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

The tumor metastasis is the major cause of the death of cancer patients.S-100A4 is a member of the S100 family of calcium-binding proteins and has been categorized as a metastasis-associated protein.S-100A4 is a candidate as a molecular marker for metastatic potential with high prognostic significance.An increase in S-100A4 protein expression has been correlated with poor prognosis of patients with breast,colorectal,gallbladder,bladder,esophageal,nonsmall-cell lung,gastric,medulloblastoma,pancreatic and hepatocellular cancers.The overexpression of S-100A4 protein can induce the increase of invasion and mobility of the tumor cells.It has been considered that S-100A4 is secreted by the tumor and stroma cells as a regulator of tumor metastasis.S-100A4 can regulate the progress of cell cycle,change cell adhesion,cell mobility and increase the survival ability of the tumor cells.

Objective To establish the quality standard for Zhitong Huazheng Dispersed Tablets.Methods Rhizoma corydalis,Radix astragali,Fructus toosendan in Zhitong Huazheng Dispersed Tablets were identified by TLC.The content of Danshensu was determined by HPLC.Results The spots on the TLC could be well separated and the method had strong specificity.The method for determinating the content of Dispersed tablets by HPLC was suitable for the quality standard with sufficient accuracy,stability and reappearance.The average recovery of Danshensu was 99.61%,RSD=1.60%(n =9).Conclusion The qualitative and quantitative analytic methods are stable and reliable.It can be used for quality control of Zhitong Huazheng Dispersed Tablets.

Objective To evaluate evidence-based practice of catheter removal strategy in patients with short-term indwelling catheter after partial nephrectomy. Try to apply the best evidence into practice, and further to improvethe quality of clinical nursing through quality review. Methods Two rounds of quality review were carried out in the 2 wards from July to December in 2016. Using the 5 review criteria of best evidence, we reviewed baseline of catheter removal strategies for patients with short-term indwelling catheter after partial nephrectomy and developed appropriate evidence-based practice. Further, the best evidence was integrated into clinical nursing practice, and the prognosis was reviewed after then. Results In the baseline review, the compliance of the 5 review criteria was 0. However, after introducing the best evidence into nursing practice,the compliance was up to 100%. The mastering of evaluation knowledge of catheter removal of nurses increased from 73.00 ± 9.35 to 94.81 ± 3.38 with significant difference (t=12.72, P<0.01). The indwelling time of catheter shorted from (5.69±0.79) d to(4.24±0.82) d. The difference was significant (t=5.47, P<0.01). Conclusions Evidence-based nursing practice improvesthe strategies of short-term catheter removal after partialnephrectomy, while closer cooperation between nurses and doctors are still needed to promote the continuous improvement of nursing quality.

Adenocarcinoma, Mucinous ; pathology ; Breast Neoplasms ; pathology ; Carcinoma, Ductal, Breast ; pathology ; Carcinoma, Renal Cell ; pathology ; Carcinoma, Squamous Cell ; pathology ; Cystadenocarcinoma, Mucinous ; pathology ; Cystadenoma, Mucinous ; pathology ; Female ; Giant Cells ; pathology ; Humans ; Osteoclasts ; pathology ; Ovarian Neoplasms ; pathology ; Pancreatic Neoplasms ; pathology ; Thyroid Carcinoma, Anaplastic ; Thyroid Neoplasms ; pathology ; Tongue Neoplasms ; pathology ; Urologic Neoplasms ; pathology

Objective To explore the clinical effect of periarticular knee fractures combined with anterolateral ligament (ALL) avulsion fracture.Methods From June 2014 to November 2015,13 patients with ALL avulsion fracture in periarticular knee fractures were fixed by the star plate,cannulated or screws suture anchor,including 9 male and 3 female with the mean age of 39.5 years (range from 28 to 51 years).6 patients were diagnosed distal femoral fracture,4 tibial plateau fracture,and 3 tibial intercondylar eminence avulsion fracture which all combined with ALL avulsion fracture.Postoperatively,all patients were treated with the adjustable knee brace for 3 months.Results All patients were followed up for 4-20 months,the mean follow-up time was 13.5 months.The average surgical time was 130 min (range from 90 to 210 min).In all 13 patients,ALL was found and identified.Bone union was obtained in all patients,and the bone union time was 11.4 weeks (10-12 weeks).7 cases were fixed with star plate,5 cases were fixed with hollow screw,and 1 case was fixed with anchor.All follow-up patients underwent anteroposterior and lateral X-rays.Pain,swelling and functional recovery of the knee joint were observed.Patients were assessed postoperatively with International Knee Documentation Committee (IKDC) score,Lysholm score,and Tegner activity scale to evaluate the clinical effect.At the last follow-up,all patients had full range of motion of the knee joint which from 0° to approximate 120°.The Lysholm,objective IKDC were 86.5 and 84.6 respectively.Among the 13 patients evaluated,9 patients were graded A,and 4 patients were graded B by subjective IKDC.The Tegner activity scale at the last follow-up was 6.7.Incision of poor healing in 1 case,and got healed after 32 d cleaning dressing.Conclusion This study confirmed the presence of the ALL.The fixation of ALL avulsion fracture in periarticular knee fractures can be an effective procedure at a minimum follow-up of 13.5 months.

Objective: To investigate the clinical features of patients with hyperextension bicondylar tibial plateau fractures (HEBTPs), and assess surgical effectiveness of HEBTP and non-HEBTP fracture patients. Methods: From June 2014 to May 2017, 82 patients with bicondylar tibial plateau fracture were included in this study. There were 63 patients with 63 knees (76.8%) that had sustained non-HEBTPs, and 19 patients with 19 knees (23.2%) that had HEBTPs, including 49 males and 33 females with a mean age of 48.3 years (range, 22-76). Of the 19 HEBTPs patients, 4 cases were hyperextension valgus injury, 9 cases were hyperextension varus injury, and 6 cases were pure hyperextension injury. All patients were treated with open reduction internal fixation combined with bone grafting or non-bone grafting. All follow-up patients were evaluated clinically and radiographically, included the incidence of associated injuries, infection, posttraumatic osteoarthritis, range of motion (ROM) of knee, numeric rating scale (NRS) for assessment of pain, and Short Musculoskeletal Functional Assessment (SMFA) scores for assessment of knee function. The fracture healing and postoperative alignment were assessed with anteroposterior and lateral X-rays. Results: All patients were followed up for 12-22 months, the mean follow-up time was 15.4 months. Bone union was obtained in all patients, and the bone union time was 12.6 weeks (ranged: 12-16 weeks). At the last follow up, all patients had full range of motion. The incidence of significant associated injuries was 36.8% in the HEVBTP group compared with 15.8% in the non-HEBTP group. The incidence of popliteal artery injury, common peroneal nerve injury and ligament injury that needed repair in 19 HEBTPs patients was 21.1%, 26.3% and 31.6%, respectively, while the corresponding incidence of complications in 63 non-HEBTPs patients was 3.2%, 4.8%, and 9.5%, respectively. The NRS pain score of HEBTPs and non-HEBTPs at 12 months after surgery was 3.89±1.9 and 2.76±1.88, respectively. The value of HEBTPs patients was higher than that of non-HEBTPs patients, But the difference was not statistically significant. The SMFA scores of HEBTPs and non-HEBTPs patients at 12 months after surgery were 27.27±19.44 and 17.09±15.87, respectively. Patients with HEBTP had higher functional (SMFA) scores and a trend of higher pain scores than those with non-HEBTP, indicating associated soft-tissue damage and developed posttraumatic osteoarthritis. Conclusion The present showed that the HEBTP is a unique fracture. These injuries result in worse functional outcomes than non-HEBTP. Physicians must recognize the possible associated injuries (included ligaments, vessels and nerves), and the treatment effect of HEBTP is relatively poor.

AIM: To investigate the effect of problem - based learning ( PBL) used in the teaching of medical students'evidence-based medicine ( EBM) .
METHODS: Five classes ( total 147 students ) were randomly selected as experimental ( PBL ) group, at the same time, another 5 classes ( total 149 students ) were also randomly selected as control group, using traditional teaching method ( lecture-based learning, LBL ) in 2010 grade. The final examination scores of the experimental group were compared with control at the end of term. In addition, all students were interviewed using self -administered questionnaire to obtain their evaluation for PBL practice. SPSS13. 0 software was used for statistical analysis.
RESULTS: The homogeneity test in baseline survey showed that the basic characteristics between the two groups of students were no significant differences, and were comparable (P>0. 05). Final exam results showed that in addition to the scores of the EBM basic knowledge indicated no significant difference between two groups of students (P>0. 05), for the 5 steps of EBM procedure, namely, asking questions, finding the best evidence, evaluating the evidence, using and practicing the evidence, re - evaluating the evidence, and the total scores between the two groups, there were significant statistically differences (P<0. 05). The results to student learning evaluation showed that there was no significant difference between the two groups (P>0. 05) in aspects of better understanding classroom knowledge, improving language expression ability, and writing skill exercises. And other residual items had a significant difference ( P<0. 05), especially in aspects of improving enthusiasm for learning, self - study ability, improving learning efficiency, information analysis and utilization ability, team collaboration, and communication between teachers and students, however, there was a very significant difference (P<0. 001) between the two groups.
CONCLUSION: PBL teaching mode can effectively improve teaching effectiveness and the quality of EBM teaching, so the this teaching mode is worth further popularizing.

Diagnosis, Differential ; Humans ; Neoplasms, Glandular and Epithelial ; diagnosis ; Thymus Neoplasms ; diagnosis

Objective To probe the changes of hormones in the model of splennic asthenia complicating gastric ulcer, and reveal the relation between thyroid gland and splennic asthenia gastric ulcer. Methods Building model of splennic asthenia complicating gastric ulcer in rats, treatment them in plus sijunzi decoction ,selecting rats with typical gastric ulcer four days after and rats with the ulcer healing basically fourteen days after building models, then the rats were divided into four groups, the model group, the treatment group, spontaneous recovery group and the control group. With immunohistochemical stain , the OD values of enzymes were analyzed with image analysis, and were analyzed statistically. Results Compare with control gronp ,4 model and 14 modelIn rats the thyrocalcitonin secretion of thyroid parafollicular decreased, Compared with 14 day control indexes in the treatment group recovered, but in the spontaneous recovery group all indexes didn’t change obviously. Conclusions In the model of splennic asthenia complicating gastric ulcer, some injury can occur on thyroid gland ,and this also promote gastric ulcer development. plus sijunzi decoction has some treating action.