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 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 study the relationship between macular pigment optical density (MPOD) and serum concentration of lutein and zeaxanthin in an adult population.Methods Twenty patients with mild cataract and 39 healthy subjects were enrolled in this study,including 15 males and 44 females.The average age was 43.75 years.Fifty-three subjects were non-smokers and 6 male subjects were smokers.Two subjects preferred meat diet,22 preferred meat-less diet,and 35 have balanced diet.MPOD was measured using heterochromatic flicker photometry at 0.25,0.5,1.0 and 1.75 degrees,and serum concentration of lutein and zeaxanthin was measured using high-performance liquid chromatography.The relationship between MPOD and serum concentration of lutein and zeaxanthin was analyzed.The differences of serum lutein and zeaxanthin between different gender,smokers and non-smokers and subjects with different dietary pattern were also analyzed.Results MPOD at 0.25,0.5,1.0 and 1.75 degrees were 0.59,0.48,0.34 and 0.18,and the average concentration of lutein and zeaxanthin were (0.45± 0.16) μmol/L and (0.11 ± 0.04) μmol/L respectively.Serum concentration of lutein and zeaxanthin in males were slightly higher than that in females,but it was not statistically significant (t=1.13,0.86;P=0.27,0.40).The differences of serum lutien and zeaxanthin between smokers and non-smokers (t=0.15,-0.11;P=0.87,0.91),among subjects of 3 dietary patterns groups were not statistically significant (Flutein=3.87,4.05,0.18;P=0.83,0.81,0.99.Fxeaxanbin=0.99,1.51,0.52;P=0.85,0.68,0.72).There was no correlation between MPOD and serum concentration of lutein (r=-0.06,-0.02,-0.07,0.03;P＞0.05) and zeaxanthin(r=0.02,0.12,0.09,0.11;P＞0.05).Conclusion MPOD was not statistically significantly correlated with serum concentration of lutein and zeaxanthin in the studied population.

Objective:To study the abnormal suppressive capacity of regulatory T cells ( Tregs) to effector cells,Th17 cells and Th9 cells in patients with mild to moderate asthma attack.Methods: Recruited asthmatic patients (n=30) and healthy control (n=30),collected peripheral venous blood from healthy control and asthmatic patients in mild to moderate attack stage respectively,and then isolated CD4+CD25+CD127-/low Tregs and CD4+CD25-T effect cells with immunomagnetic beads method ( purity was above 90%).The effect cells were cultured with PHA stimulation with or without Tregs.Measured the proliferation (3H-Thymidine), expression of RORC and PU.1 ( RT-PCR) genes,production of IL-17 and IL-9 ( LUMNEX) in effect cells with or without Tregs inter-vention.Analyzed the abnormality of Th17 and Th9 cells and the supressive capacity of Tregs on Th17 and Th9 cells in patients with asthma attack,comparing with control group.Results:Tregs of asthmatic patients could suppress the proliferation of effector cells,but less effectively than healthy control (P=0.03).In asthmatic patients,RORC expression and IL-17 production increased (P<0.05), and the suppressive capacity of Tregs to RORC expression decreased, when compared with healthy group ( P<0.05 ) .In asthmatic patients,IL-9 production of effector cells increased significantly (P<0.05),but PU.1 expression was higher than healthy group only with intervention of Tregs ( P=0.04 ) .And the suppressive capacity of Tregs to the expression of PU.1 and production of IL-9 in patients with asthma attack did not decrease (P>0.05).Conclusion:The suppressive capacity and amount of Tregs decreased,but the specific gene expression and cytokines production of Th17 cells and Th9 cells were upregulated in patients with mild to moderate asthma attack.This deficiency for the suppressive capacity of Tregs to Th17 but not Th9 cells may indicate some pathogenesis of asthma devel-opment.

Objective To compare the perioperative outcomes and postoperative complications of retroperitoneal laparoscopic partial nephrectomy ( RLPN) for the treatment of endophytic renal tumors and non-endophytic tumors.Methods Three hundred and ninety-two patients who underwent RLPN for kidney neoplasms from May 2005 to September 2012 were retrospectively analyzed . They were divided into endophytic renal tumor group ( 48 cases ) and non-endophytic tumor group ( 344 cases ) .There were no significant differences in the aspects of gender , age, body mass index, tumor side, diameter, preoperative estimated glomerular filtration rate (eGFR) between the two groups.Operative time, warm ischemia time, method of renal vascular occlusion , repair rate of renal collecting system , estimated blood loss , usage of laparoscopic ultrasonography , intraoperative complications , pathological types , postoperative hospitalization days, postoperative complications and postoperative eGFR were collected and analyzed .Results Patients with endophytic tumors had significantly more usage of laparoscopic ultrasonography (95.8%versus 1.2%, P<0.001) and higher repair rate of renal collecting system (35.4%versus 6.1%, P<0.001).Clamping segmental renal artery and without clamping renal vessels were not used in dealing with renal vessels of endophytic tumors (P<0.05).There were no significant differences of operative time , warm ischemia time, estimated blood loss , intraoperative complications , pathological types , postoperative hospitalization and postoperative eGFR (P>0.05) between the 2 groups.All the patients′surgical margins were negative.The rates of postoperative complication ( Clavien gradeⅠtoⅢb) were 4.2%and 2.9%in the endophytic group and non-endophytic group , respectively ( P >0.05 ) . Median follow-up was 42 ( 33 -108 ) months in endophytic group and 45 (33 -120) months in non-endophytic group.No local recurrence or metastasis occurred in the two groups .Conclusions In experienced hands , RLPN could represent a feasible , safe and effective treatment for selected patients diagnosed with endophytic renal tumors .Laparoscopic ultrasonography is valuable on locating the tumor and defining tumor margins in RLPN of endophytic renal tumors .

Clinical study of modified Ganmai Dazao decoction in the treatment of yang deficiency climacteric depression and observe the effects of modified Ganmai Dazao decoction on neuroendocrine system in patients with yang deficiency climacteric depression. 86 cases were randomly divided into treatment group treated with modified Ganmai Dazao decoction and control group treated with Deanxit. The curative effect was evaluated with Hamilton's depressive scale (HAMD) and pittsburgh sleep quality scale (PSQI) before and at the end of the two and four weeks of the treatment, the serum levels of serotonin (5-HT), norepinephrine (NE), estradiol (E2), follicle stimulating hormone (FSH), luteotropic hormone (LH) were detected before and after the four weeks of the treatment The results showed that the total effective power of treatment group was 88.4% and the total effective power of control group was 81.4% after four weeks interference, with insignificant difference between the two groups. After two and four weeks of the treatment, the score of HAMD decreased remarkably in both groups (P < 0.01), with insignificant difference between the two groups in same phase. After two and four weeks of the treatment, the total score of PSQI decreased remarkably in both groups (P < 0.05), with significant difference between the two groups after four weeks (P < 0.01). After four weeks of treatment, the serum levels of 5-HT and NE increased (P < 0.01), with insignificant difference between the groups. After four weeks of treatment, the serum levels of E2 increased obviously (P < 0.05), the levels of FSH decreased obviously (P < 0.05), the levels of LH decreased insignificant, with insignificant difference between two groups. This study indicates that modified Ganmai Dazao decoction has obvious therapeutic effects in the treatment of climacteric depression, and showed equivalent efficacy with Deanxit, and modified Ganmai Dazao decoction has better effect on improving the sleep quality in patients than Deanxit, the effect of improved clinical symptoms may be through adjusted levels of 5-HT, NE, E2, FSH and LH of climacteric depression.
Adult ; Depression ; blood ; drug therapy ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Follicle Stimulating Hormone ; blood ; Humans ; Menopause ; drug effects ; psychology ; Middle Aged ; Neurosecretory Systems ; drug effects ; metabolism ; Norepinephrine ; blood ; Phytotherapy ; Serotonin ; blood

Objective To analyze the autoimmune status of kidney in transgenic mice with high serum titer of anti-keratin autoantibody(AK auto Ab).Methods AK auto-Ab transgenie mice were set-up with conventional procedures,and the mice older than 20 weeks were selected for study.Urinary protein was quan- tified by Bradford method,and SDS-PAGE electrophoresis was used to analyze the type of proteinuria.Speci- mens of kidney were subjected to HE and PAS stain and immunofluorescence analysis and electrum microscopy observation were also performed.Results Compared with littcrmates,transgenie mice showed higher urinary proteins level(P

Objective To evaluate the knowledge, behavior and psychological status regarding COVID-19 epidemic in elementary and secondary school teachers, and to provide a reference for disease prevention and control at schools as well as for preparation of school returning. Methods A survey in 2 338 teachers was conducted using self-designed questionnaires about COVID-19. Results The overall awareness rate of COVID-19 knowledge was 88.79%, knowledge score was 10.65±1.09, and the school health teachers had higher score than other school staff (F＝23.87, P=0.000 1).Respondents with IP address in Hubei had higher score than those in Jiangsu, Zhejiang and Shanghai(F＝10.69, P=0.014).The top three knowledge resources were news apps (Toutiao, Tencent) (87.25%), WeChat (78.06%) and telecast (74.94%).The overall healthy behavior score was 43.59±3.12, and school doctors again had higher score than other school staff (F=11.48, P=0.02).Respondents with IP address in Hubei had higher score than those in Jiangsu, Zhejiang and Shanghai (F=17.08, P=0.000 7). During the epidemic, 100% respondents wore masks when taking public transportation, the highest rate of wearing masks, while 90.93% wore masks at family and friends gathering, the lowest rate of wearing masks.The top three types of masks being used were disposable medical masks (89.14%), surgical masks (43.63%) and N95 medical protective masks (34.09%).The highest rate of hand washing behavior was 99.83% for washing hands after going to toilet, while the lowest was 75.92% for washing hands after touching hair, ears and nose.The highest rate of other healthy behaviors was 94.14% for reducing family and friend gatherings, while the lowest was 71.60% for covering mouth and nose when sneezing or coughing. The correlation between health behavior and knowledge was statistically significant (r=0.081, P < 0.001).Correlation analysis showed that the degree of concern was related to the degree of teaching influence (r=0.768, P=0.0002), and the degree of anxiety was related to the degree of teaching influence (r=0.175, P < 0.001), while there was no correlation between the degree of concern and the degree of anxiety. Conclusion Elementary and secondary school teachers generally have high score in the COVID-19 knowledge test, and behaved well in wearing masks.Hand hygiene education should be further improved.There are concerns about the impact of COVID-19 epidemic on teaching.

Objective:To observe the effect of Governor Vessel-unblocking and mind-refreshing acupuncture plus functional training on neural development in infants with brain damage and seek an effective method for early intervention of infantile brain damage.Methods:Eighty infants with brain injury were recruited and allocated to a treatment group and a control group by their visiting sequence,with 40 cases in each group.The control group received exercise training,40 min each session and 6 sessions a week,and tuina treatment,30 min each time and 6 times a week.Based on the treatment protocol for the control group,the treatment group additionally received Governor Vessel-unblocking and mind-refreshing acupuncture,3 times a week and 10 sessions as a course at a 2-week interval.Before the treatment and after 14-week treatment,the gross motor function measure (GMFM) and developmental quotient (DQ) of Bejing Gesell developmental scale were used to evaluate the development of the infants.Results:After the treatment,the GMFM score and DQs of Gesell scale all increased by different levels in the two groups,and the intra-group differences were statistically significant (all P＜0.05);the scores of the treatment group were superior to those of the control group,and the between-group differences were statistically significant (all P＜0.05).Conclusion:Governor Vessel-unblocking and mind-refreshing acupuncture plus functional training can significantly promote the development of gross motor and cognitive functions in infants with brain damage,and it is an early and effective intervention for infantile brain damage.