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

Objective To design and manufacture a hypobaric cabin simulator for experimental animals.Methods The simulator was composed of a fully transparent working chamber,an electrical chamber,a pressure control component and a program control component,which had its body made of polymethyl methacrylate plastics,the hatch made of metal plate and support by reinforced metal bar.The air inside chamber was exhausted by the diaphragm vacuum pump,the air inflow was controlled by proportional valve,and the inner pressure and the speed of rise and decline were exactly controlled by the balance of inflow and exhaust.Results The new type of hypobaric cabin simulator had the characteristics of accurate pressure control,low fluctuation range and controllable up and down time,low noise as well as adaptable air exchange rate.Conclusion The new type of hypobaric cabin simulator matches the national standard for experimental animals,and can be used in making the animal model of high altitude diseases.

OBJECTIVETo investigate the influence of three primers on the shear bond strength between cast titanium (Ti) and composite resin.

METHODSThe disks (n = 40) were cast by commercially pure (CP) Ti, which diameter were 8 mm and thick were 3 mm. The titanium surfaces were polished with silicon carbide sand papers under running water and then treated by sandblasting and acid (4%HF) etching. They were divided into four groups: control group (group A), treated with KH-570 (group B), treated with Alloy Primer (group C), treated with Metal photo primer (group D). After treatment, the specimens were evaluated for their shear bond strengths by universal testing machine. The values were statistically analyzed. The fractured surfaces were observed by scanning electron microscope (SEM).

RESULTSThe shear bond strengths of group A, B, C, D were (9.773 +/- 0.67), (11.463 +/- 0.82), (14.224 +/- 0.75), (13.157 +/- 0.73) MPa. There were significant differences in bond strength between A and B, C, D (P < 0.01). B and C, D had significant differences (P < 0.01). C and D had no significant differences (P>0.05).

CONCLUSIONKH-570, Alloy Primer, Metal photo primer significantly improve the bond strength of ceramage composite resin to cast titanium. KH-570 group bonding strength is lower than the the Alloy Primer group and Metal photo primer group.

Objective To investigate the relationships between occupational coping self-efficacy, job stress and core competence of nurses. Methods A total of 493 registered nurses were recruited in the survey with the Chinese nurse job stressors scale, occupational coping self-efficacy scale for nurses and competency inventory for registered nurse (CIRN). The correlations were analyzed using Pearson correlation analysis. Results The total scores on occupational coping self-efficacy, job stress of nurses and core competence of nurses were (31.94 ± 6.39), (90.29 ± 17.41) and (159.93 ± 34.31), respectively. Nurses′occupational coping self-efficacy negatively correlated with (r=-0.267, P<0.01) and positively correlated with the core competence of nurses (r=0.355, P<0.01). Conclusions The occupational coping self-efficacy of the nurses can be improved by successful experiencing, verbal persuasion and positive feedback. In this way, nurses core competence can be enhanced and their job stress can be relieved and consequently the quality of nursing can be enhanced.

Objective To analyze the incidence,risk factors,clinical characteristics and pregnant outcomes of perinatal pulmonary embolism(PPE).Methods Clinical data of eight patients who were admitted to Beijing Friendship Hospital of Capital Medical University for PPE from January 2006 to March 2016 were collected.General condition,symptoms,laboratory examinations,images,treatments and outcomes of these patients were analyzed retrospectively.Results The ten-year incidence of PPE was 0.029％ (8/27 560) in this hospital.Among the eight cases,two cases were diagnosed in the first trimester,and treated successfully by thrombolytic therapy.But one of two cases stopped growth,while the other one was premature labor.There were one case in the third trimester who had successful anticoagulant therapy and five cases in the postpartum period after cesarean delivery.Among the five cases,three cases were recovered after anticoagulant therapy,one case was recovered after thrombolytic therapy and one case died.All of the eight patients were immobilized before the onset of PPE,and five of them were diagnosed after cesarean section.Four out of the eight patients were obese.Five patients had three or more high-risk factors for pulmonary embolism and the other three had two.Conclusions It is necessary to pay close attention to gravidas who have two or more high-risk factors of PPE due to its fatal outcome.

Objective To investigate the clinical features of rheumatoid arthritis combined with femur head necrosis. Methods The clinical data of 22 patients with rheumatoid arthritis combined with femur head necrosi were retrospectively analyzed. Results Among the 22 patients with rheumatoid arthritis combined with femur head necrosi, male was in 5 cases, female was in 17 cases, age was 28-69 (56.3 ± 1.9) years, and the disease duration of rheumatoid arthritis was 4-30 (14.1 ± 1.2) years. All patients had ≥ 2 grade femur head necrosis, with bilateral femur head necrosis in 9 cases, right femur head necrosis in 9 cases and left femur head necrosis in 4 cases. Only 2 cases did not take glucocorticosteroid, and the other 20 cases used glucocorticosteroid in the long-term. The treatment was no standardized. The multiple fracture was found in 4 cases by X-ray examination (the patients had no history of trauma); 4 cases examined bone density, and the results showed they all were osteoporosis. Conclusions Rheumatoid arthritis combined with femur head necrosis is not uncommon. The majority of patients receive long-term glucocorticosteroid treatment. Treatment is not standardized, and some patients are combined with osteoporosis.

Objective To compare the perioperative outcomes and short-term efficacy of three-port extraperitoneal laparoscopic radical prostatectomy (ELRP) and four-port ELRP.Methods Two hundred patients who had undergone ELRP for prostate cancer by a single surgeon from November 2010 to October 2014 were retrospectively analyzed.Among them,95 cases underwent three-port ELRP and 105 cases underwent four-port ELRP.On the basis of traditional four-port ELRP,three-port ELRP was characterized by the omission of the trocar on the inner side of right anterior superior iliac spine.The mean age was 66.8 ± 15.5 years,and mean total prostate specific antigen (tPSA) was 15.3 ± 12.4 μg/L.There were no significant differences including age,body mass index,tPSA,clinical stages,acceptance of neoadjuvant hormone therapy,history of transurethral resection of the prostate,history of diabetes mellitus between the 2 groups (P ＞ 0.05).Patients in three-port ELRP group had significantly smaller prostate volume than fourport group (35.6 ± 16.7 ml versus 42.2 ± 24.7 ml,P ＜ 0.05).The clinical factors as operative time,estimated blood loss,hospital stay,drainage tube keeping days,pathological Gleason scores,pathological stages,positive surgical margin rates,biochemical recurrence rates and urinary incontinence rates were compared between the 2 groups.Results The three-port group had significantly shorter operative time than the four-port group (81.0 ± 18.6 min versus 103.6 ±34.6 min),less estimated blood loss (102.6 ±75.8 ml versus 217.5 ± 182.9 ml),less positive surgical margin rates (13.7％ versus 27.6％).There were 9 patients having Gleason scores more than 7 in the three-port ELRP group and 29 patients in four-port ELRP group (P ＜ 0.05).There were no significant differences of hospital stay,drainage tube keeping days,pathological stages between the 2 groups (P ＞ 0.05).Eighty-three cases in the three-port ELRP group (87.4％) were followed up for 5-19 months with the median time of 11 months.Ninety-two cases in fourport ELRP group (87.6％) were followed up for 17-52 months and the median time was 27 months.There were no significant differences of biochemical recurrence rates and urinary incontinence rates between the 2 groups(P ＞ 0.05).Conclusions Compared to four-port ELRP,three-port ELRP can provide shorter operative time,less blood loss,better negative surgical margin rates,similar oncological control and recovery of postoperative continence.In experienced hands,three-port ELRP could be a feasible and effective option for localized prostate cancer.

Objective To evaluate the learning curve of three-port extraperitoneal laparoscopic radical prostatectomy(ELRP) and to minimize operative time and blood loss about this procedure.Methods From August 2013 to October 2014,the data from 95 consecutive patients,who had undergone three-port ELRP for prostate cancer,were retrospectively analyzed.The mean age was 65.9 ± 7.7 years,mean total PSA level was 15.4 ± 12.7 μg/L,and mean body mass index(BMI) was 24.8 ± 3.2 kg/m2.According to the number of procedures performed by the surgeon,all patients were classified into three chronologic groups,including group A (No.1-32),group B (No.33-64) and group C (No.65-95).There were no significant differences including age,BMI,tPSA,estimated prostate volume,clinical stages,history of neoadjuvant endocrine therapy,history of transurethral resection of the prostate (TURP) among group A,B and C (P ＞ 0.05).The operative outcomes analyzed were operative time,estimated blood loss,hospital stay,drainage tube indwelling days,pathological Gleason scores,pathological stages,positive surgical margin rates,biochemical recurrence rates and urinary incontinence rates.Among these 95 patients,the results of the first 32 cases were compared with those of the remaining 63 cases,the first 64 with the remaining 31.Results The average operative time in 95 patients was 81.0 ± 18.6 min.The sloping learning curve for this surgeon showed that the operative time for all 95 cases was strongly correlated with additional experience (| rs | =0.612,P＜0.01).Operative time,however,was not strongly correlated with the surgeon's experience in each group of A,B and C(P ＞0.05).Group A had longer operative time than that of Group B plus C(96.4 ± 11.3 min vs 73.2 ± 16.7 min,P ＜0.01).Group A plus B had longer operative time than that of group C (87.6 ± 17.2 min vs 67.5 ± 13.8 min,P ＜ 0.01).For all cases,the estimated blood loss was strongly correlated with additional experience (| rs | =0.677,P ＜ 0.01).Estimated blood loss was strongly correlated with the accumulation of experience for the initial 32 cases(| rs | =0.619,P ＜ 0.01).However,no strong correlation was observed over the next 63 cases.Group A had more blood loss than that of Group B plus C (158.7 ± 81.3 ml vs 74.1 ± 54.4 ml,P ＜ 0.01).Group A plus B had more blood loss than that of group C (125.5 ± 71.6 ml vs 55.3 ± 61.6 ml,P ＜ 0.01).But hospital stay,drainage tube keeping days were not strongly correlated with additional experience in each group(P ＞ 0.05).There were no significant correlation between the accumulation of experience and positive surgical margin rates,biochemical recurrence rates and urinary incontinence rates.Conclusion Our experience of three-port ELRP cases appears to be favorable with decreasing tendency in operative time,estimated blood loss with experience accumulation.Exposure to 32 surgeries,operative time and estimated blood loss reduced significantly,and after 64 cases operative time and estimated blood loss further reduced.

Objective To evaluate the effect of finasteride on perioperative bleeding following transurethral plasmakinetic resection of prostate (PKRP).Methods A total of 118 patients with benign prostatic hyperplasia (BPH) undergoing PKRP were randomly divided into three groups:40cases received 5mg of finasteride daily for 7 days before surgery as 1 week group,38 cases received 5mg of finasteride daily for 3 months before surgery as 3 months group,the other 40 cases without taking finasteride before surgery as control group.A comparative study of clinical data was made among the three groups.Results The operation was successfully completed in 118 cases.As compared to control group,intraoperative irrigating fluid volume[(31.5 ± 5.6) L vs.(26.4 ± 6.2) L and (24.3±5.2)L],intraoperative blood loss[(173.5± 16.9) ml vs.(163.5± 15.8) ml and (156.4±16.2) ml],loss of 1 gram prostate tissue for resection[(8.6±4.8)ml/g vs.(7.4±5.4) ml/g and (6.6±5.6) ml/g]and operation time(72.5±16.2) min vs.(58.4±17.8) min and (56.7±16.5) min in 1 week and 3 months groups with taking finasteride were decreased (all P＜0.05).And there were differences in the above indexes (all P＜ 0.05) between 1 week group and 3 months groups.Conclusions The use of finasteride before PKRP is safe and reliable to reduce perioperative bleeding in BPH patients.Moreover,taking 5mg of finasteride for three months is of better effectiveness than taking 5mg of finasteride for 1 week.

Objective To evaluate the application value of virtual touch tissue quantification(VTQ) in the differential diagnosis of small breast lesions.Methods Fifty-six patients with sixty-nine small breast lesions whose largest diameter were less than or equal to 1 cm were evaluated with VTQ.The shear wave velocity (SWV) of the lesions and normal breast tissue were measured to analyze the diversity of different pathological types lesions of SWV and to find the optimal cut-off points using ROC curve to predict small breast cancer.Resuits The mean SWV(Vm) and the ratio (mean of lesions and normal tissue) of SWV (Vm1/Vm2) in benign group was (2.93 ± 1.32)m/s,1.79 ± 0.63,respectively,and that in malignant group was (5.65 ± 2.63) m/s,3.61 ± 1.35,respectively,there were statistically significant differences between benign group and malignant group (t test,P ＜0.05).The cut-off point of Vm was determined as 4.43 m/ s,the sensitivity,specificity and accuracy of diagnosing breast cancer were 80.5％,89.3％,92.8％,respectively.The cut-off point of Vm1/Vm2 was determined as 2.37,the sensitivity,specificity and accuracy of diagnosing breast cancer were 76.9％,81.2％,89.9％,respectively.Conclusions VTQ technique can provide helpful information in the differential diagnosis of small breast lesions.