Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.

Objective To investigate the role of protein kinase C (PKC) in mechanical ventilation-induced lung injury in rats.Methods Thirty healthy male Wistar rats,weighing 250-300 g,were randomly divided into 5 groups (n =6 each):control group (group C),small tidal volume group (group S),small tidal volume and PKC inhibitor group (group S + P),large tidal volume group (group L),and large tidal volume and PKC inhibitor group (group L + P).VT =42 ml/kg,RR =40 bpm,I∶E =1∶ 2,PEEP =0,FiO2 =21％ in groups L and L + P,while VT=7 ml/kg,RR=40 bpm,I∶E=1∶2,PEEP=0,FiO2 =21％ in groups S and S+P.The rats were only tracheostonized in group C,while the rats were mechanically ventilated for 4 h in the other four groups.PKC inhibitor bisindolylmaleinide Ⅰ 0.12 mg/kg was injected intramuscularly 1 h before anesthesia in groups S + P and L + P.The animals were sacrificed immediacy after tracheotomy in group C,and at 4 h of ventilation in the other four groups and lungs were removed for calculation of wet/dry lung weight ratio (W/D ratio) and for microscopic examination.The expression of occludin was determined in the lung tissues by Western blot.Results Compared with group C,W/D ratio was significantly increased and the expression of occludin was down-regulated in the other four groups (P ＜ 0.05).Compared with group S,W/D ratio was significantly increased and the expression of occludin was down-regulated in group L,and W/D ratio was decreased and the expression of occludin was up-regulated in group S + P (P ＜ 0.01).W/D ratio was significantly lower and the expression of occludin was higher in group L + P than in group L (P ＜ 0.01).The pathological changes were attenuated in groups S + P and L + P as compared with groups S and L.Conclusion PKC is involved in mechanical ventilation-induced lung injury in rats.

Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .

Objective To compare the surgical effects of transurethal enucleation of prostate (TUEP)with transurethal resection of prostate (TURP) by a retrospective analysis of clinical data.Methods The patients in this study were divided into the groups of TUEP (enrolled in 2010 and 2011,n =77) and TURP (enrolled in 2009,n =27) with prostate larger than 60 g and smaller than 60 g respectively.Comparisons were made between the two groups in operation time,blood loss volume and weight of resected prostate.Results In the group of patients with prostate larger than 60 g,there was no significant difference in prostate weight ((88.5 ± 9.2) g vs.(107.0 ± 15.30) g,P =0.255),operation time ((91.5 ± 8.8) min vs.(118.3 ± 20.2)min,P =0.083),and weight of resected prostate ((48.0 ± 4.6) g vs.(58.4 ± 5.4) g,P =0.32) between the TUEP (53 patients) and the TURP (12 patients) groups.There was significant difference in blood loss ((110.0 ± 16.4) ml vs.(193.3 ± 22.3) ml,P =0.011) between the two groups.In the group of patients with prostate smaller than 60 g,there was no significant difference in prostate weight ((43.1 ± 3.2) g vs.(36.8 ± 3.4) g,P =0.072),operation time ((62.7 ±6.8) min vs.(69.3 ±6.2) min,P =0.431),blood loss ((56 ± 5) ml vs.(110±20) ml,P=0.082),and weight of resected prostate ((26.3 ±2.4) g vs.(23.6 ±2.1) g,P =0.291) between the TUEP (24 patients) and the TURP (15 patients) groups.Conclusion Compared with TURP,TUEP has the advantages of less blood loss in the treatment of patients with prostate larger than 60 g.With the improvement of surgeon' s experience and development of operation techniques,TURP will be replaced by TUEP.In the treatment of patients with prostate smaller than 60 g,the operation modality can be chosen by the surgeon based on his experience and proficiency.

This paper aimed to analyze the concept of symptom experience according to the aspects of definition,defining characteristics,antecedents and consequence.Symptoms experience is the perception of the frequency,intensity,distress,and meaning of symptoms as they are produced and expressed.Through the analysis of the symptom experience,to help nurses roundly understand the effects of symptoms on patients,improve symptom management and provide the basis for further research.

BACKGROUND:Low concentration of nicotine promotes the angiogenesis and facilitates the healing of skin wounds. However, the role of low concentration of nicotine on the repair of maxil ofacial soft tissue trauma especial y oral mucosa stil remains unclear
OBJECTIVE:To evaluate the effect of low concentration of nicotine on mucosa defect repair of rat hard palate.
METHODS:A circular soft tissue defect at 3 mm diameter was produced in the centre of hard palate of 65 Wistar rats. After the operation, animals were randomly divided into low concentration of nicotine with gel group, gel group and control group. Rats were sacrificed at 3, 7, 10 and 14 days post-surgery. The wound healing was detected with hematoxylin-eosin staining and the difference of wound healing in different groups was compared with gross observation and image measurement.
RESULTS AND CONCLUSION:There was no significant difference in the wound healing in different groups on day 3 post-surgery. On days 7 and 10, the group of low concentrations of nicotine with gel was faster than gel group and control group (P<0.05);the wounds were completely healed on day 14, with no significant difference among the groups. Low concentrations of nicotine may promote the mucosa defects repair of rat hard palate.

Background and purpose:Esophageal carcinoma is one of main malignancies with rapid course and a poor prognosis in China. The reasons of poor overall survival are the invasion and metastasis of the tumor. Matrix metalloproteinase (MMPs) play essential roles in promoting tumor invasion and metastasis. In this study, we aimed to investigate the expression and functional signiifcance of matrix metalloproteinase 16(MMP-16) in esophageal squamous cell carcinoma (ESCC). We expect to ifnd a lead molecule for the beneift of early detecting tumor and the development of novel treatment of ESCC. Methods:The expression levels of MMP-16 protein and mRNA in human ESCC and the matched normal tissues were determined by immunohistochemistry, Western blot and Real-Time PCR (RT-PCR). The stable Ec109 cell line with MMP-16 knockdown and negative controls were established by RNA interference technology. The cell migration, invasion, proliferation and cell apoptosis of MMP-16 in stable interfered Ec109 cell line was examined by cell counting, scratch test, Transwell test and lfow cytometry assays. The data were analyzed by t test. Results:MMP-16 protein was downregulated in cancerous group compared with the matched normal tissue and correlated with the clinical features of histological differentiation (P<0.05) and tumor stage (P<0.05). The levels of MMP-16 mRNA and protein in Ec109 were signiifcantly decreased by RNA intetrence (P<0.05). We demonstrated that MMP-16 silencing signiifcantly promoted cell invasion and migration (P<0.05), and inhibited cell apoptosis (P<0.05), while no significant effect was observed on cell proliferation (P>0.05). Conclusion: MMP-16 is downregulated in human ESCC tissues. The cell migration and invasion is promoted by interference of MMP-16 in Ec109, while the cell apoptosis is inhibited. MMP-16 may be considered as a target gene for therapy of ESCC.

Objective To describe the characteristics of the symptoms of hospitalized patients with liver cirrhosis and to provide guidelines for clinical symptom management,alleviating the symptom distress of patients.Methods By convenient sampling,125 patients with liver cirrhosis were recruited into this study.The Memorial Symptom Assessment Scale (MSAS) combined with self-designed entries were used to measure the characteristics of symptom experience in the subjects.Results Patients with liver cirrhosis experienced a number of symptoms including fatigue,abdominal distension,pain,drowsiness,loss of weight,loss of appetite,poor sleep,feeling sad,dry mouth,anxiety.The incidences of 19 symptoms were higher than 50％.Symptoms occurred frequently and constantly ranged from 0.8％ to 44.0％,the symptoms occurred with moderate to severe ranged from 1.6％ to 61.6％,and symptom distress was from 0 to 22.4％.The score of PSYCH subscale,PHYS subscale,and the Global Distress Index was (1.02±0.51),(1.03±0.36) and (1.13±0.41) respectively.The total score of MSAS was (0.80±0.29),self-designed entry was (1.00±0.55).Conclusions Hospitalized patients with liver cirrhosis suffer from an array of symptoms,common symptoms in patients with liver cirrhosis in hospital,the degree of symptom in frequency,severity and distress are differcnt.Patients' overall symptoms level is relatively low,but the degree of psychological dis-tress is higher.Medical staffs must strengthen the psychological nursing intervention for patients,using multi-dimensional instrument to do systematic assessment,making sure effective symptom management.

OBJECTIVE:To establish a method for simultaneous determination of rutin,quercetin and nuciferine in Heye gran-ule. METHODS:HPLC was performed on the column of Hypersil ODS2 with mobile phase of acetonitrile-water(containing 0.3%phosphoric acid and 0.4% triethylamine)(gradient elution)at a flow rate of 1.0 ml/min,the detection wavelength was 256 nm,the column temperature was 25 ℃,and the injection volume was 10 μl. RESULTS:The linear range was 0.012-0.240 μg for rutin(r=0.999 9),0.010 4-0.208 μg for quercetin(r=0.999 9)and 0.015-0.300 μg for nuciferine(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 98.5%-101.3%(RSD=1.1%,n=6),99.1%-101.6%(RSD=1.0%, n=6)and 98.9%-101.7%(RSD=1.2%,n=6). CONCLUSIONS:The method is simple,accurate and reliable,and can provide ref-erence for quality control of Heye granule.

ObjectiveTo investigate the effects and indication of intermittent catheterization(IC) by relative safe bladder capacity(RSBC) to treat vesical-ureteral reflux(VUR).MethodsThere were 23 male complete SCI patients, aged between 7～45 years, including 15 patients without vesicao-ureteral reflux injuried 1～3 months as control group, 3 patients in mild group affected only ureter, and 5 patients in severe group affected not only ureter but also the pelvis. All the patients were taken intermittent catheterrization according to their own RSBC companied with supersonic device. The times of IC per day is that the average total urine volume one day was divided by RSBC. The observation time is over 2 years. During the oberservation some medicine was used to enlarge some patients bladder capacity.ResultsThere were no reflux in the control group; the reflux in the mild group improved a lot, some even disappeared, and there were no change in the severe group.ConclusionIC by RSBC is effective to prevent and cure vesical-ureteral reflux in some SCI patients.