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.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

Alloys ; adverse effects ; Cobalt ; adverse effects ; Dust ; Humans ; Occupational Exposure ; adverse effects ; Tungsten ; adverse effects

It is nonlinear relationship between breath sounds and respiratory flow rate, thus breath sounds might be a new solution for respiratory monitoring. The envelope of the breath sounds was created firstly. And the linear relationship between the logarithm of envelope and the respiratory flow rate was proved. Then model parameters were derived from every subject using regression analysis. Finally, using these parameters estimated respiratory flow rate was achieved by the logarithm of envelope with 14.9% error. Therefore, respiratory flow rate estimation and respiration monitoring based on breath sounds are feasible.
Humans ; Monitoring, Physiologic ; Respiratory Sounds

We present a rare case report of foreign body of the nasal apex in a 22-year man who were hospitalized because of a bit of metal rebounded. There was slight bleeding at wound site with a feeling of pain and swelling. On physical examination, the apex lied in the median position with a bleeding cut about 3 millimeter in length. There was no visible stump on the cut or rupture in the nasal vestibular. Computed tomographic scan showed the abnormal high-density shadow in the nasal apex while the foreign body was located in the subcutaneous tissue of the antero-upper part of septal cartilage. The admitting diagnosis was foreign body in nasal apex. Endoscopic surgery was adopted to remove the foreign body.
Endoscopy ; Foreign Bodies ; surgery ; Humans ; Male ; Metals ; Nasal Cartilages ; pathology ; Nasal Cavity ; surgery ; Pain ; Subcutaneous Tissue ; pathology ; Young Adult

OBJECTIVE: To summarize the clinical characteristics and treatments of patients with malignant transformation of sinonasal inverted papilloma (SNIP), and to explore the factors influencing the prognosis of malignant SNIP. METHOD: To retrospectively analyze the clinical data of 35 patients with malignant SNIP. The prognosis affected by age, gender, pathogenetic locations, pathology, clinical stages and treatments were analysed using Kaplan Meier, Log rank and Cox method. RESULT: In our research, 5 years survival rate was 68.6% in malignant SNIP. There were 3 factors effecting the 5 years survival rate of malignant SNIP: clinical staging, histopathological features and treatments while gender, age, disease location, and percentage of the malignant cell in the entire tumor tissue had no effect on overall survival rate. Clinical staging and treatment were the independent factors that influenced the prognosis of malignant SNIP (P value was 0.019 and 0.006). CONCLUSION Risk factors that independently influence the survival of patients with malignant SNIP were the clinical staging and treatment. The degree of histo pathological features can be the secondary indicator to judge the prognosis of malignant SNIP. Endoscopic surgery or comprehensive therapy performed on patients properly is therapeutically effective.
Cell Transformation, Neoplastic ; Endoscopy ; Humans ; Nose Neoplasms ; diagnosis ; pathology ; Papilloma, Inverted ; diagnosis ; pathology ; Prognosis ; Retrospective Studies ; Survival Rate

Objective To study the effects of MACC1 down-regulation on the growth of gastric adenocarcinoma cells. Methods siRNA (MACC1-siRNA1 and MACC1-siRNA2) that can transiently silenced MACC1 was designed, syn?thesized and transfected into MGC-803 cells by lipofectamine 2000. Non-specific siRNA was transfected to be used as nega?tive control. The efficiency of MACC1 depletion was determined by Real-time quantitative PCR. MTT, colony formation and flow cytometry assay were performed to examine cell proliferation. The expressions of MACC1, P21,CDK4, CCND1 and c-myc were determined by Western blot. Results Compared with cells in negative control group, transiently silencing MACC1 decreased the expression of MACC1 in MGC-803 cells shown by Real-time PCR. MACC1 downregulation drastical?ly changed the proliferation, colony formation and cell cycle of gastric adenocarcinoma cells in vitro ( P<0.05). The expres?sions of MACC1 , CDK4, CCND1 and c-myc proteins in cells of MACC1 silence group were much lower while P21 expres?sion level was much higher than those in negative control. Conclusion Down-regulation of MACC1 result in blocking cell cycle, inhibiting proliferation of MGC-803 cells. So it may serve as a promising target in the treatment of gastric cancer.

Objective:To evaluate the human pulp response following direct pulp capping with Clearfil SE BOND (SB). Methods:45 sound human third molars in 24 volunteers were used. Pulp of 41 molars was mechanically exposed and then the teeth were divided into two groups: in group A the pulp was capped with SB, in group B the pulp was capped with calcium hydroxide (CH), another 4 teeth were served as the control. After 7, 30 and 90 days, the teeth were extracted and processed for light microscopic examination. Results:7-30 days after capping slight inflammatory reaction was observed in group A and group B. The reaction in group A was sligter than that in group B(P

[ABSTRACT]OBJECTIVETo investigate malignant transformation of sinonasal inverted papilloma(SNIP) treated by endoscopic or endoscope assisted surgery, in order to analyze its probable prognostic factors and the optimized method.METHODSThe clinical data of 27 cases with malignant transformation of SNIP treated by endoscopic or endoscope assisted surgery from September 2001 to September 2010 were reviewed. According to preoperative imaging examination and UICC staging criteria, 3 cases were T1, 8 cases were T2, 12 cases were T3 and 4 cases were T4. 16 of them received radiotherapy after endoscopic surgery while the other 11 received surgery alone. RESULTSAll cases were confirmed as squamous cell carcinoma pathologically after surgery. The 5-year overall survival rate was 77.8% for all the patients. The 5-year survival rate was 75.0% for surgery alone group, of which 5 cases recurred locally after operation. The 5-year survival rate was 81.8% for surgery combined with radiotherapy group, of which 5 cases recurred locally and 2 cases died from intracranial metastasis.CONCLUSIONEndoscopic or endoscope assisted surgery can be used in the management of malignant transformation of SNIP to improve the quality of life, with the preponderances of desired effect and less complication. Application of radiotherapy after surgery could improve long-term survival rate of the patients.

Objective To investigate the clinical characteristics of peptic ulcer in young and middle-aged patients and old-aged patients,and to improve the awareness of clinicians.Methods A retrospective analysis was performed in 351 cases (old-aged group) and 351 cases (young and middle-aged group) of peptic ulcer in our hospital from Jan,2012 to Jan,2013.The clinical data were compared between the two groups,including clinical symptoms,complications,ulcer site,size,concomitant diseases,treatment and outcome.Results (1) Clinical symptoms:the symptoms were not typical in old-aged group compared to young and middle-aged group (80.3％ vs 73％),complications as the initial symptom was more common (46.7％ vs 29.6％,P＜0.001),typical upper abdominal pain were lower than those in the young and middle-aged group (19.7％ vs 37％,P＜0.001);(2) Common complications:old-aged patients with complications was significantly higher than in the young and middle-aged group (46.7％ vs 29.6％,P＜0.05),in which bleeding,perforation and obstruction were common;(3) Ulcer site:gastric ulcer,elevation ulcer werw more common in old-aged patients than young and middle-aged patients (P＜0.05);(4) Ulcer size:giant ulcer (more than 2.0 cm) was more common in old-aged patients than young and middle-aged patients (15.1％ vs 4.3％,P＜0.05);but there was no difference in the infection rate of Helicobacter pylori (HP) between them (90.3％ vs 90.9％,P＞0.05);(5) Concomitant diseases:the incidence of concomitant diseases was higher in old-aged patients,including diabetes,cardiovascular disease,gallstones,cholecystitis,gout (47％ vs 15.7％,P＜0.05);(6) Treatment and outcome:the mortality of old-aged patients with complications was significantly higher than those in the young and middle-aged group (14％ vs 3.8％,P＜0.05).Conclusion The clinical manifestations of peptic ulcer in old-aged patients are atypical,with characteristics of high morbidity,high incidence of complications,high mortality.Early diagnosis and treatment is essential to improve the prognosis and reduce mortality.

Objectives To understand the vaccination situation of left-behind children in rural areas,provide the evidence for developing vaccination strategies for left-behind children.Methods The counties with population over 1,000,000 were selected from Anhui and Sichuan provinces respectively to conduct survery to the children who were born between the year 2003 and 2006,and had registration on vaccination book(card).Results The proportion of left-behind and outflow children are 17.94% and 6.05% respectively.The information about the children’s parents going out most came from village doctors. The proportion of the parents going out after children born was 51.60%,staying outside for more than 10 months was 78.50%. 67.97% pareets came back home during the spring festival,35.43% left-behind children went out with their parents.Conclusion Although the number of outflow children was smaller than the left-behind children,it was easy to develop immunization gap. It is the difficult part of management on EPI to migraut children. The information aboat the children’s parents going out mostly came from village doctors. It is impotant to mobilize the enthusiasm of doctors.It is especially essential that we should propagandize to the people with vaccination knowledge to the pareets came back home during spring festival.