinant human erythropoietin (rHuEPO) on lung injury induced by hepatic ischemia-reperfusion (I/R) in rats.Methods Sixty healthy male SpragueDawley rats, aged 6-8 weeks, weighing 220-280 g, were randomly divided into 3 groups (n=20 each) using a random number table: sham operation group (group S) , hepatic I/R group (group I/R), and rHuEPO group (group E).I/R and E groups underwent I/R of 70 percent of the liver.The rHuEPO 4 000 U/kg was injected intraperitoneally at 24 h before I/R in group E, while the equal volume of normal saline was given in S and I/R groups.The rats were sacrificed at 3 h of reperfusion, and lungs were removed and cut into sections which were stained with haematoxylin and eosin and examined under light microscope.Wet to dry lung weight ratio (W/D ratio) was calculated.The expression of heme oxygenase-1 (HO-1) and inducible nitric oxide synthase (iNOS) in lung tissues was determined by immunohistochemistry.The content of malondialdehyde (MDA), and activities of superoxide dismutase (SOD) and myeloperoxidase (MPO) in lung tissues were detected.Results Compared with group S, the W/D ratio, MDA content, and MPO activity were significantly increased, the SOD activity was decreased, the expression of HO-1 and iNOS was up-regulated (P＜0.05) , and the pathological changes of lung tissues were obvious in E and I/R groups.Compared with group I/R, the W/D ratio, MDA content, and MPO activity were significantly decreased, the SOD activity was increased, the expression of HO-1 was up-regulated, the expression of iNOS was down-regulated (P＜0.05) , and the pathological changes of lung tissues were reduced in group E.Conclusion The rHuEPO can alleviate hepatic I/R-induced lung injury in rats, and the mechanism may be related to up-regulated expression of HO-1 and down-regulated expression of iNOS.

Objective:To investigate the prevalence,and the factors that influence depressive symptoms among chronic respiratory disease patients in tertiary hospital.Methods:A total of 1713 outpatients and inpatients with chronic respiratory disease were selected from 8 tertiary hospitals in Jiangsu Province from July to September,2014 and screened according to the Hospital Anxiety Depression Scale-D (HADS-D).A questionnaire developed by this research group,was used to collect demographic and clinical information.Logistic regression was used to identify factors that were associated with depressive symptoms.Results:The overall rate of depressive symptoms was 46.0％.Multiple logistic analysis showed that spinsterhood (OR ＝ 0.45),higher education level (middle school /high school/technical school OR ＝0.65;college degree or aboveOR ＝0.28),BMI ≥24 (OR ＝0.71) were associated with decreased risk of depressive symptoms (P ＜ 0.05).B MI ＜ 18.5 (OR ＝ 1.52,),average income of family ≥10000 RMB (OR ＝ 1.37-1.96),limited daily activities (OR ＝ 1.72),poorer sleep quality (OR ＝ 1.45),and negative life events (OR ＝ 1.62) were associated with increased risk of depressive symptoms (P ＜ 0.05).Conclusion:The prevalence of depressive symptoms among chronic respiratory disease patients in tertiary hospitals in Jiangsu Province was higher.Marital status,education level,income,BMI,limited daily activities,subjective sleep quality,negative life events may be the related factors of depressive symptoms of chronic respiratory diseases patients.

BACKGROUND:The ankle is one of the most important joints of human body. Medial maleolar fractures are very common, and there are lots of surgical methods to treat it. A traditional approach is open reduction and internal fixation. As views changed, percutaneous cannulated screw internal fixation become increasingly popular, but various clinical studies are stil needed to analyze the efficacy of these two methods. OBJECTIVE:To compare the recovery of joint function after medial maleolus fracture repaired by open reduction and internal fixation and percutaneous cannulated screw fixation. METHODS:A total of 63 cases of medial maleolus fracture, who were treated in the Department of Orthopedics, People’s Hospital of Xinyi City from March 2009 to March 2013, were enroled. According to repair plan, they were divided into two groups: open reduction and internal fixation group (n=29) and percutaneous cannulated screw fixation group (n=34). Ankle function was assessed in accordance with Kofoed ankle score standard on admission and at 3 months after repair. RESULTS AND CONCLUSION:The patients were folowed up for 3 to 12 months. Among 29 cases in the open reduction and internal fixation group, the wound was healed at grade A in 27 cases and at grade B in 2 cases; 29 cases were reset, and no poor reduction was found. In the percutaneous cannulated screw fixation group, 34 cases had healing at grade A, with the presence of good reduction. Al patients experienced bone union, and no infection appeared. In accordance with Kofoed score, at 3 months of folow-up, the satisfaction rate was 97% in the open reduction and internal fixation group, and 100% in the percutaneous cannulated screw fixation group. These data suggest that both open reduction and internal fixation and percutaneous cannulated screw fixation for medial maleolus fracture obtained positive effects, but percutaneous cannulated screw fixation showed smal surgical trauma, which could reduce the rate of infection and contributed to early functional recovery of ankle joint.

Objective To investigate the effects of ulinastatin pretreatment on oxidative stress response and hepatocyte growth factor (HGF) after hepatectomy in rats.Methods One hundred and twelve pathogen-free male Sprague-Dawley rats,aged 3 months,weighing 230-280 g,were randomly divided into 2 groups (n=56 each): group hepatectomy (group H) and group ulinastatin pretreatment (group U).Left and median lobe resection was performed and then liver ischemia was induced by blood flow occlusion of right and caudate lobes for 30 min,followed by perfusion in both groups.Ulinastatin 50 000 U/kg was injected intravenously at 5 min before occlusion in group U.Eight rats in each group were chosen and the blood samples were taken from the inferior vena cava for measurement of serum ALT and AST activities and HGF concentration before ischemia and at 1,6,12,24and 48 h of reperfusion.Then the right lobe were removed for determination of apoptosis,SOD and myeloperoxidase (MPO) activities,MDA content,expression of proliferating cell nuclear antigen (PCNA) and liver regeneration.Apoptotic index was calculated.Another 8 rats in each group were chosen and the 7 day survival rate was recorded.Results Compared with group H,the levels of ALT,AST,MPO aud MDA and apoptotic index were significantly decreased,and the levels of HGF and SOD,PCNA expression and liver regeneration were significantly increased at different time points in group U (P ＜ 0.05).There was no significant difference in 7 day survival rate between group H and group U (P＞ 0.05).Conclusion Ulinastatin pretreatment can strengthen liver regeneration after hepatectomy in rats,the underlying mechanism may be related to inhibition of oxidative stress response and increase in HGF production.

Objective To approach the effect of telbivudine for preventing recurrence of virus and improving renal function in patients with hepatitis B cirrhosis after liver transplantation with renal insufficiency,and observe the mid-and long-term efficacy.Methods We prospectively researched 17 cases of hepatitis B cirrhosis after liver transplantation with renal insufficiency.Maintenance irnmunosuppression protocol at our centre mainly included calcineurin inhibitor (tacrolimus for 12 cases,and sirolimus for 5 cases).These recipients (n =17) remained under the entecavir (n =10),tenofovir (n =4),lamivudine + adefovir (n =3) for at least 6 months before transformation to telbivudine.We detected HBV-DNA level in serum and ensured no rejection during study,necessarily punctured the graft liver for biopsy to determine if there was rejection.The basal values of blood serum creatinine (Scr) and estimated glomerular filtration rate (eGFR,CKD-EPI formula) were recorded.The Scr and eGFR at 6th month before research and basal values and at 6th and 12th month after telbivudine administration were detected,at the same time the general state and adverse reactions were evaluated.Results During the average follow-up period of 20.2 months,1 patients died.The Ser levels detected in the rest 16 patients were 105.74± 18.24,112.26± 18.67,96.48±22.0 and 89.17± 19.56μμmol/L respectively at 6th month before,basal time and 6th,12th month after telbivudine administration.The eGFR values were 72.56 ± 14.39,66.23 ± 16.61,79.77 ± 20.15 and 83.93 ± 23.67 mL/(minute,m2) at different time points respectively.As compared with the basal value,the Scr and eGFR levels were improved obviously (P＜0.05) at 6th and 12th month after telbivudine administration.The proportion of patients with eGFR ＜60 mL/(min·m2) in 16 cases was 25％,37.5％,12.5％ and 6.3％ respectively at 6th month before,basal time and 6th,12th month after telbivudine administration.The serum creatine phosphokinase level was increased (1 023 IU/L) in 1 patient (6.3％),and decreased after transformation of telbivudine to tenofovir at 3rd month after end of research.No rejection and HBV occurred.Conclusion The telbivudine improves renal function in patients with hepatitis B cirrhosis after liver transplantation with renal insufficiency.Meanwhile,telbivudine prevents hepatitis virus B recurrence.However,large samples of long-term clinical data are needed to further confirm.